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External Defibrillator Warnings Not Adequate

TUESDAY, Aug. 8 (HealthDay News) -- One in five external defibrillators used to re-start failing hearts has been prone to some sort of mechanical defect over the past decade, a new study finds.

What's more, U.S. Food and Drug Administration advisories on potentially malfunctioning defibrillators often aren't reaching the right people, the researchers warned.

"These are lifesaving devices, important devices, so I can understand a low threshold for issuing a recall. But there needs to be a better notification system in place," said study lead author Dr. William H. Maisel, director of the Pacemaker and Defibrillator Service at Beth Israel Deaconess Hospital in Boston.

His team published its findings in the Aug. 9 issue of the Journal of the American Medical Association.

External defibrillators now are routinely available in public places such as airports, sports arenas and casinos, and some models are approved for home use. They are designed to prevent sudden death from cardiac arrest.

Their effectiveness is such that the number issued each year has increased tenfold, from about 20,000 in 1996 to about 200,000 today. But during that time, the FDA has also issued 52 advisories covering 385,922 defibrillators or accessories, the study found.

Typically, an advisory was issued in the form of a press release, by the FDA or the device manufacturer, Maisel said. "That is not an adequate information system for the public to learn what is being done," Maisel said. "The press release might not even be picked up by the media. There needs to be a better registration system for the people who purchase the devices and a better notification system when recalls are issued."

Despite all the safety alerts and recall notices, only 370 defibrillator malfunctions were reported by individuals using the devices, the researchers found. However, Maisel stressed that "malfunctions are notoriously underreported."

He believes a monitoring system closer to that for implanted defibrillators, such as the one given U.S. Vice President Dick Cheney after he suffered a mild heart attack. Those types of implanted devices are routinely registered with the manufacture at the time of implantation.

Right now, individuals who purchase external defibrillators are given cards to return to the manufacturer to help keep track of them, but "many consumers are wary of providing that kind of personal information," Maisel said.

Dr. Dwight Reynolds, chief of the cardiovascular division of the University of Oklahoma Health Science Center and president of the Heart Rhythm Society, said alerting everyone responsible for defibrillator maintenance is a tough job. They are "a very disparate group," Reynolds said. "They are in casinos, airports, schools, all sorts of places, so developing a methodology for notifying these folks is critical."

"The challenge is finding the right people to notify," he said.

Reynolds did find some good news in the report, however. While the number of advisories has increased with the number of devices in use, the rate at which those advisories are issued has not increased, he said.

And he stressed that defibrillators continue to save lives across the nation every day. "The most important message is that their value in preventing sudden cardiac deaths far outweighs their problems," Reynolds said.

More information

For more on external defibrillators, head to the U.S. Food and Drug Administration.