医疗器械,特别是高新复杂的仪器如CT、MRI、激光等的临床应用,在给患者带来快速迅捷诊疗服务和提高了医院经济效益的同时,医疗器械不良事件的发生率也在不断增高。本文结合《医疗器械临床使用安全管理规范(试行)》,从人和物的安全状态的角度进行分析,对医疗器械临床使用安全管理的相关方面进行了探讨。 The clinical application of medical devices, especially high and new complex instruments such as CT, MRI and laser, has brought rapid and prompt diagnosis and treatment services to patients and improved the hospital’s economic benefits. Meanwhile, the incidence of adverse medical device events is also on the rise. In this paper, the “clinical management of medical devices using safety management practices (Trial)”, from the perspective of people and things in the security state analysis of the clinical use of medical devices safety management related aspects were discussed.