失效模式与效应分析法在管腔器械质量控制中的应用

APPLICATION OF FAILURE MODE AND EFFECT SPLIT METHOD IN THE QUALITY CONTROL OF LUMEN APPLIANCE

目的比较分析失效模式与效应分析法(FMEA)在管腔器械质量控制中的应用效果。方法该院2013年3月—2015年8月组建FMEA试验小组,在医院消毒供应中心管腔器械清洗过程中运用FMEA模式,对照分析试验前后RPN值、供应中心管理质量评分、目测洁净率、残留血阳性率、管腔器械清洗满意度。结果经运用FMEA模式,研究后6个失效模式中的RPN值均明显低于研究前,消毒供应中心管腔器械清洗质量指标均出现明显下降,管腔器械目测洁净率达到100%,试纸法检测残留血阳性率下降至3.56%,医护人员对管腔器械清洁满意度分别为98.6%、97.3%。结论通过长期研究证实,在消毒供应中心管腔器械质量控制中运用失效模式与效应分析法(FMEA),降低管腔器械清洗中的安全风险,显著提升管腔器械清洗质量。

Objective To compare the effect of failure mode and effect split method（FMEA）in the quality control of the lumen instruments.Methods In author＇s hospital from March2013 to August 2015,a FMEA experimental group was established,and the FMEA model was used in the process of cleaning equipment management in disinfection supply center.Then RPN value,supply management center quality score,visually clean residual blood rate,positive rate,lumen instruments cleaning satisfaction were observed before and after the experiment.Results By using FMEA model,the RPN value of 6 failure modes after studying were significantly lower than before the study.The lumen cleaning quality indexs in sterilization and supply center were decreased,lumen devices visually clean rate reached 100%,the positive rate of blood decreased to 3.56% residue test paper.The cleaning satisfaction of doctors and nurses on the lumen equipment were98.6%,97.3% respectively.Conclusions In the long term study,the failure mode and effect split method（FMEA）are used to reduce the safety risk in the cleaning of the vessel,and the quality of the vessel is significantly improved.