Cummins R O, Chesemore K, White R D
Department of Medicine, University of Washington, Seattle.
JAMA. 1990;264(8):1019-25. doi: 10.1001/jama.264.8.1019.
The Defibrillator Working Group of the Food and Drug Administration reviewed data from the Medical Device Reporting System and a recent five-state survey, as well as information presented at two Food and Drug Administration-sponsored conferences. These data include 156 reports of defibrillator problems to the Emergency Care Research Institute Problem Reporting Network, 495 reports of device problems to the Medical Device Reporting System, 676 reports of "defibrillator failure" in the five-state survey, 594 inspections of in-service defibrillators, and site visits to 212 emergency care facilities. The Defibrillator Working Group concluded that the frequency of defibrillator failures during clinical use may be unacceptably high. While some failures are attributable to component malfunctions, evidence suggests that errors in operator use and errors in defibrillator care and maintenance account for a high proportion of defibrillator failures. Inadequate initial training and cursory continuing education increases the chances of operator errors at the moment when correct operation is needed most. Failure of operators to perform daily equipment checks leads to poor familiarity with the equipment and failure to identify component failures or damaged devices. Many defibrillators and batteries are kept in service beyond an expected useful life, given their level of clinical use. In smaller hospitals and emergency medical services systems periodic maintenance responsibilities are not always appropriately delegated between qualified engineering personnel and defibrillator operators, and some systems completely lack services from clinical engineers. The objectives of the Defibrillator Working Group are to make personnel who use defibrillators more aware of the potential for errors in operator performance and in periodic maintenance and to recommend improvements in training, maintenance, and defibrillator design. This article presents the initial observations and recommendations of the working group.
美国食品药品监督管理局的除颤器工作组审查了来自医疗设备报告系统和近期一项五州调查的数据，以及在食品药品监督管理局主办的两次会议上提交的信息。这些数据包括向急救护理研究所问题报告网络提交的156份除颤器问题报告、向医疗设备报告系统提交的495份设备问题报告、五州调查中的676份“除颤器故障”报告、594次在用除颤器检查以及对212个急救护理设施的实地考察。除颤器工作组得出结论，临床使用中除颤器故障的发生率可能高得令人无法接受。虽然一些故障可归因于部件故障，但有证据表明，操作人员使用不当以及除颤器护理和维护方面的失误在除颤器故障中占很大比例。初始培训不足和继续教育敷衍了事增加了在最需要正确操作时操作人员出错的几率。操作人员未能进行日常设备检查导致对设备不熟悉，无法识别部件故障或损坏的设备。鉴于其临床使用水平，许多除颤器和电池在超出预期使用寿命后仍在使用。在较小的医院和紧急医疗服务系统中，定期维护职责并不总是在合格的工程人员和除颤器操作人员之间得到适当分配，而且一些系统完全缺乏临床工程师的服务。除颤器工作组的目标是让使用除颤器的人员更加意识到操作人员在操作和定期维护中出错的可能性，并建议改进培训、维护和除颤器设计。本文介绍了工作组的初步观察结果和建议。
