First-of-its-kind elastomeric respirators without the problematic exhalation valve were recently approved by CDC NIOSH.

If your email program has trouble displaying this email, view as a webpage. Elastomeric Respirator Innovations Play a Critical Role in Response to COVID-19 By Suzanne Schwartz, M.D., M.B.A., Director, Office of Strategic Partnerships and Technology Innovation, Center for Devices and Radiological Health "Since the COVID-19 public health emergency was declared over a year ago, access to personal protective equipment (PPE) for health care personnel has been a significant challenge. In particular, the supply chain for respirators, which are regulated by the U.S. Food and Drug Administration when they meet the definition of a device, has been heavily stressed as health care personnel and health systems have fought to secure these critical devices…." "A major obstacle limiting the wider use of reusable respirators in health care settings has been the inclusion of exhalation valves as a design feature…. Solving these challenges has not been easy, but, working together, health care personnel, device manufacturers, and scientists have created a new path forward. Specifically, CDC NIOSH has worked interactively with industry to recently approve first-of-its-kind elastomeric respirators without an exhalation valve…." "By addressing respiratory protection and source control needs, elastomeric respirators can provide the solutions our health care personnel need to stay safe while saving lives…." Read More Questions? If you have questions, contact the Division of Industry and Consumer Education.

Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA