Authors (including presenting author) :
Shek YY, Ng WS, Lam KL, Ko SM, Lee CK
Affiliation :
Sterile services department, Pok Oi hospital, New Territory West Cluster
Introduction :
Vaporized hydrogen peroxide (H2O2) low temperature sterilization is commonly employed to sterilize heat-and moisture-sensitive reusable invasive medical devices (RIMDs), including certain plastics, electrical devices, and corrosion-susceptible metal alloys. The sterilization process involves introducing H2O2 vapor into the sterilizer chamber, which contacts and sterilizes the exposed surfaces of the devices. As routine validation and monitoring of the sterilization process are recommended in accordance with relevant standards, including ISO 14937 and ISO 22441, the use of a high-accuracy and robust data logger is studied and introduced to operation for monitoring the sterilization cycle. It was found that implementing the data logger enables real-time monitoring capabilities, providing valuable data to ensure compliance with cycle parameters necessary for effective pathogen eradication, while maintaining the integrity and safety of sterilized items.
Objectives :
The study aims to evaluate the suitability of using a precision pressure-temperature logger to verify that the operating cycle functions correctly, as demonstrated by the values of the cycle variables indicated and recorded by the H2O2 sterilizers.
Methodology :
Precision data logger (EBI 12-TP190) was programmed to identify the vacuum and plasma stages of 4 cycle types: Standard, Duo, Express, and Flex cycles in the H2O2 sterilizer, STERRAD 100NX. The passing criteria for pressure, temperature, and holding time at different stages were defined based on the sterilizer settings. After setup, the data logger was placed inside the H2O2 sterilizer, and temperature and pressure were continuously monitored throughout the cycle. Upon completion, the data was extracted to evaluate the overall results and compare the nominal and actual parameters.
Result & Outcome :
The EBI12-TP190 for H2O2 sterilization provides assurance, precision, and data-driven validation throughout the sterilization procedure, ensuring the operating cycle functions correctly. With automatic, continuous recording of temperature and pressure (high precision pressure measurement down to 0.1 mbar), users can set up alerts to be notified immediately if any logger falls outside its desired range. Values from the vacuum stage and sterilization phase can be exported for reviewing single-point values. The precision data logger (EBI 12-TP190) is suitable for routine monitoring the STERRAD 100NX low temperature H2O2 gas plasma sterilizer.
