According to the study, published in the Aug. 9 issue of the Journal of the American Medical Association (JAMA), FDA advisories and manufacturer alerts concerning malfunctioning units are usually issued in the form of press releases, which are unlikely to reach the general public.
"That is not an adequate information system for the public to learn what is being done," said lead researcher Dr. William H. Maisel, director of the Pacemaker and Defibrillator Service at Beth Israel Deaconess Hospital in Boston. "The press release might not even be picked up by the media."
AEDs have proven effective in many emergency situations, spurring their sales from about 20,000 in 1996 to almost 200,000 this year. Unfortunately, the study found the FDA issued about 52 advisories on 385,922 defibrillators or defibrillator accessories during that same time. The primary issues were electrical or software-related, and secondary problems included failure to detect the arrhythmia, failure to shock and battery problems.
Maisel and co-author Dr. Jignesh Shah noted that there is no technical information on the performance of AEDs, and reported that they had to analyze weekly safety alerts and recalls to get solid data.
"These are lifesaving devices, important devices, so I can understand a low threshold for issuing a recall," Maisel said. "But there needs to be a better notification system in place.
"One in five recalls is a high number for any product, let alone a life-saving product," he said. "These advisories occur frequently, they affect a lot of AEDs, and the mechanisms in place to notify AED users are poor ... Potentially, there are a lot of recalled AEDs that have not been replaced or repaired."
"I find it curious but not surprising," added FDA critic Mike Adams, "that safety warnings about faulty medical devices are barely mentioned while FDA attacks on Chinese herbs and nutritional supplements receive press conferences and national headlines. The FDA clearly has a double standard when it comes to issuing warnings that impact public safety," he added.
The study noted that the number of malfunctions still pales in comparison to the number of lives saved. As sudden cardiac death is the leading cause of death in the United States -- taking 330,000 lives a year -- the authors noted that quick and proper use of a defibrillator could save many lives.
Study authors suggested in conclusion that "Efforts should be directed at developing a reliable system to locate and repair potentially defective devices in a timely fashion."
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