第二类医用电气设备抽检问题分析与监管建议  

Problems Found in Sampling Inspection of Class Ⅱ Medical Electrical Equipment and Suggestions for Supervision

作　　者：周冬 齐健 吴璠 王志远 黄珊珊 ZHOU Dong;QI Jian;WU Fan;WANG Zhiyuan;HUANG Shanshan(Anhui Center for Drug Evaluation and Inspection,Hefei,Anhui,China 230051)

机构地区：[1]安徽省药品审评查验中心,安徽合肥230051

出　　处：《中国药业》2023年第6期15-20,共6页China Pharmaceuticals

摘　　要：目的 提升医疗器械质量安全保障水平。方法 以2014年至2021年国家医疗器械质量监督抽检中第二类有源医疗器械中的医用电气设备不符合标准规定项目情况为例,总结不合规产品类别、项目类型及存在的问题,与产品相关的注册技术审查指导原则,与产品相关的风险清单和检查要点,基于国家医疗器械质量监督抽检视角分析存在的质量风险。结果 不合规项目共581项,涉及产品428批,归属13大类产品。不合规项目类型有电气安全(252项,43.37%),标识、标记或随机文件(168项,28.91%),产品性能(154项,26.51%),不能正常使用(7项,1.20%);数量(批次)排前3的产品类别为物理治疗器械(100批,23.26%),医用诊察和监护器械(85批,19.86%)及注输、护理和防护器械(47批,10.98%)。不合规产品共涉及35个一级产品类别和54个二级产品类别,其中28个一级产品类别的产品已出台相关注册技术审查指导原则。结论 建议加强标准宣传贯彻力度,严格上市前注册管理要求,加大上市后监管力度,提前介入并靠前服务,以及加强医疗器械质量风险会商,严控医疗器械产品质量安全,提升相应保障水平。Objective To improve the quality and safety guarantee level of medical devices.Methods Taking the unqualified items of medical electrical equipment in the class Ⅱ active medical devices from the national medical device quality supervision and sampling inception from 2014 to 2021 as an example,the non-conforming products categories,item types and existing problems,the guiding principles for technical review of registration related to the products,and the risk list and inspection points related to the products were summarized.The existing quality risks were analyzed from the perspective of national quality supervision and sampling inspection.Results There were 581 non-conforming items,involving 428 batches of products,belonging to 13 categories of products.Non-conformance items included electrical safety (252 items,43.37%),identification,marking or random files(168 items,28.91%),product performance (154 items,26.51%),and abnormal use (7 items,1.20%).The top three product categories in terms of quantity (batch) were physical therapy equipment (100 batches,23.26%),medical diagnosis and monitoring equipment(85 batches,19.86%) and infusion,nursing and protective equipment (47 batches,10.98%).Non-conformance products involved35 primary product categories and 54 secondary product categories,of which 28 primary product categories have been issued with relevant technical review guidelines for registration.Conclusion The quality and safety of medical devices can be strictly controlled to improve the corresponding guarantee level by strengthening the publicity and implementation of standards,strictly enforcing pre-marketing registration management requirements,strengthening post-marketing supervision,carrying out the early intervention,advanced service and strengthening quality and risk consultation of medical devices.

关 键 词：第二类医疗器械 有源医疗器械 医用电气设备 质量监督 质量抽检 上市后监管 

分 类 号：R95[医药卫生—药学]