FDA to strengthen oversight of medical devices
By HME News Staff
Updated 10:21 AM CDT, Mon August 26, 2024
WASHINGTON – The Food and Drug Administration has begun building a surveillance system to look for potential safety issues in medical products ranging from surgical masks to implantable pacemakers.
More than 1.7 million injuries and 83,000 deaths over a recent 10-year period in the U.S. have been potentially linked to faulty medical devices, according to a 2018 study by the Government Accountability Office.
Active postmarket surveillance involves the ongoing review of evidence—derived from the analysis of data sources such as electronic health records, billing claims, pharmacy and other data—to detect medical device safety issues that may otherwise go unreported. FDA has taken steps to establish an active postmarket surveillance system for medical devices. These include:
- establishing a coordinating center in 2016 to partner with FDA to organize a network of data sources (health systems and other collaborators);
- completing in 2021 the cloud-based data infrastructure necessary to collect evidence of medical device performance while protecting patient privacy; and
- planning to begin active postmarket surveillance of two medical devices by December 2024, with plans to expand over 5 years (see figure).
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