Congressional auditors say U.S. health regulators are at fault 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 14th. Senator Charles Grassley, in a statement, had this to say:
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. It looks like the FDA is missing an opportunity to proactively identify and address risks presented by unsafe devices.
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, and the FDA recently expanded a recall of coronary imaging catheters from Boston Scientific Corp. The FDA, which issued seven high-risk device recalls in June, says it has already taken steps to improve the recall process with a program started 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.
Source: Insurance Journal
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