Suzanne Schwartz of the FDA Center for Devices and Radiological Health emphasizes the importance of new elastomeric respirator innovations used to make reusable masks without exhalation valves, which are well suited to healthcare personnel working on the front lines of COVID-19 response.
Specifically, CDC NIOSH has worked interactively with industry to recently approve first-of-its-kind elastomeric respirators without an exhalation valve by Mine Safety Appliances (MSA) Safety incorporated and elastomeric respirator configurations with an exhalation valve cover from the company 3M. NIOSH also just approved the Dentec Safety Specialists half mask respirator 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. Though they require higher costs up front because they are reusable, they can provide a cost-effective approach in the long-term to disposable N95 FFRs.
These innovative designs for reusable respirators intended for use in health care settings address current design needs, are authorized for use during the public health emergency through the FDA’s umbrella emergency use authorization (EUA) for NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency once they are approved by NIOSH and listed on the NIOSH Certified Equipment list (CEL) for non-powered air purifying respirators with particulate protection, and may have far-reaching benefits as we refine the nation’s responses to public health crises in the future.
Read more at the FDA.