Defibrillator failures. Causes of problems and recommendations for improvement. Defibrillator Working Group.

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.