医院新技术准入管理的个案研究  

A Case Study on New Technology Access Management in Hospital

作　　者：吴朝阳[1] 韩薇[1] 刘风和 WU Chaoyang;HAN Wei;LIU Fenghe(Department of Medical Administration,Beijing Anzhen Hospital,Capital Medical University,Beijing 100029,China)

机构地区：[1]首都医科大学附属北京安贞医院医务处,北京100029

出　　处：《中国卫生标准管理》2023年第13期59-64,共6页China Health Standard Management

摘　　要：《医疗技术临床应用管理办法》第十二条规定未纳入禁止类、限制类的医疗技术,医疗机构可以根据自身功能定位、技术服务能力等自行决定开展。经导管主动脉瓣置换术(transcatheter aortic valve implantation,TAVI)是近30年来心血管领域突飞猛进的新技术,2010年,国内首次完成该手术。此类未纳入禁止和限制类的、具有国内引领性的医疗新技术准入管理一直是医疗机构新技术审查的难点,本文通过对首都医科大学附属北京安贞医院经导管主动脉瓣置换术新技术准入历程进行回顾与介绍,并提出管理建议:一是省级层面规范临床研究向临床应用转化期间的管理;二是各专业协会定期公布具有临床应用前景的转化目录;三是加强新技术准入与新增医疗服务收费项目的衔接。Article 12 of the administrative measures for the clinical application of medical technologies stipulates that medical technologies that are not included in the catalogue of prohibited and restricted technologies,a medical institution may decide on its own development according to its own functions,tasks,technical capabilities,etc.Transcatheter aortic valve implantation(TAVI)is a new technique in the field of cardiac and vascular surgery in recent 30 years.In 2010,TAVI was performed for the first time in China.The management of access to new medical technologies,which are not included in the category of prohibition and restriction and have domestic leadership,has been a difficult point in the review of new medical technologies in medical institutions,this article reviews and introduces the new technology of transcatheter aortic valve replacement in Beijing Anzhen Hospital,Capital Medical University,and puts forward the management suggestion:first,standardize the management of clinical research to clinical application at the provincial level.Second,professional associations regularly publish the transformation catalogue with clinical application prospects.Third,should strengthen the link between new technology access and new medical service charges.

关 键 词：医疗技术 新技术准入 经导管主动脉瓣置换术 医疗技术临床应用管理 卫生技术评估 个案研究 

分 类 号：R194[医药卫生—卫生事业管理]