BOSTON A new study shows that automated external defibrillators (AEDs), the devices used to resuscitate victims of sudden cardiac arrest, had a greater than 20 percent chance of being recalled for potential malfunction over the past decade.
The findings, reported in the August 9 issue of The Journal of the American Medical Association (JAMA), suggest the need for a more reliable system to locate and repair potentially defective devices in a timely fashion.
"Though they are simple to use, AEDs are, in fact, complex medical devices," explains the study's senior author William Maisel, MD, MPH, director of the Pacemaker and Defibrillator Service at Beth Israel Deaconess Medical Center (BIDMC) and Assistant Professor of Medicine at Harvard Medical School. "It is therefore not surprising that they may occasionally malfunction. An AED recall rate of 1 in 5 over the past decade, however, is too high."
The portable units provide voice commands, automated heart rhythm analysis, and if necessary, shock delivery to resuscitate victims of cardiac arrest. Their ease of operation -- coupled with their clinically proven ability to improve the survival of cardiac arrest victims -- has resulted in their widespread use in recent years.
"During the period we followed between 1996 and 2005 the annual number of AEDs distributed increased almost 10-fold, from fewer than 20,000 in 1996 to nearly 200,000 in 2005," says Maisel. Many public areas such as airports, sports arenas, casinos, schools and churches are now routinely outfitted with AEDs, and certain AED models have even been approved by the U.S. Food and Drug Administration (FDA) for use without a prescription, enabling consumers to purchase them more easily.
In their study, Maisel and coauthor Jignesh Shah, MD, of BIDMC's Cardiovascular Division determined the number and rate of AED safety alerts and recalls (collectively referred to as "advisories") as well as the number of
Contact: Bonnie Prescott
Beth Israel Deaconess Medical Center