US FDA needs better recall monitoring, says GAO (Reuters)
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. Its report, dated June 14, was released to the public on Wednesday. "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...
