【摘要】 目的 探讨失效模式与效应分析(FMEA)在手术外来器械管理中的应用价值。方法 选取2020年10—12月及2021年1—3月于某三甲医院手术室采用外来器械的手术为研究对象,1 362台外来器械手术作为对照组,采用常规管理。1 429台外来器械手术作为观察组,采用FMEA管理,由小组成员对外来器械管理中可能出现的失效模式进行危害分析,比较两组实施FMEA管理前后高风险失效模式RPN值、不良事件发生率、相关人员满意度。结果 手术外来器械管理中潜在高风险失效模式分别为器械商备物不全、器械性能不佳、器械清洗不合格等。通过FMEA管理,观察组高风险失效模式RPN值均低于对照组,RPN值总分由996分降至231分。不良事件发生率观察组显著低于对照组,差异有统计学意义(P<0.001)。手术相关人员对外来器械管理满意度评分均高于对照组,差异有统计学意义(P<0.05)。结论 FMEA应用于手术外来器械管理,能够降低管理风险,降低不良事件发生率,提高满意度,有助于提高管理质量。更多还原

【Abstract】 Objective To explore the application value of failure mode and effect analysis(FMEA) in the management of foreign surgical instruments.Methods The operations using foreign instruments in the operating room of a class III hospital from October to December 2020 and January to March 2021 were selected as the research object.1 362 foreign instrument operations were used as a control group,and routine management was adopted.1 429 foreign instrument operations were used as the observation group and managed by FMEA.The team members conduct a hazard analysis of possible failure modes in the management of external devices.The RPN value of high-risk failure modes,the incidence of adverse events,and the satisfaction of related personnel were compared between the two groups before and after the implementation of FMEA management.Results Potential high-risk failure modes in the management of surgical foreign equipment were incomplete equipment preparation,poor equipment performance,and unqualified equipment cleaning.Through FMEA management,the high-risk failure mode RPN values of the observation group were lower than those of the control group,and the total RPN score was reduced from 996 points to 231 points.The incidence of adverse events in the observation group was significantly lower than that in the control group,and the difference was statistically significant(P<0.001).The satisfaction scores of operation-related personnel for external device management were higher than those of the control group,and the difference was statistically significant(P<0.05).Conclusion The application of FMEA to the management of foreign instruments in surgery can reduce management risks,reduce the incidence of adverse events,increase satisfaction,and help improve management quality.更多还原