腹膜透析机不良事件风险分析  

Risk Analysis of Automated Peritoneal Dialysis Machines

作　　者：黄琳[1] 刘玉菲 桑媛 王永港 田月洁[1] 陈雷[5] HUANG Lin;LIU Yu-fei;SANG Yuan;WANG Yong-gang;TIAN Yue-jie;CHEN Lei(Shandong Center for ADR Monitoring,Shandong Jinan 250014;Yantai Center for ADR Monitoring,Shandong Yantai 264670;Weihai Institute for Food and Drug Control,Shandong Weihai 264200;Dongying Center for ADR Monitoring,Shandong Dongying 257000;Affiliated Hospital of Shandong University of Traditional Chinese Medicine,Shandong Jinan 250011)

机构地区：[1]山东省药品不良反应监测中心,山东济南250014 [2]烟台市药品不良反应监测中心,山东烟台264670 [3]威海市食品药品检验检测研究院,山东威海264200 [4]东营市药品不良反应监测中心,山东东营257000 [5]山东中医药大学附属医院,山东济南250011

出　　处：《中国医疗器械信息》2024年第17期1-3,44,共4页China Medical Device Information

基　　金：国家“十三五”医疗器械不良事件重点监测项目(项目名称:“十三五”药品安全规划腹膜透析机不良事件重点监测,项目编号:食药监办械监[2016]173号)

摘　　要：检索美国食品药品监督管理局制造商和用户设备体验数据库中2016年~2023年腹膜透析机不良事件报告,对检索的757例不良事件报告进行统计分析。此外,在山东省内选取10家使用腹膜透析机的医疗机构作为“十三五”期间的腹膜透析机重点监测哨点,开展多中心主动监测研究,对腹膜透析机的使用情况进行全面监测,并对监管机构、医疗机构、生产企业提出了改进建议,为腹膜透析机安全使用和监管提供参考。The Manufacturer and User Facility Device Experience(MAUDE)database of the US FDA was searched for AE reports of APD machines from 2016 to 2023,and 757 retrieved AE reports were statistically analyzed.In addition,10 medical institutions using APD machines in Shandong Province were selected as key monitoring sentinel sites for APD machines during the 13th Five-Year Plan period,and a multicenter active monitoring study was conducted to comprehensively monitor the use of APD machines.And then some suggestions were proposed to regulatory agencies,medical institutions and manufacturing enterprises.References were provided for the safe use and regulation of APD machines.

关 键 词：腹膜透析机 医疗器械 不良事件 风险 监测 

分 类 号：R459.5[医药卫生—治疗学]