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 BI System

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.



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