Enclosures without negative pressure may increase risk
In a letter
published August 21, the FDA alerted healthcare providers (HCPs) and facilities that the use of passive protective barrier enclosures (those without negative pressure) when treating patients who are known or suspected to have COVID-19 may pose an increased health risk to patients and health care providers.
A passive protective barrier enclosure is a transparent device designed to cover a patient’s head and upper body that incorporates one or more ports through which the HCP’s hands are passed to perform medical procedures, and that does not include fans, air filters, or other features and is not intended to generate negative pressure. On May 1, the FDA issued an Emergency Use Authorization (EUA) for passive protective barrier enclosures used as a physical barrier to prevent HCP exposure to pathogenic biological airborne particulates by providing an extra layer of barrier protection, when used in addition to Personal Protective Equipment (PPE), to reduce the risk of transmitting COVID-19 from a patient to HCPs treating them. However, the FDA now is 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.
Athough, the FDA has not received any medical device adverse event reports related to the use of passive protective barrier enclosures during the COVID-19 pandemic, the FDA believes HCPs should be aware of potential risks or complications associated with their use so they can take appropriate precautions. Based on this information, the FDA is also revoking the current umbrella EUA for passive protective barrier enclosures issued in May.
HCPs should not use passive protective barrier enclosures without negative pressure, as they may not be effective in decreasing HCP exposure to airborne particles, and in some circumstances, may instead increase HCP exposure to airborne particles. Their use may also contribute to complications such as increased intubation times, lower first-pass intubation success rates, increased patient hypoxia time, and damage or tearing to PPE from the enclosures. If electing to use a protective barrier enclosure for additional protection during aerosolizing procedures by HCPs, FDA recommends the use of devices that incorporate negative pressure. FDA has authorized the use of several negative pressure barrier enclosures
Protective barrier enclosures (with or without negative pressure) should never be a replacement for using PPE. Any protective barrier enclosure should be removed if it impedes the HCP’s ability to perform a medical procedure on a patient.