FDA revokes umbrella EUA for some patient barrier enclosures
On 20 August, the US Food and Drug Administration (FDA) revoked the umbrella emergency use authorization (EUA) it had previously issued for passive, non-negative pressure protective barrier enclosures that are intended to be a physical barrier preventing healthcare provider exposure to airborne pathogens.The EUA was issued on 1 May 2020 during the public health emergency of the coronavirus pandemic. The passive protective barriers included in the EUA, consisting of a transparent enclosure covering the patient’s head and upper body with ports for provider access for procedures, were designed to be used in addition to personal protective equipment for additional protection when treating patients with COVID-19.
“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,” said FDA in announcing the revocation.
Simulations of intubation procedures have shown that the barriers covered under the umbrella EUA may not be protective, may slow intubation times and decrease first-pass intubation success, and may damage gloves and gowns during use. Additionally, some barriers may not prevent particulate escape in the intended manner.
FDA clarified that the agency has not received any actual medical device adverse event reports related to the use of devices covered by the umbrella EUA. Still, “FDA can no longer conclude that the known and potential benefits of protective barrier enclosures, for such use, outweigh the known and potential risks of such product,” so the statutory requirements for issuance of an EUA are no longer met.
Instead, FDA now says that public health would better be protected by “individualized consideration of each EUA request for protective barrier enclosures.”
Devices that were covered by the 1 May 2020 umbrella EUA may not legally be introduced into interstate commerce. However, the devices that were distributed under the EUA are still authorized for emergency use for their intended purpose.
FDA