Recalling Implantable Medical Devices

Medical device manufacturers, like pharmaceutical companies and food growers and processors, must meet safety standards established and enforced by the Food and Drug Administration (FDA). The FDA implements recall regulations mandated by Congress, including recall compliance and recall standards that must be met in the event of a medical device recall. This recall classification system applies to all types of medical devices, including implantable medical devices, portable medical devices you carry with you or use at home, and medical devices used by doctors and medical staff in hospitals and clinics.

Recalls of medical devices follow the three recall classifications established by the FDA, based on the degree of potential risk to the public: Class I recall, Class II recall and Class III recall. But, given the nature of the products, medical device manufacturers can usually expect to manage their implantable medical device recalls under a Class I recall standard.

One of the most difficult things about managing the recall of an implantable medical device is determining exactly who has the product, where that person is, and how to reach them. People are always on the move and their contact information often changes. It is critical that implantable medical device manufacturers have the means to track and trace their devices and their owners. In the event of a recall, these data are essential for alerting consumers about risks associated with their implantable medical device. The FDA will be watching to make sure that the manufacturer is in compliance with recall regulations and that their recall management process is effective.

The FDA later this year will be publishing a proposed set of regulations for a Unique Device Identification system for all medical devices, including implantable medical devices. The system aims to standardize the way medical devices are identified in hopes of improving the medical device recall process and making recall management easier. Likewise, the regulations will assist with adverse event reporting and documentation. Properly implemented and managed, this system can save manufacturers time and money throughout the recall process.

Companies will be most successful in preparing for a recall and establishing an internal recall strategy by thoroughly understanding the FDA recall regulations, including new rules affecting the recall process for implantable medical devices.