Dufresne Sylvie, Leblond Hélène, Chaunet Marc
R&D Department, TSO3 Inc, Québec, Québec, Canada.
Am J Infect Control. 2008 May;36(4):291-7. doi: 10.1016/j.ajic.2007.06.006.
A safe alternative to ethylene oxide for reprocessing heat-sensitive lumen medical devices, such as endoscopes, is needed. The effectiveness of a new, safe, low-cost, and environmentally friendly low-temperature sterilization process using ozone was assessed.
Rigid lumen devices were used to assess the maximum length of lumens of different internal diameters that can be sterilized in the TSO(3) model 125L ozone sterilizer. Two inoculation techniques were used. An inoculated wire was placed inside lumens with internal diameters of 0.8 mm and larger, whereas lumens with an internal diameter of 0.5 mm were inoculated directly.
Lumens with internal diameters of 0.5 mm, 1 mm, 2 mm, 3 mm, and 4 mm with lengths varying between 45 and 70 cm can be sterilized with ozone. Calculation of the log reduction value for each size demonstrated the achievement of a sterility assurance level of 10(-6). Experimental results demonstrated a linear relationship (with r(2) = 0.990) between the length of lumen that can be sterilized in the 125L ozone sterilizer and its internal diameter. Effective sterilization of an ACMI ureteroscope that is more challenging in terms of sterilant penetration in a small lumen (0.8 mm) compared with the stated lumen claims confirms that the relationship can conservatively be used to predict the length of a lumen device that can be sterilized in the 125L ozone sterilizer for a given diameter.
Intermediate sizes of lumen devices that can be sterilized in the 125L ozone sterilizer can be interpolated from the linear relationship between diameter and length found in the present study.
对于诸如内窥镜等热敏性管腔医疗器械的再处理，需要一种环氧乙烷的安全替代方法。评估了一种使用臭氧的新型、安全、低成本且环保的低温灭菌工艺的有效性。
使用刚性管腔器械评估在TSO(3) 125L型臭氧灭菌器中可灭菌的不同内径管腔的最大长度。采用了两种接种技术。对于内径为0.8毫米及以上的管腔，将接种线置于管腔内，而内径为0.5毫米的管腔则直接接种。
内径为0.5毫米、1毫米、2毫米、3毫米和4毫米且长度在45至70厘米之间变化的管腔可用臭氧灭菌。计算每种尺寸的对数减少值表明达到了10(-6)的无菌保证水平。实验结果表明，125L臭氧灭菌器中可灭菌的管腔长度与其内径之间存在线性关系（r(2)=0.990）。与规定的管腔要求相比，对在小管腔（0.8毫米）中消毒剂渗透更具挑战性的ACMI输尿管镜进行有效灭菌，证实了该关系可保守地用于预测给定直径下125L臭氧灭菌器中可灭菌的管腔器械长度。
可在125L臭氧灭菌器中灭菌的中等尺寸管腔器械可根据本研究中发现的直径与长度之间的线性关系进行内插。
