Significant Risk Medical Devices – Cardiovascular

Cardiac defibrillation involves administering an electrical current to individuals experiencing life-threatening ventricular dysrhythmias, namely, ventricular fibrillation (VF) or pulseless ventricular tachycardia (VT). According to Advanced Cardiac Life Support (ACLS) guidelines, pulseless VT and VF are treated similarly. Among adults, VF is the most frequent cause of sudden cardiac arrest. The preferred and definitive treatment for VF is electrical defibrillation. This procedure delivers an electrical shock to the chest using either manual paddles or adhesive “hands-free” pads. Modern defibrillators commonly employ biphasic waveforms, which require lower energy levels for effective defibrillation compared to the older monophasic waveforms [1]. Prompt delivery of defibrillation has been associated with reported survival rates as high as 75% [2, 3]. However, the likelihood of a positive outcome decreases by approximately 10% for each minute that defibrillation is delayed [4, 5].