FDA: Barrier Enclosures for Aerosol-Generating Procedures May Increase Risk to HCPs
Agency revokes EUA for those without negative pressure design
Citing increased risk to healthcare workers and patients, the Food and Drug Administration (FDA) has revoked emergency use authorization (EUA) for barrier enclosure devices that cover a COVID-19 patient’s head and upper body during aerosol‐generating procedures such as tracheal intubation.
The FDA describes these so-called “passive protective barriers” as “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.”1
Healthcare personnel (HCP) “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,” the FDA wrote in a letter to industry and healthcare. “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 [personal protective equipment] from the enclosures. These complications may be due in part to the barrier enclosure design characteristics and restricted mobility of the HCP’s arms in a restricted space to maneuver the accessories needed to establish a definitive airway.”
On May 1, the FDA issued an EUA for passive protective barrier enclosures to reduce the risk of transmitting COVID-19 from patients to HCPs.
“However, the FDA now is aware of preliminary evidence2,3 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,” the FDA stated.1,2 “Although 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.”
Other FDA recommendations in the letter include:
- Use negative pressure devices while using protective barrier enclosures. FDA-authorized negative pressure barrier enclosures can be found on FDA’s EUA website. According to the FDA, a detailed review of data showing decreased HCP exposure to airborne particles, usability, and other safety and performance measures of negative pressure devices indicate the benefits of the devices outweigh the risks.
- Protective barrier enclosures — with or without negative pressure — are not a replacement for PPE.
- Any protective barrier enclosure should be removed if it is an impediment to performing a medical procedure on the patient.
- Food and Drug Administration. Protective barrier enclosures without negative pressure used during the COVID-19 pandemic may increase risk to patients and health care providers — letter to health care providers. Aug 21, 2020. https://www.fda.gov/medical-devices/letters-health-care-providers/protective-barrier-enclosures-without-negative-pressure-used-during-covid-19-pandemic-may-increase
- Simpson JP, Wong DN, Verco L, et al. Measurement of airborne particle exposure during simulated tracheal intubation using various proposed aerosol containment devices during the COVID-19 pandemic. Anaesthesia 2020;10.1111/anae.15188. doi: 10.1111/anae.15188. [Online ahead of print].
- Begley JL, Lavery KE, Nickson CP, et al. The Aerosol box for intubation in COVID-19 patients: An in-situ simulation crossover study. Anaesthesia 2020;75:1014-1021.
- Food and Drug Administration. Emergency Use Authorization: EUA information, and list of all current EUAs. Sept. 25, 2020. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
Citing increased risk to healthcare workers and patients, the Food and Drug Administration has revoked emergency use authorization for barrier enclosure devices that cover a COVID-19 patient’s head and upper body during aerosol‐generating procedures such as tracheal intubation.
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