FDA Clears Attest Super Rapid BI System for Use With Steam Sterilization

The US Food and Drug Administration (FDA) has cleared 3M’s Attest Super Rapid Biological Indicator (BI) System for use with steam sterilization, adding to its availability to be used with vaporized hydrogen peroxide (VH2O2).

The tech can be used with both steam and VH2O2 simultaneously in any incubation well, enabling “facilities to simplify, standardize and streamline their sterilization department’s workflow to help ensure every instrument is safe for patient use and keep surgeries on schedule,” according to 3M.

While the use of steam for sterilization has been the go-to method for more than a century in medicine, not all medical equipment is capable of being sterilized with steam—especially as devices become more sophisticated—requiring the use of low-temperature sterilants such as VH2O2 and ethylene oxide (EO). According to 3M, the all-inclusive Attest BI product range “provides sterilization assurance monitoring solutions across all 3 modalities of steam, [VH2O2] and [EO].”

Results from the Attest BI are provided in only 24 minutes and is attainable through a software upgrade to the existing Attest Auto-reader 490 and 490H units. The upgrade allows all users to utilize the newly approved software at no charge and includes the added benefit of 3M’s Any-Well technology.

“When we received FDA clearance for the Rapid Readout BI System for VH2O2 in July 2017, it was a logical leap to extend that technology to steam sterilization,” Srini Raman, MBA, the Business Director of Device Reprocessing at 3M, said in a statement. “But we didn’t stop there. We worked to combine steam and VH2O2 BI readouts into one system to help customers streamline workflow processes, as well as support patient safety initiatives by enabling facilities to realistically implement every load monitoring.”

Coupled with the company’s dual-reader technology, the Attest product will help reduce risk and advance efficiency through standardization of the process of sterilization. The product can reportedly be used with the same 3M BIs and test packs that are already available and will be applicable with the 3M Attest Web App and primary instrument tracking systems.