Rep. Payne, Jr.’s Ventilator Design gets FDA Approval, Production Could Start Immediately

April 15, 2020
Press Release

Media Contact:  Patrick Wright   --  Patrick.Wright@mail.house.gov 

Washington, D.C. — Congressman Donald M. Payne, Jr. has found a way to get New Jersey the ventilators it needs to save lives. 

The Food and Drug Administration (FDA) has approved a new emergency ventilator design to help the state and the rest of the county treat patients with COVID-19.  The move comes one week after Rep. Payne, Jr. and Rep. Collin Peterson (MN) co-wrote a letter to Stephen Hahn, FDA commissioner, on April 7, 2020, that asked the agency to review the design to help supply hospitals and health care facilities during this global pandemic.  Also, the University of Minnesota will make production specifications available online for free later this month.  Once they are available, local manufacturers could begin production immediately.    

Congressman Payne, Jr. said he was delighted that the FDA approved the design soon after it received his letter.        

“This is great news for New Jersey and our country,” said Congressman Payne, Jr.  “I knew this ventilator could be a solution to the critical health needs of thousands of coronavirus patients who are suffering from this disease.  It was obvious we couldn’t wait for the President to take appropriate action to get medical supplies to the states, so I wanted to find other ways to protect and treat our citizens.  Once again, I thank Rep. Peterson for his partnership and my 43 colleagues in the House for joining our effort to help Americans and health care professionals nationwide.”    

Rep. Payne, Jr. called New Jersey Governor Phil Murphy about it and Vice President Mike Pence, chair of the White House Coronavirus Task Force, contacted designers about the device already.  With the nation in dire need of ventilators and states bidding against each other for the limited supplies, this new ventilator is a viable option to care for the thousands of coronavirus cases across the country.  Now that the FDA has approved it, new ventilators could start arriving in hospitals and health care facilities nationwide within days of production. 

Rep. Payne, Jr. and Rep. Peterson were joined on the letter by 43 bipartisan members of Congress, including the entire New Jersey delegation.  The co-signers were Reps. Terri A. Sewell (AL), Bobby L. Rush (IL), Betty McCollum (MN), Cindy Axne (IA), Angie Craig (MN), Mikie Sherrill (NJ), C.A. Dutch Ruppersberger (MD), John B. Larson (CT), Tom Malinowski (NJ), David Trone (MD), Christopher H. Smith (NJ), Ilhan Omar (MN), Mike Gallagher (WI), Peter T. King (NY), Greg Stanton (AZ), Kelly Armstrong (ND), Dean Phillips (MN), Elise M. Stefanik (NY), Lee Zeldin (NY), Darren Soto (FL), Albio Sires (NJ), Julia Brownley (SC), Ann Kirkpatrick (AZ), Bill Pascrell, Jr. (NJ), Grace F. Napolitano (TX), Bonnie Watson Coleman (NJ), Andy Kim (NJ), Josh Gottheimer (NJ), Yvette D. Clarke (NY), Bennie Thompson (MS), Stephen F. Lynch (MA), Jeff Van Drew (NJ), Brendan F. Boyle (PA), Pete Stauber (MN), Nydia M. Velázquez (NY), Marcia L. Fudge (OH), Donald Norcross (NJ), Sean Patrick Maloney (NY), Gilbert R. Cisneros, Jr. (CA), Vicente Gonzalez (TX), Nanette Diaz Barragán (CA), and Frank Pallone (NJ).

Read the original letter below.

 

The Honorable Stephen Hahn
Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

 

Dear Commissioner Hahn:

With Americans dying daily from COVID-19 and states bidding against each other for life-saving ventilators, we urge you to review immediately the University of Minnesota’s ventilator design to help address the nationwide shortage of ventilators.

This ventilator was specifically designed to respond to the current COVID-19 crisis and can be manufactured quickly in mass quantities.  Also, it has a project sponsor who has partnered with industry leaders across the country in healthcare, manufacturing, and component distribution to ensure that they can immediately begin production once they have approval from FDA.

As local governments and hospitals are desperate to acquire needed ventilators, we urge you to use your emergency authorities to expeditiously review this ventilator design so we can treat more patients and save more American lives. Thank you.

Sincerely,

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