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目的 探讨失效模式与效应分析在消毒供应中心锐器伤风险防控中的应用效果.方法 根据失效模式与效应分析工作流程,确定主题,组建团队,制定可复用医疗器械处理流程,分析各流程步骤中的锐器伤潜在失效模式、失效原因及影响因素,进行严重度、发生频率和不易探测度评分,计算事先风险数,根据分析结果制定相应改进措施并落实.结果 实施失效模式与效应分析后,关键失效模式RPN值较实施前明显下降,差异有统计学意义;消毒供应中心员工锐器伤发生人次从2015年的12人次降低到2016年的4人次.结论 应用失效模式与效应分析有助于降低消毒供应中心锐器伤风险.“,”Objective To explore the effect of the Failure Mode and Effect Analysis (FMEA) in risk prevention and control of sharp instrument injury in the Central Sterile Supply Department (CSSD).Methods Based on the process of FMEA,the following procedures were implemented accordingly:to determine the theme,form a team,formulate the flow chart of reusable medical instruments treatment,analyze the potential failure modes,causes and influence factors in each processing steps,evaluate the severity (S),frequency of occurrence (O) and likelihood of detection (D),calculate risk priority number (RPN),make some corresponding improvement measures and for implementation.Results The RPN of key failure mode was markedly reduced after one year application of the FMEA,and the difference had statistically significance.The occurred sharp injury in the CSSD decreased from 12 to 4 person-times.Conclusion Application of FMEA can help to reduce sharp instrument injury risk in the CSSD.