摘要
目的:分析我国无源医疗器械不合格主要情况和原因,提出改进建议,为生产企业加强生产体系管理、提升产品质量提供参考。方法:总结2018-2019年国家医疗器械抽检反映出的我国无源医疗器械质量状况,分析主要不合格品种和项目,归纳不合格成因,提出改进建议。结果与结论:我国无源医疗器械不合格检出率总体稳定,不合格成因主要集中在产品设计或生产工艺未经有效验证、原材料验收和研发能力不足、出厂检验能力不足、标准理解不透彻。建议无源医疗器械生产企业从加大研发投入、改进产品设计、优化并验证确认生产工艺、原材料创新、提升灭菌和包装工艺、加强供应商管理、严格验收和放行检验、加强法规和标准跟踪等方面改进提升;药品监督管理部门应进一步引导无源医疗器械生产企业改进提升。
Objective:To analyze the main situation and possible causes of the unqualified passive medical devices in China in order to provide references for enterprises to strengthen production system management and improve product quality.Methods:The quality status of passive medical devices in 2018-2019 and the causes of disqualification were summarized,and suggestions for improvement were put forward.Results and Conclusion:The detection rate of unqualified passive medical devices in China is generally stable.The causes of the unqualified mainly lie in the lack of effective verification of product design or production process,the lack of raw materials'check and acceptance and their R&D capability,the lack of factory inspection capabilities and the lack of thorough understanding of standards.It is suggested that passive medical device manufacturers should increase investments in research and development,improve product design,optimize and verify production engineering,innovate raw materials,improve sterilization and packaging,strengthen supplier management,impose strict inspections on check&acceptance and release,and strengthen the tracking of regulations and standards.It is also suggested that the drug supervision and administration department should further guide the passive medical device manufacturers to improve.
作者
郝擎
姚秀军
李晓
张欣涛
Hao Qing;Yao Xiujun;Li Xiao;Zhang Xintao(National Institutes for Food and Drug Control,Beijing 102629,China;Shandong Quality Inspection Center For Medical Devices,Jinan 250101,China)
出处
《中国药事》
CAS
2021年第1期58-64,共7页
Chinese Pharmaceutical Affairs
关键词
无源医疗器械
抽检
质量
原材料
无菌
标准
passive medical devices
sampling inspections
quality
raw materials
sterilization
standards
