卫生技术评估:医疗器械科学监管的重要工具  

Health technology assessment:the important tool for scientific regulatory of medical devices

作　　者：李海龙 徐佩佩[1,2,3,4] 曾力楠 陈哲[1,2,3] 沈建通 王溪[6] 卓志[6] 易秋莎[1,2,3] 李幼平[7] 张伶俐 LI Hailong;XU Peipei;ZENG Linan;CHEN Zhe;SHEN Jiantong;WANG Xi;ZHUO Zhi;YI Qiusha;LI Youping;ZHANG Lingli(Department of Pharmacy,West China Second University Hospital,Sichuan University,Chengdu 610041,P.R.China;Evidence Based Pharmacy Center,West China Second University Hospital,Sichuan University,Chengdu 610041,P.R.China;Key Laboratory of Birth Defects and Related Diseases of Women and Children(Sichuan University),Ministry of Education,Chengdu 610041,P.R.China;West China School of Medicine,Sichuan University,Chengdu 610041,P.R.China;School of Medicine,Huzhou University,Huzhou 313000,P.R.China;Medical Devices Support Department,West China Second University Hospital,Sichuan University,Chengdu 610041,P.R.China;Chinese Evidence Based Medicine Center,West China Hospital,Sichuan University,Chengdu 610041,P.R.China)

机构地区：[1]四川大学华西第二医院药学部,成都610041 [2]四川大学华西第二医院循证药学中心,成都610041 [3]出生缺陷与相关妇儿疾病教育部重点实验室,成都610041 [4]四川大学华西临床医学院,成都610041 [5]湖州师范学院医学院,浙江湖州313000 [6]四川大学华西第二医院医学装备保障部,成都610041 [7]四川大学华西医院中国循证医学中心,成都610041

出　　处：《中国循证医学杂志》2021年第1期2-7,共6页Chinese Journal of Evidence-based Medicine

基　　金：四川省科技计划重点研发项目(编号:2020YFS0035)。

摘　　要：卫生技术评估(HTA)是指对卫生技术性质及影响的系统评估,是采用卫生干预或卫生技术对社会、经济、组织和伦理所产生问题进行评价的方法体系。针对目前医疗器械领域可用性、可及性、可负担性、合理和安全性的问题,HTA能系统评估医疗器械的特性、效果和影响,为科学决策提供循证依据。本文从医疗器械的管理现状与挑战出发,介绍HTA的起源与发展、基本范畴、评估流程和主要评估内容,并通过案例介绍HTA在医疗器械管理中的应用,旨在推动HTA在医疗器械管理领域的发展,使医疗器械管理更加科学规范。Health technology assessment is a systematic assessment of the nature and impact of health technology.It is a science that solves the problems of health intervention or health technology on society,economy,organization and ethics.Aiming at the current issues of availability,accessibility,affordability,rationality and safety in the field of medical devices,health technology assessment can systematically evaluate the characteristics,effects and impact of medical devices,and provide evidence-based basis for scientific decision-making.Starting from the current status and challenges of medical device management,this paper introduces the origin and development,basic scope,assessment process and main assessment content of health technology assessment,and introduces the application of health technology assessment in medical device management through case studies,so as to promote development of health technology assessment in the field of medical device management and make medical device management more scientific and standardized.

关 键 词：卫生技术评估 医疗器械 监管科学 

分 类 号：R197.1[医药卫生—卫生事业管理]