Data presented today at the Heart Rhythm Society's 27th Annual Scientific Sessions finds that during a 10-year study period more than one in five automatic external defibrillators (AEDs) were recalled due to potential malfunction. The findings represent some of the first data available on safety and reliability of the devices, which are used to resuscitate victims of cardiac arrest.
"AEDs provide automated heart rhythm analysis, voice commands, and shock delivery and can be used by individuals with minimal training or experience," explains the study's lead author William H. Maisel, MD, MPH, director of the Pacemaker and Device Service at Beth Israel Deaconess Medical Center (BIDMC) and Assistant Professor of Medicine at Harvard Medical School. "As a result, widespread installation of AEDs has occurred in recent years." In fact, he adds, the annual number of the devices distributed between 1996 and 2005 increased almost 10-fold, from fewer than 20,000 to nearly 200,000.
"Public places such as airports, sports arenas and casinos are now routinely outfitted with AEDs and the U.S. Food and Drug Administration [FDA] has approved certain AED models for home use," he says. "Unfortunately, as AED use has increased, so too has the number of recalled devices."
Maisel and his colleagues reviewed weekly FDA Enforcement reports to identify recalls and safety alerts (collectively referred to as "advisories") affecting AEDs. Enforcement reports are issued by the FDA to notify the public about potentially defective medical devices which may not function as intended.
During the study period -- beginning in 1996 and ending in 2005 -- the authors found that the FDA issued 52 advisories involving either AEDs or critical AED accessories, affecting a total of 385,922 devices.
"The results showed that during this 10-year study period, more than one in five AEDs were recalled due to a potential malfunction," says Maisel, noting that electrical and software problems were the most common reasons for the advisories being issued. In addition, he adds, the number of devices that were recalled increased significantly over time.
In a separate analysis of publicly available FDA data, the authors found that during the same 10-year period, 370 confirmed AED malfunctions occurred during attempted resuscitation of cardiac arrest victims.
"While AED malfunctions do occasionally occur, the number is small in comparison to the number of lives saved by these important devices," notes Maisel. "However, because the number of AEDs in distribution continues to increase rapidly, efforts should be directed at developing a reliable system to locate and repair potentially defective devices in a timely fashion."
Maisel and coauthor Jignesh S. Shah, MD are members of the Cardiovascular Division, Beth Israel Deaconess Medical Center, Boston. William Maisel is an FDA consultant and chair of the FDA Circulatory System Medical Device Advisory Panel. The opinions expressed herein are the personal views of the authors and do not necessarily represent the policies, practices, positions or opinions of the FDA.
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