Annals of emergency medicine
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More people die in the United States each day of potentially reversible VF than of any other cause of death, reversible or not. Early defibrillation is the definitive treatment. Automated external defibrillation is a proven technology now confirmed to have saved thousands of lives. ⋯ FDA personnel may view such reports of device problems in association with patient deaths as evidence that an intrinsically flawed technology has reached the marketplace without rigorous testing and evaluation. From the clinician's perspective, however, these reports represent a small numerator over a huge denominator of daily, lifesaving clinical use. The non-FDA participants at the two meetings have stated that the FDA complaints appear to be random and reveal a lack of understanding of AED technology.(ABSTRACT TRUNCATED AT 400 WORDS)