Characterization of External Defibrillator Output and Its Impact on Defibrillation Protection of Medical Equipment

Abstract

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 defibrillation protection standards and associated resuscitation guidelines. OBJECTIVE This study aimed to explore potential implications for future defibrillator requirements, defibrillation protection standards, and resuscitation guidelines based on the parameters of commercially available defibrillators. METHODS Defibrillator brands were identified from the registration records of the National Medical Products Administration, the U.S. Food and Drug Administration, and the European Database on Medical Devices. Key defibrillation parameters were collected from manufacturer-provided data. RESULTS All studied devices employ biphasic waveforms, with biphasic truncated exponential (BTE) being the most common, followed by rectilinear biphasic (RB), and a smaller number using pulsed biphasic (PB). Except for PB devices, maximum output voltages are below 3 kV. While energy required for effective defibrillation decreased, some manufacturers retain 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 efficacy.

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