FDA STATEMENT August 10, 2006 Regarding JAMA Article on Recalls and Safety Alerts Affecting Automated External Defibrillators
MedSun: Newsletter #7, September 2006

Automatic external defibrillators (AEDs) are important medical devices. Numerous studies have shown that thousands of lives are saved each year using these devices to treat patients in sudden cardiac arrest. In the past decade, these devices have become simpler to use and have been placed in more public places like airports and schools.

A recent article in the The Journal of the American Medical Association (JAMA) titled “Recalls and Safety Alerts Affecting Automated External Defibrillators” helps inform the public about the safety of AEDs. FDA supports this kind of research, and most of the conclusions reached in the JAMA article are consistent with FDA's own findings. However, there are a few points on which the agency differs.

First, the authors assert that manufacturers are unable to track AED units, making it impossible to know how many AED units were actually fixed or taken out of service. However, under FDA regulations, manufacturers are required to track AEDs and are doing so with processes in place to identify the location of a device in the event of a recall. Our records show that these devices are being tracked with a high level of accuracy. In fact, more than 95 percent of the AEDs affected by Class I recalls in 2005 were returned to the manufacturers or taken out of service. Fewer than 3 percent were lost or stolen.

Second, the authors state that there has been an increase in the number of AEDs affected by advisories during the study period. This is true; however, FDA believes that improvements in the devices' ability to self-diagnose hardware and software problems may contribute to this trend. This capability may result in users reporting problems before a device is ever used on a patient. Also, while more than 21 percent of AEDs were affected by an advisory, it does not necessarily mean that they malfunctioned. A device advisory is issued when a medical device has the potential to exhibit a certain failure mode, not only when a device has, in fact, failed.

We continue to depend on our ability to work with owners of AEDs when these devices are subject to a recall and have taken steps in recent months to improve our communication and collaboration with the broader community. AED users should continue to report device malfunctions to the manufacturer and to FDA. In addition, users should heed device error messages and warnings during regular device self-checks and respond appropriately to recall notices and safety alerts.

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