失效模式与效应分析在外来医疗器械处理流程中的应用

Effect of failure mode and effect analysis in the processing flow of loaner medical instruments

目的探讨失效模式与效应分析(FMEA)在消毒供应中心外来医疗器械处理流程中的应用,并评价其实施效果。方法采用便利抽样方法,选取2019年3—7月首都医科大学宣武医院消毒供应中心处理的3128包外来医疗器械为对照组,选取2019年8—12月首都医科大学宣武医院消毒供应中心处理的3220包外来医疗器械为观察组。对照组实施常规管理,观察组实施FMEA管理,比较两组外来医疗器械风险优先指数(RPN)变化及外来器械管理质量。结果外来医疗器械处理过程中主要失效模式包括器械清洗不合格、器械不符、湿包、包内指示卡漏放。通过改进措施进行风险干预后RPN值下降;外来医疗器械清洗不合格率由4.73%降至0.86%,器械不符发生率由0.89%降至0.15%,湿包发生率由0.51%降至0.09%,包内指示卡漏放率由0.38%降至0,差异均具有统计学意义(P<0.05)。结论在外来医疗器械处理流程应用FMEA可以有助于提高外来医疗器械管理质量,保证器械使用安全,提高消毒供应中心工作质量。

Objective To discuss the application of failure mode and effect analysis(FMEA)in the treatment process of loaner medical instruments in the Disinfection Supply Center,and evaluate its implementation effect.Methods Using convenience sampling,3128 packages of loaner medical instruments processed by the Disinfection Supply Center of Xuanwu Hospital affiliated to Capital Medical University from March to July 2019 were selected as the control group,and 3220 packages of loaner medical instruments processed by the Disinfection Supply Center of Xuanwu Hospital affiliated to Capital Medical University from August to December 2019 were selected as the observation group.We compared the changes in the risk priority number(RPN)of the two groups of loaner medical instruments and their management quality.Results The main failure modes in the processing of loaner medical instruments included unqualified cleaning of the instrument,non-conformance of the instrument,wet package,and missing indicator card in the package.After the risk intervention through improvement measures,the RPN reduced,and the unqualified cleaning rate of loaner medical instruments dropped from 4.73%to 0.86%,and the rate of instrument non-conformance decreased from 0.89%to 0.15%,and the rate of wet package decreased from 0.51%to 0.09%,and the missing rate of indicator card in the package dropped from 0.38%to 0,and the differences were all statistically significant(P<0.05).Conclusions The application of FMEA in the treatment process of loaner medical instruments can help to improve the management quality of loaner medical instruments,ensure the safety of the use of the instruments,and improve the quality of the work of the Disinfection Supply Center.