Human Resources For Medical Devices - Who
HUMAN RESOURCESFOR MEDICAL DEVICESThe role of biomedicalengineersWHO Medical device technical series
WHO MEDICAL DEVICE TECHNICAL SERIES: TO ENSURE IMPROVED ACCESS, QUALITY AND USE OF MEDICAL DEVICESGlobal atlas ofmedical devicesDEVELOPMENTOF MEDICALDEVICE POLICIES,STRATEGIES ANDACTION PLANSHUMAN RESOURCESFOR MEDICAL DEVICESThe role of biomedicalengineers2017WHO Medical device technical series2011Medical deviceinnovation*in developmentResearchand developmentWHO MEDICAL DEVICE TECHNICAL Research and developmentGlobal Model RegulatoryFramework for MedicalDevices including in vitrodiagnostic medical devicesWHO Medical device technical seriesDepartment of Essential Health TechnologiesWorld Health Organization20 Avenue AppiaCH-1211 Geneva 27SwitzerlandTel: 41 22 791 21 11E-mail: medicaldevices@who.inthttp://www.who.int/medical devices/en/ISBN 978 92 4 150140 82017Medical devicenoMenclatureAssessmentManagementMedical devices*in developmentNEEDS ASSESSMENTPROCESSWHO Medical device tecHnical seriesHEALTH TECHNOLOGYASSESSMENT OFMEDICAL DEVICESWHO MEDICAL DEVICE TECHNICAL SERIESWHO MEDICAL DEVICE TECHNICAL SERIESInteragency list of priority medicaldevices for essential interventionsfor reproductive, maternal,newborn and child health20112011WHO list of prioritymedical devices forcancer managementBreastCervicalodhoildChColonLe ukemungia LPROCUREMENTPROCESSRESOURCE GUIDEWHO MEDICAL DEVICE TECHNICAL SERIESProstate2016MEDICAL DEVICEDONATIONS:CONSIDERATIONS FORSOLICITATION ANDPROVISIONWHO MEDICAL DEVICE TECHNICAL SERIES20172011INTRODUCTION TOMEDICAL EQUIPMENTINVENTORYMANAGEMENTWHO MEDICAL DEVICE TECHNICAL SERIES2011MEDICAL EQUIPMENTMAINTENANCEPROGRAMMEOVERVIEWWHO MEDICAL DEVICE TECHNICAL TEMWHO MEDICAL DEVICE TECHNICAL SERIES2011Safe uSe ofmedical deviceSWHO Medical device tecHnical seriesDecommissioningmeDical DevicesWHO Medical device tecHnical series*in developmentMedical devicesWHO Medical device tecHnical series
HUMAN RESOURCESFOR MEDICAL DEVICESThe role of biomedicalengineersWHO Medical device technical series
Human resources for medical devices, the role of biomedical engineers(WHO Medical device technical series)ISBN 978-92-4-156547-9 World Health Organization 2017Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercialShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; igo).Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercialpurposes, provided the work is appropriately cited, as indicated below. In any use of this work, there shouldbe no suggestion that WHO endorses any specific organization, products or services. The use of the WHOlogo is not permitted. If you adapt the work, then you must license your work under the same or equivalentCreative Commons licence. If you create a translation of this work, you should add the following disclaimeralong with the suggested citation: “This translation was not created by the World Health Organization (WHO).WHO is not responsible for the content or accuracy of this translation. The original English edition shall bethe binding and authentic edition”.Any mediation relating to disputes arising under the licence shall be conducted in accordance with themediation rules of the World Intellectual Property Organization.Suggested citation. Human resources for medical devices, the role of biomedical engineers. Geneva: WorldHealth Organization; 2017. Licence: CC BY-NC-SA 3.0 IGO.Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris.Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submitrequests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing.Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such astables, figures or images, it is your responsibility to determine whether permission is needed for that reuseand to obtain permission from the copyright holder. The risk of claims resulting from infringement of anythird-party-owned component in the work rests solely with the user.General disclaimers. The designations employed and the presentation of the material in this publicationdo not imply the expression of any opinion whatsoever on the part of WHO concerning the legal statusof any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers orboundaries. Dotted and dashed lines on maps represent approximate border lines for which there maynot yet be full agreement.The mention of specific companies or of certain manufacturers’ products does not imply that they areendorsed or recommended by WHO 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 WHO to verify the information contained in this publication.However, the published material is being distributed without warranty of any kind, either expressed orimplied. The responsibility for the interpretation and use of the material lies with the reader. In no eventshall WHO be liable for damages arising from its use.Design & layout: L’IV Com Sàrl, Villars-sous-Yens, Switzerland.Editorial consultant: Vivien Stone, Etchingham, UK.Printed by the WHO Document Production Services, Geneva, Switzerland.
