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1 WHO compendium of innovative health technologies for low-resource settings Assistive devices ehealth solutions Medical devices Other technologies Technologies for outbreaks
2 WHO Library Cataloguing-in-Publication Data WHO Compendium of Innovative Health Technologies for Low Resource settings, Assistive devices, ehealth solutions, Medical devices, Other technologies, Technologies for outbreaks. I.World Health Organization. ISBN Subject headings are available from WHO institutional repository World Health Organization 2015 All rights reserved. Publications of the World Health Organization are available on the WHO web site (www. who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: ; fax: ; Requests for permission to reproduce or translate WHO publications whether for sale or for non-commercial distribution should be addressed to WHO Press through the WHO website ( copyright_form/en/index.html). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Graphic design and layout by Mrs Jillian Reichenbach Ott, Genève Design. Printed by the WHO Document Production Services, Geneva, Switzerland
3 WHO compendium of innovative health technologies for low-resource settings Assistive devices ehealth solutions Medical devices Other technologies Technologies for outbreaks
4 Acknowledgements The call, evaluation, and compilation of submissions for the Compendium were managed by the World Health Organization (WHO) Medical Devices team, Policy Access and Use unit of the Essential Medicines and Health Products department under the coordination of Ms Adriana Velazquez Berumen and supervision of Dr Gilles Bernard Forte and Mr Cornelis de Joncheere. Field experts evaluated submitted technologies without external financial compensation. We thank each and every applicant and reviewer who dedicated countless hours to the publication in order to help identify potential health technology solutions For the evaluation of medical device, assistive device, ehealth solution, in vitro diagnostic and Ebola relief technology submissions we thank: Dr Meena Cherian, Dr Sergey Eremin, Mr Michael George Kay, Mr Chapal Khasnabis, Professor Francis Moussy, Mr Andrea Pupulin, Ms Anita Sands, Dr Rosa Vallenas and Ms Diana Zandi from WHO headquarters, Geneva, Switzerland Mr Ken Steffen Frahm, Dr Sabata Gervasio, Mr Ernest Nlandu Kamavuako, Mr Dan Stieper Karbing, Dr Thomas Nørgaard Nielsen and Mr Andrew JT Stevenson from Aalborg University, Denmark Dr Roberta Joppi, Italian Horizon Scanning Project, Pharmaceutical Department of the Local Health Unit, Verona, Italy iv Dr Brendon Kearney, Health Policy Advisory Committee on Technology (HealthPACT), Australia Dr Setefilla Luengo Matos, Agencia de Evaluacion de Tecnologias Sanitarias (AETS), Madrid, Spain Dr Hubert Messner and Dr Grazia Molinaro, Neonatal Intensive Care Unit, Regional Hospital, Bolzano, Italy Mr Maurice Page, HUMATEM, France Dr Ute Pieper, Independent Environmental Health Expert Dr Manlio Prosperi, Niguarda Ca Granda Hospital, Milan, Italy Thanks to the medical devices staff: Dr Yukiko Nakatani and Ms Adriana Velazquez, and short term consultants: Mr Antonio Migliore, Dr Miriam N. Mikhail, Ms Gabriela Jimenez Moyao, Mr Didier Mukama and Ms Daniela Rodriguez, as well as the following interns: Marina Alfons, Ileana Freige, Ying Ling Lin, Samantha Straitz and Dr Grace Wu. Special thanks to intern Megan M. Smith for organizing the documents for final review, extracting information from submissions and completing data sheets to compile content for publication The coordination of the Compendium project and the evaluation of the submissions were managed by the Medical Devices team, Policy, Access and Use unit of the Essential Medicines and Health Products department under the direction of Adriana Velazquez-Berumen, coordinator, and Jennifer Barragan, technical officer, the Disability and Rehabilitation team of the Violence and Injury Prevention and Disability department under the direction of Chapal Khasnabis, and the ehealth unit of the Knowledge Management and Sharing department under the direction of Diana Zandi and Misha Kay. For the evaluation of submitted medical devices, assistive devices and ehealth solutions we thank: Aurora Llanos Méndez from Agencia de Evaluación de Technologías Sanitarias de Andalucía (AETSA), Seville, Spain; Antonio Migliore and Maria Rosaria Perrini from the Agenzia Nazionale per i servizi sanitari regionali (Agenas), Rome, Italy; Gaizka Benguria-Arrate, Iñaki Gutiérrez-Ibarluzea, and Nora Ibargoyen-Roteta, from the Basque Office for Health Technology Assessment (Osteba), Vitoria-Gasteiz, Spain; Debra Kriger and Andra Morrison from the Canadian Agency for Drugs and Technologies in Health (CADTH);
5 Alexandre Barna, Martin Blachier, Emmanuel Charpentier, Bjorn Fahlgren, and Marc Vanicatte from the Committee for Evaluation and Diffusion of Innovative Technologies (CEDIT), Paris, France; Kees Groeneveld and Cees A. Postema from the Health Council of the Netherlands (GR), The Hague, The Netherlands; Brendon Kearney and Linda Mundy from the Health Policy Advisory Committee on Technology (HPACT), Queensland, Australia; Setefilla Luengo-Matos from the Agencia de Evaluacion de Tecnologias Sanitarias (AETS) Institute of Health Carlos III, Madrid, Spain; Orna Tal from the Israeli Center for Emerging Technologies (ICET), Israel; Roberta Joppi and Chiara Poggiani from the Italian Horizon Scanning Project (IHSP); Kristina Routh, Biruntha Senthinathan, and Sue Simpson from the National Institute for Health Research Horizon Scanning Centre (NIHR HSC), University of Birmingham, United Kingdom; Marianne Klemp and Inger Natvig Norderhaug from the Norwegian Knowledge Centre for the Health Services (NOKC), Oslo, Norway; Dr Johan Borg from Lund University, Sweden; Kevin Clausen from the Nova Southeastern University, USA; Antoine Geissbuhler from the University Hospital Geneva, Switzerland; Kendall Ho from the University of British Columbia, Canada; Tove Sorensen from the Norwegian Centre for Telemedicine, Norway. Special thanks to Heike Hufnagel and Amir Sabet Sarvestani who managed the call for innovative health technologies and the submissions. We are additionally grateful to Keiko Fukuta for her support in producing the Compendium and Belén Valladares Vaquero for her support throughout the project. For their financial support of the 2013 edition we thank the Japan Ministry of Health, Labour and Welfare, the Netherlands Ministry of Health, Welfare and Sport, and the US Agency for International Development The coordination and organization of the Compendium project and the evaluation of the medical device submissions were managed by the Diagnostic Imaging and Medical Devices unit of the Essential Medicines and Health Products department of the World Health Organization under the direction of Adriana Velazquez- Berumen, team coordinator, and Heike Hufnagel, technical officer. The coordination and evaluation of the ehealth solution submissions were managed by the ehealth Unit of the Knowledge Management and Sharing department of the World Health Organization under the direction of Diana Zandi, Health Academy Project Manager, and Misha Kay, Manager, Global Observatory for ehealth. The contribution of the following persons and institutions has been invaluable: For the evaluation of submitted medical devices we thank Euroscan represented by Sue Simpson and Brendon Kearney and the following Euroscan members: Rosimary Terezinha de Almeida, Angaja Phalguni, and Beth Boddice from the National Horizon Scanning Centre (NSCH), University of Birmingham, United Kingdom; Alexandre Barna, Emmanuel Charpentier, Bjorn Fahlgren, and Marc Vanicatte from the Committee for Evaluation and Diffusion of Innovative Technologies (CEDIT), Paris, France; Setefilla Luengo, Iñaki Imaz-Iglesia, and Jesús González Enríquez from the Agencia de Evaluacion de Tecnologias Sanitarias (AETS) -ISCIII, Madrid, Spain; Aurora Llanos from Agencia de Evaluación de Technologías Sanitarias de Andalucía (AETSA), Seville, Spain; Antonio Migliore and Maria Rosaria Perrini from the Agenzia Nazionale per i servizi sanitari regionali (Agenas), Rome, Italy; Orna Tal from the Division of Medical Technology Policy (DMTP), Ministry of Health, Jerusalem, Israel; v
6 Sirpa-Liisa Hovi and Marjukka Mäkelä from the Finnish Office for Health Technology Assessment (FinOHTA), Helsinki/Tampere, Finland; Kees Groeneveld and Cees A. Postema from the Health Council of the Netherlands (GR), The Hague, The Netherlands; Inger Natvig Norderhaug, Helene Arentz-Hansen, and Tove Ringerike from the Norwegian Knowledge Centre for the Health Services (NOKC), Oslo, Norway; Paul Fennessy, Linda Mundy, Kaye Hewson, and Brendon Kearney from the Health Policy Advisory Committee on Technology (HealthPACT), Queensland, Australia; Nora Ibargoyen-Roteta, Gaizka Benguria-Arrate, and Iñaki Gutiérrez-Ibarluzea from the Basque Office for Health Technology Assessment (Osteba), Vitoria-Gasteiz, Spain. We also thank DIMDI (German Institute of Medical Documentation and Information) represented by Hans- Peter Dauben for their support concerning the organization of the evaluation phase as well as Ahmet Metin Gulmezoglu and Helena Ardura-Garcia from WHO for their input. For the evaluation of submitted ehealth solutions we are grateful to: Antoine Geissbuhler, University Hospital Geneva, Switzerland Kendall Ho, University of British Columbia, Canada Pradeep Ray, University of New South Wales, Australia Tove Sorensen, Norwegian Centre for Telemedicine, Norway For their collaboration we thank the Centre for Global Health at the University of Michigan represented by Kathleen Sienko and directed by Sofia Merajver; we especially thank Amir Sabet Sarvestani and Eva Shiu for their assistance with identifying potential technologies and contacting the respective developers for the Compendium vi For her design of the Call announcement as well as her contribution to the successful launch of the Call we thank Lisa Stroux. For their valuable input on the submission template we thank Tony Easty from the University of Toronto, Mladen Poluta from the University of Cape Town, Lisa Stroux from the University of Oxford, and Santiago Ocejo from ProMujer, Mexico City. We would like to thank the following WHO interns: Yen Low for her support in producing the Call announcement, Bryan Ranger for his support in producing the Compendium, and Rahul Rekhi, Shreesh Naik, Alicia De Hoyos Reyes, and John Akrofi for their support in different phases of the project. All illustrations were provided by the developers who submitted the technologies. For their financial support in the 2012 edition we thank the Ministry of Health, Labour and Welfare, Government of Japan, as well as The Netherlands Ministry of Health, Welfare and Sport. For their financial support in the 2011 edition, we profoundly thank the Bill and Melinda Gates Foundation.
7 Table of contents Acknowledgements iv Technologies by health topic xi Introduction xiv Terms, conditions and disclaimers xv ehealth solutions 2014 Doctor assistant app e-health software for NCD health education Electronic Health Record (EHR) solution Smartphone-powered cloud-enabled portable Electrocardiograph (ECG) Medical devices 2014 Anaesthesia delivery for low resource setting Cooling mattress for neonates Infant radiant warmer for primary care Infant resuscitation and suctioning device Infant T-piece resuscitator Infusion pump Integrated respiratory blower & humidifier Low-cost computed tomography scanner Low pressure anaesthetic machine with pneumatic ventilator Mobile-enabled non-invasive measure-through motion and low perfusion pulse oximeter. 15 Neonatal bag-mask Non-invasive haemoglobin monitoring device Oxygen reservoir filling system Pulse oximeter Trans-oral nasopharynx brush biopsy-quantitative PCR for epstein barr virus DNA detection 20 Z-arm digital x-ray Other technologies 2014 Breastfeeding simulator Healthy newborn kit Task and room light for health workers Technologies for outbreaks 2014 Alcohol & chlorine free sanitizer Autoclave powered by solid fuel Bleach dilution gauge Disposable patient transfer sheet Formaldehyde gas sterilizer Inexpensive cleaning and sterilization kit Medical device transfer and storage system Portable, power-free medical instrument sterilizer Safi-safe water drops U-sterilize vii
8 viii Assistive devices 2013 Artificial prosthetic knee joint Child wheelchair Hollow mattress Magnetic prosthetic suspension system Pen-mounted CCTV camera Polycentric prosthetic knee joint Polypropylene endoskeletal lower limb prosthetic system Prefabricated components for lower limb orthoses ehealth solutions 2013 Blood pressure ereader epharmacynet system Health and hospital information system Hearing screen erecord Maternal and child health mobile services Mobile supply chain management tool Remote healthcare solution SMS-DMCare SMS service T1D system (Type 1 Diabetes system) TeleOphthalmology aided primary eye care Medical devices 2013 Bedside newborn phototherapy Compact portable ultrasound Dry blood spot screening Electro-hyperthermia Fecal occult blood test Infant radiant warmer Infant warmer Infrared ear thermometer LED phototherapy for neonatal jaundice Low pressure anaesthesia machine Mandibular repositioning device Oscillometric ankle-arm measurement Oscillometric blood pressure measurement Oxygen concentrator-driven bubble CPAP Telecardiology Umbilical artery doppler analyser Other technologies 2013 Postpartum uterus trainer Pressure cooker autoclave
9 Assistive devices 2012 Solar charger for hearing aid ehealth solutions 2012 Biometric technology in healthcare Case-based smartphone messaging platform Cervical cancer screening information system Computer-aided detection for Tuberculosis Electronic consultation register Health workforce information systems Integrated smartreader & cloud services Maternal health Tanzania Medical cloud mhealth platform for community health workers New media to train health workers Primary health care continuous quality improvement (CQI) tools Rapid SMS providing availability of essential medicines Real-time measurement of meteorological events on public health Smart phones for supportive supervision for TB Telemedicine for HIV/AIDS care Telemedicine network Tele-ophthalmology software application Teletrauma Medical devices 2012 Automated solar-powered blood pressure monitor Interventional cardiovascular lab Intramedullary nail and interlocking screw system Mobile ECG with web-based telemedicine platform Multi-parameter remote diagnostic kit Non-invasive hypothermia indicator for newborns Non-invasive vascular age risk prediction Non-surgical male circumcision device Oral syringe dosing clip Point of care diagnostic device for total WBC Portable anaesthesia machine Sputum mobilization device Urine albumin test Other technologies 2012 Auto stop electrochlorinator Birthing simulator for training Low smoke stove ix
10 x Assistive devices 2011 Manual wheelchairs and mobility devices ehealth solutions 2011 Medical data communication system Mobile technology to connect patients to remote doctors Treatment response software application Medical devices 2011 Fetal heart rate monitor Isothermal nucleic acid amplification system for POC diagnosis Non-pneumatic anti-shock garment Oxytocin in prefilled auto-disable injection system Parasitological test system Phototherapy for neonatal jaundice treatment Portable haemoglobin meter Portable ventilator Prefilled auto-disable injection system Reusable neonatal suction device Self-powered pulse oximeter Transcutaneous bilirubin measurement system for infants Ventilator using continuous positive airway pressure Other technologies 2011 Newborn simulator for resuscitation training Point-of-use water disinfection system Water filter Appendix
11 Technologies by health topic Assistive devices Artificial prosthetic knee joint Child wheelchair Hearing screen erecord Hollow mattress Infusion pump Magnetic prosthetic suspension system Manual wheelchairs and mobility devices Pen-mounted CCTV camera Polycentric prosthetic knee joint Polypropylene endoskeletal lower limb prosthetic system Prefabricated components for lower limb orthoses Solar charger for hearing aid Task and room light for health workers Basic equipment for health facilities and home health care Automated solar-powered blood pressure monitor Blood pressure ereader Infrared ear thermometer Oscillometric blood pressure measurement Prefilled auto-disable injection system Self-powered pulse oximeter TeleOphthalmology aided primary eye care Healthcare management Case-based smartphone messaging platform Doctor assistant app e-health software for NCD health education Electronic Health Record (EHR) solution epharmacynet system Health and hospital information system Health workforce information systems Medical cloud Medical data communication system Mobile supply chain management tool Mobile technology to connect patients to remote doctors New media to train health workers Primary health care continuous quality improvement (CQI) tools Rapid SMS providing availability of essential medicines Real-time measurement of meteorological events on public health Remote healthcare solution Smartphone-powered cloud-enabled portable Electrocardiograph (ECG) Telemedicine network Teletrauma Treatment response software application xi
12 xii Devices for infectious diseases Auto stop electrochlorinator Biometric technology in healthcare Computer-aided detection for Tuberculosis Integrated smartreader & cloud services Isothermal nucleic acid amplification system for POC diagnosis Non-surgical male circumcision device Point-of-use water disinfection system Smart phones for supportive supervision for TB SMS service Sputum mobilization device Telemedicine for HIV/AIDS care Water filter Devices for infection prevention Alcohol & chlorine free sanitizer Autoclave powered by solid fuel Bleach dilution gauge Disposable patient transfer sheet Formaldehyde gas sterilizer Inexpensive cleaning and sterilization kit Medical device transfer and storage system Pressure cooker autoclave Portable, power-free medical instrument sterilizer Laboratory Dry blood spot screening Fecal occult blood test Parasitological test system Point of care diagnostic device for total WBC Trans-oral nasopharynx brush biopsy-quantitative PCR for epstein barr virus DNA detection 20 Medical imaging Low-cost computed tomography scanner Z-arm digital x-ray Monitoring Mobile-enabled non-invasive measure-through motion and low perfusion pulse oximeter. 15 Non-invasive haemoglobin monitoring device Pulse oximeter Non-communicable diseases Cervical cancer screening information system Electro-hyperthermia Interventional cardiovascular lab Low smoke stove Mandibular repositioning device Mobile ECG with web-based telemedicine platform Multi-parameter remote diagnostic kit
13 Non-invasive vascular age risk prediction Oscillometric ankle-arm measurement Portable haemoglobin meter Portable ventilator SMS-DMCare T1D system (Type 1 Diabetes system) Telecardiology Tele-ophthalmology software application Urine albumin test Reproductive, maternal, neonatal and child health Bedside newborn phototherapy Birthing simulator for training Breastfeeding simulator Cooling mattress for neonates Compact portable ultrasound Electronic consultation register Fetal heart rate monitor Healthy newborn kit Infant radiant warmer Infant radiant warmer for primary care Infant resuscitation and suctioning device Infant T-piece resuscitator Infant warmer LED phototherapy for neonatal jaundice Maternal and child health mobile services Maternal health Tanzania mhealth platform for community health workers Neonatal bag-mask Newborn simulator for resuscitation training Non-invasive hypothermia indicator for newborns Non-pneumatic anti-shock garment Oral syringe dosing clip Oxygen concentrator-driven bubble CPAP Oxytocin in prefilled auto-disable injection system Phototherapy for neonatal jaundice treatment Postpartum uterus trainer Reusable neonatal suction device Transcutaneous bilirubin measurement system for infants Umbilical artery doppler analyser Respiratory Support Integrated respiratory blower & humidifier Low pressure anaesthetic machine with pneumatic ventilator Oxygen reservoir filling system Ventilator using continuous positive airway pressure Surgery Anaesthesia delivery for low resource setting Intramedullary nail and interlocking screw system Low pressure anaesthesia machine Portable anaesthesia machine xiii
14 xiv Introduction One of the cornerstones of the Universal Health Coverage (UHC) initiative is access to health technologies. Medical devices, assistive devices and ehealth solutions are health technologies that save lives or improve quality of life. However, too many people worldwide suffer unnecessarily because they lack access to affordable health technology. In low- and middle-income countries the problem is even more acute and high-quality, appropriate, available, accessible and affordable medical technologies are severely needed to fill this gap. The objective of the compendium series of innovative medical devices, assistive devices and ehealth solutions is to provide a neutral platform for technologies which are likely to be suitable for use in less resourced settings. It presents a snapshot of several health technologies which might have the potential to improve health outcomes and the quality of life, or to offer a solution to an unmet medical/health technology need. It is released to acknowledge some success stories and at the same time, to raise awareness of the pressing need for appropriate and affordable design solutions and to encourage more innovative efforts in the field. This effort also aims to encourage greater interaction among ministries of health, procurement officers, donors, technology developers, manufacturers, clinicians, academics and the general public to ensure greater investment in health technology and to move towards universal access to essential health technologies. All submissions to the Call for Innovative Health Technologies for Low-Resource Settings underwent an evaluation process; technologies were assessed by an expert panel based on the material and evidence provided by the applicant as well as publicly available information. Note that for a selected technology, the inclusion in the compendium does not constitute a warranty for fitness of the technology for a particular purpose. All innovative solutions in the compendium are presented in one page summarizing the health problem addressed, the proposed solution and product specifications, based on data, information, and images provided by the developers of the technologies concerned. Due to the Ebola outbreak, the 2014 call was extended to include medical devices for outbreaks, including disinfection technologies. Many innovations are in the way and are being tested in the field; we look forward to increasingly list new technologies that can be affordable, easy to use, safe and of good quality, which can be available for low resource settings especially in case of emergencies, outbreaks and for non-communicable diseases. This volume now includes 127 Technologies from 36 Countries, on the following areas: Assistive devices, Basic equipment for health facilities, Devices for infectious diseases and for infection prevention, Healthcare management, Medical imaging, Laboratory, Monitoring, Non-communicable diseases, Reproductive, maternal, neonatal and child health, Respiratory support and Surgery. Every year the process became increasingly selective; the parameters of evaluation more stringent and more evidence had to be made available or requested from the manufacturer. This compendium is another step in the ongoing process to better target global health needs and priorities. It is important to note that while many technologies are being marketed, the quality and safety are doubtful. Important is to highlight that academia, innovators and medical devices industries innovate and find ways to target the priority diseases with affordable, good quality and safe technologies. Additionally, delivery systems must allow medical devices to reach their final destination, whether being used by health care workers or patients. Challenges in regulatory approval, selection, procurement, evaluation, distribution channels, delivery, user training and maintenance until decommissioning should be remembered at all times. WHO guidance regarding this process is available in the Medical Devices Technical series, at devices/management_use/en/ The distribution channels should also guarantee that there will be effective maintenance and spare parts available, so that these technologies remain useful at the point of care. It is imperative that innovative, affordable and good quality health technologies are being used by the base of the pyramid, that is, the majority of population, to have access to better and most appropriate technologies to match their health needs; this will enable disease prevention, early diagnostics, effective treatment and assistive care as appropriate. In cases where there are low availabilities of supplies, infrastructure or specialized human resources, innovative technological solutions should be envisaged for low resource settings in order to empower health care staff with better tools. Many challenges lie ahead. Both the unfinished MDG agenda and the new Sustainable Development Goals that were approved this year hope to bring universal health coverage to all populations. To achieve this goal it is essential that scientific and technological advances, research and development as well as innovative technologies have a substantial supportive role in health care; this will best place us to reach the highest attainable level of global health.
15 Terms, conditions and disclaimers Compendium for innovative health technologies: Ebola relief technologies, medical devices, ehealth solutions and In-Vitro diagnostics for low-resource settings 2011, 2012, 2013 and 2014 WHO reserves the right not to select any application or to annul the solicitation process at any time, without thereby incurring any liability or any obligation to inform the applicants of the grounds for the WHO s action. WHO reserves the right, at any time during the solicitation process, to modify the scope of the Call. At any step in the evaluation process, WHO reserves the right to issue an amendment to the Call detailing the change to only those applicants who have not been officially eliminated at that point in time. Applications will be evaluated by WHO, in collaboration with partner experts and institutions, in its sole discretion, taking into account the criteria outlined above. There is no obligation by WHO to reveal, or discuss with any applicant, how a submission was assessed, or to provide any other information relative to the selection process. Incomplete applications and applications submitted after the deadline will, in principle, be disregarded unless WHO, in its sole discretion, decides otherwise in respect of such incomplete or late application. WHO may request applicants to submit complementary or additional information as a condition for consideration. Any possible requests to submit complementary information and/or to submit a more detailed application, as well as any discussions ensuing therefrom, will be exploratory only, and do not mean that the applicant concerned will be selected. WHO will not be held to offer applicants any explanation or justification as to why their proposal has been rejected and/or why they have not been selected. The list of selected applications will not necessarily be made public as such. The submission of applications, the subsequent selection process and outcome of the selection process will not be subject to any claim of any kind whatsoever, or appeal. Each applicant will be notified in writing by WHO (by ) whether or not the submission has been selected. Any and all costs and expenses incurred in relation to, or ensuing from, the submission of an application (including the possible complementary information and/or a more detailed proposal, if so requested by WHO) will not be subject to claims for financial compensation of any kind whatsoever. WHO does not warrant that any medical devices, innovations, concepts or products that may be used, identified or otherwise developed from selected proposals will be successfully commercialized in target countries, or that WHO will finance or otherwise support the development or commercialization of any product. By selecting applications, WHO will not be held to endorse any product but will solely aim at drawing stakeholders attention to innovative technologies with a view to furthering development and availability of, and access to such innovative health technologies. The mention of specific companies or of certain manufacturers products at any stage of the selection process or subsequently will not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned, nor that they have been found to be safe and efficacious. Without WHO s prior written approval, selected applicants shall not, in any statement of an advertising or promotional nature, refer to their selection under this Call for innovative health technologies. In no case shall selected applicants use the name or the emblem of the World Health Organization, or any abbreviation thereof, in relation to their business or otherwise. The same applies to all applicants during the selection process and thereafter. xv
16 ehealth solutions 2014
17 ehealth solutions 2014 Doctor assistant app Country of origin Mauritius Disorganized healthcare systems is a drawback in low and middle income countries. Paper-based systems are known to promote an erratic performance. The aim of this app has been to harness the computational power of smart devices to build a simple EMR for daily usage Simple, easy to use and free EMR for tablets and smartphones. The software is an Android based application that runs an SQLite Database in background overlaid by a beautiful user-friendly interface. The digital footprint of the application is approximately 1 MB only but allows unlimited data entry for patients. Doctor assistant app has been launched in March 2014 but already count 1800 users worldwide. Developer s claims of products benefits The application runs on a stable Android platform. Despite having 1.5 million apps on Google Play, none have resembled the app so far. No actual maintenance is required and it is readily accepted by users. The app requires minimal resources but the output is massive in terms of making healthcare practices become paperless. Operating steps The application is freely available on Google Play and can be installed easily. The usage is straightforward and resemble most of the software currently available for Android. No specialized knowledge is required. The app can easily input data by typing, handwriting recognition or even speech to text. Data can be saved to Google Drive, Dropbox or attachment Effectiveness for Low-Resource Settings The software is being used by about 70 doctors in Mauritius. Here the paper-based system is a major problem. The market penetration of smartphones in the Island has been 200% over the past two years. So, it is the right environment for the expansion of the app. Moreover, making it freely available on the Google Play suits the current economical setting perfectly Evaluation The evaluation has been carried out through questionnaires, online surveys and direct interview. Customer satisfaction is as high as 90%. In addition, all the feedbacks received are used to make the application better through regular updates. The application is being used worldwide keeping in mind that we never did any commercial advertisement or marketing. Every week 100 new users are received worldwide. This company has paired up with local software company to expand the software in collaboration with Mauritius Research Council and University of Mauritius. The more advanced version of the software includes cloud capabilities, picture management, Google Print and integration with the Mauritius National ID card via NFC technology Use and environment User: physician, technician, nurse, midwife, family member, medical students or patients Training: Minimal training required, system is self-explanatory and easy to use. Setting: Any Health Care Settings Solution specifications Software, Hardware Requirements: Android System, requires 1 MB free space Date of Commercialization: 2014 Retail price (USD): Freely Available Country used in: Worldwide Contact Amal Bholah Telephone Web 1
18 ehealth solutions 2014 e-health software for NCD health education Country of origin It addresses NCD at individual level, community and primary health care level. Target audience: Global population, people between years. Specific emphasis on the developing world which is hit the hardest with 86% of NCD related deaths occurring in the developing world, where 29% of deaths occur among people under the age of 60. Progress to date on NCDs has been vastly inadequate. The size and complexity of the epidemic and its universal impact makes NCDs everyone s problem. Internet-based, cell phone-enabled application, works with or without internet to deliver a retooled and re-engineered Primary health care model that is nurse driven, patient-centred and NCD orientated. Acute patients serve as a source and feeder to the unobtrusive perpetual universal screening for NCD. Seeking out individuals who have established NCD, qualify their NCD status and quantify their risk of developing complications. NCD free individuals are assessed for risk of developing NCD, risk factors that drive such risk are identified. System generated health education tools that are based on international guidelines Developer s claims of products benefits This is a new approach that integrates multiple disjointed approaches currently out there in the market. The best private initiated NCD program in South Africa by the Centre for Diabetes and Endocrinology, is largely paper based, serves only diabetic patients belonging to the medical aid industry. Some of the best internationally acclaimed chronic disease management organizations in South Africa are largely concerned with cost containment and not disease containment and are not open to the general public Suitability for low-resource settings The application has various modules that are PC, cell phone and web-based, provided free to end users such as the general public, wellness organisations, and NGOs who do NCD screenings. Nurses who work in poorly resourced settings are able to deliver specialist level NCD diagnosis and care through access to real-time support by a doctor or specialist at a remote location. This functionality maximises the use of scarce human resources often faced in the developing world. Evaluation This application is designed to meet HIPAA and HL7 best practices, has been tested in a primary healthcare setting and within a community of secondary school teachers in Benoni, South Africa. Based on the positive feedback received from the test sites, the application has been enhanced by adding new and ground breaking features such as a personal portable health records and virtual consultation functionality, as well as a re-engineered community outreach module. Future challenges are expected in making the application available to the general population and greater medical industry including research organisations. Funding and financial support for up-scaling the solution and making accessible to a wider audience in various languages Use and environment User: Self Use/Patient, Physician, Nurse, Family Member Training: Training requirements are based on the level of use. individual users have simple self-explanatory modules, clinics will be supplied with user interphase, electronic user manuals and video demonstrations Settings: Rural, Urban, Outdoor and Indoor Settings, at home or any level of healthcare centre. Solution specifications South Africa Solution is used to support: Electronic Health Records/ Electronic Medical Record, mhealth Software, Hardware Requirements: Internet, Cellular Phone Network, laptop Software Specifics: The software is designed in modules, the modules that provide the widest possible impact on NCD awareness, risk assessment, diagnosis and health education are free to the general public NGOs and Nurses. Modules that are intended for the insurance industry and medical practice management will be made available at a stipulated price for the specific industry. Availability: Patients can download a free clinical grade NCD android app from the website. Nurses and doctors can access the free NCD software by creating clinics with own corporate image from this website. Diabetics and hypertensive patients may subscribe to the Premium NCD still to be priced. Larger clinics also purchase this new re-engineered primary healthcare application designed for NCD, HIV/AIDS and Ante Natal care orientated primary healthcare centers Country used in: South Africa Contact Nao Norman Sipula Telephone Web 2
19 ehealth solutions 2014 Electronic Health Record (EHR) solution Country of origin According to the WHO, about 80% of NCD deaths occur in low and middle income countries. Considering the fact that about 70% of people with diabetes and hypertension do not show symptoms, periodic monitoring is important for the early detection of these diseases as well as their prevention and control. Currently there are limitations on the data available to monitor NCDs. The Electronic Health Record (EHR) solution presented has the capability to improve the quality, safety, and efficiency of patient care. It s use can assist with medication safety, tracking, and reporting and eliminate concerns about the legibility of paper medical records. Its other advantages include the facilitation of improved communication between health care providers and the promotion of quality of care through optimized compliance with guidelines. Despite obstacles to widespread adoption in resource poor settings, use of the EHR as a real-time, evidence-based support tool can help busy healthcare providers increase the quality of the care they provide through improved care coordination, communication, and documentation. Developer s claims of products benefits The state of patient safety and drug data management in low resource environments is one of an inefficient, paper driven, improperly documented business process. Where conversion to an electronic record has been attempted, the solutions have usually been complex, not customized for the local environment and generally difficult to adopt. This EHR brings a comprehensive, well designed, easy to configure and manage solution to these problems. This software solution is template based, with flexibility to adjust the business process to suit the existing flow and cause very little disruption. Suitability for low-resource settings This ERH solution is ideal for public health clinics with little or no funding to afford such a technology on their own. Some of which include the HIV ART Clinic in Nigeria, HIV Clinic in Ghana, Chronic Care Clinic at the Korle-Bu Polyclinic, The Malaria Control Programme Clinics, The EPI Clinics. These are resource limited settings with weak and poorly linked health management and referral systems. Patient medical records are largely housed in a poorly coordinated file room which is usually very full and some patient medical records binders can be seen lying on the floors due to lack of space. Processes are largely manual, not properly documented and error prone. Patient health data is incompletely and inaccurately recorded, leading to inefficient decision making and poor program monitoring and evaluation. Operating steps Pre-installation Readiness Assessment. Implementation Planning and Software Requirements Specification. Hardware requirements assessment. EHR installation and network configuration. Data Integration. Ongoing Training and Support. Continuous quality improvement Regulatory status Adheres to HL7 and ICD10 standards. The intent is to make the EHR solution more available to health facilities and clinics in rural and low resource areas with little access to technology. This will require providing both the computers and software to run the system. The usage locations should have a continuous power supply or enough power to charge laptops to allow usage during work hours. Users should be computer literate as a pre-requisite and will be trained on the use and support of the system Use and maintenance User: Patient, Physician, Technician, Nurse, Midwife, Pharmacist or Lab Technician Training: Training by experienced product support team. Basic computer usage ability is a pre-requisite. Training will take approximately 5 days to become an expert user. Maintenance: Scheduled, automated data backup by any trained support person Setting: To be used in Rural or Urban Indoor Settings and in Primary, Secondary and Tertiary Levels of Health Care Power source requirements: Requires 240 V continuous power supply or for min 1.5 hrs to charge battery (battery life is 9 hrs) Solution specifications Ghana and India Software Requirements: Runs on basic laptop or desktop computer. Retail price (USD): It is sold at $5000 per license which covers up to ten integrated users. Other features: The software is configurable to the local terminology of most intended users and uses. Supports English, Hindi, Bengali, Tamil Year of commercialization: 2003 Currently sold in: Ghana, Tanzania, Uganda, Zimbabwe, Kenya, India Contact Haggar Hilda Ampadu Telephone Web 3
