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Fourth WHO Global Forum on Medical Devices Fourth WHO Global Forum on Medical Devices REPORT AMTZ-Kalam Convention Centre, Visakhapatnam, India 13 to 15 December 2018 Fourth WHO Global Forum on Medical Devices REPORT AMTZ-Kalam Convention Centre, Visakhapatnam, India 13 to 15 December 2018 WHO/MVP/EMP/2019.04 © World Health Organization 2019 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along 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 be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation: Fourth WHO Global Forum on Medical Devices, AMTZ-Kalam Convention Centre, Visakhapatnam, India, 13-15 December 2018. Geneva: World Health Organization; 2019 (WHO/MVP/EMP/2019.04). 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 submit requests 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 as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. 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 WHO 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 and dashed 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 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 or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. This publication contains the report of the Fourth WHO Global Forum on Medical Devices, AMTZ-Kalam Convention Centre, Visakhapatnam, India, 13-15 December 2018 , including the abstracts of the presentations from individuals or organizations that do not represent the decisions or policies of WHO. Printed by the WHO Document Production Services, Geneva, Switzerland. Design and layout by Genève Design Contents Acknowledgements –––––––––––––––––––––––––––––––––––––––––––– viii Acronyms and abbreviations–––––––––––––––––––––––––––––––––––– x Introduction –––––––––––––––––––––––––––––––––––––––––––––––––––– 1 Fourth WHO Global Forum on Medical Devices: Context –––––––––– 2 Medical devices in WHO – overview of achievements 2017–2018 3 Fourth WHO Global Forum on Medical Devices: Content –––––––––– 4 Programme overview . 4 General programme . .4 Workshops . 9 Plenary sessions . 10 Parallel oral sessions . 10 Posters . 11 Exhibition spaces . 11 Attendees . 11 Fourth WHO Global Forum on Medical Devices: Outcomes –––––––– 13 Conclusions . 13 Next steps . 14 Evaluation . 15 References –––––––––––––––––––––––––––––––––––––––––––––––––––– 16 Annex 1: Conference Programme ––––––––––––––––––––––––––––––– 17 Workshops . 17 Plenary sessions . 21 Parallel oral sessions . 26 Posters . 34 Exhibitions . 34 v Fourth WHO Global Forum Annex 2: Workshops –––––––––––––––––––––––––––––––––––––––––––– 36 Workshops: Title and author(s) . 36 Workshops: Title, author(s) and abstract . 39 Annex 3: Parallel oral sessions ––––––––––––––––––––––––––––––––––– 49 Parallel oral sessions: Title and author(s) . 49 Parallel oral sessions: Title, author(s) and abstract . 56 Annex 4: Posters –––––––––––––––––––––––––––––––––––––––––––––––– 85 Posters: Title and author(s). 85 Posters: Title, author(s) and abstract . 90 Annex 5: Evaluation –––––––––––––––––––––––––––––––––––––––––––– 107 5.1 Immediate feedback . 107 5.2 Feedback received during the conclusion of the Forum . 119 5.3 Final Evaluation feedback . .120 Annex 6: List of registered participants ––––––––––––––––––––––––––– 128 Government or other public institutions . 128 United Nations or intergovernmental organization . .145 Non-governmental organization . .147 Academia . 154 Private health delivery institution . .161 Independent consultants . 164 Private medical device industry. 