AHA Tells FDA that Prescription Requirement Has No Effect on Safety of AEDs
 

WASHINGTON, July 30 /U.S. Newswire Press Release/ -- The American Heart Association told a Food and Drug Administration (FDA) panel yesterday that it supports the removal of the prescription requirement for automated external defibrillators (AEDs).

The FDA's Circulatory System Devices Panel of the Medical Devices Advisory Committee met today to decide whether or not to lift the prescription requirement currently required for anyone wishing to obtain an AED. AEDs are portable medical devices that provide the most effective treatment for sudden cardiac arrest victims who have a deadly abnormal heart rhythm known as ventricular fibrillation.

"Out-of-hospital sudden cardiac arrest is common, lethal, debilitating and costly," said Graham Nichol, M.D., chair of the American Heart Association's AED Task Force. "Many of these events occur in the home. CPR, defibrillation and advanced cardiac life support provided by emergency medical services (EMS) providers are effective if prompt. However, it is difficult for EMS systems to arrive on scene within the first few minutes following most cardiac arrests."

Sudden cardiac arrest is responsible for approximately 340,000 adult deaths in the U.S. that occur outside the hospital or in the emergency department. Approximately 95 percent of those who suffer sudden cardiac arrest outside a hospital die. For many people, sudden cardiac arrest is the first sign of cardiovascular disease.

Nichol conducted a review of the scientific literature from 1966 to the present to identify any adverse effects associated with the use of defibrillators. He uncovered no reports describing inappropriate shocks administered with AEDs -- only a small number of inappropriate shocks were made with manual defibrillators.

"We are unaware of any published or unpublished evidence that requiring a prescription prior to dispensing an AED increases the likelihood that a responder will be able to use the device, or that a prescription requirement decreases inappropriate use or adverse effects," said Nichol. "Therefore, the American Heart Association supports removal of the prescription requirement for AEDs."

Nichol emphasized the need for lay responders in both public and home settings to receive proper training in CPR and the use of AEDs.

The American Heart Association currently lacks sufficient scientific data to recommend for or against the use of AEDs in the home. A large, multi-year national study -- the HAT trial -- sponsored by the National Heart, Lung, and Blood Institute and Philips Medical Systems, Inc., is currently underway to measure whether early defibrillation provided by family members using AEDs at home will increase survival. Results of the trial are expected in several years.

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Dr. Nichol's comments to the panel are available upon request.


To: National Desk, Health Reporter

Contact: Tagni McRae, 214-706-1383, or Kelly Kennai of the American Heart Association, 202-785-7900