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FDA Updates Information on Respirator Decontamination Systems

The U.S. Food and Drug Administration (FDA) is reissuing the Emergency Use Authorizations for decontamination systems that are authorized to decontaminate compatible N95 respirators for use by healthcare personnel (HCP) to prevent exposure to pathogenic biological...

First Patient Treated in Clinical Trial of BCL System

CairnSurgical, Inc., an innovator striving to make breast cancer surgery more precise, announced that the first patient has been treated in its U.S. pivotal trial of the Breast Cancer Locator (BCL) System at Massachusetts General Hospital.

Rush Oak Park Hospital Adopts Surgical Workflow Technology, ExplORer Surgical, Increasing Team Confidence and Reducing OR Challenges

ExplORer Surgical, the only comprehensive intraoperative case support and workflow platform, has reinvented the way surgical support teams prepare and complete effective surgeries with two-way video for case support and remote proctoring to create a digitized playbook.

AORN Releases 2021 Guidelines for Perioperative Practice

The Association of periOperative Registered Nurses (AORN) has published the 2021 Guidelines for Perioperative Practice with six revised guidelines.

3M Submits 510(k) Application for Rapid Steam Sterilization Assurance

3M has announced its submission for 510(k) clearance with the U.S. Food and Drug Administration (FDA) for its Attest Super Rapid System for Steam Sterilization, which will provide biological indicator (BI) results in 24 minutes. The clearance of a faster readout time for steam will continue to enhance patient safety while increasing workflow advantages for sterilization professionals.

“The focus of our sterilization science at 3M is on increasing patient safety through every means possible,” says Srini Raman, 3M business director of device reprocessing. “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.”

The addition of the 3M Attest 490 Auto-reader to 3M’s sterilization portfolio, pending 510(k) clearance, will mean customers can count on 3M for a simplified, standardized approach to BI processing for both steam and VH2O2 results in just 24 minutes.

The new system will utilize existing hardware and will continue to use the same BI technology.

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