Characterization of external defibrillator output and its impact on defibrillation protection of medical equipment.

BACKGROUND

Defibrillators constitute a critical component of emergency care for ventricular fibrillation and pulseless ventricular tachycardia. Advances in defibrillation technology point to the potential need for reassessing current requirements for defibrillation protection and associated resuscitation guidelines.

OBJECTIVE

This study aimed to establish reference information for future directions in defibrillator requirements, defibrillation protection requirements, and resuscitation guidelines based on the parameters of commercially available defibrillators.

METHODS

Defibrillator brands were identified from the registration records of the China National Medical Products Administration, the U.S. Food and Drug Administration, and the European Database on Medical Devices. Key defibrillation parameters were obtained from publicly available manufacturer documentation.

RESULTS

A total of 31 manufacturers and 115 external defibrillators were identified. All studied devices employ biphasic waveforms, with biphasic truncated exponential being the most common, appearing in products from 24 of 31 manufacturers (77.4%). Except for pulsed biphasic devices manufactured by Schiller, maximum output voltages are below 3 kV. Maximum energy limits vary across devices, with some models retaining an upper limit of 360 J.

CONCLUSION

Incorporating biphasic waveforms into defibrillation protection tests may be appropriate. Adjustments to the requirements and guidelines of defibrillation voltage or energy could be considered, depending on market trends and future studies on defibrillation efficacy.