统计过程控制在血液透析机质量控制中的应用

Application of Statistical Process Control in the Quality Control of Hemodialysis Machines

目的通过统计过程控制技术对血液透析机基本技术参数进行监测,评估血液透析机的设备性能及受控状态。方法收集医院2021年9—11月期间3种品牌各5台血液透析机在透析过程中的电导率数据,利用统计过程控制技术对记录数据进行处理并采用Minitab18.0软件绘制均值-极差控制图(X-R),计算监测过程中固有起伏波动状态(C_(p))和波动状态能力指数的高低(C_(pk)),判断血液透析机的设备性能及受控状态。结果通过均值-极差控制图监控血液透析过程中电导率可预警血液透析机稳定状态,当均值-极差控制图出现走势异常或者超过允许误差点的数据时,对血液透析机进行预防性维护后监控数据恢复正常;当均值-极差控制图中过程能力控制系数C_(p)<1时,表明设备控制能力极差,此时对血液透析机进行故障排查和维修后监测数据恢复正常。结论统计过程控制可实现对血液透析机性能参数的监测、评估,保证设备使用的安全可靠;数据监控中能够及时对不稳定状态发出预警,提示工程师对设备进行维护、保养及采取其他适当措施,使设备长时间保持稳定状态。

Objective The statistical process control technology was used to monitor the basic technical parameters of hemodialysis machines,so as to evaluate their performance and control state.Methods The electrical conductivity of hemodialysis machines of three brands(five sets of each)in the hospital from September 2021 to November 2021 was collected during dialysis.Statistical process control technology and Minitab18.0 software were used to implement data processing and draw mean-range control diagram(X-R)to calculate the fluctuating state of intrinsic fluctuation(C_(p))and capacity index of fluctuating state(C_(pk))during the monitoring period and judge the performance and control state of hemodialysis machines.Results The mean-range control diagram was used to monitor electrical conductivity during hemodialysis and to warn the stable state of hemodialysis machines.When the trend of the mean-range control diagram was abnormal or the data exceeded the allowable error point,the monitoring data of the dialysis machine could be restored to normal after preventive maintenance;When the process capacity control coefficient C_(p) in the mean-range control diagram was less than one,it indicated that the equipment control ability was extremely poor,at this time,the monitoring data of hemodialysis machine was restored to normal after troubleshooting and maintenance.Conclusion Statistical process control technology can monitor and evaluate the performance data of hemodialysis machines and ensure the safe and reliable use of them.In the data monitoring,the unstable state can be timely warned,prompting engineers to maintain and take other appropriate measures to keep the machine in a stable state for a long time.