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FDA reevaluates safety of automated external defibrillators
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The FDA recently announced it plans to strengthen its review of automated external defibrillators to help improve the quality and reliability of the devices.
According to an agency press release, there have been 111 AED recalls, affecting more than 2 million devices, and about 72,000 medical device reports associated with the AED failure since 2005. Many recalls and reports were associated with design and marketing issues, including insufficient control of components.
The FDA issued a final order requiring AED manufacturers to submit premarket approval applications, which undergo a more rigorous review than what was required to market these devices in the past, according to the release. The strengthened reviews will focus on requirements needed to ensure the safety and reliability of devices and their essential components and accessories.
William Maisel
“Automated external defibrillators save lives,” William Maisel, MD, MPH, deputy director for science, chief scientist and acting director of the FDA’s Office of Device Evaluation, said in the release. “These changes to the way these devices are reviewed will allow us to more closely monitor how they are designed and manufactured. This will go a long way towards correcting long-standing problems and ultimately improving the reliability of these devices.”
Current AEDs will remain on the market until the new premarket approval application requirements are implemented. The updated AEDs are expected to be enforced on July 29, 2016. Updated AED accessories are not anticipated until Jan. 29, 2020.