New data finds defibrillator recalls to be common

Data presented May 19, 2006 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, M.D., M.P.H., 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.