Devices Doctors

Goals & Purpose

Explore methodologies and share experiences related to the Evaluation of Medical Device Technologies with REDETSA members.
The topics of interest of the Medical Devices working group are:
– Harmonization of methodologies and adaptation of methodologies
– Organizational impact
– Prosthesis and endoprosthesis
– Laboratory equipment (diagnostic tests)
– Criteria for decision making

Members of the group

  • Victoria Hurtado – Ministry of Health of Chile (Chile)
  • Veronica Gallegos Rivero – National Center for Technological Excellence in Health-CENETEC (Mexico)
  • Veronica Alfie – Institute of Clinical and Health Effectiveness-IECS (Argentina)
  • Silvina Benchetrit – Ministry of Health of the Government of the City of Buenos Aires, Argentine Public Network for Health Technology Assessment-RedArets (Argentina)
  • Marisa da Silva Santos – National Institute of Cardiology-INC (Brazil)
  • Joana Ferreira da Silva – CGATS, National Commission for the Incorporation of Technologies in the Single Health System-CONITEC (Brazil)
  • Daniele de Almeida Cardoso – CGATS, National Commission for the Incorporation of Technologies in the Single Health System-CONITEC (Brazil)
  • Aila Coelho do Carmo – CGATS, National Commission for the Incorporation of Technologies in the Single Health System-CONITEC (Brazil)
  • Daniela Marreco Cerqueira – National Health Surveillance Agency-ANVISA (Brazil)
  • Priscilla Consigliero – National Health Surveillance Agency-ANVISA (Brazil)
  • Janepsy Diaz – Public Health Institute-ISP (Chile)
  • Wendy Beatriz Villalta Quintanilla – Superintendence of Sanitary Regulation of El Salvador (El Salvador)
  • Mario Ernesto Vega Valenzuela – Superintendence of Sanitary Regulation of El Salvador (El Salvador)
  • Jose Adam Sandoval – Salvadoran Social Security Institute -ISSSS (El Salvador)
  • Fairy Venus Escobar Eguizabal – Guatemalan Social Security Institute-IGSS (Guatemala)
  • Andrea Mercedes Rivera Santillan – Institute for Health Technology Assessment and Research-IETSI/EsSalud (Peru)
  • Jose Alfredo Zavala Loayza – Institute for Health Technology Assessment and Research-IETSI/EsSalud (Peru)
  • Maribel Castro Reyes – Institute for Health Technology Assessment and Research-IETSI/EsSalud (Peru)
  • Oscar Gianneo – National Resources Fund-FNR (Uruguay)
  • Andrea Gimenez – Health Technology Assessment Agency of Uruguay-AETSU (Uruguay)
  • Alejandra Croci – University of the Republic (Uruguay)
  • Rossana Rivas – University of Vermont (USA)

Results - Job made by the group

The document: Perspectives for Health Technology Assessment of Medical Devices in Latin America: A methodological review, was developed. It is the product of collaborative work by members of the working group, with the aim of identifying methodologies and offering guidelines for the development of health technology assessments (HTA) of medical devices (MD) by members of the Health Technology Assessment Network of the Americas (RedETSA).

In recent months, the group also participated in the review of the WHO document “Health technology assessment of medical devices Second Edition WHO Medical device technical series” sent for consultation. A consolidated report with the comments of the group participants was sent.

Links of interest

The following methodologies developed in the Americas region were identified:

Methodological Guidelines. Preparation of Studies for the Evaluation of Medical Assistance Equipment.

Ministry of Health, Secretariat of Science, Technology and Strategic Inputs, Department of Science and Technology. Ministry of Health of Brazil; 2013

CENETEC-Health

Guide for the Economic Evaluation of Medical Devices. 2017

CENETEC-Health

Guide for the Clinical Evaluation of Medical Devices. 2017

Augustovski F, Alfie V, Alcaraz A, García-Martí S, Drummond MF, Pichón-Riviere A

A Value Framework for the Assessment of diagnostic Technologies: A Proposal Based on a Targeted Systematic Review and a Multistakeholder Deliberative Process in Latin America. Value Health. 2021;24(4):486–96.