title: Maintenance of defibrillators in a state of readiness.
abstract: Since 1984, the US Food and Drug Administration (FDA) has utilized the Medical Device Reporting system as a mechanism for reporting adverse incidents associated with the use of medical devices, including external defibrillators. The frequency and content of these reports prompted an FDA-conducted five-state study of defibrillator-user training and maintenance practices for both devices and batteries. The study also included inspection and testing of defibrillators and batteries to assess their state of maintenance. A detailed review of the reports and of the five-state data confirmed that in the majority of cases, adverse incidents were related to improper defibrillator operation and maintenance, prompting the FDA Center for Devices and Radiological Health to launch an educational effort directed toward those who operate and maintain defibrillators. Proper maintenance of batteries (both nickel-cadmium and sealed lead-acid) was a major component of the educational thrust, because battery failure was identified as a recurrent and preventable problem. In an effort to correct the diverse types of incidents being reported, checklists were developed by the FDA for both manual and automated defibrillators. The checklists are designed to cover the spectrum of reported problems related to both device and user. The advent of more stringent FDA adverse incident-reporting regulations, coupled with increased use of defibrillators in diverse settings with varying usage frequencies, would seem to give a major impetus to the regular use of these checklists wherever defibrillators are employed.
authors.affiliation: Department of Anesthesiology, Mayo Clinic, Rochester, Minnesota.
authors.forename: R D
authors.initials: RD
authors.lastname: White
mesh_terms: D004554:Electric Countershock / Q000295:instrumentation*; D004630:Emergencies; D004868:Equipment Failure; D006323:Heart Arrest / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D014481:United States; D014486:United States Food and Drug Administration