Cummins R O, White R D, Pepe P E
Department of Medicine, University of Washington, Seattle, USA.
Ann Emerg Med. 1995 Nov;26(5):621-31; discussion 632-4. doi: 10.1016/s0196-0644(95)70015-3.
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)
在美国，每天因潜在可逆转的室颤死亡的人数比因其他任何死亡原因（无论是否可逆转）死亡的人数都多。早期除颤是决定性的治疗方法。自动体外除颤是一项经过验证的技术，现已证实挽救了数千人的生命。与所有医疗设备和技术一样，不可能做到完美。一些问题，比如本文所讨论的两个案例所代表的问题，是不可避免且可以接受的，几乎无需担忧。人们不会因为一名患者突然出现意外的过敏反应（作为行为的错误）或另一名患者出现意外的耐药菌（不作为的错误）就停止生产和分发青霉素。美国食品药品监督管理局（FDA）必须明白，自动体外除颤器即使不完美，也远没有完全没有除颤器那么危险。自动体外除颤器最终使许多急救医疗服务（EMS）系统能够实现早期除颤。停止使用自动体外除颤器或关闭其制造商可能意味着大量生命不必要地丧失。因此，计划实施早期除颤项目的急救医疗服务机构应继续推进此类计划。为何一个重要的联邦监管机构专门对这项技术进行严格审查，这让医疗设备领域的许多观察人士感到困惑。FDA官员主持了两次会议，讨论FDA官员对自动除颤技术持续存在的担忧。这些会议包括来自美国心脏协会（AHA）、美国心脏病学会、美国急诊医师学会（ACEP）、除颤器制造商以及其他相关组织的代表。FDA领导层一再关注通过FDA医疗设备报告系统获取的数据。国会要求FDA调查“关键医疗设备”问题的报告。由于除颤器的使用指征是心脏骤停，除颤器的使用与患者死亡之间必然存在高度关联。FDA工作人员可能会将此类与患者死亡相关的设备问题报告视为一项本质上有缺陷的技术未经严格测试和评估就进入市场的证据。然而，从临床医生的角度来看，这些报告在日常大量挽救生命的临床使用这个庞大分母中只占很小的分子。两次会议中的非FDA参会者表示，FDA的投诉似乎是随机的，且显示出对自动体外除颤器技术缺乏了解。
