与药品一样,医疗器械亦具有两重性,除能够治疗、预防疾病,改善人体各项机能外,在使用过程中,由于使用对象范围的扩大、使用时间的延长以及使用环境的改变等,还可能存在这样或那样的安全隐患,对患者或者使用者造成伤害,甚至死亡,即引发医疗器械不良事件。例如,除颤器因存在故障而导致心脏病人死亡;心 Medical products, like pharmaceuticals, also have a dual nature. In addition to being able to treat, prevent and improve the body’s functions, medical devices may also be present during use due to extended use, prolonged use, and changes in the use environment This and other hidden dangers of safety cause injury or even death to the patient or user, which may lead to medical device adverse events. For example, defibrillators cause death of heart patients due to failure; heart