Sharp Increase Where Defective Product Carried Reasonable Probability of Death, FDA Says
Recalls of defective medical devices nearly doubled in the decade from 2003 through 2012, according to a Food and Drug Administration report due Friday.
The total number of recalls rose to 1,190 in 2012, up from 604 in 2003. There was a sharp increase in recalls where the defective product carried a reasonable probability of death. In 2012, there were 57 of these so-called Class I recalls, up from seven in 2003.
The analysis by the FDA’s center for medical devices was undertaken in part to respond to a 2011 report by the Government Accountability Office. That document noted that recalls by companies often came too late to do much about the defects in products, since thousands of them had already been implanted in patients. A recall means a product is removed from the market, or that it is corrected in response to a defect.
An example of a device that was hard to retrieve was the 2007 recall by Medtronic Inc.MDT +0.30% of its Sprint Fidelis defibrillator wires, or “leads.” These tended to fracture in a small number of patients, resulting in some patient deaths. About 268,000 of them had been implanted in patients before the recall, and many of those still were implanted at the time.
Medtronic has said its system in which doctors’ offices monitor patients remotely now provides an early warning if the device is about to fail.
Steve Silverman, director of the FDA medical device center’s office of compliance, said a portion of the recalls stemmed from inspections by the agency. Others, he said, followed a 2010 workshop the agency held on reducing unnecessary radiation exposure from X-rays and such imaging devices. The workshop made hospitals more acutely aware of the issue of high dosing, so more flaws were reported.
He said he wasn’t able to provide numbers of devices or patients covered by the recalls, but said, “The rate of recall lags industry growth.” The FDA said the numbers of medical devices increased by about 25% from 2008 through 2012.
Wanda Moebius, a senior vice president at the industry trade group AdvaMed, said, “The increase in recalls reflected in the data can be attributed primarily to companies taking a more cautious, pro-active, patient-centric approach to quality, safety and reporting of events to FDA.”
Diana Zuckerman, president of the National Research Center for Women & Families and a critic of FDA device regulation, said, “You have to wonder whether a more rigorous regulatory effort before devices went on the market would have avoided these recalls.”
Marcia G. Crosse, health-care director at GAO, said, “The very fact that they are analyzing data on this is an improvement, as they weren’t doing this when we reported in 2011.”
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