手术器械管理中应用失效模式与效应分析法的效果研究

Effect study of failure mode and effect analysis in surgical instrument management

目的研究失效模式和效应分析法(Failure Mode And Effect Analysis, FMEA)在手术器械管理中的应用效果。方法以2016年6月至2017年6月6 932台手术为研究对象,以2016年12月31日前的手术为对照组,以后的手术为研究组,研究组采用FMEA进行手术器械的管理。两组患者性别(c2=2.535,P=0.111)、年龄(t=1.508,P=0.132)、手术类别(c2=9.047,P=0.060)等临床资料无明显统计学差异,具有可比性。对研究组和对照组的失效后果的严重程度(S)、失效模式发生的概率(O)、失效模式的可检测度(D)、RPN以及手术室人员和手术医生对手术器械管理的满意度进行评价。结果研究组的器械性能不佳、器械周转时间长、器械清洗不合格、交接人员不熟悉管理流程、器械使用登记不全的失效模式RPN分值均低于对照组,差异具有明显统计学意义(P<0.05)。研究组的手术室人员及手术医生对手术器械管理的满意度评分均高于对照组,差异有统计学意义(P<0.05)。研究组的不良事件发生率低于对照组(c2=180.133,P=0.000)。其中交接人员不熟悉流程、器械使用登记不全、器械清洗三类不良事件的发生率均为研究组低于对照组,差异有统计学意义(P<0.05)。结论 FMEA应用于手术器械管理可以明显降低风险,提高手术室人员以及手术医生的满意度,并降低不良事件发生率,有利于规范手术器械管理,建议临床推广。

Objective To study the application effect of failure mode and effect analysis (failure mode and Effect Analysis, FMEA) in surgical instrument management. Methods 6 932 surgeries from June 2016 to June 2017 were studied, the operation was the control group before December 31, 2016, and the later operation was the study group, and the study group used FMEA to manage the surgical instruments. There was no significant statistical difference in clinical data such as sex (c2=2.535,P=0.111), age (t=1.508,P=0.132) and surgical category (c2=9.047,P=0.060) in the two groups, which was comparable. The severity of the failure consequences of the study Group and the control group (S), the probability of Failure mode (O), the detectable degree of failure mode (D), RPN and the satisfaction of operating room personnel and surgeons with the management of surgical instruments were evaluated. Results The failure mode RPN score of the study group was lower than that of the control group, and the difference was statistically significant (P<0.05) because of the poor performance of the equipment, the long turnaround time of the instrument, the unqualified equipment cleaning, the non-familiarity of the handover personnel with the management process, and the incomplete registration of the device. The satisfaction scores of the operating room personnel and surgeons in the Study Group on the management of surgical instruments were higher than those in the control group, and the difference was statistically significant (P<0.05). The incidence of adverse events in the study group was lower than that in the control group (x^2=180.133,P=0.000). Among them, the handover personnel are not familiar with the process, the device use registration is incomplete, the device cleaning three kinds of adverse events incidence rate is lower than the control group, the difference is statistically significant (P<0.05). Conclusion The use of FMEA in surgical instrument management can obviously reduce the risk, improve the satisfaction of operating room personnel and surgeons, and reduce the incidence of adverse events, is conducive to standardizing the management of surgical instruments, and recommends clinical promotion.