FDA advises caution on defibrillators
Certain HeartStart automated external defibrillator devices made by Philips Medical Systems might be unable to deliver needed defibrillator shocks in a cardiac emergency, the Food and Drug Administration said Dec. 3.
In September 2012, Philips Healthcare initiated a recall of HeartStart FRx, HeartStart HS1 Home and HeartStart HS1 OnSite AEDs due to the failure of an internal electrical component, which affected 700,000 devices.
Philips said in a November 2013 Medical Device Safety Notice that the problem with the internal electrical component could cause the AEDs to fail to deliver a shock. The machines were manufactured and distributed between 2005 and 2012.
There is debate over whether AEDs, which deliver an electric shock to the heart for those in cardiac arrest, should be in long-term care facilities. Some specialists believe defibrillators, if used quickly, can potentially save residents with arrhythmias. AEDs often are found in schools, churches and other community sites, and first responders often rely on them.
The FDA recommends inspecting and monitoring HeartStart AEDs.
“If the device indicates it has detected an error during a self-test, the FDA advises users to keep recalled HeartStart AEDs in service until a replacement from Philips Healthcare or another AED manufacturer is obtained,” said Steve Silverman, director of the Office of Compliance in the FDA's Center for Devices and Radiological Health. “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.”
In March 2013, the FDA issued a proposed order that, if finalized, “would require manufacturers of AEDs and accessories to submit premarket approval applications that focus specifically on the critical requirements necessary to assure AEDs are safe and effective.”