20 ehealth solutions 2014 Smartphone-powered cloud-enabled portable Electrocardiograph (ECG) Country of origin Thirty-two percent of all deaths are due to cardiovascular disease, 80% of which occur in low- to mid-income countries. By enabling remote telemedicine diagnostics, these smartphone-powered devices connect patients living in rural areas with cardiologists in urban settings. These higher quality diagnostics can enable physicians to make better decisions, leading to better outcomes. The technology is a low-cost portable electrocardiograph device that allows medical professionals to acquire ECG readings of patients with symptoms of cardiovascular disease. Medical professionals can then send readings to colleagues in remote facilities via a secure tele-cardiology system that allows doctors to view the ECG on their phones and laptops. The device is small enough to fit in the hand and weighs 40g; this extreme portability eases use for physicians who need to travel long distances and enables health workers to obtain ECGs when in remote locations lacking access to large traditional devices. Developer s claims of product benefits The current 12-lead electrocardiographs are usually large, difficult to use, and require a stable source of electricity and expensive disposable electrodes. This device is 10X smaller, 10X cheaper, uses reusable electrodes and is powered by a smartphone or tablet. This system also enables remote telecardiology diagnoses. Suitability for low-resource settings The device is intended for use in rural settings without access to stable electrical infrastructure, disposable electrodes, or even physicians who can interpret ECGs. The device is powered by the provider s smartphone, which can be recharged either beforehand or with solar panels, uses reusable suction electrodes and allows for secure telemedicine communication with remote physicians who are able to interpret the ECG Evaluation This technology was deployed in the Kisoro District Hospital in Uganda and was recently deployed to a hospital in Malawi. The device has been used by 10 physicians to diagnose 50 patients. The Kisoro Hospital suffers frequent power outages, and does not have access to disposable electrodes; however, the hospital does have physicians trained to interpret ECG results. Making and distributing these devices on a large scale will be a key challenge to improving global accessibility to ECGs. Building automated diagnostic algorithms and improving telemedicine features (such as MD crowdsourcing) could be useful in rural areas. Willingness to reduce the price of this device even further and support a larger range of devices by using Bluetooth wireless technology. These devices could be even smaller and lighter and would work with a larger range of smartphones (i.e. Android, ios, Windows, Nokia). Use and environment User: Physician, Technician, Nurse Training: N/A Settings: Rural, Urban, Outdoor and Indoor Settings and Primary, Secondary, and Tertiary level health centres Solution specifications United States of America Software, Hardware Requirements: Access to a cellular network enables telemedicine features, but is not necessary for use Software Specifics: smartphone app Currently sold in: Uganda and Malawi Retail price (USD): 300 USD Year of commercialization: 2014 Contact Chow Lin Telephone Web 4
21 Medical devices 2014
22 Medical devices 2014 Anaesthesia delivery for low resource setting Country of origin Weight (kg): 70 China Unsafe anaesthesia causes morbidity/mortality with the problem being more pronounced in developing countries. In developed markets, anaesthesia related mortality is approx. 11,700/yr. for a population of 1B and 138M surgeries. For developing nations, the anaesthesia related mortality is approx. 45,000/yr. for a population of 6B and 96.2 surgeries. A 6 times increase in population, but the number of surgeries is less by 40%. So there is still a large % of population with no access to hospitals with OTs. The proposed anaesthesia machine is a compact, integrated, and intuitive anaesthesia delivery system. The machine provides general inhalation anaesthesia and ventilatory support for patients during surgery as well as monitoring and displaying various patient parameters. The anaesthesia machine is composed of the anaesthetic breathing system, anaesthetic gas transfer and receiving systems, anaesthetic vapour delivery devices, anaesthetic ventilator, and accessories. The machine is lightweight and compact for easy manoeuvrability. The anaesthesia machine also offers enhanced monitoring capabilities (SpO2 monitoring) and advance ventilation that includes WYSIWYG (What You Set Is What You Get) Tidal Volume setting Developer s claims of products benefits The offerings from the leading vendors are primarily targeted for use in areas where resources, both physical and economical, are not constrained. Also, they are targeted to address a broad range of health cases thus driving up the costs of the equipment & increasing the complexity of the equipment. Local players focus on cost reduction, more often than not, at the expense of quality, safety and reliability. In all these areas, this equipment outscores them Suitability for low-resource settings Infrastructure: compact frame designed for mobility throughout the hospital. Extended battery life of up to 360 minutes, which allows continued work, even during extended procedures in unstable power environments. Training Effort: decreases training effort with its intuitive design, straightforward User Interface, and an in-depth clinical training package that helps new users quickly acclimate to the machine s advanced features Regulatory status The equipment is CE certified. Field trials are taking place in each of the target country/region. Anticipated challenges are in terms of underdeveloped infrastructure and personnel with reduced skill levels. The strategy to overcome the latter challenge is to educate the end user thoroughly about the product via focused trainings - both in theory and practice. The former challenge will be addressed feeding the learnings from the field trials into the next iteration of the product. Apart from this, there will be focused effort to train the personnel in the target areas on safe surgery practices and how the equipment enables them to perform the same Use and maintenance User: Intended to be used by a physician or technician. Training: The manufacturer s representative in the region where the equipment is planned to be used will provide the training. The manufacturer will provide all the equipment required. Time required is 2 days. Maintenance: Calibration required at time of use, along with scheduled annual maintenance. Setting: Designed for use in indoor rural or urban settings in primary, secondary or tertiary levels of healthcare facilities Energy and Other Requirements: Runs off either batteries or continuous power supply of V. Requires proprietary software, which ensures reliable working of the Anesthesia machine. Key functionality includes display, monitoring, ventilation, leak tests, self-tests & diagnostics. There is no specific license fee associated with the software. Necessary software for proper functioning of the machine is provided with every machine. Pipeline input range: 280 kpa to 600 kpa/41 psi to 87 psi Dimensions: 1480mm x 900mm x 700mm Consumables: Inhalation Agents, Delivery gases - O2, N2O Retail price (USD): Other features: The software, along with user manuals, is available in following languages: English, French, Spanish, Portuguese, Turkish, Russian, and Vietnamese & Indonesian. Breathing system auto-clavable at 134 C Year of commercialization: 2012 Currently sold in: India, Vietnam, Philippines, Malaysia, Indonesia, Singapore, Algeria, Nigeria, Kenya, Morocco, Senegal, Tanzania, Togo, Uganda, Cote D ivoire, Honduras, Paraguay, Lebanon, Pakistan, Bangladesh Contact Prasad Rotti Telephone Web 6
23 Medical devices 2014 Cooling mattress for neonates Country of origin India Birth asphyxia is the medical condition resulting from lack of oxygen in a newborn infant. It is a major cause of Hypoxic Ischemic Encephalothapy and consequential brain damage or even death. According to WHO data of 2012, birth asphyxia accounted for 10% of the deaths of children under 5 years old. Statistics of each country for 2010 is enclosed. Therapeutic hypothermia induced by cooling to around 33 C for three days after birth is the prescribed treatment. The Cooling Device for Neonates is a low cost technology to induce therapeutic hypothermia among newborn infants suffering from birth asphyxia. It is a noninvasive, whole body passive cooling device, which works via conduction of heat from the newborn by a cool surface maintained at a constant temperature. The working principle behind the device is use of phase change materials (PCM) designed to melt/freeze at the temperatures which would ensure a temperature regulation of the infant between 33 and 34 C for up to 72 hours. PCMs do this by the virtue of their latent enthalpy at their melting/freezing temperatures. PCMs absorb heat from the baby thereby cooling the baby. The device uses two PCMs which has a melting/freezing temperature of 29 C and 21 C and an insulated cradle to place these PCMs. A gel bed is placed above the PCMs to give a comfortable surface for the baby. Developer s claims of products benefits Several control instruments are used to cool the neonate currently and maintain the temperature between C. These offer high accuracy but are very expensive. The proposed technology is 1/10th price of the servo control devices and still offers the same accuracy with the added advantage of portability, ease of use as no electronic components are involved. Ice packs are also used to cool the baby but they tend to overcool the baby leading to adverse side effects. Suitability for low-resource settings The majority of deaths from birth asphyxia, occur in developing countries where the main resource constraint is money and availability of electricity. With the proposed technology, the cost has been reduced by 90%. The device cools passively using PCMs so makes access to a constant power source unnecessary. PCMs can be pre-cooled and stored for use when power is available. Operating steps Pre-cool the PCMs FS-29 and FS-21 in a refrigerator for a period of 6-8 hours. Place the 3 pre-cooled PCM FS-29 slabs in the insulated cradle. On top, place 2 slabs of PCM FS-21. Place the gel bed above the PCMs. Place the complete set in the bassinet of a standard infant warmer. Place the baby over the gel bed. Use a rectal probe to measure the temperature continuously. If temperature decrease below 33 C, use warmer to increase temperature. Regulatory status Although currently in India neither is required, the company has started the process of ISO and CE certification and is expected to receive both in the next 3-5 months. The major challenge is to bring acceptability and develop confidence for the product among the medical community. The company has adopted a three point strategy to make the product available across the globe. Products are being given free of cost to established hospitals/doctors locally and the results are being shared in medical journals so as to establish confidence. The company is setting up an effective distributor network across the Indian sub-continent, South East Asia and Africa to utilize the distributors already widespread reach in hospitals. Partnership with NGOs are being pursued so that treatment of birth asphyxia can be taken up as a social issue. Simultaneous pursuit of above paths will lead to quick accessibility. Use and maintenance User: physician or nurse only Training: no additional training required, follow user instructions provided with technology Maintenance: No maintenance is required. Setting: Designed for use in rural or urban settings at primary, secondary or tertiary levels of health care facilities Facility and Energy requirements: A domestic refrigerator is required for freezing the PCM; the temperature of NICU should be maintained above 25 C. Also requires basic facilities for monitoring the vital parameters of the newborn during treatment. Weight (kg): 13 kg Dimensions: 620mm x 460mm Consumables: None Lifetime: 3 years Retail price (USD): 1200 Other features: Able to maintain temp of 33.5 C for a period of 72 hours as required Year of commercialization: 2014 Currently sold in: India Contact Ankit Jhanwar Telephone Web 7
24 Medical devices 2014 Infant radiant warmer for primary care Country of origin Weight (kg): 37 Dimensions: 1500mm x 800mm x 800mm Consumables: heat reflector skin patch Lifetime: 7 years India Nearly 2/3 of all newborn deaths (4 million annually) occur in 10 countries, India being largest contributor with 876,000. Lack of skilled personnel, infrastructure and affordability are big challenges to providing primary care. Hypothermia at birth is one of the most significant risk factors of neonatal mortality irrespective of birth weights and gestational ages. Urgent action is needed to address the issue of neonatal deaths and progress on MDG4, since 40% of under 5 deaths are in new-borns. Infant radiant warmer with uniform heating: the warmer features a patented J-profile design that reflects heat uniformly to the bed for more thermal stability. Reduced heat loss: the heater is made with a cartridge (Calrod-like) technology that allows for rapid warming of cold surfaces, thus helping to reduce cold stress for the babies. Safe contact with the patient: All patient contact surfaces are made with biocompatible materials chosen to be gentle on the baby s delicate skin. Rugged: The warmer s electrical system is engineered to operate without a voltage stabilizer and can withstand voltage fluctuations of upto 390V. Clear observation: With a LED-based observation lamp emitting a white light, the warmer allows for great patient observation. Developer s claims of products benefits Many cheap warmers available in the market are unreliable, break down frequently and do not deliver the desired level of clinical performance. There are others that are feature heavy and very highly priced and much beyond the buying capacity of primary care buyers. With Calrod technology for the best clinical outcomes, ruggedness and reliability (unique 5 years warranty) and at extremely affordable prices. Suitability for low-resource settings Designed for a low resource health facility with poor infrastructure (intermittent power, power fluctuations, no electricity), low-skilled nurses, lack of space, low purchasing power. Easy to use: the device is plug-in and use requires minimal training. Rugged & Reliable; can withstand voltage fluctuations up to 390V. Comes with 5 year maintenance warranty. The temperature probe is made of Kevlar (material used to make bullet proof vests) Affordable: Low purchase price, low maintenance & service costs. So far, the warmer has been installed in many challenging environments across India and ASEAN with poor room air temperature control, constant power outages, rugged environment and a limited availability of skilled clinicians. The rugged and reliable design was well suited to the challenging environment and usage conditions. Operating steps Plug in the assembled unit to a power source and switch on the device. The warmer performs a self test, then switch ON in the manual heating mode. Use this mode to pre-heat, if needed. Place the baby on the mattress in the bassinet and attach the skin probe to the baby. Toggle to the baby mode and set the control temperature for thermoregulation. Regulatory status CE certified (CE 01236). Biocompatible: All surfaces coming in contact with the patient are biocompatible (EN ISO :2009/AC:2010). EN regulations - MedicalElectrical Equipment. The product conforms to RoHS requirements (residues of hazardous substances). Other: EN Medical devices, EN Medical Device software, EN ISO Application of risk management to medical devices, EN ISO Quality Management Systems, EN Symbols for use in the labeling, EN The product is low cost and meant for low resource settings. One of the obstacles is government specifications and tenders. The documents need to be updated with new technologies so that the product can reach the markets it is actually meant for. Use and maintenance User: Intended for use by a physician, nurse, or midwife Training: Basic training manual (quick reference guide) provided and video available Maintenance: No scheduled maintenance required Setting: Designed for rural and urban indoor settings and in primary, secondary and tertiary level health care facilities. Energy and Facility requirements: Requires a continuous power Supply of 230V and an environment within the range of C and 30-75%RH Retail price (USD): Other features: mobile Year of commercialization: 2014 Currently sold in: India, Malaysia, Indonesia, Vietnam Contact Sumit Mehrotra Telephone Web 8
25 Medical devices 2014 Infant resuscitation and suctioning device Country of origin Weight (kg): 3 kg Dimensions: 140mm x 222mm x 195mm Consumables: Adapters to connect oxygen hose, oxygen hose, dovetail mount, suction canister, bag & mask, oxygen tubing, infant masks. Lifetime: 7 years Retail price (USD): 600 India Nearly 2/3 of all newborn deaths (4 million annually) occur in 10 countries. Birth asphyxia is a leading contributor of neonatal deaths (23% of total neonatal deaths). Low birth weight & premature babies are especially prone to the same. Limited access to quality resuscitation devices & skilled care in low resource settings are big challenges. Urgent action is needed to address the issue of neonatal deaths and progress on MDG4, since 40% of under the age of 5 deaths are in newborns. Effective suction. Controlled resuscitation. One solution. The resuscitation and suctioning device is a compact solution for suctioning and resuscitation needs immediately after delivery. The device is completely gas driven and doesn t require electricity and suctioning works on the gas Venturi technique. The compact design doesn t allow for gas leakage and doesn t use any gas when switched off. It is mountable on the Infant warmer thereby providing a complete neonatal care solution with thermoregulation and resuscitation. One baby-one bed. Developer s claims of products benefits The current standard of care includes bag & mask devices (no accurate pressure control), gas powered devices (not comprehensive). For suctioning the devices are manual (no clinical efficacy) or electrically operated and are bulky. This prohibits users from effectively delivering care to the patient. The device presented here is a compact unit that combines suctioning and resuscitation in a single unit making it really easy to use. It doesn t require electricity so is well adapted to low resource settings. Suitability for low-resource settings An ideal solution for low-resourced clinical settings with poor infrastructure low skilled nurses, lack of space, low purchasing power. The compact technology combines suctioning and resuscitation in a single unit making it easy to use. It doesn t require electricity so is well adapted to low resource settings. It is affordable with low maintenance & service costs and also comes with the option of a reusable bag & mask accessories. Operating steps Mount and fasten the unit onto (the dovetail rail) of an infant warmer. Keep the device in OFF condition and fasten the oxygen hose to the backside of the device. Connect the suction tubing to the suction port; connect the oxygen tubing and bag & mask to the oxygenation port on the front of the device. Check the functioning of the device by switching it ON and occluding the ends of the tubing and bag & mask devices. Use for suctioning & resuscitation as needed. Regulatory status CE Certificate Number: CE Notified Body Number:0086. ISO certification (ISO13485), EN ISO: RoHS compliant. One of the obstacles is government specifications and tenders. The documents need to be updated with new technologies so that the product can reach the markets it is actually meant for. Product adoption, awareness, education, training, distribution to penetrate market Use and maintenance User: Nurse or Physician Training: Minimal training. Operator manual and product videos included with techology. Maintenance: No scheduled maintenance required. Setting: Rural and urban indoor setting for all levels of health care in primary, secondary and tertiary levels of care Energy requirements: Gas powered, oxygen supply of 40-80psi at 70 LPM Facility requirements: erequired an ambient environment within the ranges of C and 0-90% RH Price of consumables (USD): 100 Other features: Adapters to connect oxygen hose, oxygen hose, dovetail mount, suction canister, bag & mask, oxygen tubing, infant masks. Year of commercialization: 2014 Currently sold in: India and Countries in Africa and ASEAN Contact Sumit Mehrotra Telephone Web 9
26 Medical devices 2014 Infant T-piece resuscitator Country of origin Weight (kg): 5 kg Dimensions: 145mm x 313 mm x 222mm Consumables: T piece apparatus Lifetime: 7 years Retail price (USD): India Nearly 2/3 of all newborn deaths (4 million annually) occur in 10 countries. Birth asphyxia is a leading contributor of neonatal deaths (23% of total neonatal deaths). Low birth weight & premature babies are especially prone to the same. Limited access to quality resuscitation devices & skilled care in lowresourced settings are big challenges. Urgent action is needed to address the issue of neonatal deaths and progress on MDG4, since 40% of under 5 deaths are in newborns. T-piece resuscitation that is easy, economical to use and is designed for safety The compact, T-piece resuscitation device with in-built air-oxygen blende is gas powered and allows for precise control of delivery pressures and accurate blending of air-oxygen to deliver to the patient. The compact design doesn t allow for gas leakage and doesn t use any gas when switched off. Being extremely easy to use (single PIP knob operation, etc.), the caregiver can focus his/her attention on the baby rather than managing equipment. Developer s Claims of Product Benefits The devices available offering the current standard of care do not provide a comprehensive resuscitation solution. The bag & mask device is manually operated and doesn t provide accurate control of pressures and gas flows. Other gas-operated devices require additional components & accessories (e.g. blender, flowmeter, connectors) to operate efficiently. The Infant T-Piece Resuscitator is an integrated and compact device with a built in blender and flowmeter with simpler controls making it really easy to use and operate. Suitability for low-resource settings This resuscitator works well in government district hospital that has semi-skilled nurses and limited infrastructure (frequent power outages, etc.). The Resuscitator is fully gas driven and doesn t need any electricity to operate. It is easy to use and is rugged & reliable thus making it very usable in low resource settings. It comes with a Quick reference guide that makes for quick reading and quick understanding for the operator. So far, the unit has been successfully deployed and tested across many pilot sites in India and in Malaysia. These range from small private clinics, district hospitals, mother & child hospitals. Clinicians found that the clinical outcomes were favorable and that their workflow became simpler compared to existing devices. Clinicians appreciated that the product would be exceptionally useful in rural settings. Operating steps Ensure that the ON/ OFF the switch located on the front of the unit, is OFF. Connect the air and oxygen supplies to the rear of the device via hoses. Connect the T-piece to the gas port on the front of the device. Turn ON the ON/OFF switch and adjust the PIP and flow rate via the knobs to the required value. Resuscitate the patient. Regulatory status CE Certificate Number: CE Notified Body Number:0086. ISO certification (ISO13485), EN ISO: RoHS compliant One of the obstacles is government specifications and tenders. The documents need to be updated with new technologies so that the product can reach the markets it is intended for. Product adoption, awareness, education, training, distribution to penetrate market are all part of the process to taking this product to market. Use and maintenance User: Intended for use by physician or nurse Training: Minimal training required, device is accompanied by operator manual and videos. Maintenance: Will require blender calibration every 2 years Setting: Designed for use in rural and urban indoor settings for secondary and teriratory levels of health care facilities Energy and facility requirements: Gas powered ( compressed oxygen and air)requires psi, 70 LPM, also requires environment to be in eth ranges of C and 0-90% humidity Price of consumables (USD): 100 Year of commercialization: 2014 Currently sold in: India, Malaysia, Brunei and Countries in Africa and ASEAN. Contact Sumit Mehrotra Telephone Web
27 Medical devices 2014 Infusion pump Country of origin Infusion pumps are in widespread use in clinical settings such as hospitals, nursing homes, and in the home for the delivery of nutrients, medications or fluids. A rugged and portable infusion pump can be a life-saving difference for those in need of infusions especially for areas of natural disaster or low-resource settings. Ruggedized rotary peristaltic design pushes fluid around a rotor providing positive pressure. Bag can be anywhere. All other pumps are linear peristaltic pumps, which require IV bag above the pump. Can be used in any axis, even upside down. All others break frequently and cannot take remote site abuse or extreme heat, cold or moisture. Developer s claims of products benefits This pump is economic, doesn t break, can be in any position, bag can be anywhere, is simple to operate and lasts a very long time. Others have had many recalls, bag must be vertically above the pump, and often need repair. Suitability for low-resource settings This device is economic, needs not maintenance, never breaks. Well suited for use in remote environments (for example in he North Slope oil well platforms, a doctor was able to use this technology to treat herself for cancer in Antarctic). Customers include Doctors Without Borders in Chad, and in Haiti by NYC Fire Department after the 2010 earthquake. Operating steps According to the results of the Homeland Security test, the pump requires little training. Simply open the rotor door, insert the tubing, rotate the rotor and close the door. At this point the pump is ready for use. Regulatory status The technology has had trials at Temple University (accuracy), Butterworth Hospital (accuracy & blood haemodialysis), Ohio State (accuracy), Navy Submarine Station (hyperbaric chambers, Genentech (TPA clinical trial) This current pump is ideal and proven for emerging market countries (ruggedness, simplicity, always works). Now working to come out with a modular three channel unit, much smaller in size (2lbs), modular pump in 2015 with added wireless and a drug library Use and maintenance User: Can be used by the patient, physician, technician, nurse, midwife or family member Training: Can be done by film, operating instructions or by company representative Maintenance: Regular maintenance not required, the manufacturer, engineer or technician must do repairs. Setting: Designed to work in any healthcare setting or for home use Energy Requirements: Runs off of either batteries which require 220V for recharging, or DC. Software Requirements: Proprietary Software required, used to operate the pump Weight (kg): 2 Dimensions: 110mm x 110mmx 180mm Retail Price (USD): Price of Consumables (USD): 6.50 United States of America Other Features: Works in temperature range of -10 to 120 C Year of Commercialization: 1984 Currently sold in: US, Canada, Jordan, Syria, Egypt, Chad, Costa Rica, Brazil, Dubai Contact Norman S. Heyman Telephone Web xx 11
28 Medical devices 2014 Integrated respiratory blower & humidifier Country of origin This technology aims to help irregularly breathing patients from infants, paediatrics, adults and the elderly requiring varying degrees of respiratory support in the forms of additional oxygen, pressure support, humidification, improving breathing efficiency, and or tolerance to therapy. This includes but not limited to: hypoxia, pneumonia, bronchiectasis, mucocitus, COPD, and other forms of chronic or acute respiratory illness. The device is a humidifier with an integrated flow generator that delivers a wide range of flow rates (2-60 L/min) delivering warmed and humidified respiratory gases, with or without supplementary oxygen, to spontaneously breathing patients through a variety of patient interfaces. The motor entrains room air and supplemental oxygen, if required. The integrated humidifier heats and humidifies these dry gases. A heated breathing tube connects to the device and carries warmed and humidified gases to the patient via nasal cannula or tracheostomy interface. Software controls flow and heating, adjustable by the user. Developer s Claims of Product Benefits Typically respiratory supports in high acuity patients involve a ventilator with a humidifier and gas sources for air and oxygen. The new technology removes the need for a ventilator and air source by combining a blower and humidifier to support the patients across the acuity spectrum. It can also be used in low acuity settings providing O2 therapy with the added benefit of humidification and the display of delivered O2 fraction, which is only estimated in current practice Suitability for low-resource settings The minimum requirement for the device to provide respiratory support via delivery of warmed and humidified air is electricity supply and clean water for the humidifier. No air supply is required. Operating steps The user slides the water chamber onto matching ports and connects the breathing tube via a simple sleeve locking mechanism onto the device. Supplemental oxygen may be connected if required. The water level in the water chamber is automatically controlled via a float mechanism. The patient is fitted with a nasal cannula/tracheostomy interface to receive the warmed and humidified gases. The user sets the desired flow and temperature using push buttons to navigate the menu on the colour display Regulatory status Complies with ISO risk management, ISO 8185 respiratory humidifiers, IEC electrical safety, IEC electromagnetic compatibility, ISO biocompatibility New therapies require time for market awareness in distribution channels and government recognition for reimbursement in each country s medical system. Increasing regulations and burden to comply are some of the challenges in making this device available in the market. Further education on awareness and benefits of new therapy and continued publications on therapy efficacy are some of the ways to make the technology more accessible Use and maintenance User: Patient, Physician, Nurse or Family Member Training: User manuals are sufficient for use of the device, however in home, and self-users, medical professional may be needed to provide some assistance Maintenance: No routine maintenance required. Setting: To be used indoors either at home ro in any level of health care facility Energy or Facility requirements: Requires a continuous power supply of 230V. Also requires special software, which is proprietary and embedded within the device to control the device heating, flow, alarms, and display/menu settings. There is no software license fee. The facility must also have a clean water supply and if eth patient requires, a wall supply of Oxygen. New Zealand Weight (kg): 2 Dimensions: 295mm x 170m x 175mm Consumables: Breathing tube, humidifcation chamber, nasal cannula, air filter Lifetime: 5 years Retail price (USD): Price of consumables (USD): 100 Other features: It is possible to change factory defaults for flow rate, temperature, oxygen alarm limits and a choice of 27 languages. Year of commercialization: 2010 Currently sold in: Australia, New Zealand, USA, Canada, EU, China. Selected countries in South East Asia, Middle East. Contact Jon Clausen Telephone Web
29 Medical devices 2014 Low-cost computed tomography scanner Country of origin China The Computerized Tomography Scanner is a front line modality for general imaging of multiple anatomical organs like brain, chest, abdomen, spine, blood vessels, and joints etc. It offers high spatial resolution along with the ability to complete a scan within seconds in most use cases that is vital to imaging time critical patients such as trauma and stroke. This low-cost innovation is a compact 16-slice CT scanner designed to provide exceptional image quality for all routine CT imaging needs and support advanced applications such as CT Angiography, Colonoscopy and Perfusion. With 0.35mm isotropic resolution and an array of dose reduction technologies the scanner delivers detailed visualization of patient anatomy and pathology at lower patient dose. The scanner is equipped with a console computer and dual monitors that hosts a simple user interface and essential advanced applications for 3D visualization, post processing, filming, and reporting. Developer s claims of products benefits With Emergency Mode & Digital Tilt technologies, operators can position and scan patients much quicker on a CT385 scanner Compared to previous designs, this CT scanner with digital tilt can be up to 23% faster for brain CT scans. Higher spatial resolution helps doctors see more detail and improve their diagnostic confidence. With a small footprint and minimal siting requirement of 10.1m2, this is one of the most compact 16-slice CT design systems and 16% smaller than previous 2-slice CT. An ecomogination rated product with Energy Save mode helps reduce power consumption by up to 41%. Lower powers input requirement by 20% compared to previous generation of 16-slice CT scanners. Remote service tools allow global service engineer online access to diagnose up to 30% of issues in a timely manner. Suitability for low-resource settings The compact, 16-slice CT scanner that can fit in a minimal site space of 10.2m2. This is lower than previous generation and other 16-slice CT systems. A ecomagination rated product that consumes 40% lower power using an Energy Save mode. With broadband network the CT system can be connected to a remote service center for expert service engineers and applications support. Operating steps This CT scanner has a one time power-up procedure after which patients are loaded on the patient table and operator positions the patient using the gantry control panel. The CT host computer allows the operator to select a scan, set scan parameters and complete the scan. The console software also also allows viewing, post-processing, and reporting Regulatory status CE Compliant (IEC ), ROHS compliant, Japan Ministry of Health Approved, Regulatory clearance for sale in 146 countries as of July 2014 The business strategy is continued investment in developing more affordable CT scanners through new technical advancements in areas like detector, power electronics, and gantry mechanical design to name a few. In addition, we continue to address ease of use through simpler user interface and workflow development working with target users in tier II/III areas of emerging markets Use and maintenance User: Physician, Technician or Radiologist Training: Initial training by manufacturer, and operator manuals Maintenance: Requires regular maintenance 3 times annually by trained engineer, technician or manufacturer Setting: Intended to be used in secondary or tertiary levels of Health Care Facility Energy requirements: Continuous power supply of 420V Facility requirements: The CT scanner room temperature requirement is 18C to 26C and 30% to 60% RH. The scanner room size and shielding for X-rays should be as per local regulations Software Requirements: The system includes standard operating software that is installed on a control computer. There are several software clinical applications that are optional and individual licenses are sold based on customer need. Weight (kg): 1700 Dimensions: 1783mm x 1741 mm x 921mm Retail price (USD): Other features: The user interface and workflow software is available in several regional languages. Dutch, French, German, Italian, Norwegian, Spanish, Swedish, Portuguese, Korean, Japanese, Turkish Year of commercialization: 2012 Currently sold in: Many countries. Emerging market countries include Egypt, Morocco, Nigeria, Rwanda, Pakistan, Philippines, India, Myanmar, Cambodia, Vietnam, Bangladesh, Indonesia, Afghanistan, Turkey, Mexico, Columbia, Argentina, Ukraine (partial list) Contact Srikanth Suryanarayanan Telephone Web
30 Medical devices 2014 Low pressure anaesthetic machine with pneumatic ventilator Country of origin United Kingdom Two billion people globally have no access to emergency or surgical care and conditions treatable by surgery account for 11% of the global burden of disease. In remote or rural locations and low-income countries anaesthesia machines may be non-existent, unreliable or unaffordable, preventing essential surgery. Anaesthesia is vital for surgical treatment of traumas, hernias, tumours, burns, infections, congenital deformities, and for life saving emergency obstetric care such as Caesarean sections. This complete anesthesia machine has been specifically designed to provide reliable inhalational anesthesia in difficult environments. It is easy to operate, economical to run and needs minimal maintenance. It can continue to function, without interruption, if either the oxygen or electricity supply fails. It consists of a versatile breathing system; a pneumatically driven ventilator; an oxygen concentrator (that supplies oxygen & air to the patient and to drive the ventilator); and an uninterruptible power supply for voltage stabilization and battery backup. It can be used in the operating theatre for anesthesia or in intensive care as a ventilator or as a source of pre and postoperative oxygen. The machine is suitable for both pediatrics and adults. Developer s claims of products benefits Conventional anesthetic machines are designed for use in well-equipped hospitals in wealthy countries. Hospitals in many parts of the world have limited resources, no oxygen, electricity or technical support. In these circumstances, sophisticated anesthetic machines are unable to function. This machine has been designed to overcome all these problems and deliver safe, affordable anesthesia in the difficult conditions of low-resource settings. No expensive consumables of compressed gases are needed. Suitability for low-resource settings The machine is designed to function in the most challenging low-resource settings including where supplies of electricity and compressed gases are unreliable or absent, there is no skilled technical support, environmental conditions are hostile (eg temperature, humidity, dust) and infrastructure is limited. The design incorporates many specific features to overcome all these problems. This machine is based upon an established anesthesia system that is known and respected worldwide as a safe and reliable machine for low-resource settings and which has proved itself by more than ten years of service in some of the most difficult locations around the world. Numerous publications refer to the successful application of this machine in low resource settings. Operating steps Utilizing medical gases from the inbuilt oxygen concentrator, the patient can be anaesthetized and ventilated using the simple set up instructions. It is suitable for nurse anesthetists or anesthetic clinical officers. Regulatory status Produced in an ISO certified factory. The product is tested to ISO and is in the process of conformity assesments and CE marking. The technology will be demonstrated at forthcoming conferences in Africa, Asia and Europe. We will be co-authoring papers for publication in peer-reviewed journals. Use and maintenance User: physician, nurse, anaesthetic clinical officer Training: Machine comes with manual and training DVD films providing full instructions for operation and maintenance Maintenance: Minimal maintenance required, can be performed on-site by technician or trained personnel Setting: Designed for use in rural, or urban, indoors settings and suited to use in primary, secondary and teriary levels of health care facilities. Energy requirements: The machine options based on resources available. It can run off batteries, which require a V power supply for recharging or continuous power supply of V. Weight (kg): 98 kg Dimensions: 420mm x 660mm x 1450mm Consumables: Anaesthetic agent only. Can be used with isoflurane and halothane, or sevoflurane Lifetime: 10 years Retail price (USD): Price of consumables (USD): Based on chosen anaesthesia agent. Other features: mobile Currently sold in: more than 60 countries worldwide Shelf life: 5 years Contact Robert Neighbour Telephone Web
