The U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of Oceanetics' Negative-pressure Respiratory System with Advanced Ventilation Return (NRSAVR), or "Nurse Saver" by healthcare providers (HCP). The NRSAVR provides an extra layer of barrier protection in addition to personal protective equipment (PPE) to prevent HCP exposure to pathogenic biological airborne particulates by providing isolation of hospitalized patients with suspected or confirmed diagnosis of COVID-19, at the time of definitive airway management, or when performing medical procedures, or during transport of such patients during the COVID-19 pandemic.
In the EUA, the Secretary of HHS determined that "[t]here are no FDA-approved or -cleared devices for use as an extra layer of barrier protection in addition to PPE to prevent HCP exposure to pathogenic biological airborne particulates from patients during the COVID-19 pandemic. The use of the NRSAVR-100 would allow for a greater level of protection for HCP during high-risk procedures involving manipulation of the airway, such as endotracheal intubations and in non-invasive respiratory care (such as high-flow nasal cannula oxygen, nebulizers and CPAP/ BiPAP). Based on FDA’s review of literature data and bench performance testing to test leaks and aerosol evacuation, FDA has concluded that the NRSAVR-100 may be effective in preventing HCP exposure to pathogenic biological airborne particulates by providing an extra layer of barrier protection in addition to PPE."
The EUA can be viewed in its entirety here.