医疗新技术临床应用的监管与档案管理  

Clinical Application Supervision and Archive Management of New Medical Technology

作　　者：崔洋海[1] 李小莹[1] 冀冰心[1] 王欣[1] 张艳红[1] Cui Yanghai;Li Xiaoying;Ji Bingxin;Wang Xin;Zhang Yanhong(Xuanwu Hospital,Capital Medical University,Beijing 100053,China;不详)

机构地区：[1]首都医科大学宣武医院,北京市100053

出　　处：《中国病案》2020年第12期49-50,80,共3页Chinese Medical Record

摘　　要：医疗新技术是医院可持续发展的动力源泉,也是医院核心竞争力的体现。医院在鼓励临床科室开展新技术的同时,更要做好新技术管理,实现对新技术全程监管。本文主要从医疗新技术准入、监督和档案管理等方面,阐述新技术分类管理,限制类技术按照要求进行备案管理,医院自行开展的按照医院新技术管理制度审批管理,在新技术临床应用过程中定期对新技术开展情况进行追踪评审,如:病例数、适应证掌握情况、不良反应、并发症、合并症、疗效情况及随访情况等,及时将符合条件的新技术转入常规技术管理,并做好新技术归档,重点是高风险技术的档案管理,做到对新技术全过程管理,并结合实际工作经验,就加强新技术临床应用的监管与档案管理进行探讨。New medical technology is the driving force and source of hospital sustainable development,which is also the embodiment of the core competitiveness of the hospital.Hospitals encourage clinical departments to develop new medical technologies.At the same time,we should do a good job in managing new medical technologies in hospitals to realize the full supervision of new technology.This paper mainly discusses the classification management of new technologies from the perspectives of access,supervision and archive management of new medical technologies,the registration management of restricted technologies according to the requirements,and the examination and approval management of hospitals according to the new technology management system.During the clinical application of new technology,regular follow-up and review will be conducted on the development of new technology,such as the number of cases,grasp of indications,adverse reactions,complications,complications,efficacy and follow-up,etc.Timely transfer qualified new technologies into routine technical management,and archive new technologies,with emphasis on the archives management of high-risk technologies,so as to manage the whole process of new technologies.Combined with practical work experience,the paper discusses how to strengthen the supervision of clinical application of new technologies and archives management.

关 键 词：医疗新技术 监管 档案管理 

分 类 号：R197.32[医药卫生—卫生事业管理]