3M has filed for 510(k) clearance with the U.S. Food and Drug Administration (FDA) for an additional indication for its Attest Rapid Biological Indicator (BI) System for vaporized hydrogen peroxide sterilization (VH202) to provide BI test results in just 24 minutes. Pending clearance, the 24-minute results are anticipated to be the fastest BI readout on the market for VH202 sterilization and will make the practice of every load monitoring increasingly feasible.
“Every minute counts when it comes to patient safety,” said Cindy Kent from the 3M Infection Prevention Division. “Central sterile departments deserve simple and effective solutions to help minimize the risk of healthcare acquired infections from surgical instruments. Faster BI readout times can increase feasibility to monitor every sterilization load, helping to provide ultimate confidence that every patient receives the same high standard of care.”
A 24-minute result would be a significant advancement over 3M’s current market-leading time of four hours, achieved with the 2016 release of the 3M Attest Rapid Biological Indicator System for VH202. With a continued focus on system enhancements following the 4-hour readout launch, 3M scientists were able to increase system capabilities including a faster readout time.