31 Medical devices 2014 Mobile-enabled non-invasive measure-through motion and low perfusion pulse oximeter Country of origin United States of America Globally, 19% of all under-five deaths are caused by pneumonia, while 26% of neonatal deaths are caused by severe infections during the neonatal period, including pneumonia or the serious blood-borne bacterial infection sepsis. From a global perspective, approximately 7% of all neonatal deaths are attributable to major congenital malformations of which at least 25% are due to severe forms of CHD. Early recognition of these diseases could potentially improve and save many lives. The proprietary technology uses adaptive filters for real-time physiologic monitoring to accurately calculate arterial saturation and pulse rate. While other pulse oximetry technologies employ one, or sometimes two algorithms to attempt to measure a patient s arterial oxygen saturation, the non-invasive device uses multiple signal processing algorithms and is the world s first Measure-through Motion and Low Perfusion pulse oximeter for medical use, allowing clinicians to noninvasively track and trend oxygen saturation (SpO2), pulse rate, and perfusion index with select Android and ios devices. Developer s claims of products benefits Flexible and easy-to-use for spot-check of the following parameters: oxygen saturation, pulse rate, and perfusion index using a mobile smart device. Ability to use compatible reusable and adhesive sensors (for Adult and Pediatric patients). Display and share information using and smart phones and facilitates remote assessment and management of patients. Suitability for low-resource settings Effective, affordable, and scalable pulse oximetry evaluation of adults and paediatrics, along with reliable follow-up in low-resource countries can significantly reduce infection-related paediatric death rates. The ease of usability and low maintenance can arm front-line health care providers with the most effective pulse oximeter that is accurate in challenging conditions of patient movement (common in paediatrics) and low perfusion. Operating steps Insert the ispo2 Rx connector into the power port of the smart device. Attach the sensor to the patient. The measurements will display on the smart device as a waveform measurement and numeric display. More details about attachment types and operational procedures can be found in the user manual accompanying the technology. Regulatory status CE Marked in France, Italy, Germany, Spain, United Kingdom and other European countries. Increase functionality to a wider range of smart mobile devices, and develop new non-invasive parameter capabilities that can be easily accessed in low-resource settings. Continue to partner with health ministries to raise awareness and improve access to technologies, develop universal standardized training for end-users, and drive further adoption of mobile devices in low-resource settings. Use and maintenance User: Can be used by patient or by any health care professional Training: Group training by a local health partner (clinician, technician, nurse, other community health worker). Maintenance: Prior to each use clean the sensor, cable and connector by wiping with a 70% isopropyl alcohol pad. Setting: Intended to be used in any setting or healthcare facility Energy requirements: draws power from attached mobile device Software Requirements: The Masimo ispo2 Rx app for Android may be downloaded from the Google Play Store, and the app for ios may be downloaded from the App Store Weight (kg): 0.07 Dimensions: 87mm x 3 mm x 2 mm Consumables: disposable batteries, cable with sensor Lifetime: 5 years Retail price (USD): 490 Year of commercialization: 2014 Currently sold in: France, Italy, Germany, Spain, United Kingdom and other European countries Contact Gary Marston Telephone Web
32 Medical devices 2014 Neonatal bag-mask Country of origin Weight (kg): 0.19 Dimensions: 72mm x 85mm x 217mm Consumables: none required, reusable system Lifetime: 5 years Shelf life: 5 years Norway Around 10 million babies born annually need assistance to breathe, and for approximately 6 million of these babies basic resuscitation such as bag-mask ventilation is sufficient, without need for more advanced measures. Lowincome countries account for over two-thirds of the world s neonatal deaths, and a large number of birth attendants need to be trained and have access to effective, affordable and therapeutic tools. The proposed solution is a reusable bag-mask for use in developing countries. It can ventilate newborns and babies up to 10 kg who need help breathing. It makes it easier to obtain mask seal and provide effective ventilations, with a new mask design and an upright stance of the bag. The bag volume is 330 ml and includes a pop-off valve, which limits the applied airway pressure to 30 to 45 cmh2o. Developer s claims of products benefits The product has 7 parts including the mask (compared to 9 to 12 parts for current manual reusable bag-masks), which makes reprocessing faster, easier, and less prone to errors. The loop tab on the bag makes it easier to remove from the valve during disassembly compared to current bag-masks. Other technological improvements include improved mask sealing, larger bag volume, added convenience to storage and transport, and high-level disinfection in low-resource setting Suitability for low-resource settings The product can be used in any setting, and does not require any electricity or automated equipment. The product can be high-level disinfected by boiling with clean water, chemical disinfection, or steam autoclaving. The product was designed with 7 parts including the mask to improve speed and ease of reprocessing between uses. Operating steps The Directions for Use (DFU) explains disassembly and reassembly, cleaning and disinfection, and testing before use. The bag-mask disassembles into 7 parts, reducing room for error with reassembly compared to other available products with more parts. After disassembly and cleaning, boiling, chemical solution, or autoclaving can disinfect the bag-mask. Before the bag-mask is ready for use, 4 steps must be performed to ensure that components are functioning correctly. Regulatory status Meets ISO :2002/EN ISO :2009, Lung ventilators Particular requirements for operator powered resuscitators, for babies up to 10 kg. Newborn Mask - Snap design, fits connectors in accordance with ISO : Anesthetic and respiratory equipment. This year, the CE marked product will be field tested in India by PATH ( as well as in Tanzania at Haydom Lutheran Hospital. The product will be offered on a not-for-profit basis for use in 75 focus countries relative to the UN Millennium Development goals. In order to achieve sufficient implementation every user should be trained or re-trained and receive follow-up support in newborn resuscitation. Use and maintenance User: Intended for use by a physician, nurse or midwife. Training: The product should only be used by persons who have received sufficient training in newborn resuscitation. This could be a one-day training program such as Helping Babies Breathe Maintenance: The product must be disinfected between patients Setting: Designed for use in indoor urban and rural settings at all levels of health care facilities. Facility requirements: The technology requires a clean water supply, temperature range of between -18 to 50 C, and availability of some sterilization method, either boiling, chemical glutaraldehyde solution or steam autoclaving can be used. Retail price (USD): 20 Other features: reusable Year of commercialization: 2014 Currently sold in: offered on not for profit basis to the 75 countries listed as focus countries relative to the UN MDGs. Contact Carolyn Purington Telephone Web
33 Medical devices 2014 Non-invasive haemoglobin monitoring device Country of origin United States of America Anaemia affects more than 2 billion people globally, resulting in 1million deaths per year. Iron deficiency anaemia, is one of the top 10 risk factors contributing to the global burden of disease. It impacts quality and length of human life along with a country s social and economic development costing $50 billion annually in GDP losses worldwide. Children, infants & women are most susceptible to anaemia, yet typically this population group has the least access to services & timely intervention. This device is an easy-to-use, lightweight, ruggedly designed handheld device that provides non-invasive and quick measurement of haemoglobin, oxygen saturation, pulse rate and perfusion index in approximately 1 minute, in virtually any environment. It takes only four simple steps to obtain all measurements. This device measures haemoglobin using similar principles as pulse oximetry with additional wavelengths of light. The device uses a sensor with multi-wavelengths of light to calculate functional oxygen saturation, haemoglobin concentration and pulse rate. Developer s claims of products benefits Current devices require painful blood draw exposing workers to blood borne pathogens, calibration/qc testing, numerous supplies requiring special storage/handling, disposal of hazardous waste, & special training/certification. The monitor is a simple easy to use multi-parameter device that doesn t require special training, supplies, or calibration to measure SpO2, pulse rate and Hg all of which it does in approximately 1 minute without drawing blood. It can be used with infants, children & adults in any setting. Suitability for low-resource settings This device is a small lightweight rugged handheld battery powered monitor designed to screen adults, children and infants for anaemia without painful blood draw virtually anywhere. Non-invasive measurement reduces fear of painful blood draws, no special handling/storage of supplies, helps addresses religious cultures concerns of blood draws, no special training required, & eliminates exposure to hazardous waste. Operating steps Connect sensor to the monitor and turn the device ON. Select sensor size using finger size guide. Place sensor on finger, thumb or great toe (for infants). The Monitor will automatically provide SpO2, pulse rate, and perfusion index first. Press the SpHb (non-invasive haemoglobin) button when tone is heard. Haemoglobin measurement will be displayed. Record measurements. Regulatory status CE Marked in France, Italy, Germany, Spain, United Kingdom, Sweden, Netherlands, Belgium, Finland, Austria, Poland, Portugal, Czech Republic, Latvia, Croatia, Slovakia, Greece, Slovenia, Romania, Hungary, Malta, Luxemburg, Ireland, Bulgaria, Denmark, and other European countries Noninvasively measuring haemoglobin empowers healthcare workers & patients across the globe, enabling them to easily identify & manage anaemia more proactively at the point of care anywhere, any time without a lab, technician or clinician. This allows a community screenings and permits health workers to focus to develop programs to address anaemia more effectively. Future work will also include education and training for both community members and health care workers of the importance of recognizing anaemia. Use and maintenance User: Intended for self-use by patient, or by any health care provider Training: Training can be accomplished individually or in groups. Material available: Operator s Manual, Quick reference guides, videos and webinars. Training takes approximately 30 minutes. Maintenance: Prior to each use clean the sensor, cable and connector by wiping with a 70% isopropyl alcohol pad. Setting: Designed to be used in any setting, including outdoor use Energy requirements: Battery operated Weight (kg): 0.37 Dimensions: 158mm x 76mm x 36mm Consumables: Disposable batteries and sensor Lifetime: 5 years Retail price (USD): 600 Price of consumables (USD): 6 Year of commercialization: 2014 Currently sold in: France, Italy, Germany, Spain, United Kingdom, Central and South America, Sweden, Switzerland, Turkey, Argentina, Australia, Canada, China, Japan, Finland, Guam, Hong Kong, India, Iraq, Israel, Italy, Jordan, Kenya, Kuwait, New Zealand, Nigeria, Qatar, Africa, Spain, US, Saudi Arabia, Belgium, Singapore, Norway, Sri Lanka Contact Gary Marston Telephone Web
34 Medical devices 2014 Oxygen reservoir filling system Country of origin Oxygen is essential in hospital wards and operating theatres, but a reliable supply is often lacking in low-resource settings. Oxygen is used in treating pneumonia, the biggest killer of children in the developing world, and other respiratory diseases. Access to oxygen can reduce mortality from childhood pneumonia by up to 35%. Oxygen is also essential for anesthesia, emergency medicine, shock, severe bleeding, and can be crucial to the survival of mothers with complications in labor A low cost solution for back up oxygen supply for use in the event of power failure and absence of cylinder or piped oxygen. Product functionality The technology consists of a compressor pump designed to fill a reservoir vessel with oxygen from an oxygen concentrator. Oxygen concentrators generate oxygen from atmospheric air, a free and inexhaustible resource. The system enables this oxygen to be stored in either a 20 liter or 100 liter reserve tank to a pressure of 5 bar (75psi) giving 100 or 500 liters of usable oxygen. This can be used in the event of power failure or absence of oxygen cylinders for direct supply to patients. It can also be used to provide up additional back up supply to run the Glostavent Anesthesia Machine. Developer s claims of products benefits Hospitals in low-resource settings rarely have piped oxygen. Oxygen cylinders are expensive, difficult to transport, and run out. The only other alternative is oxygen concentrators that generate low-cost oxygen from air, but depend on electrical power that is notoriously unreliable in low-resource settings. This technology for the first time enables storage of oxygen generated by a concentrator when power is available for use during power cuts, thus ensuring essential oxygen is always available. Operating steps The system is designed to be easy to use and does not require a skilled operator. Connect the oxygen concentrator to the compressor pump inlet. Connect the compressor pump to reservoir vessel inlet. Plug in and run the concentrator, set flow to maximum. Switch on pump to fill reservoir vessel. Store oxygen in the reservoir vessel until it is needed. Regulatory Approval In-house technical evaluation by manufacturer, an ISO certified factory. Evaluation in Low Resource Settings This technology is intended for use in low-income countries and remote locations where gas cylinders are expensive and difficult to transport, and where electrical power supply is unreliable An oxygen reservoir filling system, with four 100 litre storage vessels, was supplied to Bansang Hospital, in rural Gambia. The hospital reports the equipment is functioning well and is supporting critically ill patients in the Paediatric and Female wards. The hospital is keen to obtain further storage vessels, and the management report that the equipment is making an important contribution to improving the quality of care and reducing operational costs. The technology will be demonstrated at forthcoming conferences in Africa, Asia, the Middle East and Europe. We are coauthoring a paper for publication in peer-reviewed journals. Use and maintenance User: Physician or Nurse Training: Device comes with manual with full instructions for operation and maintenance, and a training DVD film Maintenance: Minimal maintenance which can be performed on site Setting: rural and urban settings, indoors and in primary, secondary and teritary levels of health care Energy requirements: Requires a steady power supply of 12V for 2 hours in order to recharge. Weight (kg): 13kg Dimensions: 20mm x 20mmx 330mm Consumables: No consumables requires Lifetime: 5 months Shelf life: 5 months Retail price (USD): 2635 United Kingdom Other features: mobile Year of commercialization: 2012 Currently sold in: So far sold for use in Benin, Burkina Faso, Gambia, Liberia, Malawi, and Nigeria. Contact Robert Neighbour Telephone Web
35 Medical devices 2014 Pulse oximeter Country of origin Each year, 31 million operations take place in low-resource countries without access to anaesthesia monitoring with pulse oximeters. The high cost and unsuitability of the oximeter models traditionally available have resulted in 70,000 operating rooms in these countries not having access to this technology, which is in standard use across high-income countries. In addition, 2.7 million children die each year in low-resource countries due to congestive diseases that result in hypoxemia. Early detection of hypoxemia is essential in reducing mortality and morbidity. A pulse oximeter is the most important monitoring tool in modern anaesthesia practice. It is a non-invasive device that checks the level of oxygen in a patient s bloodstream and sounds an alarm as soon as it detects the slightest unsafe change, thus avoiding hypoxia. This model is a robust hand-held device designed for use in low-resource settings where there is no access to constant electricity, biomedical engineering, consumables or replacement parts. It runs on rechargeable battery (as well as power), is available with reusable probes suitable for all ages, has a rotating screen for maximum clarity, as well as visual and audio alarms. Developer s claims of products benefits Unlike other models, this has been developed specifically for use in low-resource settings. It is robust and reliable, and can be operated using either electricity (when available) or the rechargeable battery supplied with the oximeter. On a full charge, the battery will last for more than 14 hours. Unlike the devices traditionally available, this model is compatible with Nellcor probes and is very simple to use at low-cost. No calibration or servicing is required, making it ideal for settings where biomedical engineers and service personnel are non-existent. Suitability for low-resource settings This model has been specifically designed for use in low-resource settings. It is robust and reliable, and can be operated using either mains electricity (when available) or the rechargeable battery supplied with the oximeter. On a full charge, the battery will last for more than 14 hours. Unlike the devices traditionally available, it is compatible with Nellcor probes and is very simple to use at low-cost. No training, calibration or servicing is required. Operating steps This model offers a solution to the problem of how to effectively measure blood oxygen saturation and avoid hypoxia from anaesthesia and childhood pneumonia throughout the hospital in low-resource settings. Generic probes ranging from neonatal to adult provide accurate saturation levels, as well as heart rate monitoring (Quick Start Guide attached). Regulatory status This model is CE marked (0434), meets FDA standards and conforms to IEC and ISO 9919, the international standard for pulse oximetry. In addition, the manufacturer must produce the units under conditions that meet the international standard ISO 13485:2003. The product and manufacturer have been independently examined by DNV GL and found to meet these standards. Reinforcing education will be one of the priorities for the future to make sure that the devices are used effectively. We are also looking at ways to strengthen the spare parts model to make sure that every hospital using a pulse oximeter will be able to procure the devices locally. Use and maintenance User: Intended for use by physician, technician, midwife or nurse Training: No additional training required Maintenance: No scheduled maintenance required Setting: Can be used in rural and urban settings at any level of healthcare facility Energy requirements: Requires a 100/220V power supply for recharging. Recharge time approximately 4 hours Weight (kg): 0.2 Dimensions: 123mm x 58.5mm x 28mm Consumables: None Lifetime: 2-5 years Shelf life: >5 years Taiwan, China Retail price (USD): 250 Price of consumables (USD): 25 for probes, 10 for batteries Year of commercialization: 2010 Currently sold in: Available for use in any country classified by the World Bank as low- or middle-income Contact Remy Turc Telephone Web
36 Medical devices 2014 Trans-oral nasopharynx brush biopsy-quantitative PCR for epstein barr virus DNA detection Country of origin United of States of America Nasopharyngeal cancer (NPC) affects over 80,000 individuals a year globally with the vast majority in southern China, Southeast Asia, Artic, and the Middle East/North Africa, most living in rural, less developed areas. NPC originates in obscure location of the head; lacks early signs and symptoms and often present to medical care very late with abysmal prognosis. Currently there is no suitable simple, inexpensive, non-invasive, field utilizable screening test for early detection The technology is a noninvasive early stage nasopharynx cancer (NPC) screening test that can be used in rural locations by trained healthcare workers. A sample of NP epithelial cells is collected painlessly by means of a swab of the upper throat area. The sample can then be preserved in room temperature and is analyzed for the presence of Epstein Barr virus DNA in the nuclear region of the cells. This technology is presently the only direct NPC screening test that is 99% accurate; specific in correlation with the diagnosis and able to identify NPC at its earliest stages, when treatment is most effective. Samples are easily collected and stored in remote communities, without a need for a visit to a medical specialist in a major city. Developer s claims of products benefits Currently, non-specific blood tests to detect the presence of antibodies to EBV or EBV DNA in the blood are used. These tests simply measure the levels of a tumor marker indirectly; have much lower sensitivity and specificity and only detect cancer when tumor is large and therefore has no value for early stage cancer detection. In addition, these methods require specific sample preservations methods such as refrigeration that is not practical for testing of patients from rural areas. Cancer screening is an important public health measure. A major challenge to screening efforts is public education and awareness about the importance of screening, especially in the absence of obvious symptoms. Education and riskawareness are crucial to success and provides a strategic platform for Oral Cancer (HPV) screening, which has a higher at-risk population. If the test is made available to a broader user group, it can be a model for simple, accurate, testing for virally-triggered cancers of the oral cavity of susceptible individuals in developing nations. Regulatory status The ambulatory early stage screening test for nasopharyngeal cancer has been approved for sale under CLIA/FDA, in the USA, based on its 99% accuracy rate for detection of the disease (less than 1% false positive or negative). The test provides a direct measurement of whether or not epithelial cells from the nasopharynx have been infected with EBV and contain EBV DNA, indicating that the cells have been malignantly transformed. The DNA-based genetic assay is sold as a Laboratory Developed Test under CLIA (Clinical Laboratory Improvement Amendment- FDA) in USA, Canada and Hong Kong. Additionally, a Pre-Submission for Market Approval has already been filed with the FDA in the USA. This was submitted in order to establish further precedence for the virally-triggered cancer detection platform, so that it can be made applicable for other diseases. Suitability for low-resource settings The circumpolar Inuit, Polynesians and rural North African villagers are at high-risk for nasopharyngeal cancer. A sparse population base, inaccessibility to medical specialists and low-availability of health care resources makes healthcare delivery impossible for these patients. This technology would allow early stage cancer screenings for patients in these remote locations at a fraction of health care cost and minimal dependency on specialists and health care infrastructures. The test is used in a number of primary care settings, both in Canada and Hong Kong. In addition, basic standards for training frontline healthcare workers, sampling methodology, and test procedures have been worked out for community hospital settings and doctor s offices in these locations, in anticipation of staging into more low-resource settings. The sample preservative technology is robust, eliminating the need for sophisticated temperature requirement such as dry ice or refrigeration. Use and maintenance User: Intended to be used by a physician, technician, nurse or ENT specialist Training: Persons required to use the tool will already have been trained on how to take samples. Setting: Designed for use in health care facility at all levels of care. Facility Requirements: Requires an ambient environment to be within range of -30 to 40 C, and requires mail/courier service Lifetime: single use Shelf Life: 10 Months Retail Price (USD): 300 Price of Consumables (USD): Year of Commercialization: 2010 Currently sold in: US, Canada, Hong Kong Contact Leo Chui Telephone Web
37 Medical devices 2014 Z-arm digital x-ray Country of origin It provides state-of-the-art image quality, image post-processing, operator control, dose reporting and auto system check. These features make the system reliable and easy to use while providing high-quality radiographic images in a digital environment. This patented digital detector, which captures radiographic images in digital form, is an X-ray generator/power unit. An acquisition and review workstation for image post-processing, short-term storage, and quick in-room parameter setting are included. Images may be transferred manually or automatically via DICOM network for printing, archive and view. Developer s claims of products benefits Z-shaped arm positioner allows for faster positioning and better reliability with a built in angle meter. This technology requires a lower patient dosage than other x-ray machines. It also had easy installation and less space requirements than traditional x-ray machines. Suitability for low-resource settings The device is specifically designed for low resource settings. It is designed to be rugged: e.g. all mechanical movement are tested for over 200 thousand times to survive for 10 years, severe shipping test to simulate over 1200 miles truck transportation. Smaller size and room requirement. Full functionality and perfect DR image quality. It could get benefit for rural market, which has low resource condition. Regulatory status Conforms to the requirements of Medical Devices Regulatory. Also certified ISO 13485&9001 Future developments will include continue improving product quality, and looking for more opportunity to reduce product price and contribute to more basic healthcare areas and wish more countries could gain benefit from this innovative technology. The challenge is now to implement these strategies for a lower cost. Use and maintenance User: Intended for by physician or technician. Training: Application engineer of GEHC, for normal DXR, 8 hours of training required. 4 hours training for Z-arm Digital X-ray which is much shorter than other normal DXR product. Maintenance: Annual maintenance required for proper functionality assurance. Setting: Intended to be used at all levels of health care facility Energy requirements: Required 380V of continuous power supply Software Requirements: Application software is designed base on Linux system by GEHC. Open source, no license fee needed. APP software could provide work list management, simplified auto protocol assistant and patient information management more than 600 User programmable APR which have improvements that make it easier to use by poorly trained technicians Environment Requirements: +10 C~ +35 C humidity range: 30% to 75%. Facility requirements: Facility must have radiation Isolation capabilities and ability to the system to connect to a laptop or computer. Recommended minimum room area 25m² Weight (kg): 770 Dimensions: 2400mm x 2000mm x 2300mm Retail price (USD): People s Republic of China Other features: The Software can be customized for local use including English and Chinese languages. Year of commercialization: 2013 Currently sold in: China, Thailand, Myanmar, Malaysia, and Australia Contact Liu Ming Telephone Web
38 Other technologies 2014
Stoves Envoy 850 Manual Dexterity Test
39 Other technologies 2014 Breastfeeding simulator Country of origin People s Republic of China Breastfeeding is one of the most effective ways to ensure child health and survival. Globally, about children could be saved annually if every child were optimally breastfed. Globally, less than 40% of infants under six months of age are exclusively breastfed. The product is intended to be worn by people. Along with an abstract exterior, the design enables both male and female health workers and trainers to feel comfortable while allowing an interactive role-play and hands-on demonstrations and practice. When the user performs manual milk expression techniques, the breastfeeding simulator provides positive feedback by releasing droplets of water. The product contains two 500 ml bags in a skin-like neoprene textile that the user refills with water between sessions. These bags supply the liquid for the feedback mechanism and provide a realistic feeling of postpartum breasts. Developer s claims of product benefits Existing solutions provide realism and feedback relative to the learning goals, but are costly (> 500 USD) and not portable. There are textile models that enable communication training through role-play, but are lacking in realism and feedback when the correct technique is applied. This solution provides anatomical realism, feedback, and training on communication skills through role-play at an affordable cost for large-scale implementation of training programs. Suitability for low-resource settings The product is intended for large-scale deployment of maternal and child health education programs. It is highly affordable so that NGOs can purchase large quantities for large/scale classroom learning. It is not only a demonstration tool, but also meant for individuals to role-play and practice. It is designed to be highly mobile, so that trainers can easily move it to different training sites and facilities for teaching. Operating steps Fill bags with 500ml of water each. Use belt straps to secure to body. Practice skin-to-skin care or manual milk expression. Let the simulator be available for retraining, or empty water bags for convenient transport. Regulatory status Although the simulator does not require regulatory approval, it has been tested according to the manufacturer s and developers internal requirements and quality standards (lifetime testing, durability, material compatibility, etc.). Future work involves large-scale deployment of maternal and child health education programs Use and maintenance User: Intended to be used by Physician, Midwife or Nurse for Training Purposes Training: Various NGOs will provide training, integrated as part of larger maternal and child health training programs. Maintenance: Wipe down, and filling of water tank, after and before each day of use. Setting: Can be used in any setting or level of healthcare facility Facility requirements: Clean water supply Weight (kg): 300mm x 270mm x 170mm Dimensions: 0.29 Consumables: None Lifetime: 3 years (at least 3,000 cycles) Retail price (USD): 58 Year of commercialization: 2014 Currently sold in: It is offered on a not-for-profit price to the 75 countries that have been identified by UN as focus countries relative to MDG 4 and 5. Contact Paulina Quinonez Telephone Web
40 Other technologies 2014 Healthy newborn kit Country of origin Every year, four million infants die in the neonatal period (within 28 days of birth). Of these, three million new-borns die in the first week of life. In many high neonatal mortality settings, mothers and new-borns do not have access to the basics of post-partum newborn care (thermal care, infection prevention, and feeding support), increasing risk for preventable but life-threatening infection. India has the highest number of under-five deaths This simple, low-cost technology addresses the main preventable causes of newborn mortality (hypothermia, infection and asphyxia) by providing a one stop shop for basic tools and education to ensure health of baby during the early neonatal period. The kit contains essential commodities recommended by the WHO to ensure infection reduction (e.g., bath soap, mucous extractor, Chlorhexidine gel for cord care) and thermal care (e.g., thermometer, receiving blanket, hat). The kit also includes educational tools for both the mother and health worker (e.g., pictorial newborn care guide, tips on kangaroo care and breastfeeding) Developer s claims of product benefits Currently, no convenient, comprehensive or cost-effective newborn kit on the market exists that meets the unique needs of resource-poor settings, and specifically promotes globally recognized best practices. Due to staff/supply shortages in healthcare facilities, individual components are often unavailable, forgotten, or reused without proper sterilization. This customizable kit addresses local/cultural/facility-based needs, providing ALL essentials tools together in the right place, right time. Suitability for low-resource settings This kit addresses major barriers to proper newborn care, while taking into consideration local factors ranging from harmful traditional practices to institutional bureaucracy. The kit simplifies procurement for health facilities and is more affordable compared to purchasing components separately. This educational tools address specific cultural issues that deter parents and health workers proper, recommended care (e.g., using old rags to cloth baby, applying oil/mud on the cord, etc.). Operating steps Open kit; find all tools needed for essential neonatal care. Use soap to clean baby; thermometer to check for hypothermia; Chlorhexidine to rub on the umbilical cord, clean hat and blanket to keep baby warm, etc. (all basic tools familiar to health workers). Check pictorial guide/mobile phone training for instructions on product use if needed. Health worker gives educational tools to mother. Regulatory status The Healthy Newborn Kit was recently accepted as a commitment to the Every Newborn Action Plan. The UN Health Envoy has recognized the kit as a high-impact commodity that can improve newborn health and survival. A large need exists for awareness and advocacy around best practices, particularly the use of Chlorohexidine (given the Indian policy on dry cord care and other traditional practices such as using oil and mud). This kit is accompanied as well, by a mobile phone training program intend to be use as a method for educating health workers and mothers on recommended best practices. Use and maintenance User: Intended for use by mother with explanation and training from a Physician, Nurse or Midwife Training: Pictorial guide, Mobile voice message training (optional) Setting: Intended to be used in primary and secondary health care facilities Facility requirements: Clinical Waste Disposal Facilities to dispose of products with blood. Access to mobile phone network is ideal but not required. Weight (kg): 1 India Dimensions: 300mm x 170mm x 90mm Consumables: Underpad, mucous extractor, scalpel, cord clamp Retail price (USD): 5.99 Price of consumables (USD): xx Year of commercialization: 2015 Currently sold in: India Contact Zubaida Bai Telephone Web
41 Other technologies 2014 Task and room light for health workers Country of origin Health workers working in resource limited settings struggle with poor illumination while performing critical duties like delivering new-borns and emergency care for new-borns and mothers. They often rely on sources like candles and gas lamps or cheap electric torches which often are unreliable, unsuitable and in need of assistance. There is also a need for a focused beam of light for birth-related activities like vaginal inspection, noting cervical dilatation, etc. Product Description A compact, rechargable light with a narrow focused task light, and ambient light with three brightness levels each. Shine times range between 4 to 70 hours on full charge and selected mode of brightness level. Lamp can be worn on head, neck, hung from roof or as a table lamp with simple accessories. It is rechargeable from main grid or solar panel through a micro USB port. When charged, it can also be used to as battery boost to the mobile phone. Lithium ion battery allows for long shelf life and a large number of recharge cycles. Developer s claims of products benefits This product is more robust, easier to use, and more affordable to maintain than other lights available in low-resource settings. This model does not require dry cell batteries. It can survive a 1m-drop. The bright focused light and hands free usage make it appropriate for lighting during medical procedures. It can be also used as an emergency power source to charge cell phones Suitability for low-resource settings Li-ion batteries with long shelf life, provides a maximum burn time of 70 hours. It is easy to recharge through grid using a micro USB port (even intermittent supply) and solar panel. This also can prove useful for emergency recharge of mobile phone battery. This light is easy to use with multiple light modes and usability features. Durable and robust casing for weather resistance. Regulatory status Is CE-marked. A distribution channel that works to get the lights in the hands of the intended target users is the biggest challenge. It may happen through government procurements for its public health workers or through organised channel partners in the domain. Customs duty for imports into certain nations may add to the cost of the product. Use and maintenance User: This task light is designed for all health care personnel Training: None Maintenance: Requires only regular cleaning and charging Setting: The task light can be used anywhere, in any setting Energy Requirements: Required power supply to recharge: 100V for 3 hours. If by solar power, requires 4 hours sunlight. Or continuous power supply of 5V. Expected battery life is 70 hours. Weight (kg): 0.3 Dimensions: 70mm x 70mm x 35mm Consumables: None Lifetime: 5 years Retail Price (USD): 19 People s Republic of China Other Features: can be wall mounted, attached to a head/ strap or table/mounted Year of Commercialization: 2014 Currently sold in: Rwanda, India Contact Sunny Jinjie Chen Telephone Web
42 Technologies for outbreaks 2014
43 Technologies for outbreaks 2014 Alcohol & chlorine free sanitizer Country of origin This sanitizer is a highly technical sanitizer that aims to address the problems such as Norovirus, C-diff, Ebola, Flu, Swine Flu, MERS etc. An alcohol and chlorine free sanitizer consisting of a blend of technical quaternary ammonium compounds, biguanides and surfactants. It comes in many different formats, such as wipes, hand hygiene, sprays and air fogging. It is safe to use on all surfaces, and has a residual barrier of up to 18 hours. Developer s claims of products benefits This sanitizer could be more beneficial over chlorine and alcohol. Chlorine is very harmful to the environment, skin, and health and is also very costly, hard to store and transport. Also once mixed it has a short shelf life. Alcohol causes skin irritation, can t be used in prisons, mental health institutes etc. It is widely documented that alcohol isn t effective against most viruses. This sanitizer was independently tested against Ebola. Suitability for low-resource settings No training or skill set required to use, easy to store, easy to apply, and both chlorine and alcohol free, effective and reasonably priced. Operating steps Little explanation required, use according to product package instructions. Regulatory status Tested by BluLab, ALcontrol Laboratories, BluScientific, and other laboratories. This product has been fully developed tested and is on the market. Future steps will be expanding the market. Use and maintenance User: This product is intended to be used by anyone in a medical setting Training: none required Maintenance: none required Environment of Use Setting: The sanitizer can be used in any setting and at any level of care Energy or Facility Requirements: None Shelf Life: 3 years United Kingdom Available Products: surface spray, wipes and fogging agents. Retail price (USD): 600 ml hand sanitizer Bulk Surface Wipes 56.80, Surface Spray Year of commercialization: 2014 Currently sold in: United Kingdom Contact Joel Glazebrook Telephone Web
