In an August 21 letter, the Food & Drug Administration (FDA) warns that the use of passive protective barrier enclosures without negative pressure when treating patients (such as during intubation, extubation) who are known or suspected to have COVID-19 may pose increased health risk to patients and healthcare providers.
The FDA is aware of preliminary evidence in simulated intubation, extubation procedure models of potential adverse events or complications that could occur and is revoking the current umbrella Emergency Use Authorization (EUA) for passive protective barrier enclosures issued in May.
The FDA recommends that healthcare providers:
- Should not use passive protective barrier enclosures without negative pressure because they may increase healthcare provider exposure to airborne particles. Their use also may contribute to complications, such as increased intubation times, lower first-pass intubation success rates, increased patient hypoxia time, and damage or tearing to PPE.
- If using a protective barrier enclosure during aerosolizing procedures, the FDA recommends the use of devices that incorporate negative pressure and has authorized the use of several negative pressure barrier enclosures, which can be found on its EUA website.
- Protective barrier enclosures (with or without negative pressure) should never replace use of PPE.
Protective barrier enclosures should be removed if they impede the healthcare provider’s ability to perform a patient procedure.
The FDA will continue to keep healthcare providers informed if new or additional information becomes available.
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