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中国医药导刊 ›› 2020, Vol. 22 ›› Issue (6): 416-421.

所属专题: 智慧监管专栏

• 智慧监管专栏 • 上一篇    下一篇

对无菌医疗器械生产质量管理缺陷的分析与对策研究——基于2018年国家医疗器械飞行检查结果

 肖桂金1, 于淼2, 张薇薇1, 席晓宇1*, 顾淼2*   

  1. 1. 中国药科大学国家药物政策与医药产业经济研究中心, 江苏 南京 211198;
    2. 国家药品监督管理局信息中心, 北京 100044
  • 收稿日期:2020-02-21 修回日期:2020-05-12 出版日期:2020-06-28 发布日期:2020-07-22
  • 基金资助:
    中国药科大学“双一流”学科创新团队建设项目(项目编号:CPU2018GY39);国家药品监督管理局信息中心委托项目(项目编号:2019NMPAICKY04;项目名称:互联网+药品生产监管数据融合分析研究)

Analysis and Countermeasures on Defects of Manufacturing Quality Management of Sterile Medical Device——Based on National Medical Device Unannounced Inspection Results in 2018

  1. 1.The Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University, Jiangsu Nanjing 211198, China;
    2.Center for Information, National Medical Products Administration, Beijing 100044, China
  • Received:2020-02-21 Revised:2020-05-12 Online:2020-06-28 Published:2020-07-22

摘要: 目的:分析我国无菌医疗器械生产企业质量管理存在的缺陷,并提出改进策略,以保障无菌医疗器械产品质量。方法:收集并整理2018年国家药品监督管理局对无菌医疗器械生产企业飞行检查的结果,通过描述性统计方法对企业生产质量管理存在的缺陷进行分析,并针对主要缺陷进行深入探讨。结果:22家被检企业共计发现生产质量管理缺陷283条,其中一般缺陷258条,严重缺陷25条。主要缺陷项为质量控制(占总缺陷数的13.1%,涉及20家生产企业)、厂房与设施(占总缺陷数的18.7%,涉及21家生产企业)和生产管理(占总缺陷数的21.6%,涉及22家生产企业)。结论:保障生产质量管理体系的有效、持续运行,注重对生产质量管理体系的动态调整和重视培训工作有利于无菌医疗器械生产企业保障产品质量。

关键词: font-size:medium, ">无菌医疗器械;生产质量管理;飞行检查

Abstract: Objective: To analyse the defects of manufacturing quality management of sterile medical device manufacturing enterprises in China and putting forward improvement strategies so as to ensure the quality of sterile medical device products. Methods: Collecting and sorting out the results of unannounced inspection conducted by National Medical Products Administration on sterile medical device manufacturing enterprises in 2018, then analyzing the defects of the manufacturing quality management of enterprises through descriptive statistics, and conducting further discussion about the main defects. Results: There are 283 production quality management defects in 22 inspected enterprises, among which 258 are general defects and 25 are serious defects. The main defect items are quality control (accounting for 13.1% of total defects, 20 manufacturing enterprises involved), plant and facilities (accounting for 18.7% of total defects, 21 manufacturing enterprises involved), production management (accounting for 21.6% of total defects, 22 manufacturing enterprises involved).Conclusion: To ensure the effective and continuous operation of manufacturing quality management system, pay attention to the dynamic adjustment of manufacturing quality management system and attach importance to training work are conducive to sterile medical device manufacturing enterprises to ensure quality of products.

Key words: font-size:medium, ">Sterile medical device; Manufacturng quality management; Unannounced inspection

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