September 17, 2020

NIOSH Seeks Input on Elastomeric Half-Mask Respirator Use in Healthcare, EMS

A new request for information issued by NIOSH seeks feedback regarding the use of elastomeric half-mask respirators (EHMRs) in healthcare settings and emergency medical services (EMS) organizations during the COVID-19 pandemic. The agency requests input in two areas: first, a national strategy to inform the deployment of EHMRs across the United States from the Strategic National Stockpile (SNS), and second, interest in participating in future NIOSH projects involving EHMRs in healthcare and EMS.

According to NIOSH, EHMRs are routinely used in healthcare settings, but are not typically authorized for use as U.S. Food and Drug Administration (FDA)-approved medical devices. In response to the ongoing pandemic, FDA authorized the “emergency use of medical devices, including alternative products used as medical devices” such as EHMRs. A Federal Register notice published on Monday states that the SNS intends to purchase EHMRs to be deployed to healthcare organizations as additional respiratory protection options for healthcare workers and emergency responders during the COVID-19 pandemic.

“NIOSH anticipates that the widespread use of EHMRs will ease the demand for single-use N95 [filtering facepiece respirators] in healthcare settings experiencing high numbers of COVID-19 patients,” the notice states. “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.”

NIOSH requests ideas that may be used by the SNS to gather a diverse group of healthcare organizations to participate in a deployment of EHMRs across the U.S. The agency is also seeking information related to fit-testing considerations, training, education, filter change-out schedules, cleaning and disinfection, storage considerations, and appropriate clinical care settings for EHMR use.

Organizations interested in participating in future NIOSH projects related to the use of EHMRs to supplement respiratory protection programs in hospital and EMS settings should also respond to the agency’s request. Potential participants could include hospitals, outpatient care settings, nursing homes, dental organizations, and first responders.

A description of NIOSH’s specific needs is available in the Federal Register. Responses are due by Oct. 14, 2020.