Tag archives: ventilators

COVID-19 Update: HHS Letter Permits Hospital Sharing of Ventilators

On March 30, 2020, a letter to hospitals from U.S. Surgeon General Jerome Adams and U.S. Department of Health and Human Services Assistant Secretary for Health Adm. Brett Giroir released Guidelines to Optimize the Use of Mechanical Ventilators permitting the use of a single mechanical ventilator for two patients. However, this “strategy should only be … Continue reading

COVID-19 Update: FDA will use enforcement discretion for limited ventilator modifications

By Yvonne Puig (US), Thomas Dowdell (US), Mark Faccenda (US) and Jeff Wurzburg (US) on March 23, 2020 Posted in Coronavirus, FDA & Food Safety, General

On March 22, 2020, the FDA released guidance describing an enforcement policy that will help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic. FDA’s guidance would permit “limited modifications to the indications, claims, functionality, or to the hardware, software, or materials of FDA-cleared devices used to … Continue reading