44 Technologies for outbreaks 2014 Autoclave powered by solid fuel Country of origin Surgical Site Infections (SSIs) are the most common type of infection experienced by patients. In rural settings, electric autoclaves help prevent these infections, but are expensive or impractical for hospitals to buy, maintain and use. This autoclave ensemble addresses the needs of patients and practitioners for clean medical supplies in off-the-grid health centres or emergency locations. The ensemble can also be used for the sterilization of medical waste for a cleaner environment. The stove is fitted with an adapter ring that allows the autoclave to be powered by this superefficient, institutional-sized, biomass-burning stove. The autoclave sits within the stove-body receiving heat simultaneously from both below and 360 degrees around the sides the unit by a biomass fire in the combustion chamber below. Super-efficient combustion of biomass produces a minute amount of smoke. Further, any smoke produced is expelled through an attached chimney that can be configured for both indoor and outdoor use. The stove remains safe to touch at full temp. As little as 1 kg of wood is enough to power the stove ensemble for a cycle. Ensemble is easily transportable. Developer s claims of products benefits Most existing autoclaves use electricity, making them expensive for off-the-grid health centers that must use a generator to run them. Furthermore, most waste is burned or unhygeinically disposed-off. This system harnesses the most fuel-efficient, institutional rocket stove on earth and uses one tenth the fuel to complete a sterilization cycle in under an hour. It is faster, safer, more efficient, and more environmentally-sound than alternative technologies for sterilizing equipment or waste. Suitability for low-resource settings This autoclave uses solid fuel as an energy source (e.g. wood, briquette, other biomass) and is appropriate as a primary autoclave system for rural healthcare centers (hospitals, clinics), or as a backup system for urban centers. Its fuel-flexibility, efficiency, ease of use, dependability, minimal environmental impact and minimal operating costs make it appropriate for any low-resource situation. Operating steps Insert adaptor ring on stove, prepare and load autoclave for sterilization cycle. Start fire in combustion chamber. Insert sterilizer, bring to pressure, following venting protocol. Time sterilization cycle. Remove sterilizer from stove. Vent remaining steam from unit. Regulatory status FDA Registered (Food and Drug Administration) And ISO (Medical Device) The biggest challenge is overcoming mind-sets: that burning is an appropriate waste-management practice, that electrical technology is the best in developing world settings, and that environmental health should be a consideration of any health centre. Use and maintenance User: Any trained personnel Weight (kg): 56 kg Dimensions: 880mm x 610mm x 980mm Consumables: biomass fuel (firewood, coal, pellets, etc.) Lifetime: 10 years United States of America Training: Training is possible either by watching a video or by reading the instruction manual and following directions Maintenance: Combustion chamber cleaned of ash after each use Setting: To be used in rural or urban settings, either indoor or outdoor at any level of healthcare facility Facility Requirements: Clean water supply and access to solid fuel Retail price (USD): 1600 Price of consumables (USD): variable Other features: mobile Year of commercialization: 2011 Currently sold in: Worldwide Contact Adam Creighton Telephone Web
45 Technologies for outbreaks 2014 Bleach dilution gauge Country of origin A fundamental aspect of managing Ebola within healthcare facilities is the daily preparation of bleach solutions: a 1:10 bleach solution for disinfecting bodies; a 1:10 solution for surfaces, medical devices and personal protection equipment. Current WHO guidance advocates the use of a cup measurement system or scratchmarking of levels inside buckets. This simple device reduces variance in practice, minimises human error and improves process efficiency. A Bleach Dilution Gauge to aid the rapid measurement of 1:100 & 1:10 bleach concentrations for disinfecting bodies, surfaces and personal protective equipment Product functionality A single component product, laser cut from 3mm PE plastic sheet. A flat product to minimize associated supply and distribution costs. A minimal product to minimize associated production costs Flexible manufacturing allows for production of bespoke gauges/ calibrations to match procurement contracts, variance in buckets & draft angles etc. Product s indentations provides a visual indicator of water and bleach fill levels for 1:10 & 1:100 dilution mixes. Developer s claims of products benefits The tool standardises practice, improves accuracy and reduces repetition. The Dilution gauge is an improvement over current WHO recommendations as it eliminates the following current problems with the cup-measurement system: 1. reduces variance of infection prevention practices. 2. first attempt is likely to be unsuccessful as container size requires judgement to ensure that full capacity of bucket is reached 3. accurate measurement of a 10th of a cup is problematical for a 1:100 mix 4.reduces the repetition of filling a bucket using a small capacity container Variance in bucket dimensions and their capacities has been identified as a potential challenge but deliberately responded to through the selection of a flexible manufacturing process to accommodate customer needs: differing bucket sizes, capacities etc. Use and maintenance User: physician, technician, nurse, midwife, family member Training: none required Maintenance: none required Setting: Designed for use in rural, urban, indoor, outdoor and at primary, secondary and tertiary levels of care Energy and Facility Requirements: Clean water supply, and a bucket with minimal taper Dimensions: 300mmx 30 mmx3 mm Consumables: none Retail price (USD): 1 USD United Kingdom Year of commercialization: 2014 Currently sold in: New to Market Contact David Swann Telephone Web
46 Technologies for outbreaks 2014 Disposable patient transfer sheet Country of origin During a typical shift, on average a hospital staff nurse will lift 20 patients into bed, and transfer 5-10 patients from bed to a chair. Lightweight and inexpensive but high quality and immensely strong - as well as assisting in the prevention of cross infection, the Disposable Patient Transfer sheet has been designed to make patient handling both easy and safe, helping prevent back strain and injury to the staff transferring patients and is single-use thus reducing cross-contamination This product is a single use patient transfer slide sheet ideal for departments across the hospital and to help reduce cross-contamination. This can be used in a hospital, nursing home or community setting to avoid lifting patients manually any more. It is acceptable to give a patient some support, or to perform horizontal moves with a sliding aid, if this is done according to agreed safer handling principles. Developer s claims of products benefits A few reports in the literature have suggested that textiles may have been the source of patient infections, including staphylococcal and Bacillus cereus colonization, infection in newborns and antibiotic-resistant organisms. Single-use textiles are used daily as protective barriers in a majority of hospitals. In today s healthcare environment, safety, barrier qualities, cost and infection prevention are key words of supreme importance in patient care. Single-use products meet these challenges. Suitability for low-resource settings The RCN looked at the relative expense to introduce such devices into everyday practice. They found that hospitals have traditionally assumed that it would be far too expensive to provide enough handling equipment to even consider a radical change in lifting policy. In fact, costs are not that great and the cost of not tackling the issue is likely to be much greater. There are additional and potentially very high costs associated with the problems of reusable linen used for manual handling. Operating steps Start with single use transfer sheet under supine patient. Two staff stand on one side, roll the patient onto the side, staff at the opposite side to insert the patslide under sheet. With a walking stance, two staff push supine patient to the middle only. Two staff pull supine patient over to the receiving surface. Regulatory status The product is produced in an ISO-9001 registered facility. It holds CE certificates and technical files. The product, registered with the Department of Health and this CE number with the MHRA is CA The European Declaration of Conformity Certificate is attached. Product functionality No one working in a hospital, nursing home or community setting to avoid lifting patients manually. It is acceptable to give a patient some support, or to perform horizontal moves with a sliding aid, if this is done according to agreed safer handling principles. The use of transfer assist devices must be considered as a possible source of infection or contamination of workers hands; consequently, these devices should be suitably designed and made of appropriate materials. This product is single-patient use to reduce cross-contamination. Supply of product to low-resource settings requires activities of transportation, procurement, inventory control, distribution management, and customer service. Distributors will only make a limited commitment to creating the new product market, because at some point the supplier may choose a different distributer or go direct. Therefore the new product markets are never fully developed in this route to market. The distributor simply delivers other companies ideas and generally only reacts if someone else has already done so. They can be reactive and expensive and do not necessarily add value for the end customer Use and maintenance User: Intended for use by physician, technician, nurse, or midwife Training: Minimal training required as device is easy to use and understand Maintenance: None Setting: Rural, Urban, Outdoors, Indoors, and in Primary, Secondary and Tertiary Levels of Care Energy and Facility Requirements: Incineration Facilities Weight (kg): 0.1kg Dimensions: 850mm x 1000mm x 1mm Lifetime: 10 years Shelf Life: 10 years United Kingdom Retail price (USD): 3 Other features: Single-use technology Year of commercialization: 2013 Currently sold in: Europe Contact Andrew Eakins Telephone Web
47 Technologies for outbreaks 2014 Formaldehyde gas sterilizer Country of origin Japan It is common knowledge that the sterilization of medical equipment parts is very important in infection control. Sterilization is mainly performed using Autoclave. Non-heat-resistant items such as endoscopes must be sterilized using low temperature gas sterilization such as ethylene oxide (ETO) gas. However, ETO gas must aerate over a long period of time to secure safety. It requires 24 hours or more, and in some countries its emission is the subject of regulations due to toxicity. and functionality This device sterilizes using formaldehyde gas produced by vaporising 12% aqueous formalin solution in a chamber set to 50 degrees Celsius and adjusting pressure from Mpa to Mpa. The residual gas after the sterilization is decomposed and detoxified by the oxidation reaction of the catalyst. It uses the ammonia which vaporized it as a purification accelerant in this process. Therefore, it does not directly emit formaldehyde gas into the environment after sterilization Developer s claims of product benefits Non-heat-resistant items must be sterilized with a low temperature sterilizer. But, ETO gas and H2O2 gas are expensive, and difficult to obtain in some regions and countries. Above all, It must aerate over a long period of time to secure safety. It requires 24 hours or more. This product uses formalin, which is cheap and can be obtained easily in many countries and areas, as a sterilization medium. The processing time is 310min. It can be operated several times in a day. It doesn t require special training Suitability for low-resource settings The formalin solution used as a sterilization medium is cheap and easy to obtain, as is the ammonia used as a purification accelerant for the gas decomposition. The device is powered only by electricity, so it does not need steam or water supply and drainage. Therefore, installation is extremely simple. It requires a stable electric supply, but the device is sealed in case of a blackout, and has infallible gas leak safety measures. Operating steps Push the power button, Open the door of chamber, Close the door after putting the sterilizing objects in the chamber, Push the start switch of the touch panel. After the processing, open the door and take the sterilizing objects. Regulatory approval It is approved by Ministry of Health, Labour and Welfare Government of Japan and ISO A small-sized 100V formaldehyde gas sterilizer is planned, and we intend to make it operable by battery. Use and maintenance User: Nurse, Midwife, Cleaning Staff Training: The distributor performs simple handling explanation at the setting place for about 15 minutes. Maintenece: NA Setting: Rural and Urban Settings, Indoors, Primary, Secondary and Tertiary levels Energy requirements: Continuous power supply of 200V for 6 hour recharging Facility Requirements: System requires an air exhaust duct Weight (kg): 460kg Dimensions: 840mm x 940mm x 1745mm Consumables: Formalin 12% solution and Ammonia 9% solution Lifetime: 10 years Shelf Life: 10 years Retail price (USD): 161,000 Price of consumables (USD): 3 Other features: Once installed, can be a mobile unit Year of commercialization: August, 2008 Currently sold in: Russia, Saudi Arabia, United Arab Emirates, Vietnam. Malaysia, Singapore, China, Korea and India Contact Tanaka Jingo Telephone Web
48 Technologies for outbreaks 2014 Inexpensive cleaning and sterilization kit Country of origin United Kingdom Decontamination should begin as soon as the medical instrument has been removed from the patient. This system comprises of an all-in-one Channel Cleanser and gauze designed for the initial flush and wipe of an instrument in a sachet and tub. It also combines a sachet of detergent for a thorough manual clean, with a cleaning brush, together with a sachet of peracetic acid for the disinfection of the equipment. All you need to do is just add water! This system combines all the elements required to completely clean and disinfect a medical instrument and consists of a number of sachets and cleaning brushes to achieve this in a simple and cheap way. During clinical use, medical instruments are contaminated by multiple microorganisms, and failure to appropriately reprocess and handle such equipment can result in nosocomial outbreaks and serious infections. The system offers the ability to pre-clean, manually clean and finally to disinfect such equipment in an easy and affordable way. The system is simple, and only requires the user to add water to activate the three stages of total cleaning and disinfection. Developer s claims of products benefits The system provides a high level of standardization and repeatability for the handling of medical devices and other delicate equipment and fills an important gap in the device reprocessing cycle offering a total product solution when only manual systems can be employed and no automated reprocessing machines are available. It has the features of providing a complete cleaning and sterilization cycle at an advantageous price. Suitability for low resource settings With the number of procedures growing around the world, it is vital that medical devices are processed correctly in order to keep patients and staff safe from the spread of infection. Along with adhering to rigorous cleaning and decontamination practices, proper cleaning and sterilization of expensive, delicate instruments are crucial to ensure patient and staff safety and maintain optimal function. This product provides a cost-effective solution for the safe cleaning of medical instrumentation. Operating Steps Open first sachet and put wipe in tub. Add water to activate the detergent concentrate. Wipe and flush the instrument as appropiate. Place instrument into a sink and empty the contents of the detergent sachet. Manually clean the instrument with the brush provided. Rinse the instrument. Empty peracetic acid sachet into a fresh sink of water. Disinfect the instrument for the prerequisite amount of time. Regulatory status The product is manufactured in the UK providing high quality products and enabling close control of the manufacturing process. It is produced in an ISO-9001 registered facility and holds a CE mark number MHRA is CA Supply of product to low-resource settings requires activities of transportation, procurement, inventory control, distribution management, and customer service. Distributors will only make a limited commitment to creating the new product market, because at some point the supplier may choose a different distributer or go direct. Therefore the new product markets are never fully developed in this route and the market route can sometimes be expensive without adding value to the customer. Use and maintenance User: physician, technician, nurse Training: intended users will already be familiar with cleaning and sterilization protocol Maintenance: single use, therefore no maintenance required Setting: Rural, Urban. Indoors, and in Primary, Secondary and Tertiary Levesl of Care Energy and Facility Requirements: clean water supply and incineration facilities Weight (kg): 0 Dimensions: 150mm x 200mm x 70mm Consumables: None Lifetime: 2 years Shelf Life: 2 years Retail price (USD): 30 Price of consumables (USD): None Year of commercialization: 2014 Currently sold in: New Product Contact Andrew Eakins Telephone Web
49 Technologies for outbreaks 2014 Medical device transfer and storage system Country of origin BSE (Bovine Spongiform Encephalopathy) crisis has led to heightened concerns that the human form, Creutzfeldt - Jakob disease (CJD), may be transmitted by contaminated instruments or their detachable parts. The recent re-emergence of Ebola also presents a threat of cross-contamination in areas where devices are being used and transported. Many International guidelines state that medical devices should be covered during the transportation process between the procedure room and the cleaning room. Colour coded tamper-proof bag and tag system offers a protective environment and clear identification that the equipment is clean or contaminated. During clinical use, instruments are contaminated by multiple microorganisms, and failure to appropriately reprocess and handle devices both contaminated and clean can result in nosocomial outbreaks and serious infections. The system offers a protective environment for the newly disinfected device, the green tag providing clear identification that the equipment is clean. After the procedure, the device is returned to the bag, the red tag attached and the medical device can be safely and hygienically transported back to the cleaning room, with the red tag clearly showing it as contaminated. All parts of the system are single-use to reduce crosscontamination. The system is also sterilzed. Developer s claims of products benefits The system provides a high level of standardization for the handling of medical devices and other delicate equipment and fills an important gap in the device reprocessing cycle offering a total product solution when used in combination with manual or automated reprocessing systems. It has the features of keeping the instrument safe, sealed and has a tamperproof design at an advantageous price. Suitability for low-resource settings With the number of procedures growing around the world, it is vital that medical devices are processed correctly in order to keep patients and staff safe from the spread of infection. Along with adhering to rigorous cleaning and decontamination practices, proper transport and storage of expensive, delicate endoscopes are crucial to ensure patient and staff safety and maintain optimal function. This product provides a cost-effective solution for the safe handling of medical instrumentation. Operating steps Take bag out of box, 1 green tag and 1 red tag. Place bag in a tray with red tag in base of tray. Put clean device in bag and tray. Close bag and twist. Place green tag round bag and seal. Transport device to location and use. Put dirty device in the bag. Close bag and twist. Place red tag round bag and seal. Transport device to location and clean Regulatory status The product is manufactured in the UK providing high quality products and enabling close control of the manufacturing process. It is produced in an ISO-9001 registered facility. The system is registered with the Department of Health and this CE number with the MHRA is CA It has European Declaration of Conformity Certificate. Supply of product to low-resource settings requires activities of transportation, procurement, inventory control, distribution management, and customer service. Distributors will only make a limited commitment to creating the new product market, because at some point the supplier may choose a different distributer or go direct. Therefore the new product markets are never fully developed in this route to market, and end product is often expensive. Use and maintenance User: physician, technician, nurse Training: no training required Maintenance: single use, no maintenance required Setting: Intended for use in any health care facility Facility Requirements: Requires availability of incinerator Weight (kg): 6 Dimensions: 625mm x 400mm x 115mm Consumables: none Lifetime: 10 years Shelf Life: 10 years United Kingdom Retail price (USD): 1 Price of consumables (USD): NA Other features: single use Year of commercialization: 2012 Currently sold in: US and Europe Contact Andrew Eakins Telephone Web
50 Technologies for outbreaks 2014 Portable, power-free medical instrument sterilizer Country of origin United States of America Health Problem Addressed Conditions that can be addressed by basic surgery account for 25% of the world s disease burden by some estimates (includes NCDs, injuries, obstetric complications). Surgery is a cost-effective means of saving lives and preventing disability, yet 2 billion people do not have access to this care. The ability to sterilize instruments without power eliminates a barrier to providing essential procedures to the 1.2 billion people who live without electricity. A rugged case equipped with a timer and a simple valve for a cartridge of nitrogen dioxide (NO2) gas sterilizes a wide range of medical equipment. A scrubber safely absorbs the gas at the end of the cycle, and is then disposed of with regular non-hazardous waste. NO2 is a common, well-understood gas that has been proven and patented as a room-temperature sterilant that effectively kills bacteria, viruses, and spores. Developer s claims of products benefits Recently published literature review found sterilizers were available at only 64% of hospitals in LMICs, and anecdotal evidence suggests that available sterilizers are usually in disrepair and cannot be used. Boiling/chemical immersion is used for disinfection, but does not eliminate all biological contaminants. Single-use, disposable kits can be used, but supply and waste disposal costs are unsustainable. New technology allows for equipment to be safely re-used without any existing infrastructure. Suitability for low-resource settings The sterilizer is designed for use in rural health clinics and temporary medical response units that have either no access, or unreliable access, to electricity and clean water. The nitrogen dioxide sterilization technology has been commercialized in the American industrial sterilization market, but has now been adapted to a simplified, rugged form that is appropriate for all settings due to its lack of reliance on electricity or other infrastructure. Operating steps Equipment is placed inside the case along with a gas scrubber and chemical indicator. The case is closed and locked, the valve cap is removed, gas cartridge is inserted, and the cap is screwed back on. Sterilization cycle begins; timer indicates process progress and completion. Sterilization cycle is complete, the valve cap unlocks, and the empty cartridge can be removed, unlocking the box. Chemical indicator is checked for successful exposure. Regulatory status The sterilizer holds a CE mark, as is currently being evaluated in low-resource settings. An entity has been established with a Ugandan partner for distribution of the product throughout East Africa. The company has already received a purchase order from Uganda for their Ministry of Health, and has been in talks with the Ministry of Health in Tanzania. The primary challenge lies in speeding the validation, regulatory, and production processes forward so that the need for the product can begin to be met. Supply chain design for resupply of consumables is another challenge, but the company is in the process of developing a comprehensive inventory and resupply strategy through local and international partnerships. Use and Maintenance User: physician, technician, nurse, midwife Training: Less than 1 hour program offered by Jhpiego Maintenance: As needed by nurses or technicians Setting: Rural Settings, Urban Settings, Outdoors, Indoors, Primary, Secondary and Tertiary levels Energy requirements: Timer-Safety locking mechanism runs on battery with 5 year lifetime Weight (kg) :< 5 Dimensions: 502mm x 400mm x 188mm Consumables: Cartridge of NO2 Gas, scrubber, chemical indicator Lifetime: 5 years Retail price (USD): 500 Price of consumables (USD): 5 Other features: portable, Year of commercialization: March, 2015 Currently sold in: NA Contact Ariel Trilling ariel.trillingmail.com Telephone Web
51 Innovative work The 2014 Compendium of innovative health technologies for low-resource settings included a new section of ebola relief innovations to encourage the development of health solutions for the regions experiencing this health crisis. Although not formally accepted to the 2014 Compendium due to not yet being commercialized or regulatory approved, the following technologies showed great potential and the medical devices team wish to show case them to further acknowledge the level of innovative work being put forth to bring medical technology to those who most need it.
52 Innovative work 2014 Safi-safe water drops Country of origin Haiti and the United States of America We intend to target Africa, Asia, Latin America, and the Caribbean using Safi as a health prevention to confront the outbreak of Cholera, Zika, Ebola, Schistomaisis, Chickunguyna, Marburg. The product has been shown in laboratory tests and field studies to be effective against bacteria, viruses and parasites in a solution containing only one drop of Safi treatment per gallon (or 3.78 liters) from a 100 ml Safi bottle, and 35 ml of Safi treatment for a bucket of water. Shake or stir and wait 30 minutes. After this the water is purified and safe to drink Developer s claims of product benefits Low cost, effective Water Treatment for low/resource settings. Suitability for low-resource settings Safi-Safe Water Drops is a revolutionary approach at the molecular level of water purification resulting in a persistent and cumulative solution to a country s water supply. In a single treatment we can effectively eliminate childhood dysentery, stop Cholera outbreaks right away, and neutralize E. coli contamination in a targeted environment. Operating steps Safi-Safe Water Drops is a non-toxic tasteless and odorless alternative to traditional water purifying treatments. The important advantage of Safe-Safe Water drops, is that it remains in solution indefinitely so water stored in dirty containers or contaminated by dirty hands or cups will continue to be disinfected Regulatory status Safi was evaluated and approved in 2012 by the Minister of Health in Haiti. The intent is to conduct several studies relating to zinc and copper deficiency Use and maintenance User: Intended for use by everyone Setting: Designed for use in rural and urban settings at in primary and secondary level of health care facilities Other requirements: Requires access to a fresh water supply and sterilization procedures. Year of commercialization: 2012 Currently sold in: Haiti Contact Pierrette J Cazeau Telephone Web
53 Innovative work 2014 U-sterilize Country of origin Italy One of the main problems of poorer countries is the lack of sterilization systems. Sterilization is important for everyday life in particular to have clean water, as well as to make medical treatments efficient and safe, avoiding viruses and bacteria transmission and proliferation. This system represents a power saving, easy to use and portable solution to sterilize surgical instruments and water. Ultraviolet-C light at particular wavelengths ( nm) can provide an efficient and economic means to create a portable, programmable and safe system to sterilize surgery and hospital tools, but also water and physiological solutions in suitable and compatible containers (neither polymeric nor organic material are compatible). This sterilizer is basically composed of an UVC lamp capable of inducing most of bacteria and virus death and degeneration. The inside of the case is in aluminium to maximize efficiency. It is possible to connect a control system by USB port which calculates the most efficient exposure time. Developer s claims of product benefits UVC systems have been largely developed to sterilize water. There are also some sterilizers for dentists and podiatrists, for example, because their tools are quite small. The strengths of this sterilizer are the optimization from the power consumption point of view and the possibility of using battery and solar energy. Furthermore it is completely open source and easily reproducible at low cost. Suitability for low-resource settings The sterilizer is designed to provide low energy consumption with the best compromise between efficacy and power efficiency. The control algorithm optimizes the exposition time to reach a good SAL (Sterility Assurance Level, typically ) saving much energy. The use of aluminium for the internal case increases the efficiency by 70%. The system can be equipped with solar panels and batteries in lieu of main power. Operating steps Without system control: open the case, put the object inside, close the door. After having plugged in the power supply, turn it on. Some standard exposure times are given. A homogeneous exposure needs to turn the system off and upside down the object. With system control: you can set some parameters; the display automatically shows the exposure time and turns on and off the lamp, indicating when eventually to turn the object. Regulatory status Still requires regulatory approval. The University of Pisa is developing this sterilizer with a particular attention to the optimization of energy consumption to improve the efficiency of the system: future studies will be spent in finding energy autonomy solutions, using also natural and available forms of energy as well as solar and mechanical. Furthermore UVC diodes are now starting to be commercialized: these represent a very efficient system which will be able to drastically reduce power consumption, but in this moment they still are a research tool. Use and maintenance User: Can be operated by any trained personnel Maintenance: Requires annual maintenance, which can be done on-site Setting: Designed for use in indoor health care facilities. Energy requirements: Requires a continuous power supply of 220v Software requirements: This sterilizer is intended to be completely open source and easily reproducible, so that the system control has been implemented in C language with Arduino support, but it can identically be used with other platforms. Weight (kg): 2 Dimensions: 240mm x 120mm x 120mm Lifetime: 1 year Retail price (USD): 300 Price of Consumables (USD): 30 Other features: The software, being open source, can be customized. For example it can be developed with sensors for Ozone and temperature control: these can easily be integrated in the system, intervening on the software too. Year of commercialization: Still in Development Currently sold in: Still in Development Contact Renata Bertocchi Telephone Web
54 Assistive devices 2013
55 Assistive devices 2013 Artificial prosthetic knee joint Country of origin Canada Over 25 million people living in developing countries require the use of prosthetic and orthotic devices. Individuals who have had their leg(s) amputated above the knee joint due to trauma, disease or a congenital reasons and are unable to walk without the use of a lower-limb prostheses are the target population for this product. With an above-knee prosthesis, people with above-knee amputations will be able to walk, remain independent, productive and healthy. The artificial knee joint is an integral part of the above-knee prostheses. The knee unit is simple in design and made of fiber-reinforced polymer construction. The lower end connects to a modular prosthetic system, which ultimately connects to an artifical foot. The upper end connects to a prosthetic socket with an attachment. Product functionality The knee unit utilizes a proprietary stance-phase control mechanism, termed the Automatic Stance-Phase Lock (ASPL). It is composed of a knee lock that is automatically engaged as the knee becomes fully extended thus preventing the knee from bending. A combination of a hip flexion moment and loading of the forefoot unlocks the knee. This is a natural sequence of events that occurs at each step of walking and allows the knee to be stable as needed while facilitating natural swing-phase flexion. The knee joint is fitted by a trained technician during the fabrication of the above-knee prostheses. Developer s claims of products benefits One of the most common types of knee joints used in low resource settings is the manually locking knee that requires walking with either a straight leg or an unlocked one that is very unstable. This product provides a high level of stability during weight bearing and at the same time a high level of mobility. It is easy to assemble, can be used in water and wet environments without being damaged and is also low-cost. Development stage Independent product evaluations and clinical trials have been conducted in Canada, Chile, El Salvador, Germany, India and Myanmar. It was tested as part of the ISO standard-prosthetics structural testing of lower-limb prostheses. There is a need to establish a partnership with an international distributor. In addition, finalization of negotiations in regards to production is required in order to decrease further the product cost while ensuring high and consistent quality. Use and maintenance User: Self-use Training: Not required Maintenance: On-site as needed Settings: Rural, urban, ambulatory, at home Requirements: A facility with tools and materials and trained clinical/technical personnel to fit the product into a prosthesis Dimensions (mm): 60 x 80 x 180 Weight (kg): 0.7 Consumables: None Life time (years): 3-5 Shelf life (years): 10 Retail price (USD): NA List price (USD): 100 Other features: Reusable Year of commercialization: Premarket launch 2013 Currently sold in: Germany and used in Chile, Myanmar, Tanzania, India, Nicaragua and Canada. Contact details Jan Andrysek Telephone Web
56 Assistive devices 2013 Child wheelchair Country of origin Israel About 70 million people have different health conditions ranging from spinal cord injury to birth defects requiring a wheelchair for mobility. Among them, only 5-15% have access to one and out of this population, 25% are children with disabilities. Wheelchairs can assist these children to be mobile, independent and healthy. The wheelchair consists of two large rear wheels with pushrims, two small swiveling front wheels (castors), a metallic frame, plastic seat, footrest and a cushion. It is modular in design, its components come in three separate boxes and need to be assembled as per the need of the child. Product functionality The user sits in the wheelchair and can move around manually by pushing the pushrims. It fosters independence and social integration and allows the child to leave the house, access education, and be like other children. Developer s claims of products benefits Most of the available wheelchairs in the world are for adults. Available child wheelchairs are often the miniature size of adult wheelchairs without valuing children s needs and preferences. This product has been specifically designed for children. The wheelchair is light-weight but durable, low-cost and can be assembled locally. It requires low maintenance and is very attractive to children due its design and colour. Development stage The wheelchair was developed and assessed according to DIN ISO 7176 and the WHO Guidelines on the provision of manual wheelchairs in less-resourced settings. To establish collaboration with local NGOs and governmental organizations to support training and distribution, to provide training to rehabilitation teams and to raise funds to support the wheelchair s production and distribution. Use and maintenance User: Self-use Training: 1 day training by physiotherapist, occupational therapist or rehabilitation teams Maintenance: Monthly adjustments of screws Settings: Rural, urban, ambulatory, at home, primary (health post, health center), secondary (general hospital), tertiary (specialized hospital) Requirements: Trained clinical/technical personnel to assemble the wheelchair Dimensions (mm): 800 x 400 x 740 Weight (kg): 11 with tubeless wheels, 9.5 with pneumatic tube Consumables: Cushion, accessories Life time (years): 3 Retail price (USD): 95 List price (USD): 95 Other features: Continuous-use, mobile Year of commercialization: Anticipated 2014 Contact details Chava Rothstein Telephone Web
57 Assistive devices 2013 Hollow mattress Country of origin Bangladesh People with spinal cord injuries often develop pressure sores due to prolonged sitting or lying without changing position. Sitting or lying on hard surfaces makes the situation worse. Many people while sitting in a wheelchair use a pressure relief cushion but do not have the capacity to afford a pressure relief mattress. As a result they often develop pressure sores, which are difficult to manage and expensive to treat, especially in low and middle income countries. The product is a mattress with an opening to accommodate the pressure relief seat cushion of the patient s wheelchair. Product functionality By having the space to accommodate the pressure relief seat cushion in the mattress, the pressure is relieved at the usual pressure points, such as in the tailbone and hip bones, while in the supine position. The wheelchair seat cushion is placed in the hole of the mattress to make a full mattress. The whole matress is covered with water resistant fabrics. Developer s claims of products benefits This modified pressure relieving mattress prevents development of pressure sores in the supine position. It saves on unnecessary health care expenditures to heal/manage the pressure sores. It also helps to reduce the time needed for full rehabilitation. It can be made locally with easily available and accessible resources such as an ordinary foam mattress. It is affordable and water resistant. Development stage The product has been used in a rehabilitation centre for people with spinal cord injuries. This product has been approved by the multidisciplinary team of the specialized Spinal Cord Injury Unit of the largest paraplegic centre of Bangladesh. Use and maintenance User: Self-use, family member, care-giver Training: Not required Maintenance: Not required Settings: Rural, urban, ambulatory, at home, primary (health post, health center), secondary (general hospital), tertiary (specialized hospital) Dimensions (mm): Variable Weight (kg): 7-8 Consumables: No Life time (years): 5 Shelf life (years): 5 Retail price (USD): 25 (without the cost of cushion) List price (USD): 25 (without the cost of cushion) Other features: Mobile, continuous-use Year of commercialization: 2008 Currently sold in: Bangladesh Contact details Iffat Rahman Telephone Web
58 Assistive devices 2013 Magnetic prosthetic suspension system Country of origin Malaysia A prosthesis is used as part of amputee rehabilitation and the suspension system is an important feature that affects prosthesis users quality of life. Individuals with lower limb amputation need to wear prosthesis to perform activities of daily life, especially walking. The magnetic suspension system is a magnetic coupling device, which holds the residual part of the limb (stump) inside the prosthesis (artificial limb). It consists of three parts: a metal plate inside the socket, which is attached to a prosthetic soft liner; a magnetic assembly (the source of magnetic power), which remains outside of the socket - positioned between the prosthetic socket and the pylon (internal frame of the prosthetic leg); and a switch, which connects or disconnects the coupling device. The soft liner acts as a sort of second skin between the movable soft tissue of the stump and the hard shell of the socket. The soft liner provides comfort and holds the stump inside the prosthesis with the help of the magnetic coupling device. Product functionality After donning the prosthetic soft liner, the user puts the stump inside the prosthesis. The mechanical switch is positioned in the On mode. The magnetic field will hold and retain the stump within the prosthesis. While removing, the user needs to position the switch to the Off mode, which will then allow the user to withdraw the stump from the prosthesis. The system comes with an optional acoustic safety alarm, which can warn the user about imminent possibilities of suspension failure. Developer s claims of products benefits The system is easy to fabricate, cheaper than other suspension systems, more durable and easy to use. It requires less maintenance, reduces pain in the residual limb, decreases interface pressure and reduces pistoning. Development stage The system patent is pending both in Malaysia (PI ) and the US (13/865,677). The technical aspects have been approved by the University of Malaya Medical Ethics Committee and the product has been clinically tested by lower limb amputees. The findings of a technical evaluation have been published in the Institute for Scientific Information (ISI) journals. A paper on the biomechanical evaluation of the system was awarded with the best research in the field of Advancing technologies in the 14th International Society for Prosthetics and Orthotics (ISPO) world congress. Future work includes implementation of large scale manufacturing and worldwide distribution. Use and maintenance User: Self-use Training: Not required Maintenance: On-site once a year Settings: Rural, urban, ambulatory, at home Requirements: A trained prosthetist to fit the product into a prosthesis Dimensions (mm): 30 x 30 x 30 Weight (kg): 0.25 Consumables: Batteries, if used with safety alarm Life time (years): 5 Retail price (USD): 500 List price (USD): 250 Other features: Reusable Year of commercialization: Ready to be commercialized Contact details Arezoo Eshraghi Telephone Web
