基于医疗失效模式与效应分析的消化内镜清洗消毒管理模式的建立及效果评价

Establisment and effect evaluation of disinfection quality management of digestive endoscope based on Healthcare Failure Mode and Effects Analysis

目的 构建基于医疗失效模式与效应分析(HFMEA)的消化内镜清洗消毒优化流程,并评价其应用效果。方法 选择某医院2021年1—4月临床送洗的200条消毒消化内镜作为对照组,按照WS 507—2016《软式内镜清洗消毒技术规范》清洗消毒;同年8—10月消化内镜200条作为观察组,应用HFMEA方法,分析消化内镜清洗消毒的失效模式和潜在风险原因,计算优先风险数(RPN),对需要优先解决的问题提出改进措施,并对实施HFMEA前后的效果进行评价。结果 观察组消化内镜ATP残留量、残留蛋白量及RPN值明显低于对照组(P<0.05),质量管理项目中蛋白残留、预处理不充分、终末处理不规范、酶液使用不规范和内镜清洗不规范的发生率均明显低于对照组(P<0.05)。结论 应用HFMEA模式可有效提高消化内镜清洗消毒效果,降低消化内镜质量管理不合格率。

Objective To explore application effect of Healthcare Failure Mode and Effects Analysis(HFMEA)in the cleaning and disinfection process of digestive endoscope.Methods A total of 200 cleaned and disinfected digestive endoscopes from January to April 2021 were selected as the control group,and the other 200 digestive endoscopes from August to October 2021 were selected as the observation group.The control group was managed with the Technical Specification for Cleaning and Disinfection of Flexible Endoscopy(WS 507—2016).The observing group was managed with the HFMEA model.The failure mode and potential risk causes of digestive endoscope cleaning and disinfection were analyzed,and the priority risk number(RPN)was calculated.Improvement measures for the problems that need to be solved first were proposed,and the effect before and after the implementation of HFMEA were evaluated.Results In the observation group,the levels of ATP value,residual protein,and RPN in the digestive endoscope were significantly lower than those in the control group(P<0.05).The incidence rates of issues such as protein residue,insufficient pretreatment,non-standard final treatment,irregular use of enzymatic solutions,and non-standard endoscope cleaning were all significantly lower compared to that of the control group(P<0.05).Conclusion The application of the HFMEA model can effectively improve the cleaning and disinfection effect of digestive endoscope,and reduce the unqualified rate of quality management of digestive endoscope.