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  Vol. 292 No. 15, October 20, 2004 TABLE OF CONTENTS
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FDA OKs Nonprescription Defibrillators

Mike Mitka

JAMA. 2004;292:1809.

Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

Consumers no longer need a physician’s prescription to purchase automatic external defibrillators (AEDs) for home use in the case of sudden cardiac arrest.

Noting that emergency responders take at least 9 minutes to reach a patient whose heart has stopped, advocates said the September 16 decision by the Food and Drug Administration (FDA) to grant over-the-counter status for a home defibrillator means more people with sudden cardiac arrest will be saved. The approval was granted for Phillips Medical Systems’ (Andover, Mass) HeartStart Home Defibrillator.

Opponents, however, said data have yet to show the efficacy of AEDs in the home, and that by bypassing the physician, people may miss opportunities to treat cardiovascular disease before it reaches life-threatening proportions.

Sudden cardiac arrest is the leading cause of death in the United States, with around 340 000 people dying each year. Approximately 80% of these deaths occur in the home, . . . [Full Text of this Article]







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