State of the art report
Maintenance of defibrillators in a state of readiness

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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.

References (9)

  • Emergency Care Research Institute

    Hazard: User error and defibrillator discharge failures

    Health Devices

    (1986)
  • CumminsRO et al.

    Defibrillator failures: Causes and problems and recommendations for improvement

    JAMA

    (1990)
  • WhiteRD et al.

    Charge! FDA recommendations for maintaining defibrillator readiness

    Journal of Emergency Medical Services

    (1992)
  • MarchMG et al.

    An evaluation of anesthesiologists' present checkout methods and the validity of the FDA checklist

    Anesthesiology

    (1991)
There are more references available in the full text version of this article.

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