ECRI responds to FDA Safety Alert on Laerdal automated external defibrillators.

PROBLEM

On January 26, 1994, FDA issued a Safety Alert to directors of emergency medical services (EMS) and emergency healthcare provider organizations concerning automated external defibrillators (AEDs) manufactured by Laerdal Manufacturing Corp. The Safety Alert listed problems with three different Laerdal AED models: 1. Heartstart 1000 (Laerdal's fully automated unit): Failure to recognize and treat ventricular fibrillation. FDA did not provide a recommendation to prevent this problem, but requested that any deaths, serious injuries, or serious illnesses involving Laerdal defibrillators (or other devices) be reported. 2. Heartstart 1000s (a semiautomated version of the 1000): Delivery of a second, unnecessary shock after a normal sinus rhythm had been restored by a first shock. FDA recommended that users of this model check the patient for evidence of a pulse and breathing before allowing the machine to deliver a second or repeated shocks. 3. Heartstart 3000: Keypad malfunction, faulty battery connection, and defective optocoupler components. Other than recommending that all defibrillators, regardless of type or brand, be tested at the beginning of each shift and that they undergo all periodic maintenance recommended by the manufacturer, FDA did not provide specific recommendations to address these problems.

CONCLUSIONS

ECRI has several concerns with the FDA's Safety Alert: It does not adequately characterize the frequency or severity of the problems listed and provides a specific recommendation for only one. The specific recommendation provided for the Heartstart 1000s instructs EMS systems using this model to abandon established, successful practices and to adopt a new procedure that contradicts the American Heart Association's (AHA) protocol for AED use and could cause confusion and an increased risk of operator shock. It has caused enough concern that some EMS systems have taken Laerdal AEDs out of service or have hesitated to place new units into service. Unless alternative defibrillators are used, this will prevent patients from receiving the potentially lifesaving therapy of early defibrillation and can lead to unnecessary loss of life. The FDA Safety Alert is intended to raise the awareness of safe and effective use of medical devices; it does not have the force of law.