FDA Issues Letter to Health Care Providers Regarding Use of Passive Protective Barriers

The US Food and Drug Administration (FDA) had originally approved an Emergency Use Authorization on 1 May 2020 for passive protective barriers used primarily during intubation of patients. These barriers were to be utilized in addition to appropriate personal protective equipment (PPE). However, the FDA has now received preliminary evidence in simulated models that the barriers without negative pressure still expose health care providers. They may also, restrict the providers ability to intubate. Recommendations are to utilize the barrier with negative pressure and to utilize appropriate PPE. Lastly, the barrier should be removed if it becomes an obstacle to patient care. Please refer to: https://www.fda.gov/medical-devices/letters-health-care-providers/protective-barrier-enclosures-without-negative-pressure-used-during-covid-19-pandemic-may-increase