FDA Builds Surveillance System to Identify Faulty Medical Devices: GAO

The U.S. Food and Drug Administration (FDA) has started creating an active post-market surveillance system for medical devices that can help the agency to identify faulty equipment and take necessary action such as recalls, according to a recent report by the Government Accountability Office (GAO). “More than 1.7 million injuries and 83,000 deaths in the United States over a 10-year period were potentially linked to medical devices,” the Aug. 15 report said citing a 2018 investigation by the International Consortium of Investigative Journalists. Reviewing the safety and effectiveness of medical devices is undertaken by the FDA. The FDA started efforts to establish the surveillance system, which would collect “real-world evidence” of adverse events related to medical devices, including from sources such as electronic health records and billing claims, said the GAO report....