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Doctor suggests overhaul for implant risk notification system

Ambulatory Safety Monitor, September 1, 2005

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Following the latest implant recalls, such as the June recall of 109,000 of Guidant Corporation's defibrillators, one doctor is urging for a change in how the public learns of risks associated with medical devices, according to Bloomberg News.

William Maisel, a cardiologist at Beth Israel Deaconess Medical Center in Boston and head of the Food and Drug Administration's advisory panel on heart devices, said patients should have the capability to learn as much about the risks of different medical implants as they would the safety risks of different automobiles.

"Ironically, consumers can learn more about the safety of the car they intend to purchase than they can about the reliability of their potentially life-saving" defibrillator, wrote Maisel in an article published in the Journal of the American Medical Association, according to Bloomberg News.

Maisel has proposed a system in which doctors would learn first about reported flaws and then companies would notify patients. Companies are currently required to inform the FDA about product malfunctions but have some discretion in deciding what information they must relay to the public.

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