失效模式与影响分析在软式内镜清洗消毒效果评价中的应用

Application of failure mode and effects analysis in evaluating the cleaning and disinfection effectiveness of flexible endoscopes

摘要:

目的 探讨失效模式与影响分析（FMEA）在软式内镜清洗消毒医院感染控制中的应用效果。方法 选取2020年10月－2021年10月于该院内镜中心进行清洗消毒的内镜作为对照组，运用FMEA对软式内镜清洗消毒全流程进行管理，选取2021年11月－2022年11月优化干预后进行清洗消毒的内镜作为试验组，比较两组主要失效模式的风险优先系数（RPN）、内镜消毒、医用压缩空气、漂洗用水微生物监测结果和消毒合格率。结果 FMEA优化后，6项主要失效模式RPN值明显下降，胃镜和肠镜微生物监测合格率分别由88.03%和73.08%提高至97.44%和96.15%，漂洗用水和医用压缩空气微生物监测合格率分别由30.00%和65.00%提高至95.00%和95.00%，优化前后比较，差异均有统计学意义（P < 0.05）。结论 漂洗用水和医用压缩空气的监测、同质化规范培训和完善配套的清洗耗材，是内镜清洗消毒管理中的高风险环节，应加强流程监管，实施FMEA，对提高内镜清洗消毒合格率起重要作用。

Abstract:

Objective To explore the application of failure mode and effects analysis (FMEA) in hospital infection control of flexible endoscope cleaning and disinfection.Methods Take the endoscopes cleaned and disinfected in the endoscopy center of a large hospital from October 2020 to October 2021 as the control group, then use the FMEA risk assessment method to manage the whole process of cleaning and disinfection of flexible endoscopes, and take the cleaned and disinfected endoscopes optimized after the intervention from November 2021 to November 2022 as the test group, compare the monitoring results and disinfection qualification rates of risk priority number (RPN), endoscopic disinfection, medical compressed air, and rinse water microorganisms in two main failure modes.Results After FMEA optimization, the RPN values of the six main failure modes decreased significantly. The qualification rates of gastroscope and enteroscope disinfection increased from 88.03% and 73.08% to 97.44% and 96.15% respectively, the qualification rates of rinsing water and compressed air for drying increased from 30.00% and 65.00% to 95.00% and 95.00% respectively，the differences were statistically significant (P < 0.05).Conclusion The monitoring of rinsing water and dry gas, the training of homogeneity specification, and the improvement of supporting cleaning consumables are high-risk links in the cleaning and disinfection process of endoscopes. The process supervision should be strengthened, and the implementation of FMEA plays an important role in improving the qualification rate of cleaning and disinfection of endoscopes.