title: Ventricular fibrillation, automatic external defibrillators, and the United States Food and Drug Administration: confrontation without comprehension.
abstract: 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. As with all medical devices and technology, perfection is not possible. Some problems, such as those represented by the two cases discussed in this article, are inevitable and acceptable and give little cause for alarm. One would not stop penicillin from being manufactured and distributed because of a sudden, unexpected allergic reaction in one patient (error of commission) or an unexpected resistant organism in another (error of omission). The FDA must understand that AEDs, even if they are imperfect, are not anywhere near as dangerous as no defibrillator at all. AEDs have finally allowed many EMS systems to achieve early defibrillation. Discontinuing use of AEDs or closing AED manufacturers could mean a significant number of lives lost unnecessarily. Therefore EMS agencies planning to implement early-defibrillation programs should continue with such plans. Why the agents of an important federal regulatory agency have singled out this technology for an intense review puzzles many observers in the medical-device field. Two meetings have been hosted by officials of the FDA to discuss the continuing concern the FDA officials have expressed over automated defibrillation technology. These meetings included representatives from the AHA, the American College of Cardiology, ACEP, defibrillator manufacturers, and other interested organizations. The FDA leadership has repeatedly focused on data acquired through the FDA Medical Device Reporting systems. Congress requires the FDA to investigate reports of problems with "critical medical devices." Because the indication for the use of a defibrillator is cardiac arrest, there will inevitably be a high association between defibrillator use and patient deaths. 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)
mesh_terms: D000465:Algorithms; D004554:Electric Countershock / Q000009:adverse effects* / Q000295:instrumentation*; D004562:Electrocardiography; D004632:Emergency Medical Services / Q000592:standards*; D004869:Equipment Safety; D006801:Humans; D011358:Product Surveillance, Postmarketing; D011634:Public Health; D012680:Sensitivity and Specificity; D014481:United States; D014486:United States Food and Drug Administration; D014693:Ventricular Fibrillation / Q000628:therapy*