摘要
目的对体外诊断试剂产业发展及监管措施提出建议,进一步提高体外诊断试剂质量,保障公众用械安全。方法根据2020年国家医疗器械质量抽查检验结果,通过汇总分析,总结体外诊断试剂质量状况,归纳分析产生问题的原因。结果2020年国家医疗器械抽检体外诊断试剂品种不合格检出率为1.6%,整体质量状况较好,但仍存在一些问题,如原材料管理不科学、参考品配制环节存在漏洞、标准理解不透彻、说明书管理不重视等。结论建议体外诊断试剂生产企业提高质量管理体系的约束力,强化风险管理意识,重视与监管部门的沟通交流,充分研究标准,加强说明书的管理。同时,也建议监管部门加强监督检查力度,进一步做好审评指导与标准宣贯。
Objective This paper puts forward suggestions on the development of in vitro diagnostic reagents and supervision measures for the post-marketing products,so as to further improve the quality of in vitro diagnostic reagents and ensure the safety use of medical device.Methods This paper summarizes the quality of in vitro diagnostic reagents and analyzes the causes of the problems,according to the results of the national medical device supervision and inspection in 2020.Results The overall quality of in vitro diagnostic reagents for national medical device supervision and inspection in 2020 is stable and the unqualified detection rate is 1.6%.However,there are some problems.For example,the management of raw materials is unscientific,the faultiness in the preparation of reference materials,the understanding of standards is unthorough,and the management of instructions is unimportance.Conclusion It is suggested that manufacturers of in vitro diagnostic reagents should improve the binding force of the quality management system,strengthen the awareness of risk management,attach importance to communicate with regulatory authorities,study standards sufficiently and strengthen the management of instructions.It is also suggested that the regulatory authorities should strengthen supervision and inspection,and further complete the evaluation guidance and standard publicity and implementation.
作者
李晓
张欣涛
郝擎
朱炯
洪伟
LI Xiao;ZHANG Xintao;HAO Qing;ZHU Jiong;HONG Wei(National Institutes for Food and Drug Control,Beijing,102629;Shanghai Institute of Medical Device Testing,Shanghai,201318)
出处
《中国医疗器械杂志》
2022年第4期459-463,共5页
Chinese Journal of Medical Instrumentation
关键词
抽检
体外诊断试剂
质量状况
supervision and inspection
in vitro diagnostic reagents
quality status
