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A new study, published in the Journal of the American Medical Association finds that one in five external heart defibrillators designed to revive failing hearts has had some form of mechanical defect over the last ten years.
Furthermore, the study concludes that the U.S. Food and Drug Administration''s product advisories on these defective devices are not sufficient in warning consumers.
“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 Dr. William H. Maisel, lead author of the study and director of the Pacemaker and Defibrillator Service in Boston.
According to the study, external heart defibrillators have significantly increased in popularity over the last decade. About 200,000 life-saving defibrillators are available in places such as airports, casinos, sports arenas, and some are even approved for home use.
However, the study indicates that the FDA has issued 52 advisories for 385,922 defibrillators or product accessories that have malfunctioned or contained some sort of mechanical defects.
Most defibrillator product defect warnings are issued via a press release either by the FDA or the device manufacturer. “This is not an adequate information system for the public to learn what is being done,” said Maisel.
“The press release may 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.”
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