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FDA issues safety communication for HeartStart defibrillators
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The FDA has issued a safety communication indicating that certain HeartStart automated external defibrillators may not function properly in a cardiac emergency.
Approximately 700,000 HeartStart FRx, HeartStart HS1 Home and HeartStart HS1 OnSite devices, manufactured by Philips Healthcare between 2005 and 2012, were recalled in September 2012 due to failure of an internal component that resulted in the inability to deliver a defibrillator shock.
The safety communication includes recommendations for the inspection and monitoring of these devices, and the necessary steps to take in the event of an emergency situation requiring the use of a recalled device, according to a press release.
“The FDA advises keeping all recalled HeartStart AEDs in service until you obtain a replacement from Philips Healthcare or another AED manufacturer, even if the device indicates it has detected an error during a self-test,” Steve Silverman, director of the Office of Compliance at the FDA’s Center for Devices and Radiological Health, said in the release. “Despite current manufacturing and performance problems, the FDA considers the benefits of attempting to use an AED in a cardiac arrest emergency greater than the risk of not attempting to use the defibrillator.”
The FDA will continue to closely monitor all AED manufacturers’ quality system practices and manufacturing changes that contribute to recall and adverse events associated with AEDs, according to the release.