59 Assistive devices 2013 Pen-mounted CCTV camera Country of origin India Persons with very low vision due to age related macular degeneracy or advanced glaucoma have difficulty in reading their own writing due to the small size of the written font. The closed-circuit television (CCTV) camera is mounted on a pen and connected to a computer/monitor, which shows the camera picture (written font) magnified to the extent necessary on the screen. Product functionality A person can see on the screen what he or she writes on paper with the camera-equipped pen. The magnification of the font size is adjustable using a switch on the system. Developer s claims of products benefits This camera enables persons with very low vision to see what they write. Local production is possible with easily available accessible low-cost CCTV cameras. Development stage The product has been tested by patients at one of the largest eye-hospitals in India. The idea is simple and made freely available at low cost to anyone who wishes to use it. Drawings and production details may be requested from the contact person. Use and maintenance User: Self-use Training: Not required Maintenance: Not required Settings: Rural, urban settings, at home Requirements: Continuous power supply for the PC, laptop, or monitor and camera Dimensions (mm): 200 x 20 x 20 Weight (kg): 0.5 (whole system excluding monitor) Consumables: No Life time (years): 5 Shelf life (years): 5 Retail price (USD): 20 List price (USD): 20 Other features: Portable, continuous-use Year of commercialization: Ready to be commercialized Contact details Vijayaraghavan Srinivasan Telephone Web
60 Assistive devices 2013 Polycentric prosthetic knee joint Country of origin United States of America Around 9.5 million people with an above-knee amputation living in low and middle income countries need a prosthesis to regain mobility for livelihood, employment and social integration. Most of the amputations are due to injuries, especially road traffic crashes, diabetes, and other health conditions. Modern above-knee prosthesis are prohibitively expensive, especially due to the cost of the knee joint, which is the most complex component of an above-knee prosthesis. It is a polycentric prosthetic knee joint, which mimics the movement of a normal knee joint while walking. At the same time, it provides stability during the weight-bearing phase to ensure the person can walk with their artificial limb without falling. Product functionality A prosthetic knee joint is the connector between below and above knee prosthetic components to provide knee movement like a normal knee. It usually gets attached to a modular component or a pylon at the lower end which ultimately connects to a prosthetic foot. On the other end, it connects to a prosthetic socket again through a modular attachment. Developer s claims of products benefits Prosthetic clinics in the developing world typically recycle used donated prosthetic knees or use locally made singleaxis knees. Donated knees are cost prohibitive to maintain and perform poorly in rugged environments. Single-axis knees are unstable and can buckle, especially when walking on uneven surfaces. The polycentric prosthetic knee joint provides increased stability for uneven and unpaved terrain, withstands high usage by using an oil-filled nylon polymer which self lubricates with use, it can be used in humid and wet environments and it is low cost. It provides 165 range of motion at the knee, which is critical for low and middle income countries, especially for kneeling, squatting, biking and agricultural work. Development stage The knee has been fit on over 4,600 patients, primarily in India. In 2013, the latest version of the product was tested to ISO Prosthetics structural testing of lower-limb prostheses. Successful outcomes depend on availability of trained prosthetists who can fabricate a custom socket to fit over the patient s residual limb. Scaling is currently limited to areas with established prosthetic clinics capable of providing a proper fitting. Use and maintenance User: Self-use Training: Instructions for use comes with the product, fitting training is required for prosthetists Maintenance: Not required Settings: Rural, urban settings, at home Requirements: A trained prosthetist to fit the product Dimensions (mm): 60 x 80 x 140 Weight (kg): 0.68 Consumables: None Life time (years): 5 Retail price (USD): 80 List price (USD): 80 Other features: Single-use, portable Year of commercialization: 2008 Currently sold in: India Contact details Krista Donaldson Telephone Web
61 Assistive devices 2013 Polypropylene endoskeletal lower limb prosthetic system Country of origin Due to road traffic injuries, wars and conflicts, non-communicable diseases and other health conditions, many people with disabilities have limited mobility and are in poor health. Nearly 35 million people in the world are in need of orthopaedic (prosthetic/orthotic) devices to improve mobility and their overall health. Among them, only 5-15% in low and middle income countries have access to one. The system is a set of specially designed polypropylene components to fabricate/fit lower limb prosthesis (artificial limb) for people with lower limb amputation. Usually, it comes in two varieties: 1) Trans-tibial (below-knee) and 2) Trans-femoral (above knee) amputation. The system consists of a foot piece, convex ankle, two concave cylinders, convex disc, cylindrical TT cup, flat steel washer and countersunk head bolt, lock washer and a knee unit in case of Trans-femoral (above knee) prosthesis. Product functionality The modular endoskeletal components are mostly made out of polypropylene and available in different sizes. It also comes with a prosthetic foot and other necessary materials for fabrication of the socket and cosmetic cover. A trained prosthetist fabricates the socket, selects the needed components, assembles those to make the prosthesis as per measurement and then does the fitting. Developer s claims of products benefits The product is affordable, durable, comfortable, easy to use and to maintain. It has a long shelf life and at the same time, recyclable. It is compatible with different climatic regions of the world. Development stage Products are available on the market and are being used in more than 100 projects all around the world. The product has the ISO Norm certificate by C.E.R.A.H. The product has been evaluated by the International Society for Prosthetics and Orthotics (ISPO). Future work includes development of an advanced prosthetic foot, knee and a hip joint. Use and maintenance User: Self-use Switzerland Training: Short training on use and maintenance Maintenance: On-site every 1-2 years Settings: Rural, urban, at home; for indoor and outdoor use. Dimensions (mm): Components come with different sizes to accommodate all age groups. Weight (kg): Trans-tibial 2 kg; Trans-femoral 5 kg Consumables: Polypropylene sheets, assembly items Life time (years): 3 Shelf life (years): Feet 18 months. Remaining components between 3-5 years depending on storage quality Retail price (USD): Trans-tibial 150, trans-femoral 275 List price (USD): Trans-tibial 150, trans-femoral 275 List price of consumables (USD): Foot+consumables 80 Other features: Portable, continuous-use Year of commercialization: Concept emerged in 1993, developed further since then and the development work on prosthetic foot, knee and hip is still ongoing. Currently sold in: 72 low, middle and high income countries Contact details Olivier Chappuis Telephone Web
62 Assistive devices 2013 Prefabricated components for lower limb orthoses Country of origin India Despite polio eradication drives, 0.5% of the those affected by polio or other neuromuscular conditions in India and low-income countries require some kind of orthoses. Among this population, 75% live in rural areas with the majority unable to access an orthoses due to its cost and inappropriateness for the rural environment and lifestyle. The prefabricated plastic Knee-Ankle-Foot Orthotic (PF-KAFO) system consists of two plastic thermoformed shells - one for below the knee and one for above the knee - a pair of orthotic knee joints with drop-lock and uprights which connect the below-knee and aboveknee shells, and accessories such as straps/fasteners and rivets. The prefabricated plastic shells are available in nine sizes for the left and right leg. Orthotic knee joints are available in two sizes for children and adults. Product functionality Lower limb orthoses facilitate mobility and prevent secondary deformities. Components of suitable sizes are selected from the available range, assembled as per measurement of the individual and then fitted to the user. The user attaches the orthosis to the leg by means of straps/fasteners. Locked knee joints facilitates stability during the weight bearing phase and assists in walking despite having weak/paralysed legs. Unlocked knee joints allow the user to bend his or her knee, while sitting. Developer s claims of products benefits It is comfortable, cost-effective and very appropriate for low and middle income countries. It requires a minimum of time, tools and machineries for assembly. It is suitable for a rapid fitting in remote locations. It is water proof and has the possibility of using it with or without footwear making the orthosis more culturally appropriate, especially inside the house or temple. Development stage The product has been evaluated by the International Society for Prosthetics and Orthotics (ISPO) in The second ISPO evaluation was done in Ethiopia during trials in The third ISPO evaluation was completed in 2006 after more of ten months of use in Ethiopia. The findings were presented during ISPO 2007 in Vancouver. Based on the feedback, better shells and new sets of orthotic knee joints have been developed and the new product was launched during the 7th International Conference of the Federation of African Orthopaedic Technologists (FATO), Ivory Coast, 30 September - 5 October Future work includes development of an ankle joint, introduction of the technology in the Prosthetics and Orthotics Course curriculum, and introduction of the PF-KAFO system under the assistance to disabled persons of India programme, sponsored by the Government of India. Use and maintenance User: Self-use Training: Short training on assembly and use Maintenance: Daily cleaning and checking for broken straps Settings: Rural, urban, ambulatory, at home, primary (health post, health center), secondary (general hospital), tertiary (specialized hospital) Requirements: A facility with tools, stable power supply and gait training materials Dimensions (mm): Vary by size Weight (kg): 2-4 Consumables: Velcro fasteners, rubber soles, adhesives, padding foams, stockinette, rivets, screws, nuts Life time (years): 3-5 Shelf life (years): 10 Retail price (USD): 60 for the PF-KAFO shells and 60 for the knee joints. List price (USD): 60 for the PF-KAFO shells and 60 for the knee joints. Other features: Portable, continuous-use Year of commercialization: Concept was introduced in 2003, it developed further based on the feedback and evaluations, and development work on the knee joints was finalized in The whole system was launched on 30 September Currently sold in: Bangladesh, Ethiopia, India, Kenya, Nepal, Nigeria, Sri Lanka, Tanzania Contact details Albina Shankar Telephone Web
63 ehealth solutions 2013
64 2013 ehealth Blood pressure ereader Country of origin Canada and Kenya High blood pressure (HBP) is the leading risk factor for mortality globally (WHO); 1 in 6 in developing countries has HBP (CDC). A silent killer, symptomless unless measured, leads to heart attack, stroke and disability. In sub-saharan Africa, it s underdiagnosed, poorly managed and lacks community-wide preventive strategies (AJH). Solution description The self-measured blood pressure (SMBP) e-reader positioned in social points (e.g. posho mills, bars) will be accessed by community members who want to check their blood pressure. The digital SMBP machine will capture one s blood pressure, interpret the reading, and transmit the reading to health centers through cloud information services. Community members will anonymously take readings, however, they will provide a phone number which will only be used to follow-up readings deemed at risk. Community members can check their readings as many times as they wish within the period of the project. This is an opportunity for those unaware they have high blood pressure to know and seek treatment. Functionality Using a provided step-by-step guide, the user will measure blood pressure, the machine will automatically interpret the results digitally and verbally to the user in the local language and automatically wirelessly transmit the blood pressure reading with the phone number as the only identifying information. Developer s claims of solution benefits Self-administered ease of use, a step-by-step guide and use of the local language reduces training requirements. It is cost-effective in high blood pressure management by capturing asymptomatic and pre-event at-risk users. It is population-based, thus labor saving for health providers by screening only those at risk and provides public health epidemiological surveillance of patterns in populations. Technology will be available in public areas distributed through local entrepreneurs who can use the screen platform to advertise their products thus contributing to local economies and leading to sustainability. User and environment User: Self-use/patient Training: A point of contact community based worker for a 30 minute training Settings: Rural, social settings Reviewer s comments Blood pressure self monitoring is a good way for biosensors to help patients in optimal self-management. Several studies have demonstrated that this approach improves blood pressure simply through self-monitoring, even without medications. This intervention at rural and underserved areas of the countries, having the device solar powered and sending the signals to the cloud to monitor, is a good approach to capture data. Having patients being able to access the results by phone is reasonable, although being able to access results through the same computer may be more useful, especially in understanding the longitudinal changes. Therefore, even though this approach is not novel, its practical applicability in low resource settings is an advantage. Another additional benefit would be using this to track population level data to understand the prevalence and incidence of hypertension in different regions, and whether monitoring longitudinally would reduce these rates and improve outcome of decreased sequalae of hypertension (e.g. stroke, heart attacks, etc.). Solution specifications Solution is used to support: Decision support systems, Diagnosis and treatment, Electronic Health Record, elearning/mlearning, Public health surveillance Software/Hardware requirements: The facility will require access to the Internet, access to a mobile phone, use of a computer and a stable power supply which will be solar powered Standards: ICD10 Currently used in: Canada Contact details Pamela Muthuuri Telephone Evaluation: The technology has been validated through independent, published clinical trials. The research has determined that the equipment conforms to AAMI (US-FDA) and BHS (UK) guidelines for device accuracy. Software will be developed to be used with the device to interprete readings in local language and transmit the readings in the local language to the health provider. 48
65 2013 ehealth epharmacynet system Country of origin Benin This technology is designed to solve the poor accessibility of medicine in pharmacies for patients in developing countries like Benin. It is often difficult for people in rural, as well as urban areas, to buy all medicine on a prescription in only one pharmacy. Usually they have to try several pharmacies. Solution description The system intends to help a patient to discover available pharmacies in his area with a list of available medicine in stock. The patient can use any 2G/3G enabled device to communicate with the EpharmacyNet system. That system contains a localisation-based database with a real time description of available stock of all pharmacies within a region. Then the system replies back to the patient s request with the pharmacies in an area of 10km of diameter that have the target list. Interactions between both parties in the mobile network can be done via USSD, SMS, voice or data connection depending on the patient device. The system aims to provide home delivery and online payment. Functionality A patient gets a prescription from a physician. He/she uses the epharmacynet system to enter all the medicine listed on that prescription. The physician can also use the system to check availability. The system uses the central database to help the patient find the nearest pharmacy with all medicine available in stock. Developer s claims of solution benefits Using the system, patients in villages or living far from a pharmacy may receive a prescribed medicine within two days. We can thus reduce the waiting time by up to 90%. Also the transport expenses can be reduced. The system would help to increase the quality of care provision by improving the access to pharmaceutical products. Future work includes spreading the system to all African countries and working with the pharmaceutical industry in developed countries to increase access to orphan medicines (with regards to the African market). Furthermore, we plan to manage logistics problems by developing a RFID based transport box thereby increasing security (for the patient and products) and avoid fraud during the transportation of medicine. The box can also help to keep medicine at the right temperature during transportation. User and environment User: Physician, nurse, midwife, self-use/patient, family member Training: Local EpharmacyNet system IT professionals can deliver required training within a one week period Settings: Rural, urban, at home, ambulatory, primary (health post, health center), secondary (general hospital), tertiary (specialized hospital) Solution specifications Solution is used to support: Decision support systems, diagnosis and treatment, Electronic Health Record/ Electronic Medical Record, Geographic Information System, Health research, mhealth, Management of patient information, Telemedicine Software/Hardware requirements: Internet access. Mainly, open source solutions will be implemented and no licence fees. Mobile device uses USSD, SMS or specific SIM menu to interact with the database. Additional software to include localisation in the request will be used on smartphones, tablets or equivalent. The platform uses PostgreSQL, MySQL database and Linux OS. The system is not proprietary. Standards: HL7 Currently used in: Benin Evaluation: The study has been conducted in Benin in Jan, In total, 434 people had taken part in the project in the 3 test areas. The tests took 2 weeks simultaneously in all areas. More than 95 per cent were women. The participants were satisfied with the experience. The results also demonstrated that the system is easy to use by those with limited reading and writing skills. Contact details Thierry Edoh Telephone or
66 2013 ehealth Health and hospital information system Country of origin Spain Health centers in resource poor locations have deficiencies in the management of patient and hospital information. This solution provides a platform that optimizes and improves the patient and hospital information management using free software. Solution description It is free software and is designed to be multi-platform, so it can be installed in different operating systems (GNU/ Linux, FreeBSD, MS Windows). It uses Python as the programing language, PostgreSQL as the Database engine and Tryton as the development framework. Functionality The health documentation portal explains how the solution works and is available at: Developer s claims of solution benefits It is an eco-friendly solution (100% paperless). Its free software policy is a warranty of cost reduction and sustainability - basic features needed in emerging economies The main challenge of the project is to continue raising awareness for the use of free software in public health. User and environment User: Physician, nurse, midwife, self-use/patient, family member, technician Training: United Nations University IIGH will deliver training in a 5-day duration course. Settings: Rural, urban, at home, ambulatory, primary (health post, health center), secondary (general hospital), tertiary (specialized hospital) Reviewer s comments This solution is applicable for low-resource settings as it is free; works in different operating systems, and with the modular approach is customizable to the local needs of hospitals and health centers. It is available in English, French, Spanish and can be easily translated to local languages via the tryton module translator. Solution specifications Solution is used to support: Decision support systems, Diagnosis and treatment, Electronic Health Record/ Electronic Medical Record, Geographic Information System, Management of patient information, Management of hospital information, Public health surveillance Software/Hardware requirements: Server and client workstation, laptop, mobile devices and stable continuous supply power supply. Free Software licensed under GNU Public License. Standards: ICD10, ICD10-PCS Country used in: partial list of government portals, organizations and health centers involved with GNU Health: Contact details Selene Cordara Telephone
67 2013 ehealth Hearing screen erecord Country of origin South Africa 15-20% of the world s population suffers from hearing loss, yet only fewer than 10% seek professional help due to the inaccessibility and high cost of treatment. (WHO 2012) Hearing loss has also been described to be the most prevalent disability in developed countries (Davis, 1997). Solution description The technology seamlessly integrates: 1. Optimised screening enabled by an application that provides an accurate, accessible and affordable audiogram screen; 2. Optimised diagnosis enabled by effective data management, analytics, automated reports and remote review; 3. Optimised care enabled by patient remote review, e-referral, tracking, engagement and elearning. Functionality Instructions on the touchscreen are intuitive, clear and simple. Developer s claims of solution benefits Audiology services currently rely largely on unwieldy, expensive, dedicated equipment requiring skilled personel to conduct testing. Few devices used in the field for screening are web-enabled. This device offers improvements in that it uses existing, widely available touch screen mobile phones, or tablets - thus vastly reducing the cost of screening equipment. It is very simple to operate. ehealth records are immediately captured. Adoption of technology requires regulatory approval. Initial capital for handsets or computer tablets, and headphones needs to be raised. Local policy and remote evaluation of screening outcomes needs to be developed. User and environment User: Physician, nurse, technician, self-use/patient Training: Minimal training is required Settings: Rural, urban, primary (health post, health center), secondary (general hospital), tertiary (specialized hospital) Solution specifications Solution is used to support: Decision support systems, Diagnostis and treatment, Electronic Health Record, elearning, mhealth, Patient monitoring, Telemedicine. Software/Hardware requirements: A touchscreen device, headphones. Screening Apparatus: ios (plan to add Android); platform: developed using open source software Standards: HL7 Currently used in: South Africa Evaluation: International Journal of Audiology Vol. 51, No. 8, p August 2012 Contact details Michael Melvill Telephone
68 2013 ehealth Maternal and child health mobile services Country of origin India Mobile services were developed to address some of the highest rates of maternal neonatal and infant mortality (MMR 305/100,000, NMR 35/1000, IMR 55/1000) in India by helping community health workers (CHWs) in Bihar to communicate crucial information on health behaviours to pregnant women and mothers of infants. Solution description CHWs refresh and expand their knowledge of family health using an Interactive Voice Response (IVR) training course that they can bookmark and complete at their own pace over a period of up to one year. Additionally, CHWs use a second mobile service, a job aid, which is complemented by a deck of colour coded and illustrated cards bearing life saving information, to reinforce the information that they share with families on routine visits. The services are available on any mobile handset and any network in the state, are voice-based and are accessible via common mobile short codes that bring listeners directly to training content and job aid. Functionality Job aid: When the CHW counsels family members, she dials a unique short code listed on any of the 40 cards while showing the illustrated card to the family. The call takes her to the voice of a doctor character who reinforces the health message on the card. She plays the message to the family. Training aid: CHW completes mobile course at her own pace. Developer s claims of solution benefits Training is cheaper ($1.50 for full course) and more accessible than face to face training, the content is specifically designed for local context, in simple and suitable language, and therefore more engaging and easy to remember. The services use available, cheap mobile phones that are light and easy to carry, and an accompanying deck of cards containing dial codes and additional information is light and waterproof. The services are easy to use by anyone who can dial out on a mobile phone. There is interest in taking the mobile services to other Indian states and countries. The technology is scalable, however, a challenge in taking the services to new regions is the additional investment required to adapt the content to new cultural and language contexts. User and environment Users: Nurse, midwife, self-use/patient, community health worker Training: CHWs are trained by a local NGO partner for approximately 4 days Settings: Rural, primary (health post), at home Solution specifications Solution is used to support: elearning/mlearning, mhealth Software/Hardware requirements: The infrastructure required is the same as required for access to basic mobile phone functions i.e. relatively stable power supply and access to a cellular/mobile network. It is available on any mobile handset and across all the six major network providers in the state. It uses open source software, MOTECH. Currently used in: India Contact details Allen Aoife Telephone Evaluation: The services deliver health education, rather than clinical services, thus clinical trials are not applicable. However extensive user-testing was carried out to assess the usability and accessibility of the services with CHWs across Bihar (100 health workers in four batches over six months). The technical health messages in the content were approved by the Government of Bihar and developed with input from a range of medical experts and institutions in line with WHO guidelines. 52
69 2013 ehealth Mobile supply chain management tool Country of origin United States of America Stockouts and other supply chain disruptions pose real challenges in low-resource communities. According to a WHO report, the problem is in getting staff, medicines, vaccines, and information on time, reliably, and in sufficient, sustained and affordable quantities to those who need them. Solution description The solution is an open-source turnkey product designed to strengthen logistics management through the use of mobile technology. Its purpose is to support health workers and other mobile agents who manage commodities in low-resource settings. It has been proven at scale, through real-world deployments, to provide reliable, real-time, and actionable information to improve the performance of new and existing supply chains. Functionality Users report stock through SMS, an app running on Java, Androids, or tablets, or the web. They report data such as stock levels, receipts, and orders. This is analyzed to infer indicators e.g. monthly consumption, lead times, and order fill rates. Appropriate actors are notified of impending stockouts, reorder quantities, deliveries, etc. Developer s claims of solution benefits The proposed system provides real-time, reliable, and accurate information directly to those with decision-making capabilities. It streamlines logistics systems with targeted, actionable information to supervisors and managers; it improves quality of reliable, real-time stock information to decision-makers at all levels; it facilitates detection, resolution, and prevention of stock outs; and it reduces lead times through improved supervision of requisition and delivery, and identification of bottlenecks. In the future, partnerships with local telecom companies will be sought in order to bring SMS costs down. Improvements to the system will also be made with inclusion of advanced stock level forecasting and optimal reorder point calculation. As more and more deployments launch, the body of open source technology behind the system will continue to grow, allowing each individual deployment to benefit. User and environment User: Nurse, midwife, technician, pharmacy worker, supply officer, laboratory staff, immunization teams Training: Training sessions of 1-2 days are provided by implementers, programs, and the Ministry of Health Settings: Rural, urban, ambulatory, primary (health post, health center), secondary (general hospital), tertiary (specialized hospital), medical stores Reviewer s comments The system is simple and meeting a well known challenge in the health system in low-resource settings. The system has been piloted in three relevant countries and is now in use. Solution specifications Solution is used to support: Decision support systems, Geographic Information System, mhealth, Management of hospital information, Logistics and supply chain management Software/Hardware requirements: Mobile workers require a mobile phone with SMS capability or a mobile application (and network coverage). Supervisors use a personal computer with an internet connection. As open source software, anyone is free to download and modify the code. Contact details Rowena Luk Telephone Additionally, the hosted version provides a reports customization layer which allows any developer to generate custom views, reports, dashboards, and forms, while at the same time leveraging the common shared software repository used by a community of other projects. Currently used in: Ghana, India, Malawi, Tanzania, Uganda 53
70 2013 ehealth Remote healthcare solution Country of origin India 70% of the rural population in India has very poor access to healthcare. 76% of the medical facilities are concentrated in urban areas, and there is an overall shortage of medical personnel. Thus rural patients are left to semi- and nonqualified practitioners, creating a huge disease burden. Solution description The technology enables rural patients to reach urban doctors through a telemedicine solution. This comprises of a modular data analysis unit (MDAU) - a USB powered multiparameter diagnostic device which captures ECG, temperature, heart & lung sounds, SPO2 and BP, and communicates with the remote doctor through a low bandwidth audio/video/data conferencing. The solution allows for the integration of the whole healthcare delivery ecosystem to provide meaningful service. The solution also captures the workflow of delivery processes and enables resource optimization by capturing and analysing operational service delivery data. Functionality A rural operator carries out remote consultation for the patient at the village using the internet with a doctor sitting anywhere in the world. Doctors remotely control the MDAU device to obtain medical parameters, provide a prescription to the patient, and store medical records. The solution also supports supply-chain management, lab reports and referrals. Developer s claims of solution benefits This solution works at extremely low bandwidths (32 kilobits/s onwards) for real-time audio/video/data teleconsultation, thereby reaching places where other existing solutions cannot reach. It is very easy to use by a village operator, is extremely power efficient, and works out of USB power, and comprehensive solution linking multiple providers (doctors / pharmacies / labs / hospitals), and addresses 75% of healthcare needs at the point-of-care at a fee of less than 1 USD. Future work includes working closely with healthcare service delivery partners and e-governance players to define and implement large scale projects; enhancing the technology with further diagnostics as well as ground-level delivery processes to capture them better; identifying and building relations with partners having complementary solutions (hardware and software); integrating a mobile based bluetooth enabled telemedicine solution, as even 32 kilobits/s bandwidth is not available in all of rural India; and changing the business model to include software-as-a-service. User and environment User: Physician, nurse, midwife, technician, community health worker, self-use/patient Training: On-site individual/group training, video-conferencing/desktop sharing application based e-training that takes 2 to 4 hours Settings: Rural, urban, primary (health post, health center), secondary (general hospital, at home Solution specifications Solution is used to support: Decision support systems, Diagnosis and treatment, Electronic Health Record/ Electronic Medical Record, elearning/mlearning, Health research, mhealth, Patient monitoring, Telemedicine Software/Hardware requirements: Medical device connected to USB port of PC/Laptop. Windows operating system on the PC/Laptop, an internet connection for telemedicine. Minimum 32 kilobits/s internet speed for real-time audio / video / data tele-consultation. Fixed static IPs at both ends for professional edition, and at server in enterprise edition. The specific software that comes as part of the solution, is proprietary. It has been optimized for usage in lowresource and low-skillset environment (e.g. video conferencing and real-time data transfer can work at a bandwith as low as 32 Kbps). The license fee depends on number of clients and scale of the network. Standards: HL7, ICD10 Currently used in: Primarily in India, few countries in Africa, Central & South America and Southeast Asia Evaluation: IEC compliance completed, ISO13485:2008 AC 2010 and ISO9001:2008 manufacturing process compliance. CE marking process underway. Contact details Sameer Sawarkar Telephone
71 2013 ehealth SMS-DMCare Country of origin United States of America Diabetes is now a major health concern in low- and middle-income countries. Patient education and training is a cornerstone of effective diabetes care yet is rarely available in low-resource settings. Many providers lack basic training in diabetes and health systems are poorly equipped to provide nutrition, exercise, and medication education. Solution description The product provides patients with diabetes a mobile phone-based coaching program. Patients receive automated SMS messages on their cell phones that provide education and reminders about diabetes self-care and SMS back responses to questions. Their responses help dynamically tailor the program to meet their individual needs and enable remote health workers to monitor their adherence and health needs. Functionality Patients are enrolled over the phone by a remote health worker using a web-based system. The following day patients begin receiving automated SMS messages on their phone tailored to their health condition. If patients responses suggest the need for more individual attention, an alert is sent to a remote health worker who then calls the patient. Developer s claims of solution benefits The product has several advantages over existing solutions. It leverages a commonly used platform for communication, SMS, as a means of health education. As a software solution, it provides a low-cost, scalable model for improving diabetes self-management in low-resource settings. The product is based on a novel model for behavior change that has been developed by researchers at the University of Chicago, and is currently being evaluated in a clinical trial. The biggest barrier to this product is that it requires trained health workers to provide exception based care by telephone. Training and supervision of these health workers may be challenging in low-resource settings. Another challenge is in adapting the product to other languages and customs. The behavioral model was developed in a specific cultural context, inner-city Chicago, and may not fully translate to other settings. Finally, while SMS is an increasingly common mode of communication between health workers in low-resource settings, their use in providerpatient communication is largely unexplored. User and environment User: Self-use/patient, low-skilled health worker Training: Patients require no training. Remote health workers need training in diabetes coaching (4 weeks). Settings: Rural, urban, at home. Solution specifications Solution is used to support: Patient monitoring, Telemedicine, Treatment compliance Software/Hardware requirements: Remote health workers require a computer with an Internet connection and stable power supply. However, patients only need access to a cellular phone and mobile network. The software is proprietary but will be licensed freely to public and nonprofit health organizations for use in lowresource settings. Currently used in: Pilot study conducted in 2010 demonstrated the feasibility and acceptability of the product in low-income African-Americans in the U.S. Currently, a single-arm clinical trial is underway at the University of Chicago in which 70 patients with diabetes are receiving the intervention for 6 months. Although the results are not yet published, preliminary analysis demonstrates an improvement in glycemic control (hemoglobin A1c) and in diabetes self-care activities such as treatment compliance. Evaluation: Dick JJ, Nundy S, Solomon MC, Bishop KN, Chin MH, Peek ME. Feasibility and usability of a text message-based program for diabetes self-management in an urban African-American population. J Diabetes Sci Technol Sep 1;5(5): Contact details Shantanu Nundy Telephone
