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Maintenance of defibrillators in a state of readiness
1Department of Anesthesiology, Mayo Clinic, Rochester, Minnesota.
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.
Insights
Adverse incidents with external defibrillators are often due to improper operation and maintenance. The US Food and Drug Administration (FDA) developed checklists to improve defibrillator safety and battery care.
Area of Science:
- Medical device safety
- Public health surveillance
Background:
- The US Food and Drug Administration (FDA) established the Medical Device Reporting system in 1984 to track adverse events associated with medical devices.
- External defibrillators, critical in emergency cardiac care, have been frequently implicated in adverse incident reports.
Observation:
- An FDA study investigated defibrillator user training, device maintenance, and battery upkeep across five states.
- Inspections and testing of defibrillators and batteries were conducted to evaluate their maintenance status.
Findings:
- A significant majority of adverse incidents were linked to improper defibrillator operation and maintenance practices.
- Battery failure was identified as a recurring and preventable issue, necessitating a focus on proper battery maintenance (nickel-cadmium and sealed lead-acid).
Implications:
- The FDA Center for Devices and Radiological Health initiated an educational program targeting defibrillator operators and maintenance personnel.
- Checklists for manual and automated defibrillators were created to address common device and user-related problems, promoting regular use in all settings.