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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 and analyze the effect of failure mode and effect analysis (FMEA) in the quality control of lumen instruments. Methods The hospital from March 2013 to August 2015 set up FMEA test group, using the FMEA model in the hospital disinfection supply center lumen device cleaning process, comparing the RPN value before and after the test, supply center management quality score, visual cleanliness, residual The positive rate of blood, the satisfaction of lumen device cleaning. Results By using FMEA model, the RPN values of the six failure modes after the study were significantly lower than those before the study. The cleaning quality indexes of the lumen devices in the disinfection supply center obviously decreased. The visual cleanliness rate of the lumen devices reached 100% Residual blood positive rate decreased to 3.56%, medical staff satisfaction with the lumen device cleaning were 98.6%, 97.3%. Conclusions Long-term studies have confirmed that using failure mode and effect analysis (FMEA) in the quality control of lumen devices in a sterile supply center can reduce the safety risk of lumen device cleaning and significantly improve the quality of lumen device cleaning.