FDA provides a new guide to amp up ventilatory support device production
Updated: May 6
As the number of people affected by COVID-18 grows, the Helmet-based ventilation website is focused on providing information and resources for helmet use for noninvasive ventilation in patients who have respiratory distress as a complication of the virus.
With medical equipment manufacturers overwhelmed with meeting demands, efforts are being made to reach out to companies who have not previously been engaged in the production of these helmets, including implementing its Emergency Use Authorization process.
"efforts are being made to reach out to companies who have not previously been engaged in the production of these helmets"
On that end, the US Food and Drug Administration and Health and Human Services are trying to increase the availability of products to help support patients with significant breathing issues, according to a statement from Alex Azar, Health and Human Services Secretary.
Wherever possible, health care facilities should use FDA-cleared conventional/standard full-featured ventilators to treat patients. With the current demand of helmet-based ventilation devices, the FDA is interested in connecting with manufacturers of ventilatory support devices not currently legally marketed in the U.S. Additionally, the FDA would like to connect with manufacturers who have not previously been engaged in medical device manufacturing – like auto manufacturers -- but could potentially have capabilities to increase the supply of these devices, according to information provided by the FDA.
The FDA will work with these manufacturers through its EUA process, and interested manufacturers can contact the FDA at CDRH-COVID19-Ventilators@fda.hhs.gov.
These changes will allow manufacturers and suppliers to adjust their production, equipment, and materials to be able to provide ventilators and increase supplies. Automakers like General Motors and Tesla – whose production lines were temporarily shut down -- will be able to repurpose production lines to manufacture ventilators.
The agencies believe the best way to expand production of the needed ventilators is to work with companies willing to revamp and repurpose machines to ramp up production as quickly as possible.
There are several key steps to promote the acceleration of production:
The guidance describes the agency’s intention to exercise enforcement discretion for certain modifications to these FDA-cleared devices. Typically, approval of any changes can eat up valuable – possibly life-altering – time that it takes to get products to patients. This change will allow non-medical production sites – like the automobile plants – to start making ventilator parts. The FDA is being more lenient in lieu of the current pandemic situation, by not enforcing the premarket review requirement for these types of modifications.
Another asset is the allowance of ventilators used for short-term use in ambulances to be repurposed in hospitals. The new guidelines also would allow ventilators at health care facilities to be used beyond their indicated shelf life.
As a final measure, the FDC encourages foreign and domestic manufacturers to reach out to the FDA about obtaining an emergency use authorization, allowing them to distribute their ventilators in the United States – including state-side manufacturers who have capabilities to increase production and supply.
These efforts are evidence of the FDA’s recognition of the seriousness of the immediate need to step up the production of these life-saving devices. As the number of COVID-19 cases grow by the hour, the FDA is working around the clock to address and resolve the challenges.
The FDA is continually updating its frequently asked questions from labs and test developers, providing information on alternative sources of reagents, extraction kits, swabs and more. Additionally, laboratories can call the toll-free line at 1-888-INFO-FDA, with any questions they may have about the Emergency Use Authorization process or getting supplies. The FDA also granted an Emergency Use Authorization to allow industrial-use ventilators to be used in health-care settings and to provide conservation strategies for gowns and masks to make them more readily available for use. Strategies also are being developed for the use of surgical gloves, including extending the shelf life where there is low risk of virus transmission.
For more information, click here for the full release from the U.S. Food and Drug Administration.