As the primary users of external defibrillators, clinicians play a critical role in conducting safety checks, assessing the performance of these devices, and reporting issues that impact their performance. Reporting problems with devices is one of the most effective ways to assist industry in resolving device issues and prevent future patient harm.
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 associated with external defibrillators that impact patient safety.
The following strategies may help ensure optimal performance of the external defibrillators in your facility.
Maintain competence in using your external defibrillators
- Orient yourself with the operation of your particular model(s) of external defibrillators frequently to increase your familiarity with the devices. This should be done in addition to required device competency training.
- Understand the default settings on the defibrillator, specifically the settings for switching between functions such as manual defibrillation, cardioversion, synchronization, external pacing and AED.
Check your external defibrillators routinely
- Verify that the external defibrillator battery is charging when not in use.
- Examine cables, connectors and accessories for tears, cuts or exposed wires, and replace as needed.
- Confirm the availability and compatibility of all the cables (ECG, Pacer, SPO2, NIBP, hands free, power cord), defibrillator paddles, and pads.
- Verify that all electrodes (ECG and hands free defibrillator) are in sealed packages and have not expired.
- Follow your facility’s protocol for reporting events when the defibrillator or accessory (cables and electrodes) may have caused or contributed to a death or serious injury. You are also encouraged to report any other defibrillator safety concerns following your facility’s protocol.
- Remove any problematic external defibrillator from use; tag with specifics of the problem you observed and clinician contact information.
- Report all details surrounding the event including, but not limited to:
- Make and model of external defibrillator
- Energy level used and whether shock was or was not delivered
- Waveform (biphasic truncated exponential, biphasic rectilinear or monophasic), if known
- Cardiac rhythms noted
- Drug therapy
- Paddles or pads used
- Any delay in therapy
- Outcome of resuscitation, including any adverse outcomes related to the device
- Use available resources, such as your Clinical/Biomedical Engineering Department and defibrillator instructions or troubleshooting guides, when experiencing problems with an external defibrillator or AED.
- 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.