Home > Property & Casualty > Medical device recalls jump over last decade

Medical device recalls jump over last decade

medicaldeviceRecent reports from the FDA’s Center for Devices and Radiological Health (CDRH) indicate that medical device recalls have nearly doubled (about 97%) since 2003. The Medical Device Recall Report, released last month, analyzed data from the last decade showing the number of recalls, as well as why the products had been pulled from the market. The report looked specifically at devices like ventilators, infusion pumps and external defibrillators, all of which have been historically linked to device failures, such as batter problems or improper device maintenance.

CDRH officials say that while the report’s data may appear alarming, the jump in recalls may be a good thing. The increase reflects industry efforts to improve the quality and safety of medical devices, which has resulted in a greater number of recalls reported. Manufacturers who were cited for violations in the past have an improved understanding of their products, are taking greater measures to reduce the total number of recalls, and continue to work toward increasing the overall public health benefit of medical devices. The agency says it has already made some headway – in the last three years, the CDRH says it has reduced the delay in announcing Class 1 recalls (the most serious type) by nine days. In the past, Class 1 recalls took months before they were made public, even after manufacturers had notified doctors and customers about product issues.

Several insurers offer coverage for withdrawal expenses resulting from a Class 1 recall, but coverage is limited in breadth and sub-limited to $250,000 at the maximum. To truly address the exposure of Product Recall, a separate insurance policy must be purchased.


About the Author

Amy Sinclair is an Executive Vice President and co-leader of the Life Sciences Practice in WGA’s Property and Casualty Group. She negotiates, implements and manages comprehensive insurance programs for a variety of clients, ranging from venture-backed start-up organizations up to publicly traded companies.

617.646.0229 | Asinclair@wgains.com | Connect with Amy on LinkedIn
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