对空心纤维血液透析器监管问题的分析与讨论  

Analysis and Discussion on Supervision of Hollow Fiber Hemodialyzer

作　　者：洪梓祥 冯珊[1] 叶晓燕[1] 柯军[1] 韩聪[1] HONG Zi-xiang;FENG Shan;YE Xiao-yan;KE Jun;HAN Cong(Guangdong Medical Devices Quality Surveillance and Test Institute,NMPA Key Laboratory for Extracorporeal Circulation Devices,Guangzhou Biomedical Blood Purification Materials Research and Development Key Laboratory,Guangdong Guangzhou 510663)

机构地区：[1]广东省医疗器械质量监督检验所,国家药品监督管理局体外循环器械重点实验室,广州市生物医用血液净化材料研究与开发重点实验室,广东广州510663

出　　处：《中国医疗器械信息》2021年第7期1-2,29,共3页China Medical Device Information

基　　金：广州市科技计划项目(项目名称:高性能血液灌流器的临床应用与产业化研究,项目编号:201802010019)。

摘　　要：通过对近五次国家医疗器械专项监督抽检空心纤维血液透析器专项工作进行探讨,对行业标准、注册情况以及抽检情况进行汇总分析,讨论透析器通过抽检发现不合格原因和监管现状等,为国内厂家提升产品质量以及监管部门加强监管工作提供参考。Discusses the special work of hollow fiber hemodialyzer in the past five times of national medical device special supervision and sampling inspection,summarizes and analyzes the industry standards,registration and sampling inspection,discusses the causes of unqualified dialyzer found through sampling inspection and supervision status,so as to provide reference for domestic manufacturers to improve product quality and supervision departments to strengthen supervision.

关 键 词：空心纤维血液透析器 专项监督抽检 

分 类 号：R197.39[医药卫生—卫生事业管理]