高值医疗器械替代物留样的可追溯性探讨  

Discussion on Traceability of Retained Samples of Substitutes for High-Value Medical Devices

作　　者：赵宏平 方延学 高海艳 杨喜东 武泊洋 ZHAO Hong-ping;FANG Yan-xue;GAO Hai-yan;YANG Xi-dong;WU Bo-yang(Lanzhou Seemine SMA Co.,Ltd.,Gansu Lanzhou 730100;Center for Examination and Verification,Gansu Drug Administration,Gansu Lanzhou 730070;Lanzhou Yijian Additive Manufacturing Co.,Ltd.,Gansu Lanzhou 730100)

机构地区：[1]兰州西脉记忆合金股份有限公司,甘肃兰州730100 [2]甘肃省药品监督管理局审核查验中心,甘肃兰州730070 [3]兰州医健增材制造有限公司,甘肃兰州730100

出　　处：《中国医疗器械信息》2024年第23期45-48,共4页China Medical Device Information

基　　金：中国药品监督管理研究会(项目名称:无源植入类医疗器械产品替代物留样的可行性研究及风险控制研究,项目编号:2023-Y-Q-007)。

摘　　要：由于高值医疗器械材料昂贵、工艺复杂、成品率低等原因,成品留样虽理想,但面临成本和生产压力。企业在制定留样管理规定时,需要从留样成本、安全性、有效性、可靠性等多方面综合考虑留样方式,多采用替代物留样。但目前缺乏统一的替代物留样方法与指南,企业需投入大量资源进行等同性验证和评价,监管检查人员亦需花费大量精力对方法学及验证资料的可靠性进行评估。文章基于留样法规要求和企业需求,通过对不同留样方式的成本分析与评价,提出了可行的替代物留样研究思路和技术路线,以解决替代物留样存在的问题和潜在风险,为企业实施替代物留样提供一定的参考。Due to the expensive materials,complex processes,and low yield of high-value medical devices,it is ideal to retain samples of finished products,but they face cost and production pressures.When formulating sample retention management regulations,enterprises need to comprehensively consider sample retention methods from multiple aspects such as sample retention cost,safety,effectiveness,reliability,etc.,and use alternatives to retain samples.However,there is currently a lack of unified methods and guidelines for surrogate sample retention.Companies need to invest a lot of resources in equivalence verification and evaluation,and regulatory inspectors also need to spend a lot of energy in evaluating the reliability of methodology and verification data.Based on the regulatory requirements for sample retention and enterprise needs,this article proposes feasible research ideas and technical routes for alternative sample retention through cost analysis and evaluation of different sample retention methods to solve the problems and potential risks of alternative sample retention and provide a basis for It provides certain reference for enterprises to implement substitute sample retention.

关 键 词：医疗器械 留样 替代物留样 替代物留样的可行性 

分 类 号：R197.39[医药卫生—卫生事业管理]