The FDA frequently issues safety advisories for automated external defibrillators (portable electronic device used to restore regular heart beat in patients with cardiac arrest) and accessories, although the number of actual device malfunctions appears to be relatively small, according to a study in the August 9 issue of JAMA.
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 U.S. Food and Drug Administration (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.
Jignesh S. Shah, M.D., and William H. Maisel, M.D., M.P.H., 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.
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 p
Contact: Bonnie Prescott
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