2010~2018年我国医疗器械召回情况分析
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  • 英文篇名:Analysis on medical device recall from 2010 to 2018 in China
  • 作者:张焕 ; 洪源 ; 何宇卿 ; 张雷 ; 陈其 ; 姚雯 ; 刘利萍
  • 英文作者:ZHANG Huan;HONG Yuan;HE Yuqing;ZHANG Lei;CHEN Qi;YAO Wen;LIU Liping;Department of Parmacy, Kangda College of Nanjing Medical University;Department of Clinical Pharmacy, School of Pharmacy, Nanjing Medical University;Jiangsu Hengrui Pharmaceutical Co., Ltd;Department of Finance, Sanjiang University;Department of Humanities and Management, Kangda College of Nanjing Medical University;
  • 关键词:医疗器械 ; 原国家食品药品监督管理总局和国家药品监督管理局官方网站 ; 召回事件 ; 分析
  • 英文关键词:Medical device;;China Food and Drug Administration and National Medical Products Administration office website;;Recalls;;Analysis
  • 中文刊名:中国医药导报
  • 英文刊名:China Medical Herald
  • 机构:南京医科大学康达学院药学部;南京医科大学药学院临床药学系;江苏恒瑞医药股份有限公司;三江学院财务处;南京医科大学康达学院人文与管理学系;
  • 出版日期:2020-01-15
  • 年:2020
  • 期:02
  • 基金:江苏省教育厅高校哲学社会科学基金项目(2017SJB2126);; 南京医科大学教育研究课题(2019ZC009);南京医科大学康达学院教育研究课题(KD2018JYYJZD001)
  • 页:54-57
  • CN:11-5539/R
  • ISSN:1673-7210
  • 分类号:R197.39
摘要
目的探讨我国医疗器械召回现状问题并提出建议以供参考。方法收集2010年5月~2018年12月原国家食品药品监督管理总局(CFDA)和国家药品监督管理局(NMPA)官方网站"医疗器械召回"栏信息,在召回数量、原因、级别、方式、器械分类、所属国和生产企业等方面,运用Excel进行归类分析。结果有效召回事件共1533例,均为主动召回,进口器械1251例(81.60%)、国产器械282例(18.40%);召回原因主要为设计缺陷349例(22.77%)、制造缺陷752例(49.05%);一级召回48例(3.13%)、二级召回379例(24.72%)、三级召回740例(48.27%),未标明召回级别366例(23.87%);临床检验分析仪器产品召回数最高为403例(26.29%);召回企业共涉及18个国家,数量上排前3位是美国、中国、德国。结论召回监管已显成效,制度仍需规范完善,以促进监管体系科学高效。
    Objective To explore the status quo of medical device recall in China and to make recommendations for reference. Methods All information were collected in "Medical Device Recall" section of the official websites of China Food and Drug Administration(CFDA) and National Medical Products Administration(NMPA) from May 2010 to December 2018. Excel method was used for classification analysis in terms of number of recalls, reasons, levels, methods,equipment classification, country of origin, and manufacturing enterprises. Results The total number of effective medical device recalls was 1533 cases, all of which were active recalls, including 1251 cases of imported instruments(81.60%) and 282 cases of domestic instruments(18.40%). The main recall reasons were design defects in 349 cases(22.77%) and manufacturing defects in 752 cases(49.05%). 48 cases(3.13%) were recalled with first level, 379 cases(24.72%) with second level, while 740 cases(48.27%) with third level, and 366 cases(23.87%) with un-indicated recall level. The number of Clinical analytical instruments recalls was 403 cases(26.29%), which was the largest number in category of devices recalls. 18 countries were involved in the recall process, while the top 3 were USA, China and Germany. Conclusion The recall regulation has achieved remarkable results, however, the system still needs to be standardized to improve the scientific and efficient supervision system.
引文
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