Effect of Failure Mode and Effects Analysis on Improving Cleaning and Disinfection Quality of Flexi-ble Endoscopes in Operating Theaters
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 1 247.24 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.
Operating theaterFlexible endoscopeCleaningDisinfectionFailure mode and effects analysisRisk managementNursing quality
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