"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."


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.

Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School and ranks fourth in National Institutes of Health funding among independent hospitals nationwide. BIDMC is clinically affiliated with the Joslin Diabetes Center and is a research partner of the Dana-Farber/Harvard Cancer Center. BIDMC is the official hospital of the Boston Red Sox. For more information visit www.bidmc.harvard.edu.

Read the abstract at
http://jama.ama-assn.org/cgi/content/full/296/6/655

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