A National Elastomeric Half Mask Respirator (EHMR) Strategy / Demonstration Project
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announced a request for information (RFI) regarding the deployment and use of elastomeric half-mask respirators in healthcare settings and emergency medical services (EMS) organizations during the COVID-19 crisis.
An elastomeric half-mask respirator (EHMR) is a non-powered air-purifying respirator that has a tight-fitting facepiece that covers the nose and mouth. The facepieces are made of synthetic or natural rubber material permitting repeated cleaning, disinfection, storage, and reuse. EHMRs use replaceable filters or cartridges, and they provide at least the same level of protection as single-use 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 U.S. Food and Drug Administration (FDA)-approved medical devices. However, in response to the COVID-19 crisis, FDA has issued an emergency use authorization (EUA) authorizing the “emergency use of medical devices, including alternative products used as medical devices, pursuant to section 564 of the FD&C Act,” 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 order 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. These EHMR demonstration projects would consist of healthcare or EMS organizations using EHMRs in their respiratory protection programs and providing user acceptability feedback, such as on fit testing and disinfection protocols, among other implementation parameters.
The types of potential participant organizations that will be sought include, but are not limited to, hospital systems, hospitals, hospital intensive care units (ICUs), hospital general wards, hospital emergency departments, outpatient care settings, nursing homes, dental organizations, and first responders, including, but not limited to, EMS, police officers, and firefighters.
Interested FQHCs should provide responses to one or both of the following:
1. Provide a Statement of Interest (SOI) describing interest in participating in future EHMR demonstration project activities. The SOI should describe the nature of the organization that desires to participate as a demonstration site, including type, geographical location (including rural or urban), size (e.g., healthcare staff), and prior organizational experience with the use of EHMRs. The SOI should also provide reasons for interest in participating as a demonstration site. Prior experience with the use of EHMRs will NOT be required to participate in the EHMR demonstration project activity. The description of an approach that has the potential to be effective for conducting a demonstration project will be required.
2. Provide information that will assist NIOSH in the refinement of the EHMR demonstration projects, including the following:
a. Defining the strategic parameters of this EHMR demonstration activity; for example, considerations of fit testing, training, education, filter change-out schedule, cleaning/disinfection, storage considerations, and appropriate clinical care settings for EHMR use; and
b. The potential criteria to be used to determine how the EHMR devices should be distributed to the demonstration sites; for example, the technical approach of the use of the EHMRs, and technical qualifications of key staff who would lead the initiative.
Informational submissions in response to this request for information (RFI) are due no later than October 14, 2020.