普外科手术部位感染失效模式和效应分析应用

Application of failure mode and effect analysis in surgical site infection at department of general surgery

目的 应用失效模式和效应分析(FMEA)工具为普外科手术开发基于风险的质量管理计划,以降低手术部位感染率。方法 通过对普外科2016年850例手术患者的手术过程进行回顾,以确定潜在的故障模式。对故障模式进行严重程度(S)、发生率(O)和可检测性(D)评分,计算风险优先数(RPN),提出整改措施。结果 实施整改措施后,高优先级别失效模式均能得到明显降低,医疗器械灭菌不合格的RPN下降幅度达82.86%,普外科手术部位感染也从2016年的0.94%(8/850)下降到2017年的0.11%(1/894),差异有统计学意义(χ2=4.33,P<0.05)。结论 FMEA技术可以对SSI隐性风险进行前瞻性主导量化,规范风险管理,最终有效预防和控制普外科的SSI,从而减少SSI的发生。

Objective To develop a risk-based quality management plan for general surgery department applying failure mode and effect analysis(FMEA)tools.Methods The surgical procedures of 850 surgical patients at general surgery department in 2016 were reviewed to determine the potential failure modes.The failure modes’severity,incidence,and detectability were scored;the risk priority number was calculated;and the countermeasures were proposed.Results The high-priority failure modes were all significantly reduced;and the RPN for medical device sterilization failure was declined by 82.86%after implementing corrective measures.In 2017,the surgical site infection at general surgery department also decreased from 0.94%(8/850)in 2016 to 0.11%(1/894),with a statistical difference(χ2=4.33,P<0.05).Conclusion FMEA technology can quantify the hidden risks of SSI in a forward-looking manner,standardize risk management,and effectively prevent and control the SSI at general surgery department,so as to reduce the occurrence of SSI.