不同穿透管腔穿透灭菌过程验证装置对压力蒸汽灭菌器性能的评价研究  

Evaluation of performance of pressure steam sterilizer by lumen sterilization process challenge device with different penetration difficulties

作　　者：周娟[1] 郭威 佘星武 禹华昶 李龙 刘东玲 帖金凤 苏裕心 ZHOU Juan;GUO Wei;SHE Xing-Wu;YU Hua-chang;LI Long;LIU Dong-ling;TIE Jin-Feng;SU Yu-xin(Hunan People's Hospital,Changsha,Hunan 410005,China;不详)

机构地区：[1]湖南省人民医院消毒供应中心,湖南长沙410005 [2]北京吉卡意科技有限公司,北京101304 [3]中国人民解放军疾病预防控制中心消毒与感染控制科,北京100071

出　　处：《中华医院感染学杂志》2020年第4期610-614,共5页Chinese Journal of Nosocomiology

基　　金：国家重点研发计划基金资助项目(2017YFC1200404)。

摘　　要：目的量化分析脉动真空压力蒸汽灭菌过程的蒸汽穿透性能,分析影响灭菌器实际灭菌效果的因素,寻找评价方法。方法将13个蒸汽穿透难度依次递增的螺旋型管腔灭菌过程验证装置(PCD)加化学指示物空载或随器械一起灭菌后观察化学指示物的通过情况。结果器械满载灭菌通过最高难度的平均值为6.94,优于BD空载的实验结果4.17。证明在相同机器程序中装载量对灭菌效果有影响。对在同一天的满载器械灭菌程序中,通过的最高难度值在4号与9号之间波动,同台灭菌器实际灭菌效能的波动性呈随机性。结论因压力蒸汽灭菌器存在小装载量效应,在每次灭菌操作中应对装载量做一定要求。压力蒸汽灭菌器实际灭菌效果在连续运行中因受到真空泵性能、蒸汽质量等因素的影响会不断发生波动,因此灭菌效果的波动性存在,所以使用有效的批量监测意义重大。应定期对灭菌器的实际灭菌效果进行检查,确保器械的无菌质量,提高医疗质量,保护患者的安全。OBJECTIVE To quantitatively analyze the steam penetration performance of the pulsating vaccum pressure steam sterilization process,And to analyze the factors that affect the actual sterilization effect of the sterilizer,and find an evaluation method.METHOD The spiral type lumen sterilization Process Challenge Device(PCD)with 13 steam penetration difficulties in increasing order was added with the chemical indicators unloaded or sterilized with the instrument to observe the passage of the chemical indicator.RESULTS The maximum successfully penetrated PCD results of full load were averagely 6.94,which was better comparing to that of empty load 4.17,proving that the loading capacity had an effect on the performance of a steam sterilization process in the same machine program.For the sterilization procedure of the fully loaded equipment on the same day,the hihgest difficulty value fluctuated between PCD 4#and 9#,and the fluctuation of the actual sterilization efficiency of the same sterilizer was random.CONCLUSION Due to the small loading capacity effect of the pressure steam sterilizer,certain loading requirements should be made in each sterilization operation.The actual sterilization effect of the pressure steam sterilizer will continuously fluctuate due to the influence of vacuum pump performance,steam quality and other factors during continuous operation.Because of the volatility of the sterilization effect,it is significant to use effective batch monitoring.The actual sterilizaion effect of the sterilizer should be checked regularly to ensure the aseptic quality,and protect the safety of patients.

关 键 词：灭菌过程验证装置 灭菌效能波动 蒸汽穿透性能 灭菌过程有效性 

分 类 号：R782.052[医药卫生—口腔医学]