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COVID-19 to impact general surgery procedures in U.S. in 2020, says GlobalData

Most of the hernia procedures to be performed in the U.S. will be delayed due to the COVID-19 crisis, with the exception of a minority of symptomatic cases, but will start to resume towards the end of the second quarter (Q2) of 2020, according to data and analytics...

3NT Medical Announces FDA Clearance for Colibri Endoscopy System

3NT Medical, a privately held corporation dedicated to developing single-use specialized endoscopes for the diagnosis and treatment of ear, nose and throat (ENT) disorders, has announced the FDA 510(k) clearance for the Colibri Micro ENT Scope, the world's first...

ASCA Supports ASC Response to the COVID-19 Pandemic

By Bill Prentice As I write this message, COVID-19 cases in the U.S. are continuing to rise and health care providers, federal and state officials and private citizens across the country are beginning to come to grips with the magnitude of the response needed to...

Challenging Assumptions, Evaluating Routines Can Aid Quality

By Nicholas Schmitz, PMP, LSSBB Across our personal and professional lives, we all fall into many routines; it’s part of how we’re able to perform so many different tasks every day. Have you ever arrived at work (or home), only to realize you don’t even really...

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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