失效模式与效应分析提升手术室软式内镜清洗消毒质量的效果

Effect of Failure Mode and Effects Analysis on Improving Cleaning and Disinfection Quality of Flexible Endoscopes in Operating Theaters

目的探讨失效模式与效应分析(FMEA)在提升手术室软式内镜清洗流程风险管理中的应用效果。方法选择上海交通大学医学院附属瑞金医院2021年1月1日至12月1日自动内镜清洗消毒机(AER)清洗消毒后的内镜共827镜次设为FMEA实施前组,2022年1月1日至12月1日AER清洗消毒后的内镜共844镜次设为FMEA实施后组。运用FMEA对手术室软式内镜清洗操作程序中的各个环节进行分析,通过计算风险优先指数(RPN)查找每个环节中的高危因素,针对RPN>125的关键环节制订改进方案并予以实施。比较FMEA实施前后的失效模式RPN值、内镜消毒合格率、内镜故障维修率、手术患者等待时间、手术室护士AER操作熟练度以及医生满意度。结果FMEA实施后,经过筛选并整改的5个项目的RPN值均下降至<125分;总体的RPN值由1247.24分下降至475.05分,RPN值下降率为61.91%;FMEA实施前后内镜消毒合格率及内镜故障维修率差异均无统计学意义(P>0.05);FMEA实施后手术患者等待时间短于实施前[(10.35±1.57)min vs(12.38±1.91)min],手术室护士AER操作得分及医生满意度高于实施前[(92.50±3.92)分vs(80.49±5.64)分,(93.87±2.16)分vs(83.07±3.10)分],差异均有统计学意义(P<0.05)。结论通过应用FMEA针对性优化相关操作流程,使手术室护士对软式内镜的清洗操作更加熟练,有助于提高清洗效率与质量、减少手术患者的等待时间、提升医生满意度。

Objective To explore the effect of failure mode and effects analysis(FMEA)on enhancing risk management in the cleaning process of flexible endoscopes in operation theaters.Methods In Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,827 practices of endoscope cleaning and disinfection using an automated endoscope reprocessor(AER)from January 01 to December 01,2021 were included in the pre⁃FMEA implementation group,and 844 practices of endoscope cleaning and disinfection using the AER from January 1st to December 1st,2022 were included in the post⁃FMEA implementation group.Each step in the cleaning process of flexible endoscopes in operating theaters was analyzed using FMEA.Risk priority numbers(RPN)were calculated to identify high⁃risk factors associated with each step.Corrective and preventive actions were developed and taken for the critical steps with RPN>125.The following indicators were compared pre⁃and post⁃FMEA implementation:RPN in failure mode,pass rate of endoscope disinfection,repair rate of endoscope failure,waiting time of surgical patients,theater nurses'proficiency with AER and doctor satisfaction.Results After the implementation of FMEA,the RPN decreased to<125 points for all five screened and corrected items,and the overall RPN decreased from 1247.24 points to 475.05 points with a decrease rate of 61.91%.There was no significant difference in the pass rate of endoscopic disinfection and the repair rate of endoscope failure pre⁃and post⁃FMEA implementation(P>0.05).The waiting time of surgical patients was shorter post⁃FMEA implementation than that pre⁃FMEA implementation[(10.35±1.57)min vs.(12.38±1.91)min]and theater nurses'AER operation scores and doctor satisfaction were higher post⁃FMEA implementation than those pre⁃FMEA implementation(92.50±3.92)points vs.(80.49±5.64)points,(93.87±2.16)points vs.(83.07±3.10)points,with significant differences(P<0.05).Conclusion The application of FMEA in targeted optimization of cleaning operating procedures can enhance theater nurses'proficiency in cleaning flexible endoscopes,thereby improving cleaning efficiency and quality,reducing the waiting time of surgical patients and enhancing doctor satisfaction.