摘要
目的:研究胰岛素泵校准方法,避免因微量胰岛素输注误差而造成相关不良事件的发生。方法:基于研制的胰岛素泵校准装置,通过提出胰岛素泵校准方法,确定主要计量特性指标,结合校准案例进行验证,并对不良反应事件和影响系统安全的因素进行分析。结果:依据校准方法对胰岛素泵的大剂量示值误差、基础率示值误差分别为1.46%、-1.28%,阻塞压力示值误差为-4.43 kPa,极限温度示值误差为1.6℃,其验证结果均符合要求。结论:成功建立的胰岛素泵校准方法可为《胰岛素泵校准规范》的编写提供有益参考,有助于促进胰岛素泵量值溯源和标准化的实现,加强胰岛素泵的全过程监管。
Objective:To investigate calibration method of insulin pump so as to avoid the occurrence of relative adverse events caused by the errors of the small amounts of insulin infusion.Methods:Based on the developed calibration device of insulin pump,the calibration method of insulin pump was proposed,and the mainly metrological characteristic indicators were determined.The cases of calibration were combined to conduct verification and to analyze the adverse reaction events and the factors that affected the safety of system.Results:According to the calibration method,the indication error of the large dose,the indication error of the basal rate,the indication error of blocking pressure and the indication error of limiting temperature of the insulin pump respectively were 1.46%,-1.28%,-4.43 kPa and 1.6℃,and the all verification results met the requirements.Conclusion:The successfully established calibration method of insulin pump can provide a beneficial reference for the compilation of the"Calibration Specification for Insulin Pumps",which would help to promote the realizations of the traceability and the standardization of the measurement value of insulin pump,and to strengthen the whole process supervision for insulin pump.
作者
崔宏恩
张超
邢立腾
方帅
张新白
司启益
CUI Hong-en;ZHANG Chao;XING Li-teng(Jiangsu Institute of Metrology,Nanjing 210023,China.)
出处
《中国医学装备》
2023年第5期44-49,共6页
China Medical Equipment
基金
江苏省市场监督管理局科技计划(KJ204112)“胰岛素泵校准装置的研制”。
关键词
胰岛素泵
大剂量
基础率
校准
溯源
Insulin pump
Larger dose
Basal rate
Calibration
Traceability
