Statistics have shown AEDs save lives, however, as with any medical device, they should be used with caution, and they are not without risk. In November 2022, a patient at TriStar Centennial Medical Center suffered burns to his throat, face, head, chest, and hands when a fire erupted during the use of a defibrillator. Sadly, the patient was moved to the burn unit for treatment and died. Horrifying and devastating for the family and staff, for sure.
So, what happened here? TriStar Centennial released a statement that says, “while we cannot discuss specifics, we are reviewing the care provided to the patient and the functionality of equipment.” On the face of it, the patient experienced a cardiac event and required CPR. The defibrillator was used in an attempt to revive the patient which is typical in acute care settings. Obviously, there are questions about the functionality of the equipment – did it malfunction for some reason? Was there human error? We don’t know right now!
Hopefully, TriStar Centennial will have documentation to support that:
- Staff were trained on the use of AED equipment during orientation and at least annually or when new equipment is introduced.
- The equipment was stored in a secure location.
- Charging units, etc. are maintained and audited daily to ensure equipment is ready for use as needed and documented.
- Preventive maintenance is performed and documented based on manufacturer’s recommendations.
These steps are key to supporting the appropriate process is in place, training has been done, and equipment is maintained. Simple. Right? Hopefully the provider reported the issue to the FDA Medical Device Reporting (MDR). Remember, reporting an event that involved a medical device doesn’t mean the device was the cause of the issue, only that it was involved. If you currently have or anticipate acquiring AEDs, please do things the right way, ensure that systems are in place, staff are trained, check the FDA website for medical device reports, etc. Please refer to the link below for policy samples, and the FDA MDR site. Stay informed and stay well!
For more information:
Check out this sample of HealthCap’s policy and procedure: