一次性使用卫生用品中致病菌的检测和质量控制  

Detection and Quality Control of Pathogenic Bacteria in Disposable Sanitary Products

作　　者：钟静[1] 杨立峰[1] 杨文润[1] 邓颖敏 ZHONG Jing;YANG Li-feng;YANG Wen-run;DENG Ying-min(Guangdong Institute for Quality Supervision and Inspection of Medical Devices,Guangdong Guangzhou 510663)

机构地区：[1]广东省医疗器械质量监督检验所,广东广州510663

出　　处：《中国医疗器械信息》2023年第23期23-25,166,共4页China Medical Device Information

基　　金：广东省药品监督管理局科技创新项目(项目名称:体外循环器械重点实验室项目研究;项目编号:2021ZDZ01);广东省重点领域研发计划项目(项目名称:ECMO相关体外循环设备临床前大动物安全性、有效性评价体系建设和规范制定;项目编号:2020B1111490002)。

摘　　要：目的:通过参加国家市场监督管理局组织的一次性口罩能力验证,评估实验室综合检测能力,进而提升一次性口罩的产品质量安全。方法:依据《一次性使用卫生用品中致病菌的检测参试指导书》及GB15979-2002《一次性使用卫生用品卫生标准》附录B的相关条款进行检测,在菌株分离上采用辅助检测方法:增加金黄色葡萄球菌、假单胞菌属显色培养基的划线,目的增加对目标菌的分离和准确鉴定。采用标准要求用传统生化鉴定方法对血平板、十六烷三甲基溴化铵琼脂培养基分离出来的可疑菌落进行生化鉴定,同时也对辅助检测方法显色平板分离出来的可疑菌落进行传统鉴定,对难判定的假单胞菌属显色培养基生长的可疑菌落再增加全自动生化鉴定仪进行生化鉴定。结果:传统方法鉴定结果与全自动生化鉴定仪鉴定的结果一致,国家市场监督管理局于2020年及2022年共组织了2次一次性口罩能力验证实验,本实验室能力验证结果评价均为满意,实验室的检测能力获得认可。结论:本实验室一次性口罩能力验证的检测方法及质量控制策略是可行的,值得推荐。Objective:By participating in the capability verification of disposable masks organized by the State Administration for Market Supervision,the comprehensive testing capability can be evaluated,so as to improve the product quality and safety of disposable masks.Methods:According to the Test Guide for the Detection of Pathogenic Bacteria in Disposable Sanitary Products and the relevant provisions of Appendix B of GB15979-2002 Hygienic Standards for Disposable Sanitary Products,the auxiliary detection method is used for strain isolation:Staphylococcus aureus and Pseudomonas are added to the chromogenic medium to increase the isolation and accurate identification of target bacteria.In this paper,traditional biochemical identification methods are used to identify suspicious bacterial colonies isolated from blood plate and cetane trimethyl ammonium bromide AGAR medium,as well as traditional identification of suspicious bacterial colonies isolated from color plate of auxiliary detection method.The suspicious colonies growing in chromogenic medium of Pseudomonas were identified by adding automatic biochemical identification instrument.Results:The identification results of the traditional method are consistent with those of the automatic biochemical identification instrument.The State Administration for Market Supervision organized two one-time mask verification experiments in 2020 and 2022,and the evaluation of the laboratoryʼs capability verification results was satisfactory,and the laboratory's testing capability was recognized.Conclusion:The testing method and quality control strategy for the ability verification of disposable masks in our laboratory are feasible and worth recommending.

关 键 词：一次性使用卫生用品 致病菌检测 质量控制 

分 类 号：R194.5[医药卫生—卫生事业管理]