Regulation of medical devices: post market surveillance as risk management strategy
DOI:
https://doi.org/10.22239/2317-269X.01359Keywords:
Technovigilance, Risk Management, Medical Devices, Health SurveillanceAbstract
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.
Downloads
Downloads
Published
Issue
Section
License
Copyright (c) 2019 Health Surveillance under Debate: Society, Science & Technology (Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnología) – “Visa em Debate”
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
COPYRIGHT ALLOWANCE The author (s) hereinafter designated as the ASSIGNOR hereby assign and transfer, free of charge, the ownership of the copyrights related to this ARTICLE to the Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debate, represented by FUNDAÇÃO OSWALDO CRUZ, established at Av. Brasil, nº 4365, Manguinhos, Rio de Janeiro, RJ, Brazil, CEP 21045-900, under the conditions set out below: (a) The terms and conditions set forth in this Agreement shall apply to the following: 1. The ASSIGNOR declares that they s(he) is (are) the author (s) and owner (s) of the copyrighted property of the ARTICLE submitted. 2. The ASSIGNOR declares that the ARTICLE does not infringe the copyrights and / or other property rights of third parties, that the disclosure of images (if any) has been authorized and that they s(he) assume(s) full moral and / or property liability for its content, before third parties. 3. THE ASSIGNOR assigns and transfers all copyrights relating to the ARTICLE to the ASSIGNEE, especially the rights of editing, publication, translation into another language and reproduction by any process or technique. The ASSIGNEE becomes the exclusive owner of the rights related to the ARTICLE, and any reproduction, totally or partially, is prohibited in any other means of publicity, printed or electronic, without prior written authorization from the ASSIGNEE. 4. The assignment is free and, therefore, there will be no remuneration for the use of the ARTICLE by the ASSIGNEE.
