Pack monitoring products verify whether sterilant has penetrated to the area where the Chemical Indicator (CI) was placed within the pack. Type 4, Type 5, or Type 6 chemical indicators (as defined by ISO 11140-1:2014) are designed to react to two or more of the critical variables required for sterilization—for steam sterilization, the critical variables are time, temperature, and the presence of steam.
Only Type 5 Integrating Indicators measure all three critical variables and correlate to the performance of a biological indicator at three time/temperature relationships under ideal steam sterilization conditions. Per AAMI ST79:2017¹, one or more internal chemical indicators should be placed within each package, tray, or rigid container. These indicators can be any type (Type 3, 4, 5, or 6) but preferably a Type 5 or Type 6 indicator because these types of CIs provide the user with more information on the critical steam sterilization parameters.
1. ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization & sterility assurance in health care facilities.
ANSI/AAMI ST79:20171 and AORN² recommended practices state an internal chemical indicators, such as the 3M™ Attest™ Chemical Integrator should be placed inside each package in the area, or areas, that are most difficult for sterilant to penetrate. Always read and understand manufacturers’ instructions for use (for the chemical indicator, device, and/or container).
2. Guideline for manual chemical high-level disinfection. In: Guidelines for Perioperative Practice. Denver,CO: AORN, Inc; 2020:299-326
Simple to use and easy to interpret, 3M™ Attest™ Steam Chemical Integrators feature a “moving front” style readout for easy to read “Accept” or “Reject” results.* A version with extender is also available for fast and convenient retrieval from inner packs. This Type 5 Integrating indicator correlates to the performance of a biological indicator at three time /temperature relationships under ideal steam sterilization conditions.
*Based on commissioned Gestalt survey of US OR professionals with CI placed in an actual instrument tray, shown to respondents in images of simulated-use conditions.
Every facility is different, each facility has its own sterilization and monitoring challenges. Whichever sterilization processes your facility uses, 3M can help with a range of pack monitoring products. We offer chemical indicators for internal pack monitoring for steam, ethylene oxide, and hydrogen peroxide sterilization cycles.