3M is excited to announce FDA 510(k) clearance for its 3M™ Attest™ Super Rapid Biological Indicator (BI) System for Steam, which now provides BI test results in just 24 minutes.
And there’s more. 3M is introducing an Attest™ Auto-reader software upgrade that will allow auto-reader models 490 (steam) or 490H (VH202) to start incubating both steam and VH2O2 biological indicators in one unit – and in any well of the reader.
The new software upgrade will allow current customers the ability to use the same trusted Attest™ systems with no change to 3M BIs or test packs. The upgrade is free, with no new hardware to buy.
For sterilization purposes, steam offers unmatched advantages. It’s cheap, it’s non-toxic and it’s proven. For more than 100 years, it’s been the go-to sterilant for reliable performance.
It’s an effective, efficient and inexpensive method for sterilizing items that are not damaged by high heat, such as scalpels and scissors.
However, steam is not recommended for every situation. As medical equipment becomes increasingly sophisticated, there are more items that require low-temperature sterilants such as hydrogen peroxide and ethylene oxide.
Ensuring the safety of sterilized items takes more than just following procedures. Tests for efficacy of the process are critical to making sure every instrument is safe to use on patients. As a leader in the field, 3M has been developing and improving technology for sterilization assurance for decades.
Our comprehensive Attest™ Biological indicator product portfolio provides sterilization assurance monitoring solutions across three modalities: steam, vaporized hydrogen peroxide (VH2O2) and Ethylene Oxide (EO).
With the 3M™ Attest™ BI system, you get consistent equipment, interfaces, supporting materials, processes and training, to help reduce human error and help teams work more effectively. In addition, you gain access to service, support, training and 70 years of sterilization assurance experience. 3M backs its sterilization assurance technology and products with teams of technical and support experts. Download the Attest brand Advantage brochure (PDF, 4 MB).
3M offers biological indicators (BI), chemical indicators (CI), tape and other accessories for load, pack, and exposure monitoring.
Biological Indicators (BI)
BIs contain a known number of live microorganisms and are used to assess the adequacy of a sterilization cycle. AAMI standards define BIs as the only sterilization process monitoring device that provides a direct measure of the lethality of the process.1 Releasing every load based on a BI result is recognized as a best practice, and faster BI results make it even easier to do.
Chemical Indicators (CI)
Internal pack monitoring is a crucial step in any steam sterilization process. Chemical indicators (CIs) give you the information you need about the exposure conditions achieved within a pack, tray, container or peel pouch. A chemical indicator placed inside a pack can let you know if saturated steam has penetrated to the point of placement.
3M™ Comply™ Indicator tapes act as an exposure monitor that securely seals packs while providing a visual assurance that the package has been exposed to the steam sterilization process. The Chemical Indicator lines will show a visual color change from off-white/tan to dark brown/black when the tape is exposed to a steam sterilization process.
AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities is a go-to resource for all healthcare facilities that process medical instruments with steam sterilization.
We’re pleased to make available a convenient summary of the quality assurance guidelines. Get access to the summary for use in your department.
Whether you’re interested in a product, education, or training, our 3M device reprocessing representatives are here to help. If you’re looking for live technical support, please call the Tech Help Line at 1-800-441-1922 option 2.
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1. ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities.