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Regulatory Focus™ > News Articles > 2020 > 8 > Pandemic prompts mask, ventilator EUAs from FDA

Pandemic prompts mask, ventilator EUAs from FDA

Posted 07 August 2020 | By Kari Oakes 

Pandemic prompts mask, ventilator EUAs from FDA

This week, the US Food and Drug Administration granted emergency use authorizations (EUAs) to three ventilator-related devices, issued an umbrella EUA for disposable, single-use surgical masks and provided updated information on “in-use time” for certain drugs used to treat patients with COVID-19, the novel coronavirus.
Ventilator-related EUAs
The US Food and Drug Administration (FDA) on 4 August issued EUAs for three devices that relate to mechanical ventilation of patients with COVID-19.
The first, the Subsalve Oxygen Treatment Hood, is meant to treat acute respiratory distress from the novel coronavirus by providing non-invasive positive pressure ventilation (NIPPV) by means of a hood, rather than a mask-based system. The transparent hood is classified as an authorized ventilator accessory and is meant only for use with adults who are in intensive care units.
Another ventilator-related EUA was granted to the Vortran GO2Vent with PEEP (positive end-expiratory pressure) Valve, an emergency ventilator meant to be used on patients weighing at least 10 kg requiring ventilatory support. The addition of the PEEP valve optimizes the use of the non-electrically powered ventilator for patients with COVID-19.
The third EUA for ventilator-related devices went to the nHale device. This device is meant for spontaneously breathing patients weighing at least 30 kg who require bi-level positive air pressure (BiPAP). Unlike the other two devices granted EUAs this week, the nHale device can be used in private homes, nursing homes and other assisted living facilities, and in larger spaces that have been converted to care for large numbers of individuals with COVID-19. The nHale device assists patients who need breathing support but who, under standard medical protocols, do not need invasive ventilatory support.
Umbrella EUA for masks
On 5 August, FDA issued an umbrella EUA for certain disposable, single-use surgical masks. The EUA was issued “in response to concerns relating to insufficient supply and availability of such masks.”
According to the Letter of Authorization signed by Denise Hinton, FDA’s Chief Scientist, surgical masks meeting certain criteria are authorized for emergency use in healthcare settings by healthcare providers as personal protective equipment during the pandemic. “There is no adequate, approved, and available alternative to the emergency use of these authorized surgical masks,” wrote Hinton.
Performance criteria and labeling requirements are set out in the letter, as is information that must be transmitted to FDA. Once authorized, surgical masks will be included in a searchable list in the appendix to the umbrella EUA.
FDA has provided a template for making an EUA application under this new surgical mask umbrella provision.
In-use time extension
In-use time, or the time between penetration of a container-closure system of a sterile drug (or reconstitution of a lyophilized drug) and its use, is specified on FDA-approved labels. During the public health emergency of the COVID-19 pandemic, supplies of some drugs are limited, and facilities and health care providers, said the FDA, are considering using medications that have gone beyond their labeled in-use times.
FDA is advising these facilities that “If there is a need to use these products beyond the labeled in-use time to help ensure access to the drug for patients, it is important that this period be as short as possible,” and not longer than 4 hours for medicines held in refrigeration and 2 hours for any labeled room temperature in-use time.
Products included in FDA’s advice regarding in-use time are:
  • Cisatracurium besylate
  • Phenylephrine hydrochloride
  • Bumetanide
  • Midazolam hydrochloride
  • Succinylcholine chloride
  • Famotidine
  • Hydromorphone
  • Rocuronium bromide
  • Epinephrine
  • Heparin sodium
The agency advises application holders who may wish to extend an in-use time from that currently described in the product labeling to submit a supplement to their existing application. FDA is accepting queries on this matter at CDER-OPQ-Inquiries@fda.hhs.gov.

Tags: coronavirus, FDA, US

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