FDA Says Defibrillators Need Improvement : Shots - Health News Laymen can save people's lives by using automatic external defibrillators to shock their hearts back to life. But the Food and Drug Administration says a pattern of design and manufacturing problems shows improvements are needed.
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FDA Says Defibrillators Need Improvement

An external defibrillator sits on the sidelines at a football practice at Jesuit Preparatory High School in Dallas in 2006. RON HEFLIN/AP hide caption

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About a hundred feet from my desk at NPR headquarters, an automatic external defibrillator hangs on the wall just in case someone's heart suddenly stops beating.

Devices like the one at my office are popping up everywhere. Even when used by someone with no training, the defibrillators can be lifesavers. They can sense when someone's heartbeat is out of whack, or absent altogether, and give a shock to restore a normal rhythm.

But the Food and Drug Administration says the machines, and more complicated external defibrillators used by medical professionals, need a makeover. Recalls and reports of trouble with the machines are rampant.

In the past five years there have been 68 recalls involving hundreds of thousands of individual machines made by a wide range of companies. Over the same period there have been 28,000 formal reports of defibrillator problems to the agency, including nearly 700 deaths.

Most of the recalls were caused by design problems or manufacturing lapses, the agency said. In a media briefing Monday, FDA's Dr. Jeffrey Shuren, head of the agency's medical device division, said the pattern of trouble is unusual because it applies to so many models of devices and all manufacturers. "Many of the problems are preventable and correctable," he said.

So the agency is asking the industry to do a better job and is going to hold a workshop next month to flesh out the issues. The agency is also considering a more stringent review of new defibrillators before they're approved.

"We're not taking any of these devices off the market," Shuren said. "These are live-saving devices that should still be widely used."

Heart specialists concurred. In comments during the briefing, Johns Hopkins' cardiologist Dr. Myron Weisfeldt said a bystander using an AED to revive a person with sudden cardiac arrest doubles the chances the person will survive.

Weisfeldt estimated there are at least 1 million of the automated devices available in the United States and that their use saves at least 500 people's lives each year.