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FDA safety alerts for automated external defibrillators occur frequently

ercent 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. 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.

"As the prevalence of AEDs continues to increase, the number of devices affected by advisories can also be expected to increase. Efforts should be directed at developing a reliable system to locate and repair potentially defective devices in a timely fashion." (JAMA. 2006;296:655-660. Available pre-embargo to the media at www.jamamedia.org)

Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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
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Contact: Bonnie Prescott
617-667-7306
JAMA and Archives Journals
8-Aug-2006


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