The process by which a load is monitored and released, possibly in a "Process Challenge Device," or in a test pack.
Over the long run, regular use of indicators is cost-effective, because it shows the efficacy and result of a process. This reduces the risk of recall, the release of contaminated loads and patient infections.
A BI detects the actual killing of microbial spores inside the sterilizer. Chemical indicators, or CIs, only indicate that one or more of the critical parameters for achieving sterilization have been met. Physical indicators check the critical parameters in the process and might be used as an independent process control (EN285).
Because it is impractical to quarantine every load for many hours or days, as would be the case with conventional BIs, 3M recommends the use of 3M™ Attest™ Rapid Readout Biological Indicators and Test Packs, designed to give results in as little as 1-4 hours, depending on the configuration and process.
An alternative for the biological indicator which gains more insights of the sterilization process is the 3M ETS (Electronic Test System) (UK, English). The information of the process can be downloaded to a computer. The advantages apart from the insights in the process are the possibility to store the process data digitally. In addition, the downloaded data can be used as independent process registration of each sterilization process.
If biological indicators used, they should comply with the ISO 11138, chemical indicators should comply with the ISO 11140, and physical indicators should comply with the EN 285, ISO 11140, and ISO 17665.
- The Attest rapid readout BI should be placed in a test package or tray that is representative of the load being processed, and which creates the greatest and most appropriate challenge to the sterilization process.
- The CI should be placed at the most difficult position to sterilize (worst case scenario). This could be in a PCD if equivalence between the BCD and the device is proven.
- The ETS should be started and positioned in the load. After the sterilization process the data in the ETS should be downloaded to a computer.
Reminder: In preparing a load, follow the instructions provided by the manufacturers of the surgical instruments, sterilizer and packaging system (EN868 and ISO 111607). Hold instruments open and unlocked. Do not place paper/plastic peel pouches in a container or wrapped set.