失效模式与效应分析对消毒供应室手术器械集中式管理质量及医院感染率的影响

Influence of failure mode and effect analysis on centralized management quality of surgical instruments and nosocomial infection rate in disinfection supply room

目的分析失效模式与效应分析(failure mode and effects analysis,FMEA)对消毒供应室手术器械集中式管理质量及医院感染率的影响。方法 2015年5月至2016年6月某医院以传统方法进行手术器械集中式管理(存在缺陷)为实施前阶段,2016年8月至2017年10月以FMEA方法进行手术器械集中式管理(实施整改措施后)为实施后阶段,此阶段包括成立FMEA小组,分析失效模式及失效原因,制定和完善整改措施。评估HFMEA实施前、后各因素失效模式的风险指数(RPN)。分析两个阶段手术器械集中式管理质量、消毒质量,并统计医院感染情况。结果与实施前比较,FMEA实施后精密器械损耗、器械回收不及时、器械防护不当、清洗流程错误、冲洗不彻底、培训考核不到位各RPN值显著下降。与实施前比较,FMEA实施后防护合格率、清洗合格率、灭菌合格率、包装合格率均显著升高,且均>95%,差异有统计学意义(P<0.05)。与实施前比较,HFMEA实施后手术器械消毒后生物监测、B-D试验合格率明显升高,差异有统计学意义(P<0.05)。FMEA实施前后各调查250名患者,实施前后分别感染29人次、9人次,感染率为11.60%、3.60%,差异有统计学意义(P<0.05)。结论 FMEA可及时发现医院消毒供应室手术器械管理的失败模式,有效避免其带来的负面影响,从而可提升临床工作质量及降低医院感染率。

Objective To analyze the effect of failure mode and effect analysis(FMEA)on centralized management quality of surgical instruments and nosocomial infection rate in disinfection supply room.Methods The centralized management of surgical instruments by traditional method(existing flaws)was carried out in a hospital from May 2015 to June 2016 as the stage before implementation.The centralized management of surgical instruments was carried the stage after implementation.At this stage,FMEA team was set up to analyze failure modes and failure causes and formulate and improve rectification measures.The risk priority number(RPN)of each factor of failure mode was analyzed before and after the implementation of FMEA.The centralized management quality of surgical instruments and disinfection quality in the two stages were analyzed and the situation of nosocomial infection was also statistically analyzed.Results After the implementation of FMEA,the RPN values of loss of precision instruments,failure of instrument recovery,improper equipment protection,incorrect cleaning process,incomplete washing and unqualified training assessment decreased significantly.After the implementation of FMEA,qualified rate of protection,qualified rate of cleaning,qualified rate of sterilization and qualified rate of package increased significantly,with all rates higher than 95%.The difference showed statistical significance(P<0.05).After the implementation,biological monitoring of surgical instruments after sterilization,and the qualified rate of B-D test increased significantly and the difference showed statistical significance(P<0.05).250 patients were surveyed before and after the implementation of FMEA.Before the implementation of FMEA,29 persons/times were infected and the infection rate was 11.60%while after the implementation,9 persons/times were infected and the infection rate was 3.60%.The difference showed statistical significance(P<0.05).Conclusion FMEA could detect the failure mode of surgical instrument management in disinfection supply room of hospitals,avoiding its negative effect and improving clinical work quality and lowering nosocomial infection rate in hospitals.