Sudden cardiac arrest (SCA) is estimated to account for over 250,000 deaths annually. Although all known heart diseases can lead to SCA, the life-threatening arrhythmia of ventricular fibrillation (VF) is the leading cause. Early recognition of arrhythmia and subsequent defibrillation is the most important factor in survival from a cardiac arrest due to VF. Approximately 80 percent of people who suffer SCA are at home when it happens.
An automated external defibrillator, or AED, is a portable machine that is designed to use an algorithm to distinguish VF from other cardiac rhythms, advise the rescuer that a shockable rhythm is present, and then allow for the delivery of the appropriate amplitude shock to restore the individual’s normal heart rhythm. AEDs are designed to be used by lay rescuers or first responders.
The U.S. Food and Drug Administration (FDA) cleared the HeartStart Home OTC Defibrillator (Philips Medical Systems, Seattle, WA) for home use through the 510(k) approval process on September 16, 2004. The FDA cleared indication for use is, “For the termination of ventricular fibrillation and pulseless ventricular tachycardia. These devices are intended to be used on suspected victims of sudden cardiac arrest” (FDA, 2004). The previous version of this device required a prescription. However, this device is available without a prescription.
On June 06, 2019, HeartStart Home OTC Defibrillator received FDA Premarket Approval (PMA) (FDA, 2019). There are additional devices for home use that have also been cleared by the FDA, (for example, the HeartSine Samaritan® PAD [HeartSine Technologies, Inc., San Clemente, CA]).
On January 25, 2010 the Circulatory System Devices Panel of the FDA Center for Devices and Radiological Health (CDRH) issued a recommendation that, “AEDs be classified as Class III medical devices and be subject to the regulations in accordance with [PMA] applications.” According to the FDA, AED devices, although historically classified as Class III devices, have not been subject to the requirement of submitting a PMA application to demonstrate affirmatively a reasonable assurance of safety and effectiveness. Instead, they have been allowed to enter the market following FDA clearance of a 510(k) submission, usually reserved for lower-risk devices.
On February 3, 2015 the FDA issued a Final Order which now requires all AED devices to meet PMA protocols; AED manufacturers must now submit PMA applications for FDA approval for all previously cleared AED devices. In addition, this new order requires that all new AED devices and accessories have an approved PMA in effect before being placed in commercial distribution (FDA, 2015). This order is based on the reports of 45,000 adverse events and 88 recalls received by the FDA between 2005 and 2013, many due to battery failure and improper maintenance.