2018年上半年医疗器械召回情况探讨  

Analysis of Medical Device Recall in the First Half of 2018

作　　者：张倩[1] 冯靖祎[1] 吕颖莹[1] 孙静[1] 叶秋萍 ZHANG Qian;FENG Jingyi;LV Yingying;SUN Jing;YE Qiuping(Department of Medical Engineering and Materials, The First Affiliated Hospital, Zhejiang University, Hangzhou Zhejiang 310003, China)

机构地区：[1]浙江大学医学院附属第一医院医学工程与物资部,浙江杭州310003

出　　处：《中国医疗设备》2018年第12期151-153,156,共4页China Medical Devices

基　　金：国家重点研发计划项目(2017YFC0114107)

摘　　要：目的统计2018年上半年医疗器械召回情况并对其进行分析,挖掘各统计结果表明的政策、行业现状等方面的趋势。方法采用比对去重、选取关键信息及分类统计等方法对收集到的医疗器械召回信息进行分析。结果 2018年度医疗器械召回事件呈上升趋势,一级召回略有增加,质量和设计问题仍是召回的主要原因,医疗设备召回事件最多,国产医疗器械企业召回意识相对较弱。结论医疗器械企业要注重自身产品质量和服务的提升,国产医疗器械厂商要端正对召回的态度;医疗机构要及时关注召回信息,以降低医疗器械使用风险。Objective Through the statistics of medical device recall in the first half of2018and the analysis of it,to explore the trends in the policies and the status quo of the industry indicated by various statistical results.Methods The collected medical device recall information was analyzed by means of comparison,weight removal,selection of key information and classification statistics.Results The results shown that the quantity of medical device recall incidents in2018was on the rise,the first-level recall was slightly increased,and the quality and design issues were still the main reason for the recall,the number of medical equipment recall events was the most,and the recall consciousness of domestic medical device enterprises was relatively weak.Conclusion Medical device enterprises should pay attention to the improvement of product quality and service,and domestic medical device manufacturers should have correct attitude towards recall.Meanwhile,medical institutions should pay attention to the recall information in time to reduce the risk of using medical devices.

关 键 词：医疗器械召回 使用监督 质量问题 召回等级 国产医疗器械 进口医疗器械 

分 类 号：R197.3[医药卫生—卫生事业管理]