失效模式与效应分析应用于内镜消毒管理的效果评价

Research on failure mode and effect analysis in endoscope disinfection management

目的寻找并发现纤维内镜管道内腔细菌监测不合格的原因，提高内镜清洗消毒合格率。方法应用失效模式与效应分析法对纤维内镜管道内腔细菌监测不合格结果进行分析，进行流程改造。同时用细菌学监测的方法对整改前后纤维内镜管道内腔进行抽样监测。结果管道内腔手工清洗时刷洗次数对监测结果有影响，修订管道内腔清洗消毒流程并进行员工培训，纤维内镜管道内腔监测结果较整改前有提高，合格率由84．15％提高到98．65％，差异显著。对内镜清洗消毒失效风险指数进行计算，风险较高的前2项是：操作员管腔内刷洗次数的RPN=640，管腔内刷洗方法的RPN=480，是影响监测质量的关键因素。结论对管道内腔刷洗次数进行调整，采用细菌学监测的方法对效果进行检验，管道内腔刷洗应不少于5次，可提高管道内腔细菌监测的合格率。

Objective To identify and investigate the cause of the unacceptable bacteria level in- side the lumen of fiberendoscope during monitoring so as to increase the pass rate of its cleaning and disinfection. Methods A failure mode effect analysis of the cause was done and the workflow was thereafter improved. Meanwhile, pre and post bacteriological monitor was applied to the fiberendoscope lumen sampies. Results The number of scrubbing times while manual cleaning affected the monitoring results. The scrubbing times was amended and the pass rate increased from 84.15% to 98.65%. The results were significandy different. The failure mode risk index of endoscope cleaning and disinfection was calculated, and the highest two items were： The number of scrubbing times the operators execute RPN=640, the method of lumen cleaning RPN=480. These were the key factors of qualification of monitoring. Conclusions After the amendment, no less than 5 times＇ scrubbing was required and the bacteriological monitoring method was used to analyze the effects, thereafter the pass rate of lumen bacteria monitoring can be increased significantly.