ContentsPreface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Medical device technical series – methodology. .Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6. 910. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Acknowledgements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Acronyms and abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Executive summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Biomedical engineers as human resources for health. . . . . . . . . . . . . . . . . . . . . . 20Responsibilities and roles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Biomedical engineering. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Global Strategy on Human Resources for Health: Workforce 2030. . . . . . . . . . . . . . . . . . . . . . . . . .2125271 Global dimensions of biomedical engineering. . . . . . . . . . . . . . . . . . . . . . . . . 301.1Biomedical engineers – global data. . . . . . . . . . . . . . . . .1.2Women in biomedical engineering. . . . . . . . . . . . . . . . . .1.3Biomedical engineering in international organizations . .Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .303737372 Education and training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 392.12.22.32.42.52.6Defining training and education . . . . . . . . . . . .Core curriculum and elective specialization. . .2.2.1 Core curriculum. . . . . . . . . . . . . . . . . . . .2.2.2 Elective specialization. . . . . . . . . . . . . . . .Universities – global data. . . . . . . . . . . . . . . . . .Education and training by region . . . . . . . . . . .2.4.1 Africa . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.4.2 Asia-Pacific. . . . . . . . . . . . . . . . . . . . . . . .2.4.3 Australia and New Zealand. . . . . . . . . . . .2.4.4 Europe. . . . . . . . . . . . . . . . . . . . . . . . . . . .2.4.5 Latin America . . . . . . . . . . . . . . . . . . . . . .2.4.6 North America (USA and Canada only). .International accreditation agreements. . . . . .Washington Accord, 1989. . . . . . . . . . . . . . . . . .Bologna Declaration, 1999. . . . . . . . . . . . . . . . . .List of educational institutions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .393939404243434445464950515152523 Professional associations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 543.13.2Purpose of professional associations . . . . . . . . . . . . . . . . . . . . . . . . . .Global biomedical engineering associations . . . . . . . . . . . . . . . . . . . .3.2.1 International Union for Physical and Engineering Sciencesin Medicine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.2.2 International Federation for Medical and Biological Engineering. . . . . . . . . .54555556WHO Medical device technical series1
3.33.43.2.3 Institute of Electrical and Electronics Engineers - Engineering inMedicine and Biology Society . . . . . . . . . . . . . . . . . . . . . . . . . . . .Professional biomedical associations – global data. . . . . . . . . . . . . . . .Phases of institutional development of a profession. . . . . . . . . . . . . . .3.4.1 Institutional maturity of biomedical engineering . . . . . . . . . . . . . . . . . .565659594 Certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 614.14.24.3Defining certification . . . . . . . . . . . . . . . . . . . . . . . . . .International certification of biomedical engineers . .Certification by region . . . . . . . . . . . . . . . . . . . . . . . . .4.3.1 Certification in Africa . . . . . . . . . . . . . . . . . . . . .4.3.2 Certification in the Americas . . . . . . . . . . . . . . .4.3.3 Certification in Asia . . . . . . . . . . . . . . . . . . . . . .4.3.4 Certification in Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .616364646466685 Development of medical devices policy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 735.15.25.35.45.5Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .International organizations. . . . . . . . . . . . . . . . . . .5.2.1 United Nations Population Fund. . . . . . . . .5.2.2 United Nations Office for Project Services. .5.2.3 United Nations Children’s Fund. . . . . . . . . .5.2.4 World Health Organization. . . . . . . . . . . . . .National organizations. . . . . . . . . . . . . . . . . . . . . .World Health Organization – medical devices. . .Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7373737474767778786 Medical device research and innovation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 806.16.26.36.46.56.66.76.8Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .The field of medical device innovation. . . . . . . . . . . . .Innovation competencies. . . . . . . . . . . . . . . . . . . . . . . .Skills requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . .Innovation and teams. . . . . . . . . . . . . . . . . . . . . . . . . . .The innovation process and its increasing scope. . . .Medical device innovation for low-resource settings .Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80828283848485877 Role of biomedical engineers in the regulation of medical devices . . . . . . 