Abstract
Steam sterilization of channeled medical devices requires steam penetration into narrow channels. However, a quantitative characterization of this phenomenon in practical situations is lacking. This study evaluates the effect of load, loading pattern, and wrapping system on steam penetration into channels. We tested the hypothesis that a 70 cm tube with one closed end could be representative of the worst case for steam penetration in wrapped channeled instruments in practical conditions. A validated sterilization process was run in a sterilizer equipped with infrared sensors for the measurement of water vapor fraction (WVF). WVF values collected at the closed end of an unwrapped 70 cm reference tube were compared to those obtained at the closed end of wrapped 50 cm test tubes, representative for channeled devices in the clinical practice. The open ends of the test tubes were placed inside packs, testing the effects of different combinations of wrappings, load amounts, and pack positions. The worst case for steam penetration was experimentally defined as the condition showing the lowest WVF value during the exposure phase. WVF values at the closed end of 50 cm long tubes were affected by load amount, wrapping, and pack position. Steam penetration was higher for heavier loads in rigid containers, but lower for heavier loads in soft wrappings (pouch, non-woven fabric, and crepe). In all the tested combinations of load/wrappings related to the clinical practice the 70 cm reference tube displayed lower WVF values than the wrapped 50 cm test tubes, indicating worse steam penetration in the reference than test tubes. Our findings provide experimental evidence that a 70 cm is the worst case in all practical combinations of load and wrapping encountered in the field. The 70 cm tube is a representative for a wrapped 50 cm channel with one end closed and for a wrapped 100 cm channel with both ends open. A measuring system integrating the WVF sensor on a 70 cm tube may provide a physics-based, quantitative steam penetration test for real-time monitoring of the steam sterilization process of channeled instruments.
Highlights
Steam sterilization is recommended as the preferred sterilization method for medical instruments in hospitals [1,2,3,4]
Differences in steam penetration between test and reference tubes were present during the whole process, they were evident during the first injection of steam and they progressively decreased during the process
The comparison of the measurements performed in different experimental conditions showed that steam fraction values in the test tubes were mainly affected by the load/wrapping configurations, differences were present among the three pack locations
Summary
Steam sterilization is recommended as the preferred sterilization method for medical instruments in hospitals [1,2,3,4]. To properly sterilize channeled instruments, steam penetration into the channels is required, which represents a further challenge for steam sterilization. Despite a large technological effort toward the development of new systems and standards to assess steam penetration into channels, the available tools remain limited to devices using chemical and biological indicators, which do not allow quantitative and operator-independent evaluations [9,10,11]. The development of quantitative methods, based on physical principles, is advocated for a reliable characterization of steam penetration into channeled instruments [12]
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