JAMA, FDA Look at Advisories Issued for AEDs
A recent article in the Journal of the American Medical Association (JAMA) studied FDA Enforcement Reports between January 1996 and December 2005 to identify all recalls and safety alerts (collectively referred to as “advisories”) involving automated external defibrillators (AEDs) and AED accessories. It found that during 2.78 million AED device-years of observation, 52 advisories affecting 385,922 AEDs and AED accessories were issued. Confirmed fatal AED-related device malfunctions occurred in 370 patients. Annual sales of AEDs grew by an order of magnitude during that decade. The study concludes that:
“Automated external defibrillator and AED accessory advisories occur frequently and affect many devices. Actual AED malfunctions do occur occasionally, although the number of observed malfunctions is small compared with the number of lives saved. 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.”
Yesterday the FDA commented that it mostly agreed with these findings but it challenged two assertions made by the authors of the article. First, according to the FDA manufacturers are actually able to track AED units, with more than 95 percent of the AEDs affected by Class I recalls in 2005 returned to their manufacturers or taken out of service. Second, while it’s true that more AEDs have been affected by advisories, it might well be because of the devices’ improved self-diagnosis features.
August 11, 2006 Related topics: Product Recalls, Medical Devices & Products