摘要
目的:探讨过氧化氢低温等离子灭菌器中器械装载量、压力、浓度、时间及温度等多参数调控对管腔化学过程挑战装置(PCD)监测合格率的影响及其交互作用机制。方法:采用析因实验设计,收集200锅次灭菌数据,运用t检验、二元逻辑回归及多因素方差分析进行统计分析。结果:器械量、循环1期压力及浓度对PCD合格率影响差异有统计学意义(P<0.05),而时间与温度影响差异无统计学意义(P>0.05);循环1期浓度与压力是PCD合格率的独立影响因素(P<0.05);交互作用分析显示,“压力×浓度”交互项的效应最强(F=12.047)。结论:器械量、压力与浓度之间存在协同调控关系,通过优化参数组合可有效提升高负载场景下的灭菌可靠性,为临床操作规范与设备参数设置提供了实证依据。
Objective:To investigate the effects and interaction mechanisms of multi-parameter regulation,including instrument load,pressure,concentration,time,and temperature,on the qualification rate of luminal chemical process challenge device(PCD)monitoring in a hydrogen peroxide low-temperature plasma sterilizer.Methods:A factorial experimental design was employed.Sterilization data from 200 cycles were collected and analyzed using t-tests,binary logistic regression,and multivariate analysis of variance(ANOVA).Results:There were significant differences in the effects of instrument volume,pressure and concentration in the first cycle on the qualified rate of PCD(P<0.05).The concentration and pressure in the first cycle were the independent influencing factors of PCD qualification rate(P<0.05).The interaction analysis showed that the interaction term of“pressure×concentration”had the strongest effect(F=12.047).Conclusion:A synergistic regulatory relationship exists among instrument load,pressure,and concentration.Optimizing parameter combinations can effectively improve sterilization reliability in high-load scenarios,providing empirical evidence for clinical operational protocols and equipment parameter settings.
作者
苏梅榕
阮玮娟
SU Mei-rong;RUAN Wei-juan(Zhongshan Hospital Affiliated to Xiamen University,Fujian Xiamen 361000)
出处
《中国医疗器械信息》
2026年第4期39-41,158,共4页
China Medical Device Information
关键词
过氧化氢低温等离子灭菌器
管腔化学PCD监测
灭菌参数
交互作用
析因设计
hydrogen peroxide low-temperature plasma sterilizer
lumen chemical PCD monitoring
sterilization parameters
interactive effects
factorial design