897.17.27.37.47.57.62Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Need for biomedical engineers in regulatory affairs. . . . . . . . . . . . . . . . .Medical devices regulation – scope and function in different countries.Professionals in the field of medical devices regulation. . . . . . . . . . . . . .Biomedical engineers as regulatory specialists in industry. . . . . . . . . . .Professional functions fulfilled by biomedical engineers in theregulatory domain. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7.6.1 New product planning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7.6.2 Research and development. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7.6.3 Clinical research. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7.6.4 Quality management systems and manufacturing operations . . . . .7.6.5 Marketing and sales. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7.6.6 Technical writing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7.6.7 Health economics and health technology assessment. . . . . . . . . . .7.6.8 Standards and standardization bodies. . . . . . . . . . . . . . . . . . . . . . . .HUMAN RESOURCES FOR MEDICAL DEVICES The role of biomedical engineers8989919192939393939494959595
7.77.87.9Industry and government affairs. . . . . . . . . . . . . . . . . . . . .Education and experience of industry regulatory affairsprofessionals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9595968 Role of biomedical engineers in the assessment of medical devices. . . . . 998.18.28.38.48.58.68.78.8Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 998.1.1 From performance to use in health care . . . . . . . . . . . . . . . . . . . . . 101Methods of health technology assessment. . . . . . . . . . . . . . . . . . . . . . . . 102Different disciplines in health technology assessment. . . . . . . . . . . . . . 103Core competencies required for health technology assessment. . . . . . 1038.4.1 Interdisciplinary teams. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103Survey of biomedical engineers involved in health technologyassessment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105The developing role of biomedical engineers. . . . . . . . . . . . . . . . . . . . . . 107Professional societies and international collaboration in healthtechnology assessment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1088.7.1 Health Technology Assessment international. . . . . . . . . . . . . . . . . . 1088.7.2 International Network of Agencies in HTA. . . . . . . . . . . . . . . . . . . . 1098.7.3 EuroScan International Network. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1098.7.4 HTAsiaLink. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1098.7.5 La Red de Evaluación de Tecnologías Sanitarias de las Américas . 1108.7.6 European Network for HTA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1108.7.7 Eastern Mediterranean Regional Network in HTA. . . . . . . . . . . . . 1108.7.8 Health Care Technology Assessment Division (IFMBE). . . . . . . . . . 110Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1119 Role of biomedical engineers in the management of medical devices. . . 1139.19.29.39.49.5Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Biomedical engineering activities through the life cycle of devicesand systems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9.2.1 Health technology assessment. . . . . . . . . . . . . . . . . . . . . . . . . . . .9.2.2 Procurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9.2.3 Health risk management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9.2.4 Health information technology. . . . . . . . . . . . . . . . . . . . . . . . . . . .9.2.5 Health technology management. . . . . . . . . . . . . . . . . . . . . . . . . . .9.2.6 Education and user training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9.2.7 Ethics committee. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Organizational models of biomedical engineering services . . . . . . . . .9.3.1 In-house personnel model. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9.3.2 Mixed model. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9.3.3 Third-party multi-vendor service model. . . . . . . . . . . . . . . . . . . . .9.3.4 Biomedical engineering departmental structures within hospitals.9.3.5 Key roles in a biomedical engineering department . . . . . . . . . . . .Biomedical engineering around the world. . . . . . . . . . . . . . . . . . . . . . .9.4.1 Global survey of biomedical engineering. . . . . . . . . . . . . . . . . . . . .Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2312510 Role of biomedical engineers in the evolution of health-care systems . . . . 12710.110.2Biomedical engineering for 21st-century health-care systems . .Revolutions impacting biomedical engineering. . . . . . . . . . . . . . . . . . . . . . .127127WHO Medical device technical series3
