广州医科大学学报

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。

Along with the benefits in instant,convenient medical service to the patients and increased financial incomes for the hospital provided by medical devices,particularly hi-tech facilities such as CT,MRI and laser equipments,adverse events associated with these devices are also on the rise.This paper addresses the safety control for clinical use of medical devices from the perspective of personal and property safety,based on the Interim Regulations of Safety Control for Clinical Use of Medical Devices