四川省医疗器械生产企业无菌和植入性医疗器械生产现况:31家企业调查分析  

Current situations of sterile and implantable medical device manufacturing in Sichuan Province: an investigation in 31 production enterprises

作　　者：周晶[1,2] 叶祥 蒋学华[1] 

机构地区：[1]四川大学华西药学院,四川省成都市610041 [2]四川省食品药品审查评价及安全监测中心,四川省成都市610017 [3]四川省药械集中采购服务中心,四川省成都市610041

出　　处：《中国组织工程研究》2017年第6期928-933,共6页Chinese Journal of Tissue Engineering Research

基　　金：四川省食品药品监督管理局;四川省食品药品审查评价及安全监测中心

摘　　要：背景:国家食品药品监督管理局(以下简称国家总局)于2009年12月16日发布《关于印发医疗器械生产质量管理规范(试行)的通知》,要求于2011年1月1日首先在风险较高的无菌和植入性医疗器械生产企业实施。修订后的《规范》于2014年12月29日公告发布,并于2015年3月1日起施行。目的:分析四川省31家无菌和植入性医疗器械生产企业的现状以及实施《规范(试行)》的情况,并提出针对性建议。方法:通过质量管理体系考核、监督检查、飞行检查、问卷调查等形式收集了四川省31家无菌和植入性医疗器械生产企业的相关数据资料,并对数据进行了统计分析。结果与结论:四川省医疗器械生产企业整体规模偏小,设备不够先进,从业人员素质偏低,资金不足,管理不到位。在此基础上,作者从生产和监管2个方面出发,为《规范》有效实施提出了指导性建议。BACKGROUND： The Specification of Quality Management for Medical Device Production（for Trial Implementation） issued by the China Food and Drug Administration（CFDA） on December 16, 2009 was demanded to be initially implemented in medical device manufacturers with a higher risk in sterility and implant before January 1, 2011. The revised version was published on December 29, 2014 and came into effect on March 1, 2015. OBJECTIVE： To put forward specific suggestions through analyzing the status of 31 sterile implantable medical device manufacturers in Sichuan Province and the corresponding implementation situation of the specification for trial implementation.METHODS： The relevant data of these 31 manufacturers were collected through the quality management system assessment, supervision and inspection, flight inspection and questionnaire survey. And the data were analyzed statistically. RESULTS AND CONCLUSION： The overall size of medical device manufacturers in Sichuan Province is small. There are still some other problems, such as no advanced equipment, low quality of employees, lack of funds and inappropriate management, in these manufacturers. Considering these, we have given some guiding recommendations from the aspects of production and supervision.

关 键 词：设备和供应 设施的规章和管理 组织工程 生物材料 医疗器械 医疗器械生产企业 医疗器械生产质量管理规范(试行) 医疗器械生产质量管理规范 国家食品药品监督管理总局 无菌医疗器械 植入性医疗器械 

分 类 号：R318[医药卫生—生物医学工程]