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Stricter oversight urged for defibrillators

The New York Times, January 26, 2011
A federal advisory panel on Tuesday called for stricter oversight of the defibrillators available in many schools, gyms, lobbies and other places that are used by the public to try to save victims of major heart attacks. Food and Drug Administration staff also recommended tighter controls over the automated external defibrillators, citing concerns about product recalls and reliability. Over the last five years there have been 68 recalls and more than 22,000 reports of malfunctioning devices. The F.D.A. staff said manufacturers followed up on only one-third of the reported problems. The devices have been classified as high risk but under a grandfathering clause have been regulated as if they were lower risk, which allowed them to be brought onto the market faster.

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