2020年安徽省防护类疫情防控用医疗器械生产现场检查情况分析及建议  

Analysis of 2020 Manufacturing Site Inspection of Protective Medical Devices for Infection Control in Anhui Province and Relevant Suggestions

作　　者：吴文华 王丽娜 王昆 WU Wen-hua;WANG Li-na;WANG Kun(Anhui Drug Evaluation and Inspection Center;Hefei Administration for Market Regulation;Huainan Food and Drug Inspection Center)

机构地区：[1]安徽省药品审评查验中心 [2]合肥市市场监督管理局 [3]淮南市食品药品检验中心

出　　处：《中国食品药品监管》2021年第8期74-81,共8页China Food & Drug Administration Magazine

摘　　要：目的:分析2020年安徽省防护类疫情防控用医疗器械生产现场检查情况,为提升此类医疗器械生产企业生产质量管理水平提供参考依据。方法:收集整理2020年安徽省防护类疫情防控用医疗器械生产现场检查缺陷情况,对其进行统计汇总、分析,并提出合理化建议。结论:2020年安徽省防护类疫情防控用医疗器械生产企业在机构与人员、生产管理、质量控制、厂房与设施、设备、采购等方面存在问题较多,需要企业重视人才培养,强化管理水平;监管部门需加快检查员队伍建设,加强监管与引导;探索新模式,发挥第三方补充作用。Objective:To analyze results of manufacturing site inspection of protective medical devices for infection control in Anhui Province in 2020,and to provide data for improving the quality management system of such manufacturers.Methods:Defects of protective medical devices for infection control found during on-site inspections in Anhui Province in 2020 are summarized and analyzed statistically,and suggestions are put forward.Conclusion:In 2020,problems were found in areas of structure and personnel,production management,quality control,plant and facilities,equipment,procurement,etc.for manufacturers of protective medical devices in Anhui Province.It is suggested that manufacturers pay attention to personnel training and strengthen management;regulatory departments speed up in building inspector teams,strengthen supervision and guidance,explore new models to promote industry development and give play to the complementary role of third parties.

关 键 词：疫情防控 医疗器械 生产 现场检查 

分 类 号：R197[医药卫生—卫生事业管理]