3M has a wide range of products for monitoring the results of every step of the low temperature sterilization process, from exposure monitoring, to record keeping. In fact, over half of all heat- or moisture-sensitive devices (including sterile single-use devices made by manufacturers) are sterilized with ethylene oxide.
A load is monitored and released based on the final negative result of a Biological Indicator (BI) in a Process Challenge Device (PCD). According to the CSA Z314.23-16 standard, a BI is required daily for each ethylene oxide sterilizer and cycle type used, as well as in every load that contains an implant. Only a BI can detect the actual killing of microbial spores inside the sterilizer.
Products verify whether a sterilant has penetrated to the point where the Chemical Indicator (CI) was placed in the pack. These are designed to react to the critical variables for ethylene oxide: time, temperature, ethylene oxide concentration and humidity.
A good system of records provides documentation that items have been processed, along with evidence of your ethylene oxide monitoring results. 3M™ Record Keeping Products provide a permanent record to help you meet your requirements.
Monitor Ethylene Oxide sterilization cycles with biological indicators and chemical indicators as part of your sterilization assurance program.
