Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation, the US FDA has said in a new safety communication for users of these previously recalled devices.
An AED is a device that automatically analyzes the heart rhythm in victims of sudden cardiac arrest and delivers an electrical shock to restore its normal rhythm. AEDs help save lives of cardiac arrest victims when they are working properly and used correctly. Each year, nearly 300,000 Americans collapse from sudden cardiac arrest. When normal heart rhythms are not restored quickly, sudden cardiac arrest can cause death.
Over a year ago now, in September 2012, Philips Healthcare initiated the recall of its HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDs due to the failure of an internal electrical component. The recall affected approximately 700,000 devices. In a Medical Device Safety Notice dated November 19, 2013, Philips provided consumers with updated information about the failure of an internal electrical component that could cause the AEDs to fail to deliver a shock. The devices in question were manufactured and distributed between 2005 and 2012. Users, who may include consumers and first responders, are instructed to contact Philips Healthcare immediately for a replacement AED unit.
The FDA’s newly issued safety communication includes recommendations to better inspect and monitor the readiness of these devices, as well as steps to follow if someone must use a recalled device in an emergency situation. For its part, the FDA says it will continue to closely monitor all AED manufacturers’ quality system practices and manufacturing changes that have persistently contributed to recall and adverse events associated with AEDs.
Furthermore, in March 2013, the FDA issued a proposed order that if finalized would require manufacturers of AEDs and accessories to submit premarket approval (PMA) applications that focus specifically on the critical requirements necessary to assure AEDs are safe and effective. The main objective of this proposed regulatory approach is to improve the reliability of AEDs so that they can continue to save lives.
“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.”