摘要
目的 :提高国产医疗设备技术水平,推动国产医疗设备在医院的应用。方法 :分析国产医疗设备的临床应用现状,指出国产医疗设备存在企业与医疗机构合作不足、临床成果转化机制不健全、设备评估验证体系待建立、售后保障有所欠缺等问题。结果:给出了临床优先选用国产医疗设备、鼓励国产医疗设备技术试用、优先扶持国产医疗器械上市前的临床试验、医疗机构与企业联合申报科研项目和共建售后保障体系等具体做法,并提出积极开展国产医疗设备应用评价和对比验证、建立国产医疗设备临床应用评估的标准体系及国家级的设备临床应用数据评估体系等对策,扩大国产医疗设备的应用。结论:促进国产医疗设备的优化改进与技术创新,推动国产医疗设备在医疗机构的推广应用,对国家医疗产业创新发展和行业进步意义重大。
Objective To enhance China domestic medical devices in technology level and hospital application. Methods The domestic medical devices had its clinical application analyzed. The problems of domestic medical devices fell into the cooperation of enterprise with medical institutions, commercialization of clinical achievements, devices evaluation and verification, after service and etc. Results Some countermeasures were put forward including gifting domestic medical devices priority, promoting the trials of domestic medical devices and technologies, sponsoring clinical trials of domestic medical devices before marketing, combining medical institutions with enterprises to apply for scientific research projects and to establish after service system, executing domestic medical devices application evaluation and verification, constructing standard system for domestic medical devices clinical application evaluation and national data assessment system for devices clinical application and etc. Conclusion It＇s of great value for the development of China medical industry to promote the optimization and technical innovation of domestic medical devices as well as their application in medical institutions.
作者
黄鑫
胡艳波
HUANG Xin;HU Yan-bo(Department of Medical Devices,Chinese PLA General Hospital,Beijing 100853,China;Medical Logistics Administration,Chinese PLA General Hospital,Beijing 100853,China)
出处
《医疗卫生装备》
CAS
2018年第9期75-78,共4页
Chinese Medical Equipment Journal
关键词
医疗设备
国产化
医疗机构
医疗产业
medical device
localization
medical institution
medical industry