72 2013 ehealth SMS service Country of origin Kenya Globally, 33.4 million people are infected with HIV/AIDS. While treatment scale-up in sub-saharan Africa has had dramatic public health impacts, including reducing mortality, sub-optimal medication adherence is a barrier to maximing health outcomes. Solution description The solution involves a weekly short message service (SMS) to check-in on how patients are doing and provide them the opportunity to identify whether assistance is required. Once a week, an automated text message is sent to patients asking Mambo? (Swahili for How are you? ). Participants indicate within 48 hours of receiving the message either that they are well (e.g. OK or Sawa ) or that they have a problem (e.g. Problem or Shida ). Clinicians follow-up all participants who identify a problem to provide triage, advice, or general support. Participants who do not indicate a problem, but fail to respond within two weeks, are called by a clinician to inquire as to their status. Functionality A health care worker registers patients in the system (on a laptop at the clinic). The system sends registered patients a weekly text message. A clinician reviews the incoming text messages and instances of non-response. The clinician calls patients who responded indicating a problem. Non-responders are contacted after two weeks. Developer s claims of solution benefits One of the advantages of the proposed text-message support is that it is has a strong evidence-base. In a randomized controlled trial, it demonstrated effectiveness at improving self-reported treatment adherence and viral load suppression at 12-months. Other advantages of the service include its use of existing technology, its simplicity, low-cost, and proven health care provider and patient acceptability in the local context. Part of our strategy includes the development of a sustainable business model to scale-up the service, which we are doing in our ongoing project Moving from Evidence to Action. Challenges in making the technology available to our intended user group include: i) despite high cell phone penetration in the region, not everybody who may benefit from the service has cell phone access; ii) ensuring interoperability with existing clinic systems; and iii) despite low costs, securing sustainable financing in resource limited settings. User and environment Users: Nurse, self-use/patient Training: A clinician will instruct the patient on using the system upon registration (10 min) Settings: Rural, urban, primary (health post), ambulatory Reviewer s comments Although the given mhealth solution is not unique and similar SMS solutions have been implemented in low-resource settings, this implementation in Kenya has been successful based on the evaluation that has been done. It uses the existing infrastructure, is a simple, and a low-cost intervention that has proved effective in a low-resource setting. Solution specifications Solution is used to support: Diagnosis and treatment, Health research, Patient monitoring Software/Hardware requirements: The service requires a stable power supply, cellular network, a clinician to operate the system, and a cell phone for the clinician. A laptop or desktop computer is required, with the WelTel platform (Smartphone application to stay in touch with patients taking antiretroviral medications to treat HIV/ AIDS) installed, a SMS gateway, and a GSM (Global System for Mobile Communications) modem connected to the computer to send and receive messages. The application is open source, customized software. Currently used in: Canada, Kenya Contact details Richard Lester Telephone Evaluation: 1) Lester R et al. Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial. Lancet. 2010;376(9755): ) Horvath T et al. Mobile phone text messaging for promoting adherence to antiretroviral therapy in patients with HIV infection. Cochrane Database Syst Rev
73 2013 ehealth T1D system (Type 1 Diabetes system) Country of origin Spain People with diabetes have to eat according to a fixed pattern depending on the insulin dose prescribed by the doctor. Any change in intake, sport or other daily event, cannot be safely managed by patients. Solution description This is a mobile technology to better self-manage type 1 diabetes mellitus (T1D). Factors, like food intake and exercise, are logged into the system by the patient. The T1D system takes the insulin pattern determined by their doctor and recalculates the recommended insulin dose based on the parameters introduced by the patient in their individual daily context. By personalizing data management, the system can prevent, for example, hypoglycemia during sleep. Patients gain flexiblity over their diet and security in their treatment. Patients and their doctors can connect via the system and monitor the evolution of their disease remotely. Functionality Download APP interface to mobile or computer. Enter personal information (once): height, weight etc. Enter control blood sugar/glucose levels. Enter food/drink ingested. Recommended insulin is calculated. Information is synced in realtime between diabetic and doctor. Alerts are sent to both when a potential problem is flagged. Developer s claims of solution benefits Existing solutions do not take into account individual differences in people with diabetes. The T1D system does and it creates preventive actions before problems occur. Other options focus on the now. The system focuses on the past, present and future. T1D and T2D costs healthcare systems $471 billion/year, often in response to complications. Our T1D system is a call to action for the person with diabetes to self-manage their disease and let their doctor be more time- and cost-effective. This can lead to fewer complications so less face time will be needed. The T1D system uses metric weights and measures but the United States uses avoirdupois and imperial so there is a potential need to additionally develop to address the US users satisfactorily. Future development work includes port to ios/iphone and an interface with glucometers. The T1D system puts insulin dosage adjustment and control into the hands of the person with diabetes. They become the primary monitor, not their doctor. Their disease reacts and responds to them, the individual. It does not act generically. So the T1D system treats the individual as such by reacting and responding to them, the individual. It s a fundamental shift in responsibility to self-manage a unique life and lifestyle. User and environment User: Physician, self-use/patient Training: Training is not needed. The system is very user-friendly but training videos are being produced Settings: Rural, urban, at home, ambulatory Reviewer s comments This software, available for free or at an additional cost with the premium version, can help motivate patients behavioural change in several ways: 1. By tracking food intake and caloric intake, it helps patients to understand the type of food that they eat vis-a-vis the caloric count - something health professionals cannot be too specific about. For example, a doctor in Spain would be hard pressed to articulate what a 1500 Calorie diet for his/her African or Asian patients. Patients can take responsibility and fully understand their intake and sensibly alter patterns. Recent studies suggest that the general population has difficulty accurately estimating their food intake, and this applies both to adults and even more so to teenagers. 2. Tracking food intake and setting goals are powerful ways to motivate patients to change. This system would encourage that. 3. Being able to have communication with their doctors, providing support and the ability to take the power of control of how much insulin to use gives the motivated patients incentive change take to make positive changes. Solution specifications Solution is used to support: Diagnosis and treatment, Electronic Health Record/Electronic Medical Record, Health research, Management of patient information, Patient monitoring, Public health surveillance, Telemedicine Software/Hardware requirements: Access to a cellular/ mobile network via mobile, personal computer, tablet or SmartTV. Android platform. App is free. Premium version license at $19.25/year Currently used in: Worldwide Evaluation: Currently 2,900 active users. Rating for ease of use and effectiveness between (highest satisfaction=5.0 out of 5.0). Contact details Maria Salido Telephone
74 2013 ehealth TeleOphthalmology aided primary eye care Country of origin India 1% of the population are blind and 80% of these cases are treatable or preventable. As with other health care, eye care services also have significant variations across regions and between rural and urban settings. There is a challenge of access. A shortage of ophthalmologists restricts the provision of services in rural areas. Solution description It is a web-based comprehensive software solution for primary eye care services that records the registration of patients, records systemic diseases and clinical findings, captures images, and integrates teleconsulting equipment so a base hospital ophthalmologist can review the findings and discuss the problem. It also generates prescriptions, manages the inventory of optical and medical supplies, includes financial details and tracks the patients referred to the base hospital to ensure compliance with the recommended treatment. Ophthalmologists have access to the medical record entered at the rural centre from the base hospital, and interact with the patient and provide consultancy services to the patient. Functionality The rural centre coordinator registers the patient by asking their demographic and systemic condition details and generates an ID Card. A vision technician examines the patient, enters the findings and passes a message to the base hospital ophthalmologist to come online for a consultation. The ophthalmologist consults and advises on the treatment accordingly. Developer s claims of solution benefits Community outreach programs have been the traditional approach to reach the rural community. As per the referred research, only 6.8% of the population who need eye care attend eye camps - a temporary service offered a maximum of twice per year. Primary eye care centres in rural areas are a permanent setup to provide primary eye care, diagnostic services and delivery of the services. They helped to reach 25% of the community in 4 years in support of universal coverage. Using tele-ophthalmology will enable services to treat 90% of the patients visiting the centre without any visits to the base hospital. As such there are no major challenges in the technology. Today, the majority of the eye care providers are concentrating on secondary and tertiary eye care services. This tool will enable the promotion of primary eye care. In order to implement this system, the service should be designed in such a way that the primary eye care centres are connected to secondary and tertiary centres in order to handle the patients that could not be handled at their level. User and environment User: Technician, opthalmic technician Training: Trained users handle training either onsite or remotely for 3 to 7 days Settings: Rural, primary (health post, health centre) Solution specifications A Primary Eye Care Centre offers the following facilities: sq ft of space to accommodate various examination rooms 2. Trained vision technician and coordinator of ophthalmic equipment, like slitlamp, refraction trial set and drum 3. Computer, 512 Kbps Internet connectivity, webcam Contact details Ravilla Thularsiraj Telephone The only functionality of the tool is to transmit video and audio. Any software could be designed around this tool like our auropecs. 58
75 Medical devices 2013
76 Medical devices 2013 Bedside newborn phototherapy Country of origin United States of America Global health experts estimate 10% of all newborn mortality can be attributed to jaundice. An excess of the chemical bilirubin in the blood approaches dangerous levels in more than 10% of all newborns. The result can be kernicterus, lifelong disability, severe brain damage, and death, placing an extreme burden on families and communities. Every year in South Asia and Sub-Saharan Africa, more than 5.7 million jaundiced infants need treatment, but do not receive simple phototherapy. There currently is no durable and easy-to-use phototherapy device for rural facilities, so newborn jaundice accounts for 20-33% of admissions to national-level hospitals in developing countries. Bedside Newborn Phototherapy is a device designed to treat jaundice in the mother s room in rural clinics. The double-sided, high-power LED lighting cures the most severe cases of jaundice and dramatically reduces treatment time. Developer s claims of products benefits The device is compact, intuitive, and durable enough to function in the mother s room in a rural clinic, reducing staff workload and promoting breastfeeding. The reduction in treatment time allows resources to be used to treat more infants and allows the family to go home sooner. This can decrease the cost of care, reduce loss of income, reduce exposure to infection, and return mother and baby to the safer home environment to breastfeed. Bedside Newborn Phototherapy s design uses energy-efficient light emitting diodes (LEDs) that last 5 years. It is completely sealed against dust and bugs and has no moving parts, drastically increasing product life. Suitability for low-resource settings In low-resource settings, jaundiced infants referred from rural to higher-level hospitals risk developing permanent brain damage or dying en route. Jaundiced infants are isolated from their mothers in crowded neonatal ICUs, hindering breastfeeding in the critical first days. Bedside phototherapy enables rural hospitals to treat jaundice, which reduces the burden on national-level hospitals to treat more serious conditions. It is produced locally in Vietnam. Operating steps Plug it in and press the button. Fixed two-sided lighting, one intensity setting, and an easy to clean, removable single-infant bassinet make this device hard to use improperly, thereby reducing incidence of ineffective treatment and cross-infection. Regulatory status Used IEC :2005 and IEC :2009 standards to guide the design. Pending assessment by Ministry of Health in Vietnam, recognized by the ASEAN countries. Expected date November Production of the first 200 Bedside devices is nearing completion. The first devices were delivered to hospitals in northern Vietnam during Fall 2013; over the following year the remainder will be distributed to Vietnam, Myanmar, Cambodia, Laos, East Timor, the Philippines, Thailand, Malaysia, and Ghana. The plan is to expand to a total of 1,000 Bedside devices, reaching at least 250,000 newborns. The next big challenge is to connect with additional organizations who wish to purchase and distribute the devices worldwide to reach millions of beneficiaries. Use and maintenance User: Physician, nurse, family member Training: Provided by supplying organization Maintenance: None Settings: Rural, urban settings, primary (health post, health center), secondary (general hospital), tertiary (specialized hospital) Requirements: Continuous power supply (90-264VAC), or a 12VDC input typical of car batteries and solar power systems. Dimensions (mm):660 x 380 x 495 Weight (kg): 11.8 Consumables: None Life time: 5 years Shelf life: 5+ years Retail Price (USD): N/A List price (USD): 1500 Other features: Mobile, capital equipment Year of commercialization: 2011 Currently sold in: Cambodia, East Timor, Ghana, Laos, Malaysia, Myanmar, Philippines, Thailand and more. Contact details Timothy Prestero Telephone Web
77 Medical devices 2013 Compact portable ultrasound Country of origin United States of America The device addresses the issues of maternal death, maternal near misses, newborn death, and stillbirths. Obstetric complications that may be detected by ultrasound include: placenta previa, fetal malposition, multiple gestations, ectopic pregnancy, retained placental products, fetal anomalies, and fetal demise. As a compact portable visualization tool with ultrasound technology this device provides a non-invasive look inside the body for immediate visual validation of what a clinician can feel or hear. The additional information facilitates optimization of the course of treatment for the patient and reduces time required for diagnosis, thereby reducing patient wait times and improving clinical workflow. The device is small and lightweight, which makes it easy to carry and its battery capacity provides over one hour of scanning on a single charge, giving it enough power for a full day s worth of patient exams. Developer s claims of products benefits While ultrasound forms an integral part of pregnancy management in developed nations, the technology is highly inaccessible and underused in resource poor settings. The need for trained health professionals, a certain level of infrastructure and a continuous power source limits ultrasound access in many regions. Unlike most available ultrasound devices, this compact ultrasound device is portable, easy to use and is battery operated. The device can also be charged with solar power to enable its use in areas that do not have regular grid power supply. Suitability for low-resource settings The technology is suitable for use in health centres in low-resource settings where electricity is irregular or unavailable. It is ideal for attracting more mothers to the formal health system increasing antenatal attendance and institutional delivery. The device has been used in low resource settings by health paraprofessionals in Indonesia, Tanzania, Ghana and Bangladesh. These users were competent performing limited obstetric ultrasound in rural and peri-urban health centers. Operating steps To start the device: open the flap and the device will start automatically. Select the OB preset and apply gel on the transducer to start scanning. Increase or decrease depth with the up and down arrows and auto optimize by pressing and holding the central button. Close the device after use and put on the docking station for recharging. Regulatory status The device is both FDA approved and CE marked. Use and maintenance User: Physician, technician, nurse, midwife Training: Limited obstetric training is conducted by local trainers usually in the country s capital city. Maintenance: Limited routine maintenance that can be performed by a nurse, physician,technician, or manufacturer. Settings: Rural, urban settings, ambulatory, at home, primary (health post, health center), secondary (general hospital), tertiary (specialized hospital) Requirements: Some source of power, even if intermittent, for charging the device. Dimensions (mm): 135 x 73 x 28 Weight (kg): 0.39 Consumables: Ultrasound gel, cleaning supplies Life time: 7 years Retail Price (USD): 7900 USD with considerable variation between countries List price (USD): 12,000 Other features: Software use, portable, capital equipment Year of commercialization: 2010 Currently sold in: More than 40 countries Contact details Gisela Abbam Telephone Web
78 Medical devices 2013 Dry blood spot screening Country of origin Spain and Brazil Early diagnosis and prevention are widely promoted by national health systems, international organizations and NGOs, because they have been shown to represent significant savings for health systems and the patients themselves. Despite this, access to these benefits by the poor is limited due to challenges in getting blood to labs for analysis. The test analyzes specific biochemistry parameters - uric acid, cholesterol, triglycerides, glucose, creatinine - in dried blood samples, using standard laboratory equipment. Blood samples are obtained by a single-use lancet or pin prick. The system does not require special conditions for storage or transportation and it requires only minimal investment in training the personnel that handle the samples. Using the device only requires a finger-prick. Developer s claims of products benefits The current blood diagnosis industry, which is based mainly on venous puncture, is oriented towards developed markets where costs of logistics (refrigeration and transportation) are expensive but do not represent the highest burden. However, in developing economies, these costs are unaffordable for the system or individuals and families. This test eliminates cold chain requirements, which results in major cost savings and makes a step towards universal lab blood service coverage. It also makes it possible to remove the key impediments to population monitoring through massive screening to inform health policies. The strategy is based on maintaining a solution at very low cost so that it can be offered to all people, including those that have very limited financial resources. Suitability for low-resource settings The test has been implemented in several countries. It has been used successfully in the favelas of Rio, where only 30% of the pregnant women have access to a antenatal care to prevent vertical transmission. However, with the device, samples were collected in the hospital and sent to a lab, with 100% coverage of the 84,000 women in the catchment area ensuring that there was no vertical transmission from these women to their children. The system has also been tested in In Alta Verapaz, Guatemala, with coverage for 1,500 pregnant women who live in the forest. Operating steps A few drops of blood, are dried on filter paper at room temperature ( hrs). Once dried, the sample can be transported by any means to the lab no need for cold chain. In the lab, a 3mm sample is cut. With a single drop two to four parameters (HIV, Syphilis, Hepatitis, Cholesterol, Glucose, etc.) can be analyzed, using an appropriate solvent which extracts the biological material that is required for the test. This room-temperature extraction (stove & shaker) occurs inside a micro plate and read-out is done on an ELISA s reader. Regulatory status Reagents for infectious diseases and non-communicable diseases have approval for use by authorities such as ANVISA in Brazil. It has a CE mark for its biochemistry reagents. The business model for this product is based on high volume, high quality and affordable cost. For this reason the product needs the collaboration of governments that seek data to reduce the burden of disease. One way to obtain this data is from large-scale blood screening and analysis. Use and maintenance User: Self-use/patient, physician, nurse, midwife, family member Training: One week for laboratory technicians, one hour for personnel in the field Maintenance: None Settings: Rural, urban settings, ambulatory, at home, primary (health post, health center), secondary (general hospital), tertiary (specialized hospital) Requirements: Water. At field level: lancet and filter paper; at the local laboratory: an ELISA reader. Dimensions (mm): Not provided Weight (kg): Not provided Consumables: Specific reagents Life time: Not provided Shelf life: Not provided Retail Price (USD): 5 List price (USD): 5 Other features: Mobile, single-use Year of commercialization: 2008 Currently sold in: Brazil, Guatemala, India, Spain Contact details Jordi Martí Gascón Telephone Web
79 Medical devices 2013 Electro-hyperthermia Country of origin Germany In 2008 there were 715,000 new cases (95% in advanced stages) and 542,000 deaths from cancer in Africa. The available treatments are limited and the increasing incidence of cancer is a huge burden on the struggling economies in Sub-Saharan Africa. Heating tumours increases chemo-/radiotherapy efficacy, improves survival and lowers healthcare costs. A MHz low radiofrequency electric field is applied using capacitive coupling between two electrodes. The electric field passes through the patient s body moving through the pathways with the lowest impedance. The malignant tissue has lower impedance due to the increased ion concentration in the highly metabolic tumours (as seen on PET scans). The tumour acts as a capacitor; it stores a charge and is safely and selectively heated, sensitizing it to the chemotherapy or radiation therapy treatment. Hyperthermia damages the cell walls; slows protein, DNA and RNA synthesis/repair; increases blood flow, drug delivery, oxygen, metabolism and drug reaction rate; and sensitizes hypoxic tumours to radiation. Developer s claims of products benefits The only technique other than electro-hyperthermia used in the region is interstitial hyperthermia (South Africa). Although effective, interstitial hyperthermia is complex, expensive, has high risks, and requires specialized staff and facilities. Various technologies are available internationally but they are expensive and impractical for Africa. It is safer (even for the brain) due to non-invasive, selective and deep heating. The safety, simplicity and practicality of the device make it more costeffective to use, with a capital price as much as 10 times lower than some devices. It is far more practical in limited resource settings as the treatments are only minutes and dedicated/specialized staff/facilities are not required (unlike other devices which require bunkers, MRIs, etc). It is reliable and easy to maintain with a 10 year life span. Suitability for low-resource settings In oncology, funding, resources, staff and facilities are limited. The device is safe for patients and staff; easy to use and very reliable (10 year life span). It does not require specialized facilities/equipment/consumables/staff. It comes with a UPS (protects against power surges in the region) and it is affordable and cost effective to run and maintain (only 2 services a year). It can improve treatment efficacy and lower the costs of the treatment. It has been in use in a private facility in South Africa for four months. Reports from doctors and patients confirm the safety, feasibility and practicality of the device. Operating steps Switch on the device. Let the self-test run. Choose the correct size electrode. Fix the electrode to the adjustable arm and plug in the cable to the bed. Lay the patient on the bed. Place the electrode over the treatment area. Set the treatment parameters (time/power). Press start. Device will signal end of treatment. Press stop, remove electrode, and assist patient off the bed. Regulatory status Approved by European Union (EU) - European Medical Device Directive (CE), Germany - Technischer Überwachungs- Verein (TUV), Australian Registrar of Therapeutic Goods, South Africa - Department of Health: Directorate of Radiation and Hazardous substances, Russia, Korea (KFDA), Turkey, Canada - Health Canada. The economic instability in the region is the largest challenge. The most unstable countries do not have oncology facilities offering radiation and chemotherapy, thus these countries will not be included in the target market until such time as facilities are available and technical staff are able to move safely in the countries. In countries in which facilities are available, the public health sector will be targeted as this is where the most benefit will be gained from the technology. Use and maintenance User: Physician, nurse, radiation therapist Training: One day, on site conducted by distributor Maintenance: Every 6 months by local distributor technical staff. Settings: Rural, urban settings, secondary (general hospital), tertiary (specialized hospital) Requirements: The work area should be 4m x 4m (safe for consulting areas, no shielding required). The electricity supply should be 230V/50Hz (device includes surge protector and 30 minute battery back-up). The device should be keep within +10 C to +30 C, 20% - 60% humidity, and 700 hpa 1060 hpa. Dimensions (mm): 585 x 2062 x 920 Weight (kg): 500 Consumables: None Life time: 10 years Retail Price (USD): 303,000 List price (USD): 303,000 Other features: Software use, installed stationary, capital equipment Year of commercialization: 1996 Currently sold in: Australia, Austria, Belgium, Canada, China, Denmark, Germany, Greece, Hungary, Israel, Italy, Japan, Jordan, Lebanon, Netherlands, Poland, Romania, Russia, South Korea, Turkey, Ukraine, South Africa Contact details Janina Leckler Telephone Web
80 Medical devices 2013 Fecal occult blood test Country of origin Cuba Cancer is one of the main causes of death in the world. It is expected that death by cancer worldwide will grow to reach 13,1 million in Colon cancer is among those with the highest death rate. However, the success rate of treatment is also high when detected at early stages and properly treated. The device enables fast qualitative detection of occult blood in feces. It consists of a sandwich type chromatographic immunoassay and makes use of a combination of monoclonal and polyclonal antibodies for the detection of human hemoglobin with a high degree of sensitivity. In five minutes, levels of human hemoglobin as small as 0.2 µg/ml can be spotted in feces and positive results are visually evident. The test is used for annual screening of colorectal cancer in people above age 50 and it is useful for the early diagnosis and follow-up treatment of gastrointestinal disorders that cause bleeding. The product is supplied in boxes of 20 cassettes and 20 collector flasks. Developer s claims of products benefits The test can provide highly sensitive and rapid detection of human blood in the feces. The technology uses a detection method that is specific to human hemoglobin, so the patient does not need to stop eating meat two or three days earlier as there is no interference with animal hemoglobin. Suitability for low-resource settings Standard (household) refrigeration is the only requirement. It has been used successfully in Cuba. Operating steps A small amount of feces should be taken as a sample by using the applicator incorporated to the top of the collector flask. Afterwards, the top is wound and the flask content agitated. A diluted sample will be placed on the cassette by using the collector flask dropper. In five minutes, the result can be read from the device. Regulatory status The test is registered in Cuba and Peru and is GMP compliant. It has been evaluated by Cuba s CECMED (Centro Estatal para el Control de Equipos Médicos y Medicamentos) and Peru s DIGEMID (Dirección General de Medicamentos, Insumos y Drogas). The strategy is to provide a stable supply of consumables (diagnostic kits), a stable after sales service, and technological renewal as soon as improved diagnostic kits are developed. Use and maintenance User: Physician, technician Training: None Maintenance: None Settings: Rural, urban settings, ambulatory, primary (health post, health center), secondary (general hospital) Requirements: Product should be stored in a standard (household) refrigerator between 2-8 C. Dimensions (mm): 160 x 115 x 80 (per box of 20 cassettes and 20 collector flasks) Weight (kg): 0.3 (per box of 20 cassettes and 20 collector flasks) Consumables: None Life time: 2 years Shelf life: 2 years Retail Price (USD): 2 (per test) List price (USD): 2 (per test) Other features: Portable, single-use Year of commercialization: 2013 Currently sold in: Cuba Contact details Aramís Sánchez Gutiérrez Telephone
81 Medical devices 2013 Infant radiant warmer Country of origin India In under-resourced settings, hypothermia at birth is one of the most important risk factors for newborn morbidity and mortality. 99% of newborns that die globally are in such settings. It is vital to keep newborns warm and help them achieve thermoregulation in order to prevent and minimize morbidities and mortalities due to hypothermia. The device consists of a biocompatible bed on which to place the infant, and an overhead heater that delivers radiant heat. A skin temperature probe monitors infant temperature. Heat output can be controlled manually or through baby mode (feedback mode) for thermoregulation. Visual and audio alarms are present for safety. An APGAR timer helps to efficiently take APGAR scores post-delivery. Developer s claims of products benefits Current radiant warmers have heaters typically made from quartz or ceramic. These heaters tend to breakdown faster as well as take a much longer time to heat up - up to 13 minutes in some cases. Each additional minute of cold stress can lead to increased morbidity for an infant. This device gives better clinical results because it provides uniform heating across the bed as well as a much faster warmup time (4 minutes only) that reduces the time to warm a hypothermic infant. Furthermore, the lower power consumption and long life of the heating element (Calrod heater) lead to considerable cost savings. Suitability for low-resource settings The device uses less power at startup and during operation compared to other radiant warmers. It is designed for infection control (e.g. non-stitch biocompatible mattress for no infections in stitches plus no need for a mattress cover). It has a faster warmup time for high volume environments with little pre-warming. Over 1500 warmers have been deployed in lowresource settings. The device has been designed, developed and manufactured in India based on extensive customer input in India and similar countries. It has been adopted in Tier 2 and 3 towns in India, as well throughout the country of Myanmar by the Ministry of Health. Testing of the device includes protocols that try to simulate low-resource setting issues such as voltage fluctuations, high humidity etc. Operating steps The device is usually pre-warmed in manual mode for at least four minutes. The infant is then placed on the bed mattress and the skin temperature probe is attached. The operator then switches to baby mode (feedback) and enters the desired baby temperature. The APGAR timer and observation light can be switched on as needed. Regulatory status It conforms with the requirements of Medical Devices Directive 93/42/EEC - BSI CE 0086 mark. It is also certified ISO It has US FDA 510K clearance (K121625), and it is ROHS compliant. Use and maintenance User: Physician, nurse, midwife Training: Initial training by manufacturer, and operator manual Maintenance: Annually by technician, engineer, or manufacturer Settings: Rural, urban settings, primary (health post, health center), secondary (general hospital), tertiary (specialized hospital) Requirements: Continuous power supply ( V). Can withstand some fluctuations in voltage and occassional spikes, but stable power supply is strongly recommended. General cleaning supplies to disinfect after every infant are needed. Dimensions (mm): 1120 x 655 x 1800 (minimum height), can be ordered at different settings from factory Weight (kg): 72 Consumables: Reflector patches to cover the sensor are recommended in order to provide an accurate reading Life time: 7 years Shelf life: 2 years (6 months without any operation) Retail Price (USD): 3000, with considerable variation between countries List price (USD): 3500 Other features: Software use, mobile, capital equipment Year of commercialization: 2009 Currently sold in: 115 countries. Emerging market countries include Albania, Algeria, Brazil, Bulgaria, Cambodia, Chile, Domnican Republic, Egypt, Gabon, India, Indonesia, Iraq, Jordan, Kazakhstan, Kenya, Lebanon, Macedonia, Nigeria, Palestinian Territory, Philippines, Syria, South Africa, Vietnam. Contact details Ashish Gupta Telephone Web
82 Medical devices 2013 Infant warmer Country of origin United States of America There are over 20 million premature and low birth weight babies born each year globally, with more than 95% born in developing countries. Three million babies die within the first 28 days of their life, with more than a quarter of these deaths occurring in India alone. Those who survive often grow up to have lifelong problems such as low IQ, early onset of diabetes, and heart diseases. Hypothermia is a significant problem faced by many of these babies. The infant warmer works without a constant supply of electricity. It has no moving parts, and is safe and easy to use. It is also portable, enabling newborns to be kept warm during transport. One of the other big advantages of the device is that it complements Kangaroo Mother Care (KMC).It consists of three parts - a sleeping bag to place the baby, a pouch of phase change material and an electric heater. The pouch is heated for 30 mins in the heater (second version uses boiling water instead of electrcity to heat) and then placed in the sleeping bag. It maintains the WHO recommended temperature of 37 deg C for 4-6 hours, after which it can be reheated. Developer s claims of products benefits In low resource areas in developing countries, common infant warming methods include blankets, hot water bottles, hot coals & light bulbs. These methods are ineffective and unsafe, often causing burns on babies. Some hospitals use a device called a radiant warmer which is expensive, needs a constant supply of electricity and is complicated to use. This innovative infant warmer is much lower cost (less than half) of other devices (mostly radiant warmers) available to treat hypothermia in low birthweight infants. It also has much lower running costs since it does not require a constant supply of electricity and faces a much lower incidence of breakdowns (almost zero). In addition, it is much easier to use and reduces the load of nurses/doctors. In comparison to make-shift solutions such as light bulbs, this is safer and effective. Suitability for low-resource settings The technology is meant for use in low-resource and remote primary and secondary healthcare facilities. These facilities have intermittent access to electricity and very low doctor/nurse to patient ratio. With just beds, these facilities may administer over 200 deliveries a month. This infant warmer works well with intermittent electricity in these settings, reduces the load of nurses/ doctors due to ease of use and quicker monitoring, and does not occupy much physical space. The device has been deployed in more than 50 low-resource and remote primary/secondary government healthcare facilities across India. Doctors and nurses have given extremely positive feedback about the device s ease of use resulting in reduced workload and high quality healthcare that may otherwise not be easily available in these settings. The device has been functioning well in these settings and is in frequent use. The technology is currently being produced locally. The heater requires basic electronic components which are readily available locally. The sleeping bag is made locally using a tailor. The pouch of phase change material is also packaged locally. Operating steps Sanitize all 3 components. Insert the phase change material pouch into the heater. Close the lid of the heater and push button. In 30 minutes, the alarm will ring. A green light indicates that the phase change material pouch is ready and remains lit to indicate that the heater is keeping the pouch warm. Remove pouch, check temperature indicator, and use only if indicator bar is in OK region. Place the pouch of phase change material correctly into the sleeping bag. Wrap the newborn and tighten straps to prevent the newborn from slipping. Monitor the newborn s temperature once every hour for the next 4-6 hours. When the temperature indicator on the pouch slips into the TOO COLD region, remove the newborn. Remove the pouch and reheat as needed. Regulatory status A draft CE Mark has been received. Internal processes are ISO:13485 certified. The target users are neonatologists and pediatricians (including those in government hospitals) who will use the warmer as a critical component of providing neonatal care for low birth weight infants, starting with those in India. Different strategies have been implemented to reach out to these practitioners including establishing a direct sales team and partnerships with pharmaceutical/ medical device companies for distribution. Use and maintenance User: Physician, nurse Training: No intensive training required. Basic instructions included with device in pictorial form. Maintenance: None Settings: Rural, urban settings, ambulatory, primary (health post, health center), secondary (general hospital), tertiary (specialized hospital) Requirements: Intermittent supply of electricity, limited supply of water and sanitizer (to clean the sleeping bag before placing newborns). Second version of the warmer, meant for in-home use, uses boiling water instead of electricty. Dimensions (mm): 440 x 290 x 70 Weight (kg): 4.1 Consumables: None Life time: 3 years Retail Price (USD): 250 List price (USD): 250 Other features: Portable, reusable Year of commercialization: 2011 Currently sold in: India Contact details Krishnakanth Balam Telephone Web
83 Medical devices 2013 Infrared ear thermometer Country of origin China Body temperature measurement is used to assist in disease diagnosis. The device has a sensor inside that detects infrared emitted from the tympan. It provides the body temperature based on the calculation of the amount of emittance. This ear thermometer does not require a protective cover for the sensor, and the sensor can be cleaned by wiping it directly with ethanol. Developer s claims of products benefits Other body temperature measurement options take a long time, and other ear thermometers usually require a protective cover to prevent the invasion of foreign matter. These covers may affect the accuracy of the measurement, cause infection when inappropriately used, and increase maintenance costs. The design of this device enables fast measurement (only one to two seconds), requires no protective cover, allows for easy cleaning of the sensor (wiping directly with ethanol), and has a low maintenance cost. The compact design allows for portability. Suitability for low-resource settings This device is suited for use in areas where the healthcare system is less developed given its ease of use and low maintenance costs. It is also designed for home use (especially for infants). This device is already registered and well accepted in China. Operating steps Switch on the power and check the display. Pull the ear backwards, insert the ear thermometer straight into the ear path, make sure the sensor reaches the tympan, and press the start button to measure. Measurement is complete when an audible beep is heard and the indicator is on. Read the result. Clean the sensor after use. Regulatory status The device has a Republic of China Measuring Device Manufacturing License and a Republic of China Medical Device Registration. The price of this device is still quite high compared with normal thermometers, which limits its distribution. However, the production cost will decrease with an increase in production quantity. Use and maintenance User: Self-use/patient, physician, technician, nurse, midwife, family member Training: None Maintenance: Cleaning of probe at fixed intervals Settings: Rural, urban settings, ambulatory, at home, primary (health post, health center), secondary (general hospital), tertiary (specialized hospital) Requirements: Requires batteries of type CR2032, with an environment of use between 16 and 35 degrees Celsius and 30-85% relative humidity without condensation. Dimensions (mm): 105 x 32 x 25 Weight (kg): Consumables: None List price (USD): 76 Other features: Portable, reusable Year of commercialization: 2012 Currently sold in: China Contact details Satoshi Kikuchi Telephone
