Application of failure mode and effects analysis in evaluating the cleaning and disinfection effectiveness of flexible endoscopes
- VernacularTitle: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
- Author:
Pengchao FAN
1
;
He LIU
1
;
Wenzhi LIU
1
Author Information
- Publication Type:Journal Article
- Keywords: failure mode and effects analysis(FMEA); flexible endoscope; cleaning and disinfection; quality management
- From: China Journal of Endoscopy 2025;31(4):1-7
- CountryChina
- Language:Chinese
- 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.
