医学工程部门落实《医疗器械临床使用管理办法》  

Medical Engineering Department Implements the Management Measures for Clinical Use of Medical De⁃vices

作　　者：杨风辉 潘文琴 YANG Fenghui;PAN Wenqin(Department Medical Engineering,the First Affiliated Hospital of Na-val Medical University,Shanghai 200433;Center of Clinical Medicine Support,Naval Characteristic Medical Center,Shanghai 200433)

机构地区：[1]海军军医大学第一附属医院医学工程科,上海200433 [2]海军特色医学中心临床医学保障中心,上海200433

出　　处：《解放军医院管理杂志》2021年第10期975-977,共3页Hospital Administration Journal of Chinese People's Liberation Army

摘　　要：目的探讨医疗机构医学工程部门落实《医疗器械临床使用管理办法》相关规定的方式。方法梳理《医疗器械临床使用管理办法》中需要医学工程部门承担的职责,结合医疗机构的普遍实际情况,提出落实相关规定的建议。结果分析解读《医疗器械临床使用管理办法》对医疗机构医学工程部门的要求,提出落实相关规定的建议。结论医疗机构医学工程部门是落实《医疗器械临床使用管理办法》的重要部门之一,应积极响应、落实相关规定,在此过程中也推动医学工程部门的转型发展。Objective To discuss what methods can the medical engineering department(MED)in medical institutions take to implement relative rules in“the regulation for clinical application of medical devices”.Methods The responsibilities to be undertaken by the medical engineering department in the measures for the administration of clinical use of medical devices were sorted out,and suggestions were put forward on the implementation of relevant regulations in combination with the general actual situation of medical institutions.Results The requirements of the management measures for clinical use of medical devices for the Medical Engineering Department of medical institutions were analyzed and interpreted,and suggestions were put forward on the implementation of relevant regulations.Conclusion MED of medical institutions is one of the main departments to implement the regulation for clinical application of medical devices.It should actively respond to and implement relevant regulations,and promote the transformation and development of medical engineering departments in this process.

关 键 词：医疗器械临床使用管理办法 医学工程 转型发展 

分 类 号：R197.32[医药卫生—卫生事业管理]