FDA calls in expertise on heart device safety: report
Posted on: Friday, 7 April 2006, 01:47 CDT
NEW YORK (Reuters) - The U.S. Food and Drug Administration plans to turn to outside medical experts to help it review the safety of heart devices, such as defibrillators, that are already on the market, the New York Times said on Friday.
Daniel Schultz, director of the agency's Center for Devices and Radiological Health, told the Times the move would mark the first time that the FDA would have outside experts regularly advising it about the safety of medical devices being sold.
The move comes after a rash of recalls of life-saving heart rhythm management devices made by Guidant Corp. and other manufacturers and follows criticism over Guidant's failure to notify physicians and the public about life-threatening defects in some of its defibrillators.
The FDA also came under fire for its lack of supervision of the Guidant matter. The agency usually relies on manufacturers to alert it to problems with medical devices.
Defibrillators are devices used to jolt a dangerously racing heartbeat back to its normal rhythm.
The agency's decision also comes as a medical group that represents doctors who implant such devices is preparing to release a report recommending changes in how data about heart units is collected and disclosed.
Schultz said in a telephone interview with the newspaper that the agency plans to expand an existing advisory panel that reviews and approves new heart devices for sale, adding members who will help the FDA oversee the safety of marketed products.
Those experts will be asked to help the FDA interpret data from device manufacturers and will also be available to advise on how best to respond to immediate problems such as recalls, he told the newspaper.
"We recognize that we need to do a better job and that we need to do a better job in leveraging outside expertise," he told the newspaper. "This seemed like a logical first step in doing that."
Source: REUTERS
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