What Medical Device Manufacturers Need to Know About Recalls

In today's world where medical devices have become increasingly complex, it's critical that device manufacturers fully understand their quality and risk management processes to minimize the chance of a product recall. As medical devices evolve in complexity and add software and connectivity features, software- and cybersecurity-prompted recalls are becoming more prevalent.

In "The Hows and Whys of Medical Device Recalls," published in Sedgwick's Recall Index 2024 Edition 2, Exponent authors Sangeeta Abraham, Nicholas Benetatos, and Marta Villarraga highlight the importance of understanding the recall framework and quality and risk management processes to mitigate risk. In particular, they discuss key regulatory developments like the Food and Drug Administration's Center for Devices and Radiological Health (CDRH) 2024 Safety Report and the creation of a Global Unique Device Identification Database (GUDID), enabling improved device tracking throughout the total product lifecycle. The article also explores FDA's use of real-world evidence to strengthen active surveillance and the Voluntary Improvement Program (VIP), which includes an appraisal of quality system maturity.

In addition, the authors analyze key trends, including how multiple sources of materials and components in supply chains make it challenging to identify potentially affected devices in the event of a recall. According to the authors, having robust traceability records linking devices to specific component or material vendors and moving recall notifications to a digitized platform could provide medical device manufacturers with the speed and accuracy needed to identify potentially affected devices.

From the publication: "Recall processes will need to keep evolving as CDRH continues to strengthen postmarket surveillance activities and the medical device recall program and medical devices continue to increase in complexity."