On September 14, the National Institute for Occupational Safety and Health (NIOSH) issued a request for information and comment on the deployment to and use of elastomeric half-mask respirators (EHMRs) by emergency medical services (EMS) organizations and in healthcare settings during the ongoing coronavirus diseases 2019 (COVID-19) pandemic (85 FR 56618).
COVID-19 is a respiratory disease caused by infection of the SARS-CoV-2 virus.
EHMRs would be purchased by and distributed from the Strategic National Stockpile (SNS) to alleviate shortages of N95 filtering facepiece respirators (FFRs). NIOSH asked for suggestions for a national strategy to purchase, deploy, and use EHMRs and statements of interest from EMS organizations and healthcare facilities that would like to participate in NIOSH demonstration projects.
Comments are due to the institute by October 14. NIOSH is not currently accepting any applications for distribution of EHMRs from the SNS.
EHMRs are nonpowered air-purifying respirators that have a tight-fitting facepiece that covers the nose and mouth. The respirators use replaceable filters or cartridges and can be cleaned, disinfected, stored, and reused. They provide at least the same level of protection as single-use N95 FFRs.
EHMRs are tested and approved by NIOSH for respiratory protection in U.S. workplaces. While they are used at times in healthcare settings, EHMRs are not considered medical devices subject to Food and Drug Administration (FDA) regulation.
Before the COVID-19 pandemic, the National Academies of Sciences, Engineering, and Medicine had issued a consensus report on the feasibility of using EHMRs in healthcare settings during routine and surge situations.
On March 27, the FDA issued an emergency use authorization allowing the use of alternative products like EHMRs as medical devices.
NIOSH acknowledged that hospitals found these devices to be valuable in keeping workers safe in the early weeks and months of the pandemic, especially during shortages of N95 FFRs. Medical professionals found the EHMRs comfortable to wear. Hospitals benefited from their low cost, ease of use, and ability to be cleaned and decontaminated.
NIOSH believes the widespread use of EHMRs will ease the demand for single-use N95 FFRs in healthcare settings that experience high numbers of COVID-19 patients. The SNS plans to purchase EHMRs for deployment to and use by healthcare organizations in order to diversify the respiratory protection options available to healthcare workers and emergency responders during the COVID-19 crisis.
That demonstration project might include participation from organizations like hospitals and hospital systems; hospital intensive care units (ICUs); hospital general wards; hospital emergency departments; outpatient care settings; nursing homes; dental providers; and first responders like EMS, police officers, and firefighters.
The institute doesn’t plan to limit demonstration project participation to organizations with prior experience with EHMRs, but NIOSH did ask respondents to describe how they might handle fit testing, training, education, a filter change-out schedule, cleaning/disinfection, storage considerations, appropriate clinical care settings for EHMR use, and potential criteria to be used to determine how the EHMR devices would be distributed in a demonstration project.