外科用敷贴类医疗器械产品不良事件的分析研究  

Analysis and Research on Adverse Events of Surgical Application Medical Device Products

作　　者：谢松波 尹建兵 张淑霞 张兰 XIE Song-bo;YIN Jian-bing;ZHANG Shu-xia;ZHANG Lan(Yuyao People’s Hospital of Zhejiang Province,Zhejiang Yuyao 315470;Zhejiang Medical Device Adverse Event Monitoring and Safety Research Center,Zhejiang Hangzhou 311121;Monitoring Center for Adverse Drug Reactions,Huzhou City,Zhejiang Province,Zhejiang Huzhou 313000)

机构地区：[1]浙江省余姚市人民医院,浙江余姚315470 [2]浙江省医疗器械不良事件监测和安全研究中心,浙江杭州311121 [3]浙江省湖州市药品不良反应监测中心,浙江湖州313000

出　　处：《中国医疗器械信息》2020年第13期44-46,共3页China Medical Device Information

摘　　要：近年来,国内外用敷贴类产品呈现不断上升趋势,随之出现的该类产品的各类可疑不良事件也显著增多。通过对本院近一年该类产品可疑不良事件的汇总分析及文献资料的检索,现将临床使用该产品常见的可疑不良事件表现、原因分析等内容进行综述,以期为正确认识该类产品的可疑不良事件提供循证支持。In recent years,the foreign application products are on the rise in domestic,and the number of suspicious adverse events of this kind of products is also significantly increased.Through the summary and analysis of suspicious adverse events of this kind of products in our hospital in the past year and the retrieval of literature,this paper summarizes the common manifestations and causes of suspicious adverse events in clinical use of this kind of products,in order to provide evidence-based support for the public to correctly understand the suspicious adverse events of this kind of products.

关 键 词：医疗器械 不良事件 风险点 敷贴 

分 类 号：TH789[机械工程—仪器科学与技术]