The 3M recommended best practice is to monitor every load with a biological indicator (BI)
to achieve the highest possible level of sterilization assurance.
For loads containing implantable devices, a Process Challenge Device (PCD) containing both a BI and a Class 5 integrating indicator should be used in order to comply with current AAMI ST79 standards. If an emergency situation requires an implant be released before the BI result is known, the Class 5 Integrating Indicator will provide more information regarding sterility of that item than only the sterilizer physical monitors.
Over the long run, regular use of a BI is cost-effective, because a BI detects the actual killing of microbial spores inside the sterilizer. This reduces the risk of recall, the release of contaminated loads and patient infections. Chemical indicators, or CIs, only indicate that one or more of the critical parameters for achieving sterilization have been met.
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.
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.
Reminder: In preparing a load, follow the instructions provided by the manufacturers of the surgical instruments, sterilizer and container systems. The density of wrapped packages should follow AAMI guidelines. Hold instruments open and unlocked. Do not place paper/plastic peel pouches in a container or wrapped set.
For detailed information on load control procedures and product usage, please refer to the following documents (requires Adobe® Reader® or Adobe® Acrobat®):
Load Control Monitoring Process Challenge Devices, HealthVIE
© June 2010 (PDF, 581 KB)
Understanding the safety margin built into BI monitoring
© 3M 2009 (PDF, 416 KB)
Living Organisms for Sterility Assurance - Biological Indiators
© 3M 2009 (PDF, 528 KB)
Load Control Product Information