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The US Food and Drug Administration (FDA) has revoked the umbrella emergency use authorization (EUA) it granted in May for intubation boxes once thought to keep healthcare providers safer when performing procedures on patients with COVID-19.
The FDA specified in its announcement on Friday that the change applies to boxes that lack fans or air filters and do not generate negative pressure.
In a letter to healthcare providers on Friday, the FDA said the boxes “may pose an increased health risk to patients and healthcare providers.”
Use may also result in “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,” the letter states.
Without the umbrella EUA, box designs now must be evaluated individually to determine whether the equipment would meet the requirements for an EUA.
As reported previously, research published in July suggested the boxes were not adding an extra layer of protection beyond PPE and may be doing more harm than good.
Joanna P. Simpson, MbChB, an intensivist at Eastern Health in Melbourne, Victoria, Australia, and colleagues tested five models of barriers used for protection while intubating simulated “patients” with COVID-19 and compared the interventions with having no protection. They published their findings in Anaesthesia.
Coauthor Peter Chan, MBBS, also an intensivist at Eastern Health, told Medscape Medical News last month that the virus essentially concentrates inside the box, and because the box has holes on the sides to allow providers to put their arms in, the gaps “act as nozzles, so when a patient coughs, it creates a sudden wave of air that pushes out into the face of the intubator.”
That study and other evidence were considered in the FDA’s decision.
Binita Ashar, MD, director of the FDA’s Office of Surgical and Infection Control Devices, said in the agency’s statement on Friday:
“We have carefully reviewed and considered preliminary evidence showing that there is a potential for adverse events or complications when using these devices while treating patients who are known or suspected to have COVID-19.”
She emphasized that the FDA has not received any reports of harm related to the boxes, but said, “We are taking this action to protect patients and health care providers from potential harm.”
The agency determined the EUA criteria were no longer met and revocation of the order was appropriate to protect the public.
If providers choose to use a protective barrier enclosure during aerosolizing procedures, the FDA recommends using devices that include negative pressure.
Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News, and Nurse.com, and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick
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