Medical devices post-market surveillance: analysis of notifications of Notivisa registered in the state of Paraná, Brazil
DOI:
https://doi.org/10.22239/2317-269X.01373Keywords:
Product Surveillance Post-market, Health Surveillance, Health RiskAbstract
Introduction: The medical devices post-market surveillance monitors adverse events and technical complaints of the medical devices through the National Notification Health Surveillance System (Notivisa). Companies holding the registration of products must investigate and adopt measures related to notifications. Objective: To analyze the profile of notifications of Notivisa medical devices registered in Paraná from 2006 to 2018 and the investigations of companies that own the register of medical devices notified in 2018. Method: A descriptive, retrospective, documental study of medical devices post-market surveillance notifications registered in Paraná from 2006 to 2018 and investigations registered by the 2018 notifications companies. Results: 17,122 medical devices notifications were registered in Paraná from 2007 to 2018, with only 109 notifications related to the line of equipments and 255 of products for in vitro diagnosis. From the 2,327 notifications of 2018, the responses of 404 notifications were analyzed, and the description of the adoption of corrective and, or preventive measures by the companies was identified in 20 confirmed, 22 inconclusive, 32 probable and 3 discarded notifications. In 126 notifications, there was a need for more information from the notifier to subsidize the investigation by the company. Conclusions: Notivisa contributes to the monitoring of the quality, efficacy and safety of medical devices and enables the analysis of the companies’ performance in containing health risks.
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