FDA To Step Up Inspections On Risky Medical Devices

The Food and Drug Administration is developing a surveillance system to enhance its decade-long initiative to track potential safety risks associated with defective medical devices. This effort, highlighted in a recent Government Accountability Office report, comes in response to FDA data indicating that faulty medical devices may have contributed to over 1.7 million injuries and 83,000 deaths in the U.S. over the past 10 years.

The surveillance system will cover a wide range of medical devices, from implantable pacemakers to surgical masks, impacting tens of millions of Americans. The FDA plans to launch its surveillance initiative by December 2024, initially focusing on a small number of devices before gradually expanding. This system will draw on data from electronic health records, billing claims, pharmacy records, and other sources.

Mandated by Congress in 2012, the FDA was tasked with creating an active post-market surveillance system for medical devices. However, progress has been hampered by funding shortages and difficulties in tracking patients using unique device identifiers. To promote the adoption of these unique identifiers, the FDA is considering advertising campaigns to educate health systems about their benefits. Additionally, the agency is assessing both current and future costs associated with active surveillance and is exploring alternative funding options.