失效模式与效应分析在提升手术室软式内镜风险管理中的应用

目的：探讨失效模式与效应分析（FMEA）在提升手术室软式内镜风险管理中的应用效果。方法：选择我院2021年1月1日-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；选择2022年1月1日-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工具，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）值查找每个环节中的高危因素，并对RPN＞125的关键环节制定并实施改进方案。比较FMEA实施前后失效模式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使用熟练度以及医生满意度的变化。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%；比较FMEA实施前后内镜消毒合格率，两者无统计学差异（P>0.05）；FMEA实施后手术患者等待时间为10.35±1.57min，低于实施前的12.38±1.91min（P＜0.05）；手术室护士AER操作考得分为92.50±3.92分，高于实施前的80.49±5.64分（P＜0.05）；医生满意度为93.87±2.16分，高于实施前的83.07±3.10分（P＜0.05）；比较FMEA实施前后手术室软式内镜故障维修率，两者无统计学差异（P>0.05）。结论：通过FMEA干预，优化手术室软式内镜清洗流程，加强手术室护士专业知识技能培训与考核，使手术室护士软式内镜清洗操作更加熟练，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。

Application of failure mode and effect analysis in improving the risk management of flexible endoscopy in operating room

OObjective: To explore the application effect of failure mode and effect analysis (FMEA) in improving the risk management of flexible endoscopy in operating room. Methods: A total of 827 endoscopes cleaned and disinfected by automatic endoscopic cleaning and disinfection machine (AER) in our hospital from January 1 to December 1, 2021 were selected as the pre-FMEA group. A total of 844 endoscopes after AER cleaning and disinfection from January 1 to December 1, 2022 were selected as the post-FMEA group. The FMEA tool was used to analyze each link in the operating procedure of flexible endoscopic cleaning in the operating room, and the high risk factors in each link were found by calculating the value of risk priority index (RPN), and the improvement plan was developed and implemented for the key link with RPN > 125. The changes of failure mode RPN value, endoscopic disinfection qualification rate, endoscopic failure repair rate, waiting time of surgical patients, AER proficiency of operating room nurses and doctor satisfaction before and after FMEA were compared. Results: After the implementation of FMEA, the RPN values of 5 projects after screening and rectification all decreased to < 125 points; The overall RPN decreased from 1247.24 to 475.05, with a decrease rate of 61.91%. The qualified rate of endoscope disinfection before and after FMEA was compared, and there was no statistical difference between them (P>0.05). The waiting time after FMEA was 10.35±1.57min, which was lower than 12.38±1.91min before FMEA (P < 0.05). The score of AER was 92.50±3.92 points, higher than 80.49±5.64 points before implementation (P < 0.05). Doctor satisfaction was 93.87±2.16 points, higher than 83.07±3.10 points before implementation (P < 0.05); The failure repair rate of flexible endoscope in operating room was compared before and after FMEA implementation, and there was no statistical difference between the two (P>0.05). Conclusion: Through FMEA intervention, the cleaning process of flexible endoscope in operating room can be optimized, the training and assessment of professional knowledge and skills of nurses in operating room can be strengthened, the cleaning efficiency and quality of nurses in operating room can be improved, the waiting time of surgical patients can be reduced, and the satisfaction of doctors can be improved.