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"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."

Sudden cardiac death is a leading cause of death in the United States, accounting for nearly 330,000 deaths annually. Successful resuscitation of persons with cardiac arrest depends on prompt emergency care, with early defibrillation a key component to improved survival.

The use of automated external defibrillators (AEDs) and their increasingly widespread distribution in public places, including many airports, sports arenas, and shopping centers, has resulted in the saving of innumerable lives, according to background information in the article. AEDs are easy to use, but are technically complex devices that occasionally malfunction.

The FDA is responsible for the safety and oversight of medical devices in the United States, and occasionally issues recalls and safety alerts (collectively referred to as “advisories”), a number of which have involved AEDs. Little is known about the reliability of AEDs.

Maisel and Jignesh S. Shah, M.D., both of Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, analyzed weekly FDA Enforcement Reports between Jan. 1996 and Dec. 2005 to identify all recalls and safety alerts involving AEDs and AED accessories. Confirmed AED device malfunctions were identified by reviewing AED-related adverse events reported to the FDA.

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 actual AED malfunctions by analyzing weekly FDA Enforcement Reports and reports of AED-related adverse events. (The FDA routinely issues such "advisories" to notify the public about potentially defective medical devices.)

There were 52 advisories (4.5 per year) during the study period, affecting 385,922 AEDs and AED accessories. Automated external defibrillators were recalled in 9 of the 10 study years, and AED accessories were recalled in 7 of the 10 years studied. No year was advisory free.

Overall, 21.2 percent of AEDs were affected by advisories during the study period, most often due to electrical or software problems. Every major AED manufacturer recalled products during the study period. Recalls and safety alerts more often involved AEDs than AED accessories.

“This study reassuringly demonstrates that despite increasing AED complexity, the AED advisory rate did not significantly increase during the study period. However, AED and AED accessory advisories do occur frequently," according to the authors.

"The annual number of AED advisories and the annual number of AEDs affected by advisories increased, and numerous confirmed AED malfunctions occurred during the past decade. Still, the total number of device malfunctions is small compared with the number of lives saved. Indeed, hundreds of thousands of patients underwent attempted resuscitation of ventricular arrhythmias by an AED during the study period accounting for thousands of lives saved,” the authors write.

	FDA Answers Report
	FDA Finds Points of Disagreement with JAMA Report Questioning Safety of Automated External Defibrillators August 14, 2006 – The Food and Drug Administration has found areas of disagreement with an article in the current issue of the Journal of the American Medical Association that found a need for a more reliable system to locate and repair potentially defective Automatic External Defibrillators (AEDs) in a timely fashion. A statement from the FDA says the agency supports this kind of research and most of the conclusions reached in the JAMA article are consistent with FDA's own findings. However, there are a few points on which the agency differs. Read more...

"AEDs are responsible for saving thousands of lives," notes Maisel. "Time to defibrillation is the most important determinant of survival for patients who have suffered a cardiac arrest." However, he adds, as AED distribution continues to increase, the number of devices prone to malfunction can also be expected to increase.

"Unlike implantable cardiac defibrillators (ICDs) which are routinely registered with the manufacturer at the time of implantation, no such process reliably occurs with AEDs," Maisel explains. "Our study demonstrates that there is an urgent need to develop a more reliable system to identify and repair potentially defective AEDs in a timely fashion and to better notify AED owners when their devices are recalled."

Editorial:
Automated External Defibrillators - Device Reliability and Clinical Benefits

In an accompanying editorial, N. A. Mark Estes III, M.D., of the New England Medical Center and Tufts University School of Medicine, Boston, comments on the findings of Drs. Shah and Maisel.

“While efforts to develop rigorous mechanisms to accurately monitor device performance will undoubtedly have costs, these efforts are essential to achieve the best possible clinical outcomes.

"Device manufacturers and the federal government should allocate the funds required to make this effort successful. Initial steps should be guided by knowledge that many advisory AEDs remain in service and have not been appropriately evaluated. Additional measures to accurately track those who purchase and use these devices are needed.

"Subsequent measures will require the best efforts of health care professionals, regulators, manufacturers, and the public working collaboratively to develop a transparent, rigorous, and systematic approach using the best practices of evidence-based medicine in postmarketing surveillance.

"From these efforts, guidelines for monitoring, communicating, and performance should be established. During cardiac arrest, when each minute really matters for survival, all stakeholders share the duty of ensuring the highest possible standards of AED reliability.”

Editor's Note: Financial disclosure - Dr. Estes reports that he has served on the speaker’s bureau and has received honoraria from Medtronic, Guidant, and St. Jude Medical and that he has served as an expert witness in Stone vs. Frontier.

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