USA – 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…