FDA Clears 3M’s Biological Indicator System with 24-Minute Readout for Steam Sterilization

Sterilization departments are on the front line of defense in the fight against surgical site infections. To help facilities increase patient safety and provide a higher standard of care, 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. The new 24-minute system is attainable through a software upgrade to existing 3M Attest Auto-reader 490 and 490H units.
 
The software upgrade enables all customers who have existing hardware to receive the benefit of a 24-minute readout at no extra charge. In addition, the upgrade provides an added benefit of Any-Well technology. Each upgraded BI Auto-reader will have the ability to read both steam and vaporized hydrogen peroxide (VH2O2) BIs simultaneously in any incubation well. These innovations enable 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.
 
“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,” said Srini Raman, 3M Business Director of Device Reprocessing. “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.”
 
The new 24-minute results for steam BIs, coupled with the dual-reader technology, builds upon the Attest brand advantage by helping to reduce risk and enhance efficiency by working to standardize and simplify sterilization processes. Customers will also be able to use the same 3M BIs and test packs already available in the market today, allowing for an easy and smooth transition. All Attest Auto-readers will also continue to provide connectivity with the 3M Attest Web App and primary instrument tracking systems for digital record keeping.