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U.S. Department of Health and Human Services

Medical Devices

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Strategies for Clinical and Biomedical Engineers to Maintain Readiness of External Defibrillators

Introduction

Clinical and biomedical engineers play an important role in conducting preventative maintenance on external defibrillators and identifying devices that are having problems or may have failed. They are also often the first to report issues about the performance of external defibrillators. Reporting problems with devices is one of the most effective ways for industry to assess the impact of the problem and determine their actions.

External defibrillators are critical life-saving devices that are used successfully thousands of times each year to treat patients experiencing sudden cardiac arrest. The FDA recognizes the important life-saving benefits of external defibrillators and that users trust they will operate properly. It is unlikely that an external defibrillator will malfunction however, the FDA is aware of infrequent problems with external defibrillators that impact patient safety.

The following strategies may help ensure optimal performance of the external defibrillators in your facility.

Conduct preventive maintenance

  • Conduct preventive maintenance of all external defibrillators according to the manufacturer's protocol and regulatory requirements and your facility’s best practice.
  • Maintain a list of software versions in your defibrillator inventory.

Manage device recalls and safety notices

  • Address safety notifications promptly for all external defibrillators in your inventory.
  • Work with the manufacturers to comply with recall strategies if your facility has external defibrillators that are affected.
  • Communicate instructions for responding to a recall to all departments involved.
  • Track recurring problems for the external defibrillators in your facility.

Train staff

  • Participate in and develop educational activities with hospital staff to promote the safe use of external defibrillators.
  • Communicate device configuration and set-up default settings with clinicians, risk/safety managers, clinical educators, materials managers, and others.
  • Evaluate routinely the effectiveness of device configuration and set-up default settings
  • Provide a quick reference user guide that describes the key functions of each external defibrillator.
  • Provide a user checklist that describes the steps of completing a performance verification check.

Monitor and report problems

  • Collect information about problems with external defibrillators. Obtain as many details as possible.
  • Be aware of incident/occurrence reports and follow-up appropriately.
  • Explore “use errors” or “no problem found” to determine underlying human factors issues.
  • Work with manufacturers to obtain defibrillator log reports following reported problems. 
  • Follow your hospital/facility protocol for reporting events, including device/user interface problems, if the problem may have prevented the rescue of a patient or caused serious injury. Consider reporting any other defibrillator safety concerns through your hospital/facility protocol.
  • Consider filing a voluntary report with the FDA for any defibrillator problem that you encounter.
  • Be aware that HIPAA restrictions do not apply to reports submitted to the FDA