Regulation of medical devices: post market surveillance as risk management strategy

• Autor(a) principal: Melchior, Stela Candioto
• Data de Publicação: 2019
• Outros Autores: Waissmann, William
• Tipo de documento: Artigo
• Idioma: por; eng
• Título da fonte: Vigilância Sanitária em Debate
• Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1359
• topic: Technovigilance; Risk Management; Medical Devices; Health Surveillance; Tecnovigilância; Gerenciamento de Risco; Dispositivos Médicos; Vigilância Sanitária

Introduction: Managing medical device risks is an activity that spans all phases of the life cycle of the product and is essential for the products available for use to behave effectively and safely. Objective: To discuss on the post-marketing surveillance model of medical device (technovigilance) in Brazil, present international experiences and reflect on their insertion in risk management. Method: Narrative review, based on regulations published on institutional sites and on texts published from 2000 on the Portal Capes, Virtual Health Library, SciELO and on the bases Bireme, ScienceDirect and Pubmed, in which technovigilance is presented as the action of State and as part of risk management in health services. Results: Different countries adopt the registration and inspection of good manufacturing practices as a way to regulate devices, which does not exhaust the risk assessment. Notification of medical devices related problems is one of the post-market surveillance strategies, in addition to cross-country information exchange, technology assessment studies, active surveillance in health services, and aggregating actual behavioral data during use. Conclusions: The technological advancement and incremental changes of DM challenge the State to review risk assessment criteria based on pre-market data, aggregating post-market related data, enabling risk identification and event chain intervention.