不同材质硬质盒和装载量对胸腔镜器械灭菌效果的影响

Impact of rigid container material type and loading volume on the sterilization of thoracoscopic instruments

  • 摘要:
    目的 探讨硬质盒材质和装载量对胸腔镜器械过氧化氢低温等离子灭菌效果的影响,以寻求胸腔镜器械硬质盒最佳材质和装载量。
    方法 以同济大学附属上海市肺科医院2024年8—9月使用STERRAD® 100NX过氧化氢低温等离子灭菌器灭菌的胸腔镜器械作为研究对象,依据硬质盒材质划分为聚乙烯器械盒组(A组)、不锈钢器械盒组(B组)和硅树脂器械盒组(C组),依据硬质盒装载量划分为(装载量<80%)8、10和12个组。比较A8、A10、A12、B8、B10、B12、C8、C10和C12共9组灭菌结束的物理参数监测、第一类化学指示卡监测、五类卡管腔化学灭菌过程验证装置(PCD)监测结果并进行评价。
    结果 不锈钢器械盒装载的胸腔镜器械B8(8个)、B10(10个)、B12(12个)组较A8、A10、A12、C8、C10和C12组在灭菌器压力检查1期和2期过氧化氢浓度更高,灭菌时间更短,差异有统计学意义(P<0.05),其次为硅树脂器械盒组,最后为聚乙烯器械盒组;9组物理参数监测、第一类化学指示卡监测和五类卡管腔化学PCD监测合格率均为100%,差异均无统计学意义(P>0.05)。
    结论 在使用过氧化氢低温等离子灭菌器对胸腔镜器械灭菌时,推荐使用不锈钢和硅树脂器械盒装载胸腔镜器械,合理控制装载量(≤12个),保证灭菌质量。

     

    Abstract:
    Objective To explore the impacts of material type and loading volume of rigid containers on the hydrogen peroxide low temperature plasma sterilization of thoracoscopic instruments, to identify the best rigid containers and loading volume of thoracoscopic instruments.
    Methods Thoracoscopic instruments sterilized by STERRAD® 100NX hydrogen peroxide low temperature plasma in Shanghai Pulmonary Hospital affiliated to Tongji University from August to September 2024 were selected as the research items. According to the material of rigid containers, the instruments were divided into polyethylene case group (A), stainless steel case group (B) and silicone resin case group (C). In terms of the loading volume, the rigid containers were divided into (loading capacity <80%) groups of 8, 10 and 12 instruments. The results of physical monitoring, the first type of chemical indicator card monitoring, and the five types of card luminal chemical process challenge device (PCD) monitoring of the 9 groups of A8, A10, A12, B8, B10, B12, C8, C10 and C12 were compared and evaluated.
    Results Compared to A8, A10 A12, C8, C10 or C12 groups, the thoracoscope instruments in the stainless steel containers in B8, B10 or B12 group had higher hydrogen peroxide concentrations and shorter elapsed time in the pressure check phases 1 and phases 2, with the differences statistically significant (P<0.05), followed by the silicone resin case group and the polyethylene case group. The nine groups of physical parameter monitoring, the first type of chemical indicator monitoring, and the five types of chemical PCD monitoring for lumen sterilization achieved 100% qualification rates, and there were no significant differences in the qualified rates of sterilization among the 9 groups (P>0.05).
    Conclusion When using hydrogen peroxide low temperature plasma to sterilize thoracoscopic instruments, it is recommended to use stainless steel or silicone resin rigid containers with a controlled loading capacity (≤12) to ensure optimal sterilization quality.

     

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