2018年体外诊断试剂国家监督抽验情况分析及对策建议

Analysis and Suggestions for National Supervision and Inspection of in vitro Diagnostic Reagents in 2018

目的:对2018年体外诊断试剂国家监督抽验品种进行分析,为国家体外诊断试剂监督执法提供科学依据。方法:通过对体外诊断试剂品种进行梳理、汇总,从产品特点、标准现状、评估基础、法定检验、探索性研究、贯标统计等方面,评估各产品风险点,研究相关对策建议,为加强体外诊断试剂监管提供参考。结果与结论:2018年共完成10个体外诊断试剂品种352批监督抽验任务,合格334批,总合格率为94.9%,整体质量较好。但仍存在个别产品检验不合格,对国家标准和行业标准的理解和执行存在偏差,标签及说明书存在缺陷等问题,监管力度相对不足。建议通过加强贯标工作、合理制订抽验计划以及完善抽验模式等措施,加强体外诊断试剂的监督管理,提高我国体外诊断试剂监督抽验水平。

Objective:To analyze the varieties of in vitro diagnostic reagents under the national supervision and inspection in 2018,and lay a scientific basis for the national supervision and enforcement of in vitro diagnostic reagents.Methods:The varieties of in vitro diagnostic reagents were analyzed and summarized.The risk points of each product were evaluated from the following aspects:product characteristics,standard status,evaluation basis,statutory inspection,exploratory research and standard-passing statistics.The related countermeasures and suggestions were provided in order to provide references for strengthening the supervision of in vitro diagnostic reagents.Results and Conclusion:A total of 352 batches of 10 kinds of in vitro diagnostic reagents have been tested for the supervision and inspection in 2018 of which 334 batches were qualified.The total qualified rate was 94.9%,indicating the overall quality was good.However,there still exist some unqualified products,deviations in understanding and implementing national and industry standards,defects in labels and specifications,and relatively insufficient supervision as well.It is suggested that the supervision and management of in vitro diagnostic reagents in China should be improved by taking up such measures as conforming to the standards,making reasonable sampling inspection plans and improving sampling inspection modes.