Health care facilities can obtain faster sterility assurance results for surgical instruments following the Food & Drug Administration’s 510(k) clearance of the 3M Attest Rapid Readout Biological Indicator (BI) System for vaporized hydrogen peroxide sterilization (VH202). BI results for VH202 sterilization cycles with the 3M Attest system can now be read in 24 minutes – the fastest readout compared to any other FDA cleared product on the market – making the practice of every load monitoring increasingly feasible.
“We’ve seen overwhelming market excitement about this system since we announced 510(k) submission in May,” said Ericka Lutz, 3M Global Marketing Manager for Sterilization. “The common reaction we’re hearing is, ‘If our hospital is able to improve efficiencies and enhance patient safety, it’s a clear win-win decision.’ ”
The 24-minute time to result is 10 times faster than 3M’s previous market-leading time of four hours, achieved with the 2016 release of the 3M Attest Rapid BI System for VH202. 3M scientists were able to increase system capabilities to achieve a faster readout time following the initial launch. Programming developments to the Attest Auto-reader 490H make it possible for existing users of the four-hour system to upgrade to the 24-minute version. Customers will not be charged for this upgrade. Prior to 3M’s development of four-hour BI test results, VH202 BI readouts typically took 24 hours.
