Latin American & Caribbean Summit on CE and HTM Results and Main priorities Murilo Contó Health Policy – Boston Scientific IFMBE-HTAD

funding by Boston Scientific Disclosure Boston Scientific Corporation (2018 – current) - Health Policy Manager IFMBE-HTAD (2018 – current) - Member-elected HTA-Division PAHO-WHO (2015–2018) - National Consultant in HTA & HTM CONITEC - Brazilian National Committee for Health Technology Adoption (2012–2015) - HTA Consultant - Medical Devices Ministry of Health of Brazil – Investment Projects (2008-2012) - Medical Equipment Division Manager Atrial Equipamentos Médicos (1998-2008) – General Coordinator funding by Boston Scientific Working to reach the universal health coverage, promoting the access for innovative medical devices to transform lives and improve the patient health.

LA Summit CE HTM - São Paulo, 20 Sep 2017 Background International Clinical Engineering & Health Technology Management Congress PAHO-WHO, Ministry of Health of Brazil, ACCE & IFMBE decided to organize LA Summit CE HTM - São Paulo, 20 Sep 2017 Reunião Latinoamericana em Engenharia Clínica e Gestão de Tecnologias em Saúde Realização: Apoio: SCTIE/DECIIS

LA&C Summit CE-HTM

Agenda - Results Numbers - Representatives from WHO, IFMBE & ACCE - 96 representatives from 18 different countries - 12 Americas region and 06 other countries - 27 presentations, 6 pannels - Speakers from: Argentina, Brazil, Canada, Chile, Colombia, Costa Rica, Dominican Rep, Ecuador, Mexico, Paraguay, Peru, USA - 01 Final round - resolutions

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Main results - Resolutions Resolutions after the Final round table – Final Report to MoH and PAHO-WHO CE is active in around 90 countries in the world with several successful cases; Need of greater engagement of professionals, organizations and governments to advance in new approaches that go beyond the traditional hospital context; Act throughout the entire life cycle of technology, since the innovation, evaluation, incorporation to the replacement; Team work with other multidisciplinary teams and focusing on patient outcomes; Define lists of essential medical devices and technical specifications; Creation of Working Group on CE&HTM, generating knowledge and RWE that feedbacks to innovation, regulatory, evaluation and investment policies; The definition of a Global standard of nomenclatures on medical devices was considered a key element for the advancement in regulation, evaluation and management

Brasília, September 18th , 2018 Considering the deadline for countries to submit to the Secretariat of the World Health Organization (WHO) is open for any requests for inclusion of items on the agenda of the next Executive Board meeting, which will take place in January 2019, Ministry of Health is keen that the topic on standardization of medical device nomenclature be included in the agenda. Ministry of Health of Brazil

Conclusion Relevance of a global standard of medical devices nomenclatures 51% of 175 countries use a nomenclatures system, which 26% use a nationally developed (source: Informal Consultation Meeting, WHO 2011) Difficulties related to the lack of comparability with other standards Key element for the advancement in regulation, evaluation and management, providing the exchange of technical information

Thank you Murilo Contó Health Policy – Boston Scientific Member Elected - IFMBE-HTAD