Audit Faults U.S. Monitoring of Medical Device Recalls

June 30, 2011

Congressional auditors have faulted U.S. health regulators for failing to track unsafe medical devices after they are recalled, opening the door to further risks to patients.

The Government Accountability Office (GAO) found 21 high-risk recalls between 2005 and 2009 where companies were unable to correct or remove faulty devices in a report dated June 14.

“The FDA can’t tell if recalls of high-risk devices were carried out successfully because it lacks criteria for assessing device recalls and doesn’t routinely review recall data,” said Senator Charles Grassley in a statement, referring to the U.S. Food and Drug Administration.

“It looks like the FDA is missing an opportunity to proactively identify and address risks presented by unsafe devices,” he said.

High profile recalls include last year’s massive recall of artificial hips from Johnson & Johnson’s DePuy unit. Some 93,000 patients worldwide had that line of hip implant. .

Medtronic had to recall heart defibrillator leads several years ago, while the FDA recently expanded a recall of coronary imaging catheters from Boston Scientific Corp.

The FDA has already issued seven high-risk device recalls this month. The agency said on Wednesday it had taken steps to improve the recall process with a program launched last November.

The GAO report suggests the FDA should review recall information to proactively identify trends, “types of recalls, devices most frequently being recalled, and underlying causes of recalls.”

The GAO found several instances where a majority of the faulty devices remain unaccounted for, including over 409,000 insulin syringes with an incorrect dose.

(Reporting by Andrew Seaman; Editing by Michele Gershberg and Tim Dobby)

Topics USA

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