STUDY NOTES MANY AED RECALLS; FDA CHALLENGES SOME FINDINGS
Automated external defibrillators (AEDs), which are used to resuscitate victims of sudden cardiac arrest, are not adequately tracked and have a greater than 20 percent chance of being recalled, according to a new study. But the FDA challenged some of the researchers' findings.
The research results, reported in the Aug. 9 issue of The Journal of the American Medical Association, point to the need for a more reliable system for locating and repairing potentially defective devices before they are used on patients.
While AEDs are portable and easy to use, they are also technically complex devices and little is known about their reliability, said lead researcher William Maisel, director of the Pacemaker and Defibrillator Service at Beth Israel Deaconess Medical Center (BIDMC), and Jignesh Shah of BIDMC's cardiovascular division. Maisel is also an FDA consultant and chair of the FDA Circulatory System Medical Device Advisory Panel.
Maisel and his team analyzed weekly FDA enforcement reports between January 1996 and December 2005 and found that the annual number of AEDs distributed increased almost tenfold, "from fewer than 20,000 in 1996 to nearly 200,000 in 2005."
Because of the complexity of AEDs, occasional malfunctions are not surprising, said Maisel. "An AED recall rate of 1 in 5 over the past decade, however, is too high."