摘要目的:探讨失效模式与效应分析(failure mode and effect analysis，FMEA)在男性气囊尿管留置所致尿道损伤的应用效果。方法:组建失效模式与效应分析团队，对男性气囊尿管所致尿道损伤可能出现的失效模式进行分析、评估，计算出风险系数值(Risk Priority Number，RPN)，对插管前评估、插管手法、插管长度的判定、插管后宣教、拔管等环节进行流程修订并质量控制。比较实施FMEA前后的RPN值及留置气囊尿管致尿道损伤不良事件的发生率。结果:实施FMEA后，男性气囊尿管风险管理中各失效模式RPN值均降低，<8分。其中插管/拔管过程中疼痛、出血、尿道撕裂伤的RPN下降更明显，留置尿管期间(插管前、插管中、插管后)疼痛发生率由(49.98%)降至(19.86%)、出血发生率由(1.27%)降至(0.13%)、尿道撕裂伤由(0.61%)降至(0.04%)，差异均有统计学意义( P<0.01)。 结论:失效模式与效应分析管理方法能够及时发现男性气囊尿管留置期间所致尿道损伤的失效模式、降低其不良事件的发生率，有效提高护理质量。

abstractsObjective:To investigate the effect of failure mode and effect analysis (FMEA) in the treatment of urethral injury caused by urinary bladder indwelling in male patients.Methods:A FMEA team was established to analyze and evaluate the possible failure modes of urethral injury caused by male balloon catheters.Risk Priority Number (RPN) was calculated, pre-intubation evaluation, intubation technique, intubation length determination, post-intubation education, extubation and other procedures were revised and quality control was performed.The RPN value before and after FMEA and the incidence of adverse events of urethral injury caused by indwinging balloon catheter were compared.Results:After the implementation of FMEA, the RPN values of each failure mode in male balloon ureter risk management decreased, less than eight points.The RPN of pain, bleeding, and urethral laceration during intubation/extubation decreased more significantly.The incidence of pain during indweling (before, during, and after intubation) decreased from(49.98%) to(19.86%), the incidence of bleeding decreased from (1.27%)to(0.13%), urethral laceration decreased from (0.61%)to(0.04%), and the differences were statistically significant ( P<0.01). Conclusions:The FMEA management method can find the failure mode of urethral injury caused by male balloon catheter indwelling in time to reduce the incidence of adverse events and effectively improve the quality of care.