FDA TAKES ISSUE WITH SOME RECENT FINDINGS ON HEART DEVICE RECALLS

The FDA Aug. 10 responded to a recent study article that found a more than 20 percent recall rate over a 10-year period for automated external defibrillators (AEDs), and pointed to a need for better tracking of the devices.

The article was published in the Aug. 9 issue of The Journal of the American Medical Association (JAMA).

The FDA said researchers overlooked the agency's ability to track AEDs, and said improvements in device technology that allow more devices to self-diagnose -- rather than actual malfunctions -- could be contributing to the rise in recall rates.

The FDA notice can be viewed at www.fda.gov/bbs/topics/NEWS/2006/NEW01429.html (http://www.fda.gov/bbs/topics/NEWS/2006/NEW01429.html).