166 vi on Medical Devices vii Fourth WHO Global Forum Acknowledgements WHO would like to thank the following for their support and contribution to the organization of the Forum: WHO Secretariat WHO Headquarters Senior management: Tedros Adhanom Ghebreyesus, Soumya Swaminathan, Mariângela Batista Galvão Simão and Suzanne Hill General coordination of the Fourth WHO Global Forum on Medical Devices: Adriana Velazquez Berumen Working group: Tomislava Bouquet, Nathalie Broutet, Can Celik, Claude Da-re, Andre Ilbawi, Robert Jakob, Noelle Mendy, Irina Nozdrina, Mercedes Perez Gonzalez, Maria del Rosario Perez, Magdalena Rabini, Christophe Rerat, Anita Sands, Cherian Varghese, Gaby Vercauteren and Hongyi Xu WHO consultants: Rebecca Baker, Lucy Hattingh, Maria del Mar Elena, Maurice Page, William Sewell, Dario Trapani, Alejandra Velez and Umberto Vitale Special thanks to the interns: Karen Kulp for helping the preparations and Joshua Daniel for compiling the present report WHO Regional Offices Poonam Khetrapal Singh, Phyllida Travis, Manisha Shridhar, Anjana Bhushan (SEARO); Alexandre Lemgruber (PAHO), Sheick Oumar Coulibaly (AFRO) and Hanne Pedersen (EURO) WHO Country Office for India Henk Bekedam, Payden, Madhur Gupta, Hilde Renne Susanne De Graeve, Sadhana Bhagwat, Preeti Kharb and Himanshu Baweja WHO Global Conference and Training Centre (GCT) Tunis, Tunisia, for logistic support Léocadie Uwindatwa-Bernier and Khaoula Aribi Joint Ministry of Health & Family Welfare and WHO India Working Group which was established for the organization of the Forum, with the following members: Arun Singhal, R.K. Vats, Mandeep Bhandari, Sachin Mittal, R.G. Singh, Eswara Reddy, Santhana Krishnan, Madhur Gupta (WHO) and Manisha Shridhar (WHO) viii on Medical Devices Ministry of Health & Family Welfare, India Senior governmental leadership J.P. Nadda, Suresh Prabhu, Devaragunda Venkappa, Sadananda Gowda, Ashwini Kumar Chaubey, Anupriya Patel and Mansukh Lal Mandaviya, Senior government officials V.K. Paul, Vijay Raghavan, Preeti Sudan, Ramesh Abhishek, Balram Bhargava, Arun Panda, Renu Swarup, Anup Wadhawan, Manoj Jhalani, Sudhanshu Pandey, Sudhansh Pant, Rajiv Aggarwal and S.B. Sinha Local Organizing Team, Andhra Med Tech Zone Government of Andhra Pradesh, India Nara Chandrababu Naidu, Nasyam Mohammed Farooq, Poonam Malakondaiah and Jitendar Sharma Team Leaders CH. L. A. Avinash, Dikshit, P. Hairkanth, Sai Krishna, Santosh Kumar, Sandeep Patnaik, Kingshuk Poddar, Srinivas Reddy, Chandra Sekhar, Parminder Singh, Amit Srivastava, N. Sudhindran and Geetha Varalakshmi Team Members K. Ananth, M. Anburajan, Anil, N.G. Anusha, Ekram Hussain Basha, Venkata Anant Bhagavati, Devarshi Bhattacharya, Nalini Chandapu, Megha Dabas, Dilip, Dinesh, Haarika, Gokul Krishna, Deepak Kumar, Naveen Kumar, Nishanth Kumar, Pratap Kumar, Yellapu Madhuri, Mohini Mehta, N. Naresh, Dhruv Oberoi, Ch. Surya Rao, Sandeep Reddy, Seema Pai, Subrahmanyam, Suneeta Rani Panda, Suresh, Swaroop, P. Tanushree, Rashi Tomer, Venkateswara Rao and P.V.S. Yugandhar External technical support from the IT team: Anand Sethi, Naveen, Ravi Mahendru and Nara International advisors Stefano Bergamasco, Ernesto Iadanza, Tom Judd and Leandro Pecchia (IFMBE); Martha Gartley (CHAI); Stewart Whitley (ISRRT); Jessica Jones (BMGF); Miriam Mikhail (RAD AID); Ralph Ives (GMTA); Amy Pavlock and Nadia Naaman (ISPOR); Mike Ruffo and Lisa Smith (PATH); Beverly Bradley (UNICEF); Marc Jaffe (Resolve); Maria Fredin (WSO); Cathy Blanc (HUMATEM); Rodolph Munoz and Salvatore Scalzo (EC); Sam Wanda (Uganda) and Salome Mwara (AMEK) Funding support Bill and Melinda Gates Foundation, Department for International Development (DFID) United Kingdom, the Government of the Netherlands, and the
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