The Ins and Outs of the US Medical Device Recall Process

Safety in healthcare has been a life long career passion of mine whether it’s fire safety, quality assurance, risk management or what I like to call the medical device safety chain. Value Analysis serves in a variety of healthcare roles healthcare in the “cradle to grave” cycle of medical devices from the comprehensive evidence based review process of new requests, to the introduction & use phase, problem solving which may include manufacturer safety alerts & recalls through product obsolescence.

I’d like to turn the spotlight on the current medical device recall process which has been a focus of attention by the federal government, professional organizations, healthcare providers, device manufacturers, distributors, recall alert services and patient advocacy groups. The awareness campaign is real and touches more than the food, drug and household goods items that you often hear about in the media. What you may not hear enough about is the ~2900 medical device recalls annually in the US, the slow pace of manually notifying healthcare providers of a recall, and the data showing it takes days to weeks or longer to locate, execute the recall instructions and close a recall.

I recently authored a DOTMED HealthCareBusiness news article reviewing how the US recall process could be enhanced- check it out:

https://www.dotmed.com/viewer/082021/

More to come on medical device recalls and other topics along the medical device safety chain.