Abstract 119: Over-the-Counter Automated External Defibrillators in Homes: Safe and Effective
Objective: In 2004, the FDA allowed the sale of Philips HeartStart automated external defibrillators (AEDs), a class III medical device previously available for purchase only with a prescription, for over-the-counter (OTC) sale. We conducted a post-market surveillance study to assess the safety and efficacy of OTC AEDs purchased for the home in the US thru December 2009.
Methods: Voluntary reports of AED use were obtained thru inquiry when owners ordered new pads and thru yearly surveys mailed to all registered owners. When there was no response to the mail survey, phone calls were attempted to identify and assess all AED uses followed by an in-depth interview and retrieval of the AED memory.
Results: There were 18 reports of a home OTC AED being used on a patient in cardiac arrest. Uses were in the responder's home or a neighbors' home in 14 (78%) cases. In 4 (22%) cases, the use occurred outside the home when the AED was routinely taken to a family business (2), walking track (1) and gym (1). The patients were male in 17 (94%) of the uses, median age 66 y/o, range 26–90. The AED responders were female in 9 (50%) uses and 4 (22%) were health care professionals that owned the AED. In 14 (78%) uses, 911 was called before AED use, in 1 (6%) after AED use started and in 3 (17%) during AED use. Patients were treated by family members in 11 (61%) uses and in 16 (89%) CPR was performed. In 12 (67%) uses, the arrest was witnessed. In 10 (56%) of the uses at least one shock was delivered, median 1.5 shocks per patient. Shock efficacy was 100% for termination of VF. Of those shocked, 8/10 (80%) had a witnessed arrest and 2/10 (20%) were unwitnessed. The patients with unwitnessed arrest who were shocked survived to hospital admission but later died in hospital 2/2 (100%). Of the patients with a witnessed arrest who were shocked, 5/8 (63%) survived to hospital discharge. There were no circumstances of unsafe emergency use of the AED or harm during use.
Conclusions: AED responders reported they felt adequately trained in 17 (94%) of cases, one felt they should have rehearsed to be faster and 17 (94%) reported they would use the device again if needed, one did not know. There were no reported safety issues. In this first report of OTC use of AEDs in the home, 5/8 (63%) of those with a witnessed VF arrest survived to hospital discharge.
- © 2010 by American Heart Association, Inc.