失效模式与效应分析对达芬奇机器人手术器械清洗质量的影响研究

目的 探讨失效模式与效应分析(FMEA)管理模式对达芬奇机器人手术器械清洗质量的影响。方法 选取手术后需消毒供应中心清洗的机器人手术器械1842件(包括机器人手臂器械、光学目镜及机器人腔镜器械及辅助器械)为研究对象。2023年3-5月采用常规管理模式对858件机器人手术器械清洗流程进行管理,设为对照组；2023年6-8月采用FMEA管理模式对984件机器人手术器械清洗流程进行管理,设为观察组,比较2组手术器械清洗流程中四项主要潜在失效风险因素的RPN评分结果、器械清洗质量评价结果以及器械清洗时间。结果 观察组中预处理不到位、器械未拆卸到最小单元、超声清洗温度不恒温、自动清洗机内器械叠放超载四个失效因素的RPN评分均明显低于对照组,差异有统计学意义(P＜0.05 )；分别采用光源放大镜检测法、管腔器械内部照明装置检测法、ATP生物荧光检测法分别对2组器械清洗后的清洗质量进行检测,观察组三种检测方法清洗质量检测合格率均高于对照组,差异具有统计学意义(P＜0.05 )；对2组机器人手术器械清洗时间进行比较,差异无统计学意义(P＞0.05 )。结论 FMEA管理模式能有效提高达芬奇机器人手术器械的清洗质量, 并保证器械良好功能,值得推广。

Study on the influence of FMEA on the cleaning quality of Da Vinci robotic surgical instruments

Objective To explore the effect of Failure Mode and Effects Analysis (FMEA) management mode on the cleaning quality of Da Vinci robotic surgical instruments.Methods 1842 pieces of robotic surgical instruments (involving robotic arm instruments, optical eyepieces, and robotic endoscope instruments) that need to be cleaned by disinfection and supply center after operation were established as the research objects. From March to May 2023, the 858 robotic surgical instruments set as the control group were cleaned using conventional management mode. From June to August 2023, the FMEA management mode was used to manage the cleaning process of the remained 984 robotic surgical instruments, as the observation group. The differences in RPN scores of four major potential failure risk factors, instrument cleaning quality evaluation results, and instrument cleaning time in two surgical instrument cleaning processes were compared. Results The RPN scores of the four failure factors (including inadequate pretreatment, non-disassembly of instruments to the minimum unit, non-constant temperature of ultrasonic cleaning, and overloading of instruments in the automatic cleaning machine) in the observation group were significantly lower than those in the control group (P < 0.05). The cleaning quality of the instruments included in the two groups was detected by light source magnifying glass detection, lumen instrument internal lighting device detection, and ATP bioluminescence detection, respectively. The qualified rate of cleaning quality detection of the three detection methods in the observation group was higher than that in the control group, and the difference was statistically significant (P < 0.05). There was no significant difference in cleaning time between the two groups (P > 0.05).Conclusion The FMEA management model could effectively improve the cleaning quality of Da Vinci robotic surgical instruments and maintain the excellent function of the instruments, which is worthy of promotion.