her contextual factors driving change in health-care systems. . . . . . 129Biomedical engineers work in many sectors. . . . . . . . . . . . . . . . . . . . . . 12910.4.1 Evolution in biomedical engineering career paths. . . . . . . . . . . . . . 131Evolution of modern medical devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . 13110.5.1 Telehealth and telemedicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13110.5.2 More sophisticated organizational and IT requirements. . . . . . . . . 132Mission critical: Systems engineering and systems of systemsengineering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132Elements of an ideal, integrated health and information technologysystem. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133Establishing a comprehensive biomedical engineering valueproposition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134Build competencies in strategic, clinical and operational domains. . . . 136Dimensions of career development in biomedical engineering. . . . . . . 13810.10.1 A biomedical engineer’s career anchor considerations. . . . . . . . . 13810.10.2 Biomedical engineering career stages. . . . . . . . . . . . . . . . . . . . . . 13810.10.3 Key emerging biomedical engineering competency opportunities . 139Training topics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141Further reading. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14111 Conclusions and recommendations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14411.111.211.3Future role of biomedical engineers in low- and middle-incomecountries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Reclassification of biomedical engineers and technicians. . . . . . .Final statement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .145146147Annex 1 Biomedical engineers by country and relevant demographicindicators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149Annex 2 Educational institutions with biomedical engineering programmes. . 154Annex 3 National and international professional biomedical engineeringassociations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207Annex 4 Survey respondents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212Annex 5 Global Strategy on Human Resources for Health: Workforce 2030 –summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213Annex 6 UN High-Level Commission on Health Employment andEconomic Growth. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216Annex 7 Current and proposed profiles for ILO for biomedical engineers andbiomedical engineering technicians. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218Annex 8 Declaration of interests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2224HUMAN RESOURCES FOR MEDICAL DEVICES The role of biomedical engineers
PrefaceHealth technologies are essential for a fully functioning health system. Medical devices,in particular, are crucial in the prevention, diagnosis, treatment and palliative care ofillness and disease, as well as patient rehabilitation. Recognizing this important role ofhealth technologies, the World Health Assembly adopted resolution WHA60.29 in May2007. The resolution covers issues arising from the inappropriate deployment and use ofhealth technologies, and the need to establish priorities in the selection and managementof health technologies, specifically medical devices.This publication has been produced in accordance with the request to the World HealthOrganization (WHO) by Member States in the WHA60.29.(1) The resolution:1. URGES Member States:“(1) to collect, verify, update and exchange information on health technologies, inparticular medical devices, as an aid to their prioritization of needs and allocation ofresources;(2) to formulate as appropriate national strategies and plans for the establishmentof systems for the assessment, planning, procurement and management of healthtechnologies, in particular medical devices, in collaboration with personnel involved inhealth-technology assessment and biomedical engineering ”2. REQUESTS the Director General:“to work with interested Member States and WHO collaborating centres on thedevelopment, in a transparent and evidence-based way, of guidelines and tools,including norms, standards and a standardized glossary of definitions relating to healthtechnologies in particular medical devices”(2)By adopting this resolution, delegations from Member States acknowledged theimportance of health technologies for achieving health-related development goals, urgingexpansion of expertise in the field of health technologies, in particular medical devices,and requesting that WHO take specific actions to support Member States.One of WHO’s strategic objectives is to “ensure improved access, quality and useof medical products and technologies.” To meet this objective, WHO and partnershave been working towards devising an agenda, an action plan, tools and guidelinesto increase access to good quality, appropriate medical devices. The Medical devicetechnical series developed by WHO already includes the following publications: Development of medical devices policies(3) Health technology assessment for medical devices(4) Health technology management›› Needs assessment process of medical devices(5)›› Procurement process, resource guide(6)›› Medical devices donations, considerations for solicitation and provision(7)›› Introduction to medical equipment inventory management(8)›› Medical equipment maintenance overview(9)›› Computerized maintenance management systems(10)WHO Medical device technical series5
