Dear Health Care Provider and Health Care Facility,

The U.S. Food and Drug Administration (FDA) is alerting health care providers (HCP) and health care facilities that the use of passive protective barrier enclosures (those without negative pressure) when treating patients who are known or suspected to have Coronavirus Disease 2019 (COVID-19) may pose an increased health risk to patients and HCPs.

On May 1, 2020, 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 Protetive 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.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.

Recommendations

The FDA recommends that 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. 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.
• 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, which can be found on FDA’s Emergency Use Authorization website.  Based on detailed review of data showing decreased HCP exposure to airborne particles, usability, and other safety and performance measures of negative pressure devices, the FDA continues to believe that the known and potential benefits for emergency use of these devices, when used as authorized, continue to outweigh the known and potential risks and do not present public health or safety concerns at this time. Although it is unknown whether negative pressure devices have the potential for similar complications as passive devices, at this time, the Agency does not have reasons, or evidences of any adverse events to believe that is the case. FDA is constantly monitoring for signals, and available literature related to authorized devices for mergency use.
• 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.

Background

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, 2020, the FDA issued an EUA for protective barrier enclosures that do not use fans, air filters or other features, and are not intended to generate negative pressure, for use by HCP when caring for or performing medical procedures on patients who are known or suspected to have COVID-19 in health care settings to prevent HCP exposure to pathogenic biological airborne particulates by providing an extra layer of barrier protection in addition to PPE. The FDA authorized the enclosures for use by HCPs in situations including, but not limited to, airway management (e.g., intubation, extubation, and suctioning of airways) and any aerosol generating procedures (e.g., nebulizer treatments, manipulation of oxygen mask or Bilevel Positive Airway Pressure (BiPAP) mask).  The umbrella EUA allowed the manufacture, distribution, and use of passive protective barrier enclosures that met the requirements in the Scope of Authorization of the Letter of Authorization, and complied with the Conditions of Authorization. Based on available scientific evidence at that time, the FDA concluded that the protective barrier enclosures may be effective at preventing HCP exposure to pathogenic biological airborne particulates by providing an extra layer of barrier protection when used in addition to PPE during certain COVID-19 situations described above.

FDA Actions

Considering the information currently available, that protective barrier enclosures may not be effective in decreasing HCP exposure to airborne particles and may pose health risks to HCPs and patients, the FDA is revoking the umbrella EUA for passive protective barrier enclosures. This means that an individual EUA request should be submitted to the FDA containing data and information on the device’s safety and performance and showing that the criteria for issuing an EUA have been met, before passive protective barrier enclosures without negative pressure can be distributed and  used.

The devices covered by the umbrella EUA are not approved and are no longer authorized by FDA for any indication and therefore cannot be legally introduced into interstate commerce. However, under section 564(f)(2) of the Federal Food, Drug, and Cosmetic Act, devices that were distributed under this EUA remain authorized for emergency use to continue to prevent HCP exposure to pathogenic biological particulates when caring for or performing medical procedures on patients who are known or suspected to have COVID-19 for which the authorized product has already been administered prior to the date of revocation, to the extent found necessary by such patient’s attending physician.

The FDA will continue to keep HCPs and the public informed if new or additional information becomes available.

Reporting Problems to the FDA

The FDA encourages HCPs to report any adverse events or suspected adverse events experienced with protective barrier enclosures.

• Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
• Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
• Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Contact Information

If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).

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References:

1. Simpson J.P, et al., Measurement of airborne particle exposure during simulated tracheal intubation using various proposed aerosol containment devices during the COVID‐19 pandemic, Anesthesia, 19June 2020, 1-9.
2. Begley J.I. et al., The Aerosol box for intubation in COVID-19 patients: an in-situ simulation crossover study, Anesthesia, August 20202. 75 (8), 1014-1021.