医疗器械不良事件,主要指的是那些已经入市的医疗器械对人体产生伤害的事故,这些医疗器械其本身并不具有很强的危险性,产品质量也是经过我国质监部门的监督过关的,只是因为在使用这些医疗器械的时候因为非正常使用情况的出现而导致了人体损害现象的发生。为了有效防止医疗器械不良事件的再次发生,降低医疗器械的不正当使用给人体造成的损害概率,医疗机构应对本医院内持有的各项医疗器械进行动态的监测和有效地管理。 Medical device adverse events, mainly refers to those who have entered the market of medical devices harm to human body accidents, these medical devices themselves do not have a very strong risk, the quality of products is also passed the supervision of quality supervision departments in our country, but Because of the use of these medical devices because of the emergence of non-normal use led to the occurrence of human damage phenomenon. In order to effectively prevent the recurrence of adverse medical device events and reduce the probability of damage to the human body caused by improper use of medical devices, medical institutions should dynamically monitor and effectively manage the various medical devices held in the hospital.