Alert on Passive Protective Barrier Enclosures

FDA is alerting health care providers (HCPs) that the use of passive protective barrier enclosures (those without negative pressure) when treating Covid-19 patients may pose an increased health risk to patients and other HCPs. The agency says it has become aware of “preliminary evidence in simulated intubation procedure models of potential adverse events that could occur or complications with protective barrier enclosures without negative pressure recently reported in the literature,” a new safety alert says. Although FDA says it has not received any device adverse event reports related to passive protective barrier enclosure use, it believes HCPs should be aware of potential risks or complications so they can take appropriate precautions. Based on this information, the agency is also revoking the current umbrella Emergency Use Authorization for passive protective barrier enclosures issued in May.