Recall Effectiveness Checks: FDA Tips
This article was originally published in The Silver Sheet
Executive Summary
Conducting device recall effectiveness checks can be tricky. Two FDA officials offer advice to make the process work smoother and explain why Unique Device Identification will be helpful in this month’s “Compliance Corner.”
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FDA Blames Over-Reporting For Record-High Recall Count In 2013; Looks To Root Causes
The number of medical device recalls initiated by manufacturers last year hit an all-time high, according to an analysis by “The Silver Sheet.” FDA says the increase resulted in part from over-reporting of recalls by wary firms that were dinged in the past by the agency for not reporting. “Once a firm has been cited by an investigator, it is a wonderful reporter of recalls after that,” FDA official Ann Ferriter said in an interview. “They report a disproportionate number of recalls.” Meanwhile, the agency looks to root causes for answers. Failing to conduct thorough root cause investigations “sends a message to the FDA that maybe you do not have control over your recall,” CDRH Recall Branch Chief Ron Brown says.
Long Road To Unique Device Identification: FDA’s ‘Mr. UDI’ Offers Peek Behind Curtain
The man who coined the term “Unique Device Identification,” Jay Crowley, opens up in an interview about hurdles FDA faced in setting up the system; anxiety he felt when Congress set a deadline for the final rule to be published; and why he believes UDI would have eventually happened organically anyway, among other UDI-related topics. “Sometimes people call me Mr. UDI … I think that name might stick for a while,” jokes Crowley, who planted seeds in 2002 for FDA’s new regulation to track and trace products. Since then it has mushroomed into an emerging program that has the backing of a majority in industry.
CDRH Terminating High-Risk Device Recalls Faster As Class I’s Increase In 2012
As the number of class I recalls climbed to a historic high in 2012, CDRH was already taking action to more quickly terminate such high-risk recalls. The device center beefed up its class I recall close-out process by developing a template to standardize terminations and ensure that recalls were appropriately addressed by manufacturers. “What we’re looking to do is to move beyond just removing the recalled device from the shelf,” CDRH official Ann Ferriter said. Officials at device firms Philips Medical Systems and Cordis sense that FDA has become more stringent, requiring nearly 100 percent of product pulled from the market before declaring a recall closed. Meanwhile, CDRH is tackling recall-related provisions outlined in the FDA Safety and Innovation Act, and an ex-FDA official explains why he believes the number of overall recalls jumped 9 percent in 2012.