84 Medical devices 2013 LED phototherapy for neonatal jaundice Country of origin India Neontal jaundice (hyperbilirubinemia) occurs in at least 60% of term infants. If untreated, it can cause irreversible brain damage. Phototherapy equipment for treatment currently available have frequent bulb replacement needs, expensive bulb replacement costs and experience frequent breakdown in remote, rural areas. The device emits light through an array of high-powered light emitting diodes (LEDs). These LEDs have been specifically selected to emit a narrow wavelength of blue light (dominant wavelength 458nm) that maximises the rate of bilirubin breakdown. The arrangement of the LEDs along with the optics have been designed to provide uniformity of light on the patient, while minimizing unwanted spill and glare outside the treatment surface. The device provides the ability to cater the treatment to the patient by allowing the caregiver to choose a high intensity (45μw/nm/ cm^2) or low intensity (22 μw/nm/cm^2) setting. Developer s claims of products benefits Most phototherapy devices on the market use tubelights or compact fluorescent (CFL) bulbs to provide phototherapy. Many of these do not provide adequate intensity or uniform coverage. Moreover, these tubelights have to be replaced frequently - every 1000 hours. This is often not feasible due to high replacement costs and availability in markets. This device is easy to use for the caregiver, has a low total cost of ownership, is designed to be rugged and reliable, and provides excellent clinical outcomes. The uniformity, intensity and wavelength of emitted light results in a 28% increase in bilirubin breakdown. It utilizes only 20W of power, which is great for electricity savings as well as for the environment. It can be used with most commercially available photovoltaic systems, or potentially car batteries connected to inverters. It is simple to use with only two buttons - on/off and high/low. Lamps last for 50,000 hours, which provides 6 years of night and day use. Suitability for low-resource settings The device is specifically designed for low resource settings. It is designed to be rugged: e.g. all moving mechanical parts such as fans have been removed from the lamphead. The cost of ownership is highly minimized by having LEDs that last 50,000 hours - 6 years of night & day use, and 50 times that of bulbs. It also uses only 20W of power. Over 2000 units have been deployed in low-resource settings. Almost one third of the device s sales in India have been to Tier 2 or 3 towns. It has been awarded the Oxford Analytica validation Healthymagination certificate for product that improves access, betters quality and reduces cost of care. The Federation of Indian Chambers of Commerce and Industry have awarded it the prestigious Healthcare Excellence Award in 2012 for innovation to solve pressing healthcare challenges in India. Operating steps The device is simple to use. After installation, it has to be plugged into mains power ( V). There are then only two buttons - On/Off and High/Low to vary the intensity. Black screws on top can be unfastened to remove the lamp head for placement on an incubator. The height of the lamp can be adjusted by unscrewing a ring in center of the pole. Regulatory status It conforms with the requirements of Medical Devices Directive 93/42/EEC - BSI CE 0086 mark. It is also certified ISO It has US FDA 510K clearance (K120168). It is ROHS compliant and a WEEE certificate is available. Use and maintenance User: Physician, nurse, midwife Training: None Maintenance: None Settings: Rural, urban settings, primary (health post, health center), secondary (general hospital), tertiary (specialized hospital) Requirements: Continuous power supply ( V) Dimensions (mm): 530 x 550 x 1700 (maximum height) Weight (kg): 10 Consumables: None Life time: 7 years Shelf life: 2 years (6 months without any operation) Retail Price (USD): 1200 with considerable variation between countries List price (USD): 1500 Other features: Mobile, capital equipment Year of commercialization: 2011 Currently sold in: 122 countries. Emerging market countries include Bahamas, Bolivia, Costa Rica, Czech Republic, Ecuador, Egypt, Gabon, Ghana, Hungary, India, Indonesia, Mexico, Moldova, Myanmar, Peru, Philippines, Poland, Romania, South Africa, Thailand, Tunisia, Vietnam. Contact details Ashish Gupta Telephone Web
85 Medical devices 2013 Low pressure anaesthesia machine Country of origin United Kingdom More than 2 billion people lack access to adequate emergency surgical services and receive just 4% of 234 million surgical procedures performed each year. A major deficiency is the lack of appropriate anaesthesia equipment which can operate despite power outages and shortages of compressed oxygen, both of which are required for conventional machines. This device allows oxygen from multiple sources, includes an integrated concentrator, pipeline, and cylinder, and can also draw in room air if no other source of oxygen is available. It can work without power during long outages without any reconfiguration during surgery. It is designed for adult, pediatric and neonatal patients. All disposables are generic. Developer s claims of products benefits Conventional anaesthesia machines require compressed oxygen to create the anaesthetic gas mixture. Most machines also need electrical power to operate. Without compressed gas or power there is no general anesthesia other than the use of ketamine. This device, however, works at ambient pressure and can adapt to loss of compressed gas or electric power. If power is available, the device creates its own oxygen supply and acts like a conventional machine (though saving money on compressed gas.) If no power or compressed gas is available, it automatically draws in room air and continues to safely deliver anaesthetic gas. Battery operated patient monitoring provides safe delivery under any circumstances. Suitability for low-resource settings Many low-resource hospitals experience power outages and stock outs of compressed gas. This device works at ambient pressure and can adapt to loss of compressed gas or electric power. Operating steps When the device is operated, the oxygen flow rate automatically matches the patient minute volume demand. If required, room air is introduced. To deliver the anaesthetic agent, ambient pressures are sufficient and compressed medical gas is not required. When required, patient ventilation is performed with bellows. Regulatory status The machine is CE marked and is produced in an ISO certified factory. The organization providing the device operates as a non-profit and sells the device to non-profit and government hospitals at a discounted price that covers manufacturing cost and delivery. It is distributed through NGOs, government tenders, sales to donor organizations and direct sales and donations to hospitals. The challenges include cost-effective distribution in low income countries, cost of training users ranging from anesthesia assistants to consultant anaesthetists, and provision of service to remote locations. The focus is on training users and local technicians and providing backup support when necessary. Use and maintenance User: Physician, anaesthesia clinical office, nurse anaesthetist Training: Training provided by local or international medical doctor anaesthetists and biomedical technicians Maintenance: Daily checklist for user with occasional replacement of the oxygen sensor and air filter Settings: Rural, urban settings, primary (health post, health center), secondary (general hospital), tertiary (specialized hospital) Requirements: Intermittent access to electrical power to charge battery. Stable power connection to use optional oxygen concentrator Dimensions (mm): 1460 x 530 x 690 Weight (kg): 130 Consumables: 80 USD/year including 60 USD for oxygen fuel cell replacement every 12 to 18 months and 20 USD for primary air filter replacement every year. Life time: 15 years Shelf life: 15 years Retail Price (USD): 15,000 List price (USD): 15,000 Other features: Software use, mobile, capital equipment Year of commercialization: 2010 Currently sold in: Ghana, Haiti, Jordan, Kenya, Malawi, Nepal, Nigeria, Rwanda, Sierra Leone, Somaliland, South Africa, Tanzania, Uganda, United Kingdom, Zambia Contact details Stephen Rudy Telephone Web
86 Medical devices 2013 Mandibular repositioning device Country of origin United States of America Over 20 million people in the U.S. have obstructive sleap apnea (OSA), yet 85% have not received treatment. The condition is even less frequently treated in developing countries. Continuous positive airway pressure (CPAP) is the usual treatment but it is expensive and requires electricity. People with untreated OSA are many times more likely to die of a stroke, heart attack, or car crash because of chronic severe sleep deprivation. For decades, dental devices called mandibular repositioning devices (MRDs) have been an effective treatment option for OSA. They need no electricity but are typically fabricated in a dental lab and fitted by a dentist, making them expensive. This device is an MRD that may be fitted with nothing more than boiling water. Its mechanism of action is the same as any other MRD and can therefore treat OSA. Developer s claims of products benefits CPAP machines are typically used to treat obstructive sleep apnea but they are expensive, have poor patient compliance, and require an electrical outlet, frequent maintenance and disposable supplies. MRDs enjoy good patient compliance, are smaller, lighter, tougher, and they don t require electricity, maintenance or supplies. However, most are individually fabricated and therefore very expensive. This device is a mass-produced MRD that is custom-fitted with nothing more than boiling water. Suitability for low-resource settings MRDs such as this device require no electricity, and unlike most other MRDs which must be individually fabricated in a manually-intensive process, the device is inexpensively mass-produced and may be custom-fitted using nothing more than a pot of boiling water and a spoon. The device may be produced anywhere, using basic injection molding equipment available worldwide. Operating steps After immersing the device in boiling water for a minute, remove and allow it to cool a bit. Then while holding the jaw forward, bite down, molding it to the teeth. To use, merely put the device in the mouth at bedtime and it holds the jaw in the same forward position, opening the airway and allowing more unobstructed breathing. Regulatory status It has been cleared by the FDA (K113022) as a Class II medical device for the treatment of obstructive sleep apnea (OSA) as well as snoring. The challenge is to familiarize the requisite agencies with the device so that they understand how it can help many people. Use and maintenance User: Self-use/patient, physician, technician, nurse Training: None Maintenance: None Settings: Rural, urban settings, at home, secondary (general hospital), tertiary (specialized hospital) Requirements: Boiling hot water Dimensions (mm): 50 x 50 x 20 Weight (kg): Consumables: None Life time: 1 year Shelf life: 5 years Retail Price (USD): 60 List price (USD): 60 Other features: Portable, reusable Year of commercialization: 2007 Currently sold in: Canada, USA Contact details Noel Lindsay Telephone Web
87 Medical devices 2013 Oscillometric ankle-arm measurement Country of origin Switzerland Peripheral artery disease (PAD) is on the rise in developing countries due to an increase in diabetes mellitus. PAD increases cardiovascular risk and is associated with chronic venous ulcers. The device is an automated oscillometric blood pressure monitor designed for clinical use. The device allows for screening of three major cardiovascular risks: PAD, AF, and hypertension. It is equipped with two cuffs for simultaneous double arm measurements and ankle brachial index (ABI) assessment, both of which are recommended screening methods for detection of peripheral arterial disease (PAD). The ABI is automatically calculated by the device. The device can also be used as a regular clinical blood pressure monitor. Since it is also equipped with an atrial fibrillation (AF) detection system, it automatically screens for AF during routine blood pressure measurement. Developer s claims of products benefits The procedure to test for PAD is commonly performed with Doppler which requires skill, is liable to observer bias and is time consuming. This device is easy to use, the procedure is conducted faster and is less liable to observer bias. The device can also be used with minimal training. Suitability for low-resource settings The device is portable and can also be used as a regular blood pressure monitor. Because of its relative low price and multiple configurations (with and without software), it is suitable to be used in small hospitals or healthcare centers. Once fully charged, many measurements can be taken making the device portable and easy to travel with (e.g. to screen in small villages). The device can diagnose PAD, hypertension and atrial fibrillation in a small amount of time. Only limited training is required. Operating steps First, a patient is measured simultaneously at both arms in the supine position to determine the arm with the highest BP. Thereafter, a cuff is placed around the arm and ankle to perform the ankle-arm measurement simultanously. The ankle-cuff is then placed on the other ankle and the procedure repeated. Regulatory status The device is both FDA approved and CE marked. Challenges include making doctors and nurses aware that this device is an automated oscillometric device that can reliably assess ABI, convincing them that general use of this device will improve awareness of peripheral artery disease, and convincing them that cardiovascular screening will lead to the prevention of cardiovascular disease and reduce overall healthcare costs. Use and maintenance User: Physician, nurse, technician Training: Can be conducted in 20 minutes by the organization/company providing the device Maintenance: None Settings: Rural, urban settings, primary (health post, health center), secondary (general hospital), tertiary (specialized hospital) Requirements: The device can work on a rechargeable battery, but also with electricity. When the user has access to a PC, the device can be controlled from the PC and a report produced. The device can be used with and without the PC software which is included free of charge. Ambient temperature for device storage and use should be between 10 and 40 degreees Celsius. Dimensions (mm): 200 x 125 x 90 Weight (kg): 1.1 (including batteries) Consumables: None Life time: 5 years Shelf life: 10 years Retail Price (USD): 1100 Contact details Willem Verberk Telephone Other features: Software use, mobile, portable, capital equipment Year of commercialization: 2008 Currently sold in: Canada, Netherlands, Spain, United Kingdom, United States, and some countries in Asia 71
88 Medical devices 2013 Oscillometric blood pressure measurement Country of origin Switzerland Pre-eclampsia and eclampsia is the second cause of maternal death (10-15% of all maternal deaths) in low and middle income countries. This device provides automated oscillometric blood pressure measurement. It measures the mean arterial pressure by which the systolic and diastolic blood pressure are then calculated using an algorithm. Developer s claims of products benefits The device is accurate in identifying pre-eclampsia and requires limited training. Studies have shown that it is user-friendly and leads to better adherence to measurement at home. Suitability for low-resource settings The device only requires batteries and has been validated for use among pregnant women and women with pre-eclampsia. In addition, cuffs are available in S, M, L, L-XL sizes in both resusable and disposable varieties. Operating steps Place the cuff on the upper arm, press the on/off button and the device automatically measures blood pressure and presents the measured blood pressure value on the LCD screen. Regulatory status The device is both FDA approved and CE marked. Challenges include making doctors and nurses aware that this device is an automated oscillometric device that can reliably measure pregnant women with high blood pressure and pre-eclampsia and that patients can screen themselves at home with this device. Use and maintenance User: Self-use/patient, physician, nurse, midwife, technician Training: Only in the case of patient self-use. Training can be provided by the midwife, nurse or physician Maintenance: None Settings: Rural, urban settings, ambulatory, at home, primary (health post, health center), secondary (general hospital), tertiary (specialized hospital) Requirements: The device can work on batteries but also with an adapter and electricity. When the user has access to a PC, the device can be used as a telemedicine device and the data uploaded to the PC and transferred via the internet to a hospital or general practitioner. However, this is optional. Ambient temperature for device storage and use should be between 10 and 40 degreees Celsius. Dimensions (mm): 150 x 100 x 50 Weight (kg): Consumables: None Life time: 5 years Shelf life: 10 years Retail Price (USD): 110 Contact details Willem Verberk Telephone Other features: Software use, portable, capital equipment, telemedicine solution Year of commercialization: 2008 Currently sold in: All of Europe (except for some Eastern European countries), Canada, United States and many countries in Asia 72
89 Medical devices 2013 Oxygen concentrator-driven bubble CPAP Country of origin United Kingdom In 2011, 1.8 million children under five died from respiratory complications, most in developing countries. CPAP (Continuous Positive Airway Pressure), a form of oxygen therapy for respiratory distress, could save many infants and preterm babies. However, the cost of conventional CPAP is prohibitive in poor countries; as a result it is often unavailable, even in lifesaving situations. Treatment of serious breathing difficulties requires the continuous delivery of a mixture of oxygen and air to the lungs. This device generates and delivers a safe, easily controllable mixture of humidified oxygen and air for CPAP treatment. It is driven by an oxygen concentrator that generates oxygen from atmospheric air, eliminating the need for expensive cylinders of compressed gases. The device delivers flows of up to 8L/min of both oxygen and air. Pressure in the system is controlled by a bubble bottle that depends on the depth of tubing under water, and is set by a simple dial on the bottle top. An oxygen/air mixing chart provided means there is no need for an oxygen analyzer. Developer s claims of products benefits Most CPAP devices available are designed for use in resource-rich countries and are inappropriate for low-resource settings. A few devices have been designed to make CPAP more widely available in low-resource settings, but these still require an external oxygen source, making them expensive to run. This device is unique in being driven by its own oxygen concentrator, a cost-efficient method of generating oxygen. This makes it possible to deliver low-cost reliable CPAP treatment in low-resource or remote areas where gas cylinders are not an affordable or practical option. The model of oxygen concentrator used in this CPAP device was selected for its durability and performance in tests. The device is robust, simple to operate and requires only minimal maintenance. Suitability for low-resource settings The device is intended for use in low-income countries and remote areas where gas cylinders are expensive and difficult to transport. The device needs no compressed gases, It delivers both oxygen and air at 8 L/min and costs just 70 pence per day. Equivalent use of compressed gas costs 70 per day. It delivers safe, affordable, reliable CPAP. Operating steps Plug in and run oxygen concentrator. Fill the bubble bottle with boiled, cooled water and connect the breathing circuit. Adjust the level of CPAP required using a simple dial control on the bottle. Flow of air and oxygen can be seen in the bottle as bubbles in the water. Connect nasal prongs or mask to the patient and continue to monitor signs of respiratory distress. Regulatory status The oxygen concentrator and CPAP system incorporated in this device have CE mark and FDA approval. The device is provided by an ISO registered company. The device will be demonstrated at forthcoming exhibtions and conferences in Africa, Asia and the Middle East. Peer reviewed clinical trials are underway in Papua New Guinea. Intention is to co-author papers for publication in peer-reviewed journals. Use and maintenance User: Physician, nurse Training: Not required. Device comes with a manual with full instructions for operation and maintenance. It has successfully been used by medical staff, without any additional special training, in low-resource settings in rural hospitals in Kenya, Papua New Guinea, Sierra Leone, the Solomon Islands and Uganda. Maintenance: Minimal maintenance by nurse/physician or technician Settings: Rural, urban settings, primary (health post, health center), secondary (general hospital), tertiary (specialized hospital) Requirements: The device requires a stable electricity supply to run. Nasal prongs and tubes are reusable and autoclavable, thus they need to be sterilized between patients. Boiled water for the bubble bottle valve is required. Dimensions (mm): 390 x 440 x 840 Weight (kg): 26 Consumables: None Life time: > 5 years Shelf life: > 5 years Retail Price (USD): 2400 List price (USD): 2400 Other features: Mobile, reusable Year of commercialization: 2012 Currently sold in: Sold in the United Kingdom for use in Afghanistan, Congo, Kenya, Malawi, Papua New Guinea, Sierra Leone, Solomon Islands, Uganda. Contact details Robert Neighbour Telephone Web
90 Medical devices 2013 Telecardiology Country of origin France Chronic cardiovascular disease The system consists of a 12-lead electrocardiograph (ECG) that transmits its recordings via satellite or any solution available on site: 2G, 3G, ADSL, WiFi, to a web platform where data is accessible. An elastic belt facilitates operation by eliminating the installation of 10 ECG electrodes. Developer s claims of products benefits This device is easy to use and can even be operated by the patient without the support of a health professional. It also provides quick medical advice through the development of an online medical file that simplifies the relationship between health professionals. Suitability for low-resource settings The device prevents the need for patient transport when monitoring chronic cardiovascular disease and it allows for specialist advice in areas far from specialized healthcare facilities. Operating steps The stretch belt equipped with the pre-placed electrodes is placed on the patient s chest. The recorded data is directly sent to a specialist. The data is stored remotely and the cardiologist performs the reading on a smartphone or computer via the Internet. Regulatory status The product is CE marked and manufactured by an ISO certified company. Data transfer is secure and compatible according to Telemedicine laws. Future work includes the addition of new sensors (e.g. spirometry, SpO2, blood pressure, balance, thermometer) and the generalization of the service platform to meet the increased need for prevention and management of chronic diseases, while allowing a reduction in health care costs. Use and maintenance User: Self-use/patient, physician, nurse, family member Training: The training can be done by locals familiar with the device. Training time is about 15 minutes. Maintenance: Yearly maintenance by technician Settings: Rural, urban settings, ambulatory, at home, primary (health post, health center), secondary (general hospital), tertiary (specialized hospital) Requirements: Power supply for recharging and access to the internet Dimensions (mm): 270 x 150 x 140 Weight (kg): 1.54 Consumables: None Life time: 10 years Shelf life: 5 years Retail Price (USD): 2000 List price (USD): 1500 Other features: Software use, portable, capital equipment, telemedicine solution Year of commercialization: 2011 Currently sold in: France and in Francophone African countries. Contact details Jean-Luc Rebiere Telephone Web
91 Medical devices 2013 Umbilical artery doppler analyser Country of origin South Africa Placental insufficiency is a major cause of intrauterine growth restriction. Doppler ultrasound to assess the flow velocity of the umbilical artery of the fetus with poor growth is the only method of antenatal surveillance that has significantly improved perinatal outcome, but Doppler technology is often unavailable at the primary care level. The technology uses Doppler waveform analysis for reliable and costeffective antenatal screening in low-resource environments. The technology measures blood flow in the umbilical artery of the fetus at greater than 24 weeks gestation. From such a measurement, decisions can be made about the ability for the placenta to provide sufficient nutrients and oxygen in order to sustain adequate fetal development. The ultrasonic Doppler probe connects to the USB port of a standard Pentium PC or laptop on which proprietary software is installed. The product consists of a graphic user interface, operational software and the physical mechanical parts of the probe (hosing, acoustic nose, etc.). The external speakers, printer, and notebook are off the shelf products. The system allows for a database facility, serial monitoring, plotting and printing of results, quality assurance and remote expert support. A 3G data connection (integrated SIM card) is necessary if remote expert support is desired. Developer s claims of products benefits 2D ultrasound with Doppler mode are available at secondary and tertiary care facilities in South Africa but operation requires sonography skills and training. Sonographers are expensive are scarce in South Africa. This system is based on continuous-wave technology, which is easier to use and already proven to be as reliable as the more expensive and larger duplex mode machines found in ultrasound units. By introducing the simple-to-use Doppler to primary antenatal care, it is anticipated that this device could significantly reduce the numbers of referrals to a higher level of care. Suitability for low-resource settings The system requires little management and few consumables apart from the gel to operate the probe and thermal printer paper if maternity case records are to be maintained. The system is rugged as well as water and acid resistant. It has demonstrated that simple PC-based, continuous wave Doppler ultrasound device operated by a midwife at the antenatal study clinic is effective in identifying patients at risk for placental insufficiency and in excluding pregnant women from additional tests for fetal well-being. Operating steps Enter patient details, palpate to determine fetal orientation, apply gel to probe and move it across the abdomen to detect umbilical blood flow with good audible signal. Record measurement, review waveform diagram and plotted indices, follow clinical management suggestions. Save patient file, print result and staple into the maternity case record. Regulatory status Two external audits for ISO are scheduled for November and December The audit for CE marking is scheduled for February include training device operators in conducting waveform Doppler measurement, establishing a medical device management system to support devices in the field, developing a reliable remote expert support (telemedicine) feature for quality assurance and assistance of clinical personnel in the field, and pursuing liability insurance system accreditation and tender-based procurement by Departments of Health. Use and maintenance User: Nurse, midwife Training: Yes Maintenance: Daily cleaning/removal of any gel from keypad and probe by the nurse Settings: Rural, urban settings, primary (health post, health center), secondary (general hospital) Requirements: Access to electricity to charge the battery of the notebook because the probe is powered directly from the computing device via USB connection. A lockable treatment or storage room against theft protection during hours when the clinic is closed. 3G connection if remote expert support is desired. Dimensions (mm): 300 x 250 x 70 Weight (kg): 2.2 (includes notebook, probe, speakers, charger, and thermal printer) Consumables: Transmission gel, thermal printer paper Life time: 10 years Shelf life: 1 year Retail Price (USD): 2400 List price (USD): 1100 Other features: Software use, telemedicine capability, mobile, capital equipment Year of commercialization: Anticipated 2014 Contact details Rita van Rooyen Telephone Web
92 Other technologies 2013
93 Other technologies 2013 Postpartum uterus trainer Country of origin Norway There is a large unmet need for family planning and postpartum uterus care. 95,000 maternal deaths can be prevented annually if women who desired to postpone or avoid childbearing had used effective family planning. The intrauterine device (IUD) is an effective, safe and reversible long acting family planning method, and can be safely inserted immediately after delivery of the placenta. The product represents an anatomically correct postpartum uterus from 10 minutes up to 48 hours after the delivery of the placenta, enabling the teaching and practice of the insertion of the postpartum IUD and balloon/condom tamponade, among other practices such as cervical and vaginal inspection, gauze packing, bimanual compression and removal of placental parts. Due to its size and simplicity, the instructor can actively interact with the learners and observers during hands-on practices, obtaining instant feedback from the uterine cavity and the vagino-uterine angle. It works as a stand-alone product and also in combination with a birthing simulator. Developer s claims of products benefits Current models of IUD placement trainers are expensive, heavy, require additional accessories and are not durable enough. Their vague anatomical features causes misinterpretations and malpractice (such as too low IUD placements, resulting in increased expulsion rates). Their high cost prevents large-scale implementation as well as high-frequency, low-dosage training. There are no other solutions in the market that can provide high-fidelity training in various postpartum uterine interventions. Suitability for low-resource settings The product was developed to facilitate efficient training in low-resource settings for important, lifesaving postpartum interventions. The simplicity and durability allows it to be used in any setting and also facilitates that it can be purchased and distributed in large quantities, so that health providers in even the most rural areas can access it for the important frequent refresher training that will enable them to maintain skills learnt during the initial training course. The device was designed to be highly realistic where essential (particulary in feeling of the fundus and cervical-vaginal angle), culturally adapted, flat packed for easy transport and storage, highly affordable, durable and easy to use. In addition, it is designed to facilitate role play and efficient training. Operating steps The product is easily prepared for use by one quick step and is fully manually operated. Regulatory status Not applicable. It is classified as a training device. In order to achieve efficient implementation of better quality postpartum uterus care and postpartum IUD insertion, the product should be available for health care workers during their initial training - and importantly - also for subsequent regular refresher training. Ideally, there should be a simulator available in every health facility. The greatest barriers for widespread implementation are believed to be financing (although highly affordable, funding may be needed from governments or aid organizations) and distribution (due to bureaucracy and often prohibitive customs rates). Use and maintenance User: Physician, nurse, midwife, instructors and students in courses for postpartum interventions Training: None Maintenance: General cleaning of training product after use by wiping with a moist cloth and drying. Settings: Rural, urban settings, ambulatory, primary (health post, health center), secondary (general hospital), tertiary (specialized hospital) Requirements: The product is operational in any setting and environment. There is no need for electricity or other advanced infrastructure. Dimensions (mm): 350 x 200 x 175 Weight (kg): 0.65 Consumables: None Life time: 3 years Shelf life: 3 years Retail Price (USD): 50 List price (USD): 50 Other features: Portable, reusable Year of commercialization: 2013 Currently sold in: It is offered on a not-for-profit price to the 75 countries that have been identified by UN as focus countries relative to MDG 4 and 5. Contact details Ingrid Lærdal Telephone Web
94 Other technologies 2013 Pressure cooker autoclave Country of origin United States of America Healthcare associated infections are the most frequent threat to patient safety worldwide, and Surgical Site Infections (SSIs) are the most common type of infection. The effects of SSIs on patients and health-systems are both severe and underestimated, and the burden of infections falls on the patient population with the highest level of need. The pressure cooker autoclave is an affordable, easy to use autoclave. An electronic sterilization monitor connects to a pressure cooker via an integrated thermal sensor. The monitor provides verbal instructions to health post employees in their native language. It notifies them when their attention is required and guarantees whether or not instruments were fully sterilized at the end of each cycle. Information regarding frequency, features used, and rates of successful sterilization cycles is sent via cellular networks to an online database where location and usage information can be viewed and analyzed. Developer s claims of products benefits Medical instrument boilers and autoclaves are available in some regions. Boilers are the most common sterilization method used, but are ineffective and can leave instruments contaminated. The low-cost autoclaves that are currently available require electricity, which is often intermittent at best, and therefore they often go unused. The principal benefits of the pressure cooker autoclave are convenience and efficacy. Pressure cookers can completely sterilize medical instruments whereas boilers cannot. Spoken instructions in the local language facilitate use for health post employees, enhance staff efficiency, reduce training costs, and ensure that the sterilization protocol is followed correctly. Remote monitoring helps health administrators to measure the impact of the devices and know they are used regularly. Suitability for low-resource settings The pressure cooker autoclave is intended for use in remote and resource-constrained clinics in lower and middle-income countries. By removing the dependency on electricity and featuring a built-in instructor, it is suitable for areas without regular electricity and addresses education and training challenges faced by normal autoclaves. Operating steps Users select how the medical instruments are packaged (wrapped in linen or not) on the cycle monitor. Verbal instructions then help users complete a successful sterilization cycle. At the end of the cycle, the monitor notifies users whether sterilization was successful, and how to maintain the instruments clean until use. Regulatory status Meets CDC standards for sterilization by exposure to high temperature and pressure. The manufacturers hold ISO 9001:2008, ISO 13485:2003 QMS certifications and UL certifications. CE mark certification is in progress. Remote clinics typically do not have the funds necessary to purchase their own equipment. In order to reach the intended users, governments or other health administration bodies will first purchase the autoclaves to distribute to intended consumers. Governments often have little incentive to be early adopters of new technology. Finding the correct strategy to move the product to the intended users is the primary challenge facing the pressure cooker autoclave. User and environment User: Nurse, health post employee Training: None Maintenance: None Settings: Rural, urban settings, primary (health post, health center), secondary (general hospital), tertiary (specialized hospital) Requirements: Almost no infrastructure requirements are necessary to operate this autoclave. Fresh water should be used each time new instruments are sterilized. A heat source capable of boiling water must be employed. Whatever is typically used to cook food can be used, including gas, coal, electric or solar. Dimensions (mm):300 x 300 x 500 Weight (kg): 3 Consumables: None Life time: 10 years Shelf life: 15 years Retail Price (USD): 250 List price (USD): - Other features: Software use, mobile, capital equipment Year of commercialization: Awaiting CE mark Contact details Mark Maples Telephone Web
95 Assistive devices 2012
96 Assistive devices 2012 Solar charger for hearing aid Country of origin Botswana & Brazil 7% of the world s population is hearing impaired. That is a total of 312 million people, of whom two-thirds are living in developing countries. The extent of hearing loss leads to unnecessary poverty and hardship in the families and communities affected, and by extension, to the larger society. It also costs governments up to 3% of their GNP. Rechargeable hearing aid, solar charger and rechargeable hearing aid battery. Product functionality This device has a rechargeable hearing aid battery which costs $1 and lasts 2-3 years. To charge the battery, a novel, but not patented, solar powered battery recharger was developed, which can be recharged via the sun, household light or plug in using a Nokia cell phone electrical recharger. Developer s claims of product benefits This device is the only low-cost rechargeable analogue and digital hearing aid on the market. Operating steps During the day a solar panel charges 2 AA rechargeable batteries. Once or twice a week, one takes out the rechargeable hearing aid battery and puts them in the charger. The next morning these batteries are ready to use again. One can also charge the batteries using a household light or plug-in. The batteries fit into 85% of all hearing aids. Development stage Countries that receive these rechargeable hearing aids, solar charger and rechargeable batteries to do not require FDA or CE approval, but all of these component suppliers have FDA, CE and are ISO approved. The technology is offered for free to like-minded non-profit organizations. In addition, the company helps write the business plans, raise money, and set up manufacturing operations for others for free. User and environment User: Self-use/patient Training: None Maintenance: Yes, 3-5 years change batteries Settings: Rural, urban, at home Requirements: Sunlight Dimensions (mm): 40 x 20 x 15 Weight (kg): 0.3 Consumables: Rechargeable AA and rechargeable hearing aid battery Life time: 10 years Shelf life: 5 years Retail Price (USD): 48 List price (USD): 24 Other features: Portable, reusable Year of commercialization: 2002 Currently sold in: 39 developing countries Contact details Howard Weinstein Telephone Fax
97 ehealth solutions 2012
98 2012 ehealth Biometric technology in healthcare Country of origin India Tuberculosis (TB) is one of the biggest public health problems in India. The country holds one-fifth of the global TB burden with nearly 2 million new cases and 330,000 TB-caused deaths every year. Patients who do not complete the entire course of treatment often develop drug resistance. Solution description The system utilizes a simple interface with minimal text and color coding for ease of use in low-literacy areas. The system synchronizes up-to-date reports with a central Electronic Medical Record (EMR) database located at the office headquarters. The application uses.net Framework and runs locally on any Windows machine. Primarily an offline application, it sends daily attendance reports through SMS to an online server, through the USB modem. When the patient registers onto the system they provide a fingerprint, which is used throughout their course of treatment to track their treatment schedule. If a patient misses a dose, an SMS is sent to their counselor by the end of the day. Functionality Patients registered at the terminal log their visit to a TB center on a fingerprint reader. At the end of each day, the attendance record is compressed into a text message and sent to an online server. If a patient misses a dose, the counselor receives a text message and must follow up with the patient within 48 hours to take their medication. Developer s claims of solution benefits The ecompliance initiative is the first to apply biometric attendance monitoring to tuberculosis treatment. No other TB control system can provide verifiable evidence to back up their TB statistics. The innovation s transparency and accountability are two of its strongest aspects. While other TB programs have digitized their systems, these programs rarely cater to impoverished areas, relying on the Internet or 3G networks to relay information. Funding is needed for operations of the system and the ever-changing field of technology. User and environment User: technician, counselors. Training: training on the system takes 3-4 hours and is given by one of the biometric team members. Settings: rural, urban, home, ambulatory, primary, secondary, and tertiary. Solution specifications Solution is used to support: Electronic Health Record/ Electronic Medical Record; mhealth. Software/Hardware requirements: Netbooks for use in the treatment centers and access to SMS network to work with the netbook. The software is open-source and can be downloaded from the website for free. Country used in: India Evaluation: There has been one pilot study at the treatment centers, and a follow up of a qualitative study in 25 centers in two states. Over 2,300 patients have been registered. The qualitative study interviewed 8 health workers, 4 center owners and 23 patients. Findings suggest that the terminal helps draw patients to the center by incentivizing health workers and convincing patients to come. Contact details Sandeep Ahuja Telephone
