FDA Update: Protective Barrier Enclosures Without Negative Pressure Used During the COVID-19 Pandemic May Increase Risk to Patients and Health Care Providers

Protective Barrier Enclosures Without Negative Pressure Used During the COVID-19 Pandemic May Increase Risk to Patients and Health Care Providers

As the FDA learns more about what is effective and what isn’t or possibly harmful for the treatment of COVID-19, they make adjustments. Here is an EUA that they issued for a medical device back in the beginning of MAY that they now see was not effective and removing it from the EUA. The EUA was a good idea but the medical community needs to understand that the EUA is not an approval.

On May 1, 2020 the FDA issued an 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. This is when used in addition to PPE to reduce the risk of transmitting COVID-19 from a patient to HCPs treating them.

The FDA is now aware of preliminary evidence in simulated intubation procedure models of potential adverse events that could occur as well as complications with protective barrier enclosures without negative pressure. However, the agency 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 related with their use in order to take appropriate precautions. The FDA is also revoking the current umbrella EUA for passive protective barrier enclosures issued in May, based on this new information. The devices covered by the umbrella EUA are not approved and are no longer authorized by the FDA for any indication and therefore cannot be legally introduced into interstate commerce. Devices that were distributed under the 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.

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 emergency 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.

For the full update, please visit the FDA’s website.

For information on the EUA and Life After the EUA contact us.

For any further questions about this update and what this means for your company, please email mdi Consultants at [email protected] RE: EUA.