From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices; Comment on “Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review”
نویسندگان
1 Division of Cardiology, University of California, San Francisco, CA, USA
2 Division of Cardiology, University of California, San Francisco, CA, USA
doi
10.34172/ijhpm.9446چکیده
Both the US Food and Drug Administration (FDA) and European Medical Device Regulation maintain the authority to require post-market surveillance for novel, high-risk medical devices. Yet, the current post-market surveillance system has several limitations. In their systematic review, Hoogervorst and colleagues highlight opportunities for improvement in the European medical device registries for the cardiovascular and orthopedic fields by standardised reporting of structural and methodological characteristics. Currently, there is heterogeneity in the governance, data collection, data reporting, and auditing of post-market surveillance registries, which limits their utility. Innovation in post-market surveillance mechanisms should include developing consensus around standardized safety outcomes by health condition, using artificial intelligence to identify patterns of harm in large or unstructured databases, continuing to invest in active surveillance networks to ensure the safety and effectiveness of high-risk medical devices, and educating physicians and care providers around adverse event reporting mechanisms. More resources and prioritization of post-market surveillance globally is needed to prioritize patient safety.
