September 17, 2020

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

Editor’s note: This news article has been updated to reflect the extension of the comment period related to the Federal Register notice “A National Elastomeric Half Mask Respirator (EHMR) Strategy for Use in Healthcare Settings During an Infectious Disease Outbreak/Pandemic.” A new notice published on Oct. 13 extends the comment deadline until Dec. 14, 2020. In addition, NIOSH will host a webinar on Nov. 18 to provide an overview of EHMRs, summarize the Federal Register notice, and discuss expectations of organizations that wish to participate in this effort.

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 Sept. 14 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. A second Federal Register notice announces that responses are now due by Dec. 14, 2020.

On Nov. 18, NIOSH will host a webinar related to its request for information. The webinar will provide an overview of EHMRs, summarize the Federal Register notice, and discuss expectations of organizations that wish to participate in this effort. NIOSH hopes to gather the input of hospitals and hospital systems, outpatient care settings, long-term care facilities, dental practices, and first responder organizations, among others. Individuals who wish to attend the webinar must register online.