Priority medical devices›› Interagency list of priority medical devices for essential interventions onreproductive, maternal, new born and child health(11)›› Protective equipment for Ebola(12)And will include, in 2017, the following publications, which are under development: Human resources for medical devices (the present document) Model regulatory framework for medical devices Priority medical devices for cancer managementThese documents are intended for use by policy-makers at ministries of health,biomedical engineers, health managers, donors, nongovernmental organizations andacademic institutions involved in health technology at the district, national, regional andglobal levels.Medical device technical series – methodologyThe first documents in the Medical device technical series were written by internationalexperts in their respective fields, and reviewed by members of the Technical AdvisoryGroup on Health Technology (TAGHT). The TAGHT was established in 2009 to providea forum for both experienced professionals and country representatives to developand implement the appropriate tools and documents to meet the objectives of theGlobal Initiative on Health Technologies (GIHT). The group met on three occasions.The first meeting was held in Geneva in April 2009 to prioritize which tools and topicsmost required updating or developing. A second meeting was held in Rio de Janeiro inNovember 2009 to share progress on the health technology management tools underdevelopment since April 2009, to review the current challenges and strategies facing thepilot countries, and to hold an interactive session for the group to present proposals fornew tools, based on information gathered from the earlier presentations and discussions.The last meeting was held in Cairo in June 2010 to finalize the documents and to helpcountries develop action plans for their implementation. In addition to these meetings,experts and advisers have collaborated through an online community to providefeedback on the development of the documents. The concepts addressed in the Medicaldevice technical series were discussed further during the First Global Forum on MedicalDevices in September 2010. Stakeholders from 106 countries made recommendationson how to implement the information covered in this series of documents at the countrylevel.(13) These extensive discussions formed the background for the current book inthe series: Human resources for medical devices.For the development of the current book the following activities took place:1. Global BME surveys, the outcomes of which are highlighted in this book and resultspresented in the WHO medical devices website and in the WHO Global HealthObservatory.(14)In 2009, WHO launched “Biomedical engineering global resources,”(15) a WHOprogramme to gather information on academic programmes, professional societies andthe status of BME worldwide.6HUMAN RESOURCES FOR MEDICAL DEVICES The role of biomedical engineers
Figure 1 WHO Medical device technical seriesWHO MEDICAL DEVICE TECHNICAL SERIES: TO ENSURE IMPROVED ACCESS, QUALITY AND USE OF MEDICAL DEVICESGlobal atlas ofmedical devicesDEVELOPMENTOF MEDICALDEVICE POLICIES,STRATEGIES ANDACTION PLANSHUMAN RESOURCESFOR MEDICAL DEVICESThe role of biomedicalengineers2017WHO Medical device technical series2011Medical deviceinnovation*in developmentResearchand developmentWHO MEDICAL DEVICE TECHNICAL Research and developmentGlobal Model RegulatoryFramework for MedicalDevices including in vitrodiagnostic medical devicesWHO Medical device technical seriesDepartment of Essential Health TechnologiesWorld Health Organization20 Avenue AppiaCH-1211 Geneva 27SwitzerlandTel: 41 22 791 21 11E-mail: medicaldevices@who.inthttp://www.who.int/medical devices/en/ISBN 978 92 4 150140 82017Medical devicenoMenclatureAssessmentManagementMedical devices*in developmentNEEDS ASSESSMENTPROCESSWHO Medical device tecHnical seriesHEALTH TECHNOLOGYASSESSMENT OFMEDICAL DEVICESWHO MEDICAL DEVICE TECHNICAL SERIESWHO MEDICAL DEVICE TECHNICAL SERIESInteragency list of priority medicaldevices for essential interventionsfor reproductive, maternal,newborn and child health20112011WHO list of prioritymedical devices forcancer managementBreastCervicalodhoildChColonLe ukemungia LPROCUREMENTPROCESSRESOURCE GUIDEWHO MEDICAL DEVICE TECHNICAL SERIESProstate2016MEDICAL DEVICEDONATIONS:CONSIDERATIONS FORSOLICITATION ANDPROVISIONWHO MEDICAL DEVICE TECHNICAL SERIES20172011INTRODUCTIO
who medical device technical series: to ensure improved access, quality and use of medical devices who medical device technical series human resources for medical devices the role of biomedical engineers development of medical device policies, strategies and action plans who medical device technical series
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