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Activ Surgical Announces FDA Clearance for ActivSight Intraoperative Imaging Module

Activ Surgical announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s ActivSight Intraoperative Imaging Module for enhanced surgical visualization.

Metrex Surface Disinfectant Portfolio Secures EPA Approval

The U.S. Environmental Protection Agency (EPA) has approved all eight surface disinfectant products made by an infection prevention leader, Metrex, as effective against SARS-CoV-2, the novel coronavirus that causes COVID-19.

Olympus Supports Safety Actions Regarding Surgical Smoke

Olympus has announced its support of The Joint Commission’s recommended safety actions for managing the hazards of exposure to surgical smoke for health care staff in operating rooms.

Exofin Fusion Redesign Receives FDA Approval

Chemence Medical, a leader in medical cyanoacrylate devices and products, announced the U.S. Federal Drug Administration’s (FDA) 510(k) approval of the company’s redesigned exofin fusion skin closure system.

Some Filtering Facepiece Respirators Concern FDA

The U.S. Food and Drug Administration (FDA) is concerned that certain filtering facepiece respirators (respirators) manufactured in China may not provide consistent and adequate respiratory protection to health care personnel exposed to COVID-19. These concerns are based on test results from the National Institute for Occupational Safety and Health (NIOSH) showing that some of these respirators do not meet their labeled performance standard.

This Letter to Health Care Providers describes:

  • Changes to the FDA’s Emergency Use Authorization for respirators manufactured in China and removal of some of these respirators from the Appendix listing authorized respirators.
  • Considerations for health care organizations when using or purchasing respirators.
  • Actions the FDA has taken to help ensure the quality of respirators.
  • Instructions for reporting problems with respirators to the FDA.

Read the full Letter to Health Care Providers at FDA.gov »

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