COVID-19: FDA ventilator guidance gives clarity for scale-up and opens EUA path

Erin McCallister Senior Manager, Health Research Institute, PwC US March 27, 2020

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A new Emergency Use Authorization (EUA) and guidance from the FDA issued Sunday should open the door for more companies in and outside the US to supply ventilators and/or parts to speed the scale-up of these necessary medical supplies in the wake of COVID-19. The agency also gave guidance on the import of personal protective equipment (PPE).

In severe cases of COVID-19, some patients experience acute respiratory distress syndrome (ARDS), requiring the need for ventilator support.

On March 24, FDA issued an EUA for non-traditional ventilators to be used in healthcare settings to treat patients. Specifically, the EUA includes anesthesia gas machines, positive pressure breathing machines and manual, non-inflating resuscitators as well as ventilators approved for home use or an alternative facility use.

The EUA also included alternative supplies for ventilators, such as tubing connectors and accessories.

The final FDA guidance issued on March 22 accelerates the pace of scaling up ventilator production by providing clarity on alternative supplies as well as information for new manufacturers looking to add ventilators as a new product and for existing ventilator manufacturers that want to bring non-traditional suppliers online and provides the EUA as a path for companies with ventilators approved outside the U.S.

Alternative products include anesthesia gas machines, continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) machines to treat patients with respiratory insufficiency, oxygen concentrators, and ventilators outside of their “cleared environment of use,” such as a ventilator cleared only for home use that would now be allowed for use in a healthcare facility.

Alternative products and supplies include, continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) machines, motors, batteries, or other electrical components; material changes to components in the gas pathway or with other patient tissue contact; filtration to minimize aerosolization; as well as certain software and hardware modifications.

The guidance also allows for shelf life extensions to various ventilator components without pre-market notification. However, the manufacturers must document any changes in the device master record and change records and any of the changes must be made according to FDA standards for the specific device type, with relevant standards listed in the guidance.

The FDA will also work with makers of ventilators not approved in the US or with nontraditional medical device manufacturers via the EUA process.

The guidance outlines information that companies with ventilators not approved in the US should send to the FDA, including general information about the device, marketing authorization in countries where it is approved, a copy of the label, and whether the device is manufactured according to certain compliance standards.

For nontraditional medical device manufacturers with the capabilities to increase the supply of ventilators, the FDA recommends that they contact the agency and describe their proposed approach. “FDA intends to work collaboratively with these manufacturers through its EUA process,” the guidance states.

HRI impact analysis

PPE and ventilators in the US are in short supply as the COVID-19 outbreak worsens.

A Feb. 14 note from the Johns Hopkins Bloomberg School of Public Health Center for Health Security highlighted the potential shortfall. Based on past studies of influenza outbreaks, the demand for assisted ventilation could increase by 25% or more while acute care hospitals had only about 62,000 ventilators, with about 46% being used for pediatric and neonatal patients.

As of Thursday, according to Johns Hopkins University, there were 75,233 confirmed cases of COVID-19 in the US, but as testing becomes more widespread and the virus spreads, the number is expected to increase and could outpace the availability of these critical medical supplies.

The FDA’s guidance on alternative supplies as well as the provision of the EUA to bring other nontraditional manufacturers into the fold could address potential shortfalls and help manufacturers scale up production.

The need for such easing of certain regulatory requirements and clarity around alternative suppliers was one of the steps highlighted by PwC’s partners and directors to help ventilator manufacturers scale the production of these critical medical supplies.

Manufacturers of PPE and other crucial supplies could require similar regulatory clarity as they weigh the opportunities and challenges in meeting the surge in demand caused by the COVID-19 pandemic.

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Contact us

Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Crystal Yednak

Senior Manager, Health Research Institute, PwC US

Erin McCallister

Senior Manager, Health Research Institute, PwC US

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