99 2012 ehealth Case-based smartphone messaging platform Country of origin United States of America This technology is focused on addressing the diagnostic/treatment support and information resource needs of healthcare providers in Botswana, a country with the 2nd highest prevalence of HIV and 4th highest prevalence of TB. There are about 40 physicians per 100,000 people and access to physician care outside of city centers remains challenging. Solution description A mobile medical platform that 1) connects resident physicians to their peers & faculty for timely team-based case consultations related to patient care; 2) provides access to a global network of physicians (via Swinfen Charitable Trust s Telemedicine programme) for external referrals; and 3) enables easy, centralized access to important medical resources relevant to Botswana. Users can: Complete case forms, including images & videos, and send to colleagues for consultation Send messages to the entire team or individuals Search message history Share geographic location Search and share references such as local treatment guidelines and PubMed. Functionality Users sign-on and set their status as on call or online and indicate their location. They can see others status and location. Users complete a case consult form, attach media such as photos or videos, and share with team members for comments. Users are notified of news messages & replies via notifications on their device and in the app. Developer s claims of solution benefits The application provides an integrated platform for physicians to communicate efficiently about patient care and to access and share reference information through a single app on a mobile device. Users benefit from telemedicine consults & searchable message threads (thereby learning through a shared case-based model) and have access to country-specific guidelines & journal abstracts. The product captures usage data allowing for analysis and is designed for low-resource/marginal-connectivity settings. The challenges - and the opportunities for solutions - are spread across a number of categories: namely, Software -> Hardware -> Personnel -> Programs. Given that each of these category silos have their own unique set of issues (e.g., design & development of information architectures optimized for low-bandwidth settings; procurement at a costeffective price of smart devices for Sub-Saharan Africa; recruitment, training, & engagement of field pilot professionals; and administrative management of multiple groups through protocols, feedback & study design) it is essential to operate across categories in an integrated and iterative manner. User and environment User: physician Training: an initial two-hour training session, including demonstrations and cases. Settings: rural, urban, home, ambulatory, primary, secondary, and tertiary. Solution specifications Solution is used to support: Telemedicine; elearning/ mlearning; mhealth; Geographic Information System Software/Hardware requirements: Use of this product requires an Android mobile device and access to mobile Internet or WiFi connection for full-access to all the features of the system. However, users without a data connection can still prepare and save case information using an offline mode for later uploading. Software is proprietary developed specifically for deployment by the Botswana-UPenn Partnership and its physician teams. Contact details Sankalpo Ghose Telephone The product is still in Field Pilot / R&D phase and has not yet been commercialized. Standards: It adheres to HIPAA security & privacy rules for PHI data. Currently used in: Botswana Evaluation: No studies have been conducted on the technology yet, but the team is in the process of designing a study to evaluate the technology with local partners. 83
100 2012 ehealth Cervical cancer screening information system Country of origin Argentina In Argentina, cervical cancer is the second most common cause of death by tumours, in women from 35 to 64 years old, there is a death rate of 7.1 / 100,000 and an incidence of 23.2 / 100,000. Each year, in Argentina, 1,800 women die and a further 3,000 new cases are diagnosed. Women of low socioeconomic status are more vulnerable due to lack of access to screening. Solution description The national information online system of screening allows for the monitoring and appropriate treatment of affected women by providing nominalized lists of women included in the national prevention programme. The national information system identifies women with pathological paps for their diagnosis and treatment. It also provides indicators to monitor and evaluate the prevention programme. Functionality The national online information system allows for coordination of health services that are involved with uterine cervical cancer prevention, serving as a support of the monitoring of health services. It is used at the primary care level, cytology laboratories, gynaecology services and central level. Developer s claims of solution benefits It is an online information system that links services and users so that the information related to screening, diagnosis and treatment supports the management of the service network. It allows for the flow of information among different health services and country areas, allowing the monitoring of women in all stages of prevention, even those living in remote areas. It has an alert system that allows for faster detection of problems with women in need of diagnosis and treatment. Incorporation of modules on breast and colon cancer screening, diagnosis and treatment. User and environment User: physician, technician, nurse, midwife, administrative staff. Training: none Settings: rural, urban, ambulatory, primary, tertiary. Reviewer s comments This system is deployed nationally for cervical cancer screening, treatment and capturing of data. It is also being developed and used localy and requires very low resources. A formal evaluation of this program would be helpful to contribute evidence, and this would form a basis upon which other countries might want to consider adopting it. Solution specifications Solution is used to support: Decision Support Systems; Electronic Health Record/Electronic Medical Record Software/Hardware requirements: Access to a computer connected to the Internet. It uses the database engine SQL- Server, ASP programming language. The ministry of health has licenses for using them, so it was decided to develop the described tool on this platform. The software development is an open source and it belongs to the ministry of health. Standards: ICD-10; Bethesda Currently used in: Argentina Evaluation: Arrossi, S; Paolino, M: Proyecto para el mejoramiento del Programa Nacional de Prevención de Cáncer de Cuello Uterino en Argentina - Informe Final: Diagnóstico de situación del Programa Nacional y Programas Provinciales. Buenos Aires. Organizacion panamaericana de la Salud; 2007, page 33. Contact details Silvina Arrossi Telephone /
101 2012 ehealth Computer-aided detection for Tuberculosis Country of origin The Netherlands Tuberculosis is the second deadliest infectious disease in the world. With early detection and proper treatment, most people with tuberculosis can fully recover. Combined efforts and investment in Tuberculosis detection can help to save millions of lives worldwide. Solution description Digital X-rays can efficiently make large numbers of chest radiographs at low cost. Computer Aided Detection software (CAD) can immediately analyse these digital images. The CAD software gives a probability percentage normal vs. abnormal consistent with TB. CAD follows the processing steps: Lung shape analysis Clavicle detection Texture analysis. Texture within the lung fields and the shape of the extracted lung fields are compared with a training database obtained from thousands of training images. Based on this analysis a grade for the image is computed. Based on the grade and the expected prevalence in the population, the probability that the image contains signs of TB is calculated. Functionality The software can be configured to run automatically after a digital X-ray has been made: the image is sent automatically to a separate computer on which the CAD software is installed, the program performs the quality check and the image analysis steps and the result is stored on disk. Developer s claims of solution benefits Present technologies are time consuming and quality/temperature sensitive or costly for hundreds of tests. With a portable digital X-ray even remote groups can be screened at low cost as the incremental costs of digital X-ray and CAD are very low. Studies done by universities and Zambart show that the sensitivity and specificity of the software to diagnose culture positive TB from chest radiograph is the same as done by clinical officers and CRRS certified human observers (no significant difference in performance). Challenges ahead: 1. Creating a computerized decision support by combining X-ray signs with clinical symptoms. 2. Evaluate CAD with GeneXpert (cartridge-based, automated diagnostic test ) as an efficiency filter in TB screening to determine who gets GeneXpert. 3. Regulatory approval. User and environment Users: physician, technician Training: a 3-hours training is provided on a laptop or PC. Settings: rural, urban, ambulatory, primary, and secondary. Solution specifications Solution is used to support: Telemedicine; Electronic Health Record/Electronic Medical Record; mhealth; Health Research. Software/Hardware requirements: Laptop or computer with MS Windows, Intel Pentium preferably i7, 8 GB RAM 120 GB HDD, Calculation time depends on amount of RAM and type of processor. CAD4TB is proprietary software that runs on any laptop or PC that meets the above specifications. Standards: DICOM, HL7 Currently used in: Zambia, South Africa, The Gambia Evaluation: The CAD software is currently used prospectively in clinical trial to make a selection with TB suspects should undergo other more expensive and time-consuming further testing. The partners CIDRZ and Zambart in Zambia are using the CAD software as a filter in TB screening to determine who gets GeneXpert. Contact details Harro Nip Telephone Fax
102 2012 ehealth Electronic consultation register Country of origin Burkina Faso In Burkina Faso, 1 in 6 children die before the age of 5. The Integrated Management of Childhood Illness (IMCI) protocol was developed by WHO to reduce child mortality but its implementation is difficult due to an insufficient number of trained health workers and because arduous working conditions increase the lack of rigor and motivation. Solution description The registre electronique de consultation (REC) is an offline web application that guides the health professionals throughout the consult to help them strictly apply the IMCI. A step-by-step approach allows for determining in real-time the illnesses of the patients as the health worker identifies the symptoms. Once the diagnostic is established, the REC identifies the appropriate treatment and the medicines to be prescribed with their dosages. The diagnostic and treatment data are centralized and restored via a secured synchronization procedure via USB drives. The REC allows agents to easily create a personal file for each patient with the history of diagnostics and treatments administered. Functionality Users launch the REC or synchronization process through a single main menu. The diagnosis is in 3 simple steps: 1. Search - if the patient already has a file in the system 2. Evaluate - each question of the IMCI protocol is answered sequentially 3. Treat - follow the identified treatment and medicines. Developer s claims of solution benefits The REC addresses key problems of the implementation of the IMCI protocol. The guided step-by-step approach ensures that the protocol is correctly applied. It avoids diagnostic errors as long as symptoms are correctly identified. Since little computer training is required to use the application, even health workers without IMCI training can safely apply the protocol. The user interface also allows for a quick data entry, reducing the time of consult per patient. The global user experience could be improved by porting the REC to tactile devices. It would ease the learning curve and limit the number of devices to one for easier maintenance. With the improvement of the telecommunication networks a wireless data synchronization would make data centralization seamless and ease the integration of the REC to national health systems. User and environment User: nurse, physician, midwife. Training: a 2-day session to learn the use of the computer and the REC. Settings: rural, urban, ambulatory, primary. Reviewer s comments IMCI is known to be difficult to implement in primary care settings and this tool provides guidance and learning opportunities for healthcare professionals, and improves continuity of care thanks to a basic electronic medical record module. Solution specifications Solution is used to support: Decision Support Systems; Electronic Health Record/Electronic Medical Record; elearning/mlearning. Software/Hardware requirements: Netbook, The REC operates in rural areas with a solar panel. Electricity is required for at least a couple of hours per day in order to recharge the batteries of the netbook. The REC was developed exclusively with open source software. The operating system is a customized Linux providing the environment necessary to run a web server locally. Currently used in: Burkina Faso Evaluation: The pilot implementation period Oct Oct was documented by the University of Geneva. A baseline study is currently in progress with the London School of Hygiene and Tropical Medicine in order to monitor the extension to 75 health centres in Contact details Thierry Agagliate Telephone Fax
103 2012 ehealth Health workforce information systems Country of origin United States of America The 2006 World Health Report identified 57 countries with human resources for health crises that have less than 2.3 health workers per 1000 population. It is estimated that more than a billion people do not have access to a health worker. Associated challenges include health workforce planning, policy, training, deployment, management and retention. Solution description The software is an open source LAMP-architecture solution (Linux, Apache, MySQL, PHP) that, once established, may be accessed via a web browser on the same computer the software is deployed, or via a LAN, or from anywhere on the World Wide Web. The software supports easy configuration of key variables (such as job titles, cadres, competencies and job structures). Information is then collected on the health workforce, either through a centralized national architecture, or a decentralized subnational architecture that can then be aggregated for national analysis. The software supports easily customized reports and charts, or the exporting of data in many common formats. Functionality Typical steps for setting up and using the software include: Adding Geographical Areas Configure database drop-downs Create a job structure Create positions Enter employee information including identifying information, contact information, dependents, position, qualifications, trainings, employment and education history Create and run reports as needed. Developer s claims of solution benefits A free and open source solution is designed to support full country adoption and ownership. The software is cost effective, easy to configure and is supported with strong documentation, elearning, and other resources. This solution also support countries to avoid vendor lock-in. All data can be exported in a variety of formats at any time for migration to a new solution if desired. The biggest challenge remains whether the users have enough access to the Internet to learn about and access the technology and associated resources. As infrastructure continues to strengthen and this situation improves, a cloudbased version can be offered to minimize initial configuration and set-up challenges. It is also part of the future plan to move from an HR Information System to an HR Management System, which is less about collecting and reporting on workforce data, and more on taking consistent and high-quality management actions. User and environment User: health managers, supervisors, workforce planners and regulators. Training: administrator training is currently available online, and user training is under development. Settings: rural, urban, secondary, tertiary, district management offices, Ministry of Health. Solution specifications Solution is used to support: Decision Support Systems; mhealth; elearning/mlearning; Health Research. Software/Hardware requirements: At minimum, a computer running Linux with Apache, MySQL and PHP installed is required. The solution offers a preconfigured appliance that has everything ready to plug into a LAN. It can also be run from a flash drive, or freely downloaded and configured as a Linux install package. LAN, WAN or Internet access is needed for remote data entry or reports. Standards: SDMX-HD Currently used in: Botswana, Ghana, India, Kenya, Lesotho, Mali, Nigeria, Rwanda, Sierra Leone, Tanzania, Togo, Uganda. Evaluation: An extensive independent evaluation has not been done. Contact details Dykki Settle Telephone Fax
104 2012 ehealth Integrated smartreader & cloud services Country of origin Canada Two of the biggest problems in infectious diseases are inadequate diagnosis and case management at point of care (POC) by health workers and inadequate resource allocation and monitoring by health managers and funders. Solution description The smartreader is a rugged, companion device for use by health workers at POC that captures and transmits a broad range of data to the cloud via local cell networks. The reader currently interprets commercially-available malaria rapid diagnostic tests (RDTs). Additional infectious disease targets are to follow in rapid succession, e.g. HIV, dengue, hepatitis. Via standard web browsers, the portal provides health managers and funders with a host of cloud information services, including data management and reporting, mapping and surveillance, based on data captured by smartreaders. Managers can connect with workers in the field to implement quality control measures, and disseminate clinical and operational guidelines. Functionality Smartreader software guides the user through RDT processing steps and data entry, interprets test results, and automatically transmits patient and worker activity data, GPS, image of RDT over cell networks to the cloud. Managers log into the portal to view/create reports, query real-time data, disseminate messages and content to readers. Developer s claims of solution benefits This solution transforms infectious disease healthcare delivery and healthcare management by enabling: high-quality healthcare delivery by minimally trained health workers at point of care real-time monitoring and analysis of point-of-care data for resource management and timely response to outbreaks evidence-based resource allocation and investment decisions by healthcare funders and industry. Distribution via franchises with local entrepreneurs, thus not only contributing to local economies and skill development, but also accelerating sales. User and environment User: physician, nurse, midwife, technician, community health worker. Training: optional training will be provided by qualified local distributors. Settings: rural, urban, ambulatory, primary, and secondary. Reviewer s comments The innovation of the project is mostly related to the hardware (smart reader for rapid diagnostic tests). However, its information components are very well integrated into a coherent set of tools, which represents the state-of-the-art. Solution specifications Solution is used to support: Decision Support Systems; mhealth; Geographic Information System; Health Research. Software/Hardware requirements: Smartreader at POC: minimally trained health worker. Data transmission from POC to cloud: any local cell network. Cloud information services: health program manager with standard web browser on any computer. Smartreader functions for 4 days on internal battery rechargeable by electric outlet, solar panel, handcrank. The software is proprietary and is charged on a pay per use basis. The system hosts third-party mhealth applications. Standards: Upcoming releases will support HL7 and HIPAA. Currently used in: Colombia, Ecuador, Kenya, Tanzania, Ghana. Evaluation: Performance was validated for 7000 patients by 50 health workers at 30 sites in four countries. Diagnostic accuracy studies fully blinded and expected to be submitted for publication in peer-reviewed journals in Contact details Adam Liederman Telephone Fax
105 2012 ehealth Maternal health Tanzania Country of origin Tanzania Maternal and neonatal healthcare in Africa faces well-documented challenges, including: 1) Limited qualified health staff, 2) Ineffective referral systems for triage to urban/higher facilities, 3) Inadequate diagnostics at point of care, 4) Limited community-level data and connectivity, 5) Uninformed patients, 6) Limited Public Private Partnership (PPP) financial models. Solution description The platform is accessed through the Internet by a netbook computer, smartphone, or other modern web device. Users submit patient data, which is validated before being sent via encrypted connection to a central database. The platform features sending / receiving SMS to patients and clinicians, portable ultrasound integration, dynamic filterbased patient cohorts for targeted follow-up, scheduling of return visits or patient referrals in a central calendar, and recording of orders and payments made during a clinic visit. An additional continuing medical education module allows online creation and publication of multimedia courses and informal clinician accreditation. Functionality 1) User registers mother at clinic. 2) User submits outcome of clinical examination and schedules follow-up visit. 3) Specialist conducts portable ultrasound examination and saves image to the mother s record. 4) Upon referral, user at another facility accesses mother s full record. 5) Mother receives targeted educational and reminder SMS. Developer s claims of solution benefits Validate data instantly and track user performance to identify areas of weakness for retraining. Enable community-based care outside of clinic setting using networked computers. Retain a full record of mother s information in health system. Generate system-wide clinical and operational reports without tedious data collection/aggregation. Enable portable obstetric-ultrasound screenings: better diagnosis, early intervention. Browser-based platform overcomes limitations of phone-based platforms. A large portion of active deployment costs come from the Internet usage and SMS costs for follow-up with patients. Deployment on a large scale would be greatly facilitated by partnership with mobile operators (e.g. corporate social responsibility initiative or volume-based pricing). Emphasis on the importance of record-keeping and the power of data will help highlight the advantages of the platform s various modules working together and motivate adoption (e.g. targeted SMS follow-up based on early identification of high-risk mothers, accreditation of health workers through online training to assess quality of human resources, detailed reports to assist management in budget allocation). User and environment User: physician, nurse, midwife, technician, facility or health system administrator. Training: one week hands-on training. Settings: rural, urban, ambulatory, primary, secondary and tertiary. Solution specifications Solution is used to support: Telemedicine; Electronic Health Record/Electronic Medical Record; elearning/ mlearning; mhealth; Reporting, portable diagnostics, facility management. Software/Hardware requirements: The server-side component of the platform requires specific software running on a secure Internet-connected data centre. The software is being made available on an international free-for-use license. Customization of data forms for use outside Tanzania may require modest technical development investment. Contact details Lushen Wu Telephone Standards: Format of structured data adheres to the Tanzania Ministry of Health maternal health card. Currently used in: Tanzania 89
106 2012 ehealth Medical cloud Country of origin United States of America Picture Archiving and Communication Systems (PACS) represent the integration of medical diagnostic images and records playing a critical role in patient diagnosis and outcome. Traditionally only medical centres in developed countries have been benefactors leaving a significant disconnect globally for resource-poor locations to also benefit. Solution description Patient information regardless of the imaging modality (ultrasound, x-ray and beyond) and/or digital medical records are scanned and uploaded by an authorized medical professional. Automatically the information is sent through a secure Digital Imaging and Communications in Medicine (DICOM) process over a standard web browser from a digital device the user is accustomed to using such as any smart phone or mobile computer. Physicians, teams of specialists and qualified medical professionals across the globe have on-the-go access through a log in user name and password with access to review patient medical information providing accurate diagnosis and second opinion reports. Functionality The DICOM sender module offers a zero foot print viewer system that allows for images to be viewed on the web. This cloud based approach requires no additional hardware or software to be purchased. Native studies are sent directly to fully functioning PACS systems or viewed through a log in user name and password over any personal digital device. Developer s claims of solution benefits Physicians will have access to images and reports allowing them to take their services to patients who could not be reached previously. Informed patient care decisions allow for a faster accurate diagnosis from anywhere in the world that has access to the Internet. Statistics show there are 2.2 billion mobile phones in the developing world while some parts have a patient-doctor ratio of one in 20,000. A mobile cloud service enables better care to be provided to more patients at a lower cost. The fundamental financial and operational model has a primary focus on the healthcare industry, one known to be cautious with technology. Confusion hinders adoption and there is some confusion about what Cloud computing can do. User and environment User: physician, nurse, technician, authorized medical professionals and health care providers. Training: remote training is provided. The service team is accessible online through a live chat feature. Settings: rural, urban, home, ambulatory, primary, secondary, tertiary. Reviewer s comments This proposed icloud Web PACS, having been tried by several countries, can conceivably be built up over time to facilitate more exchanges. The affordability of this technology in underserved communities depends largely on the company s case use fees. This is an important consideration for prospective countries when considering this system. Crossing jurisdictional governance between countries could hamper some privacy and confidentiality issues. Solution specifications Solution is used to support: Telemedicine; Electronic Health Record/Electronic Medical Record; RIS (Radiology Information Systems). Software/Hardware requirements: Access to the Internet is required with a recommended minimum bandwidth of 512K. Medical images are uploaded and viewed over personal PC or PDA s. Medical images need to be in the DICOM format. Standards: HL7, DICOM, HIPAA (The Health Insurance Portability and Accountability Act). Currently used in: Technology is used globally. The service has been originated in the USA. The current focus is throughout the Caribbean, and Central/South American markets. Contact details Mel Ferguson Telephone Fax
107 2012 ehealth mhealth platform for community health workers Country of origin High infant and maternal mortality in developing countries are a major public health concern. Community health programmes have been effective in reducing mortality but their effectiveness is limited due to lack of sufficient training, absence of performance evaluation and feedback, absence of standardized protocols and ineffective care coordination. Solution description The platform has a mobile app and a Health Insurance Portability and Accountability Act (HIPAA) compliant cloud-based platform with web interface. Community health workers(chw) use mobile phones in the field to capture data, educate patients and provide case management. The web interface is used for monitoring the program and generating reports. In the field, patient data can be stored on the phone or sent to the server. The platform supports audio, images, video data and also uses GPS and bar code data. The platform can also send reminder SMS messages, s or generate other alerts required in the workflow. Through active monitoring of data, timely, interpretable reports and targeted follow up actions can be created for CHWs and the supervisors. Functionality The CHW logs into CommCare using a username and password. The CHW selects the module (e.g. Pregnant Women) and the form (e.g. Pre-Natal) for this type of visit. The form guides the CHW through a series of questions and education prompts to provide patient specific referrals and counseling. The form is submitted to the web interface for monitoring. Developer s claims of solution benefits This technology improves care across four areas: access to care through client lists on the CHWs phones and SMS reminders when visits are due; client engagement through audio and video clips and improved credibility of the CHW; quality of care through checklists, decision support, and delivery of sensitive information through recorded voices; and)
161 Appendix Pg Name Regulatory References 71 Non-invasive vascular age risk prediction 72 Non-surgical male circumcision device FDA cleared (K103695) Certified CE Mark Class IIa Compliant to ISO Medical Devices (Quality Management systems) and FDA, 21 CFR Yusuf, S, Reddy, S, Ounpuu, S & Anand, S Global burden of cardiovascular diseases: Part 1: General considerations, the epidemiologic transition, risk factors and impact of urbanization. Circulation, 104(22): Vintro, IB Control and prevention of cardiovascular disease around the world (Editorials). Rev Esp Cardiol, 57(6): Yusuf, S, Hawken, S, Ôunpuu, S, et al Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART Study): Case-control study. Lancet, 364(9438): Allen, J. & Murray, A. 2000a. Similarity in bilateral photoplethysmographic peripheral pulse wave characteristics at the ears, thumbs and toes. Physiological Measurement 21: Bots ML., Carotid intima-media thickness as a surrogate marker for cardiovascular disease in intervention studies. Curr Med Res Opin Nov;22(11): Bots ML, Dijk JM, Oren A, Grobbee DE.Carotid intima-media thickness, arterial stiffness and risk of cardiovascular disease: current evidence.j Hypertens Dec;20(12): Allen, J., Photoplethysmography and its application in clinical physiological measurement. Physiol. Meas. 2007, 28 R1 Zahedi E., Chellappan K., Mohd Ali M.A. & Singh H. Analysis of the Effect of Ageing on Rising Edge Characteristics of the Photoplethysmogram using a Modified Windkessel Model. Cardiovascular Engineering (4): Auvert B, Taljaard D, Lagarde E, Sobngwi- Tambekou J, Sitta R, Puren A. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection, risk: the ANRS 1265 Trial. PLoS Med Nov;2(11):e298. Erratum in: PLoS Med May;3(5):e298. Bailey RC, Moses S, Parker CB, et al. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet Feb 24;369(9562): Gray RH, Kigozi G, Serwadda D, et al. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet Feb 24;369(9562): World Health Organization. Progress in scale-up of male circumcision for HIV prevention in Eastern and Southern Africa: Focus on service delivery Accessed online 2/3/2012: publications/2011/ _eng.pdf Bitega, Jean. Safety and Efficacy of the PrePex Device for Rapid Scale-Up of Male Circumcision for HIV Prevention in Resource-Limited Settings. JAIDS Journal of Acquired Immune Deficiency Syndromes: 15 December Volume 58 - Issue 5 - p e127 e134. Accessed online 2/4/2012: Fulltext/2011/12150/Safety_and_Efficacy_of_the_PrePex_Device_for_Rapid.16.aspx 73 Oral syringe dosing clip 74 Point of care diagnostic device for total WBC 43 Solar charger for hearing aid Medical products Agency, FDA 510(k) Clearance Ref 7 Certificate of Registration (LV) Ref 8 k Yin HS, Dreyer BP, Van Schaick L, Foltin GL, Dinglas C, Mendelsohn AL. Randomized controlled trial of a pictogram based intervention to reduce liquid medication dosing errors and improve adherence among caregivers of young children. Arch Pediatr Adolesc Med. 2008; 162(9): Yin HS, Wolf MS, Dreyer BP, Sanders LM, Parker RM. Evaluation of consistency in dosing directions and measuring devices for pediatric nonprescription liquid medications. JAMA. 2010;304(23)(doi: /jama/ ) Point-of care method for total white blood count; An evaluation fo the Hemocue WBC device A Osei Bimpong, C Jury R McLean, S.M Lewis Int Jnl. Lab.Hem A Comparison of 2 White Blood Cell Count Devices to Aid Judicious Antibiotic Prescribing, Janet R. Casey and Michael E. Pichichero Clin Pediatr (Phila) 2009; 48; 29 World Health Organization, 2001, Guidelines for Hearing Aids and Services 76 Sputum mobilization device 77 Urine albumin test USFDA 501(k): K091557, K060439; Class I CE mark CLIA waiver certificate Ref 7 k A002 Medical products Agency, FDA 510(k) Clearance Ref 9 Certificate of Registration (LV) Ref 10 k Novel method for sputum induction using the Lung Flute in patients with suspected pulmonary tuberculosis Fujita et al, Respirology, 2009 Sarafidis PA, Riehle J, Bogojevic Z, Basta E, Chugh A, Bakris GL. A comparative evaluation of various methods for microalbuminuria screening.am J Nephrol. 2008;28(2): Epub 2007 Nov 29.
162 Appendix 2011 For further reading about technologies and respective health problems: refer to references provided in the submission documents. Pg Name Regulatory References 90 Isothermal nucleic acid amplification system for POC diagnosis 83 Manual wheelchairs and mobility devices 103 Newborn simulator for resuscitation training CE Mark Our current manufacturing facility (capable of 1 million tests per year) has been approved by TUV for ISO 9001 and ISO 13485, and our TB tests are CE qualified ISO standard 7176, including fire retardant foam and fabric and is ISO 9001 ( ) and ISO ( ) certified Neglected diagnostics, Nature Methods - 4, (2007). Reference(s): Fang, R., Li, X., Hu, L., You, Q., Li, J., Wu, J., Xu, P., Zhong, H., Luo, Y., Mei, J. et al. (2009) Cross-priming amplification for rapid detection of Mycobacterium tuberculosis in sputum specimens. J Clin Microbiol, 47, WHO Guidelines on the provision of Manual Wheelchairs in less resourced settings. Lawn, J.E, Lee, A.C, Kinney, M., Sibley, L., Carlo, W.A., Paul, V.K., Pattinson, R., Darmstadt, G.L. Two million intrapartum-related stillbirths and neonatal deaths: Where, why, and what can be done? IJGO 2009; 107: s5-19. Stephen N. Wall, Anne CC Lee, Susan Niermeyer, Mike English, William J. Keenan, Wally Carlo, Zulfiqar A. Bhutta, Abhay Bang, Indira Narayanan, Iwan Ariawan, Joy E. Lawn. (2009). Neonatal resuscitation in low-resource settings: What, who, and how to overcome challenges to scale up? IJGO 2009; 107: s Non-pneumatic anti-shock garment 92 Oxytocin in prefilled auto-disable injection system World Health Organization (WHO) Department of Reproductive Health and Research. Maternal Mortality in 2000: Estimates Developed by WHO, UNICEF, and UNFPA. Geneva: WHO; Hensleigh PA. Antishock garment provides resuscitation and haemostasis for obstetric haemorrhage. BJOG. December 2002;109: Miller S, Ojengbede A, Turan J, Ojengbede O, Butrick E, Hensleigh P. Antishock garments for obstetric hemorrhage. Current Women s Health Reviews, 2007; 3:3-11. Miller S, Martin HB, Morris JL. Antishock garment in postpartum haemorrhage. Best Practice & Research Clinical Obstetrics and Gynaecology. 2008; 22(6): Tsu VD, Sutanto A, Vaidya K, Coffey P, Widjaya A. Oxytocin in prefilled Uniject injection devices for managing third-stage labor in Indonesia. International Journal of Gynaecology and Obstetrics. 2003;83(1): Parasitological test system 94 Phototherapy for neonatal jaundice treatment 104 Point-ofuse water disinfection system 95 Portable haemoglobin meter ISO / ISO CE mark / FDA CE mark A cluster randomized control trial was carried out by UC Berkeley in in 450 households using the UV Tube. The results are expected to be published in 2011 or 2012 BPF ANVISA / Brazil registration number: ( datavisa/consulta_ Produto_correlato/ rconsulta_produto_ detalhe.asp) Martins BM, de Carvalho M, Moreira ME, Lopes JM. Efficacy of new microprocessed phototherapy system with five high intensity light emitting diodes (Super LED). J Pediatr (Rio J). 2007;83(3): WHO. Diarrhoeal disease. Programmes and projects. Media center. Fact sheets. Vol. 2010, Brownell, Sarah A., Alicia R. Chakrabarti, Forest M. Kaser, Fermin Reygadas, Micah J. Lang, Lloyd G. Connelly, Rachel L. Peletz, Daniel M. Kammen, and Kara L. Nelson Assessment of a low-cost, point-of-use, ultraviolet water disinfection technology. Journal of Water and Health 6, no. 1 (3): 53. Stoltzfus R.J. J. Defining Iron-Deficiency Anemia in Public Health Terms: A Time for Reflection. J. Nutr. 131: 565S 567S, Juliana, C.T et al. Prevalence of anemia among preschoolers and response to iron supplementation. Jornal de Pediatria, vol 87(1), 2011.
163 Appendix Pg Name Regulatory References 96 Portable ventilator 97 Prefilled auto-disable injection system 98 Reusable neonatal suction device IEC Medical electrical equipment,part 1: General requirements for safety IEC General requirements for safety collateral standard Electromagnetic compatibility requirements and tests IEC Medical electrical equipment Part 2-12: Particular requirements for the safety of lung ventilators Critical Care ventilator The Product is FDA device listed and CE-marked. The product has been developed in accordance with ISO 9001 and ISO Tsu VD, Sutanto A, Vaidya K, et al. Oxytocin in prefilled Uniject injection devices for managing third-stage labor in Indonesia. International Journal of Gynaecology and Obstetrics. 2003;83(1): Bahamondes L, Marchi NM, Nakagave HM, et al. Self-administration with Uniject of the once-a-month injectable contraceptive Cyclofem. Contraception. 1997;56: Otto B, Suarnawa IM, Stewart T, et al. At-birth immunisation against hepatitis B using a novel pre-filled immunisation device stored outside the cold chain. Vaccine. 2000;18: Sutanto A, Suarnawa IM, Nelson CM, et al. Home delivery of heat-stable vaccines in Indonesia: outreach immunization with a prefilled, single-use injection device. Bulletin of the World Health Organization. 1999;77(2): Lawn, J.E, Lee, A.C, Kinney, M., Sibley, L., Carlo, W.A., Paul, V.K., Pattinson, R., Darmstadt, G.L. Two million intrapartum-related stillbirths and neonatal deaths: Where, why, and what can be done? IJGO 2009; 107: s5-19. WHO, Managing Newborn Problems: A guide for doctors, nurses, and midwives. WHO, Geneva, Stephen N. Wall, Anne CC Lee, Susan Niermeyer, Mike English, William J. Keenan, Wally Carlo, Zulfiqar A. Bhutta, Abhay Bang, Indira Narayanan, Iwan Ariawan, Joy E. Lawn. (2009). Neonatal resuscitation in low-resource settings: What, who, and how to overcome challenges to scale up? IJGO 2009; 107: s Transcutaneous bilirubin measurement system for infants FDA 510K # k Water filter WHO, Guidelines for Drinking Water Quality, 3rd Ed
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168 WHO compendium of innovative health Assistive devices ehealth solutions Medical devices Other technologies Technologies for outbreaks For more information, please contact: World Health Organization Department of Essential Medicines and Health Products Medical Devices 20 Avenue Appia, CH 1211, Geneva 27 Switzerland Tel: (+41) ISBN
TELEMEDICINE IN DEVELOPING COUNTRIES. Norm Archer, Ph.D. Information Systems Dept. and ehealth Program McMaster University
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