3M submits 510(k) for steam sterilization system

3M has submitted an application to receive FDA 510(k) clearance for its Attest Super Rapid System for steam sterilization.

The steam sterilization system can provide biological indicator results in 24 minutes. A faster readout time for steam will help improve patient safety while increasing workflow for sterilization professionals.

“The focus of our sterilization science at 3M is on increasing patient safety through every means possible,” Srini Raman, 3M’s business director of device reprocessing, said in a press release. “One of the best ways we can do that is to make it easy for sterilization departments to know that every load of medical instruments has met standards for sterilization before they’re released for surgery. We introduced a 24-minute readout for VH202 in July and it was met with great market excitement. Our next goal was to take this same science and apply it to steam sterilization monitoring, which 3M has been a progressive leader in for over 40 years.

Adding 3M Attest 490 Auto-reader to the company’s sterilization profile allows the company to offer a simple and standardized approach to biological indicator processing for steam and VH202 results.

The new system will use existing hardware and the same biological indicator technology that is currently in use by 3M.

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