The National Institute for Occupational Safety and Health (NIOSH) is requesting information regarding the deployment and use of elastomeric half-mask respirators (EHMRs) in healthcare settings during the COVID-19 crisis.
The Strategic National Stockpile (SNS) plans to purchase EHMRs to be deployed to and used by healthcare organizations in order to diversify the respiratory protection options available to healthcare workers and emergency responders during the COVID-19 crisis, alleviate shortages of N95 filtering facepiece respirators (FFRs).
Although EHMRs have been used routinely in healthcare settings, they are not considered medical devices pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act) and thus are not typically authorized for use as FDA-approved medical devices. However, in response to the COVID-19 crisis, FDA issued an emergency use authorization (EUA) authorizing the “emergency use of medical devices, including alternative products used as medical devices,” including EHMRs.
NIOSH anticipates that the widespread use of EHMRs will ease the demand for single-use N95 FFRs in healthcare settings experiencing high numbers of COVID-19 patients. In media reports about the COVID-19 crisis, medical professionals have noted that the use of EHMRs has been critical to the response, especially during shortages of N95 FFRs. Wearers note that EHMRs are comfortable to wear, and that given their low cost, ease of use, and ability to be cleaned and decontaminated, hospitals have found these devices to be valuable in keeping workers safe.
To gather more information from EHMR users in healthcare and emergency response settings, NIOSH is seeking input on two related endeavors: A deployment of EHMRs across the nation from the SNS, and future NIOSH EHMR demonstration projects. NIOSH’s specific information needs are described here.
Informational submissions are due no later than October 14, 2020.
Responses should be submitted to Dr. Lee Greenawald, NIOSH, 626 Cochrans Mill Road, Building 141, Pittsburgh, PA 15236, or emailed to [email protected].