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

Effects of the influence of Failure Mode and Effect Analysis on the cleaning quality of Da Vinci robotic surgical instruments

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2023年3月至8月无锡市第二人民医院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月至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月至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。比较两组手术器械清洗流程中4项主要潜在失效风险因素的风险系数(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4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生物荧光检测法对两组器械清洗后的清洗质量进行检测,观察组3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);对两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。

Objective To explore the effect of Failure Mode and Effects Analysis(FMEA)management model on the cleaning quality of Da Vinci robotic surgical instruments.Methods From March to August 2023,a total of 1 842 robotic surgical instruments(including robotic arm instruments,optical eyepieces,and robotic endoscope instruments)that require disinfection and supply center cleaning were selected from Wuxi Second People's Hospital.From March to May 2023,858 robotic surgical instruments were managed using the conventional management model,which servedas the control group.From June to August 2023,984 robotic surgical instruments were managed using the FMEA management model,which served 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 in the observation,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 group were significantly lower than those in the control group(P<0.05).The cleaning quality of the two groups' instruments was evaluated using three methods:light source magnifying glass detection,lumen instrument internal lighting device detection,and ATP bioluminescence detection.The qualified rate of the three cleaning methods in the observation group was higher than that of the control group(P<0.05).There was no significant difference in cleaning time between the two groups(P>0.05).Conclusions The FMEA management model can effectively improve the cleaning quality of Da Vinci robotic surgical instruments and ensure the excellent function of the instruments,which is worthy of promotion.