在医疗机构高端医疗器械配置增加、医疗机构医用耗材使用量大幅增长的背景下,我国医疗器械不良事件发生数量在2013~2017年逐年增加,生产企业产品召回数量也明显增加,2018年上半年主动召回数量同比增长66。7%。同时与使用相关的安全风险也有所增加,使用环境中相关风险因素与国家管理政策发生了相应变化,在对这些变化进行分析的基础上,本文提出了目前在用医疗器械安全管理方面的问题,并从法规政策、人员培训及信息化建设方面提出了相应政策建议。
<<This paper analyzes the current situation of the application and development of medical devices in hospitals,the safety situation of medical devices in use and the change of the national management policy on medical devices. In view of the existing problems and causes in the safety management of medical devices in use,this paper puts forward Suggestions to solve the problems and development prospects.
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