Army looking into use of lifesaving lung device that lacks FDA approval
July 21, 2005
Spurred by American military doctors’ success with an experimental artificial lung on soldiers wounded in Iraq, officials at the top levels of the Army’s medical command are now investigating U.S. use of the new device, Army officials said this week.
Three American troops have survived severe lung trauma caused by bomb blasts with the help of the machine — called an interventional lung assist, or ILA — said Marie Shaw, Landstuhl Regional Medical Center spokeswoman. Following those reports, Army administrators as high as the branch’s surgeon general’s office have turned their attention to the device, said Cynthia Vaughn, a spokeswoman for the Army Medical Department, or AMEDD.
Manufactured by the German company Novalung, the device is a gas exchange mechanism so new that it hasn’t been approved by the U.S. Food and Drug Administration, a stipulation that prompted AMEDD’s inquiry — though the Army won’t say exactly what it’s looking for.
“The Army Medical Department is currently investigating the issue of use of the Nova Lung [sic],” Vaughn wrote in a recent e-mail to Stars and Stripes.
But AMEDD declines to clarify exactly what it is investigating. Vaughn’s office would not comment on whether it is specifically investigating American doctors for using the unauthorized device.
“As the investigation is ongoing, it is inappropriate to comment further,” Vaughn wrote July 12 and repeated in a phone conversation Monday.
Regardless of the purpose of the investigation, sources both inside and outside the military say the Army has been collecting information on the Novalung ILA in recent weeks, possibly for an expedited process to approve it for military use.
Regensburg, Germany-based Dr. Thomas Bein, a co-inventor of the ILA, said Tuesday that Army officials contacted him within the last two weeks for a copy of his recent research on the ILA, a study chronicling its use on 90 patients from 1996 to 2004.
A spokesman for the U.S. Army Medical Research and Materiel Command, or USAMRMC — a subordinate organization of AMEDD responsible for researching and acquiring medical technology for the Army — also said his agency is coordinating discussions with Novalung.
“The Army was in discussions with the FDA and the manufacturer of Novalung to provide information to the FDA,” said Chuck Dasey, a USAMRMC public affairs officer.
For its part, the FDA cannot comment on specific companies or devices, only that it can work with the Department of Defense to “respond to special situations” to get a medical resource approved, agency spokeswoman Julie Zawisza said.
“We have procedures that would allow for the expedited review and approval of a product to meet a pressing public health need or emergency, including a state of war,” Zawisza wrote in an e-mail to Stars and Stripes.
The rules against comment also bar the agency from confirming whether it has granted conditional permission for use of the Novalung in emergency circumstances, Zawisza said.
Commercially, a proposal for FDA approval is being drafted, said a spokesman for Novalung’s administrative offices in the United States.
Approval of the Novalung is something both Bein and the parents of one soldier kept alive by the Novalung ILA have said they would welcome.
Roughly the size and shape of several CD cases stacked together, the device keeps people alive by performing the work of the lungs when they are too damaged to function properly.
Compact and transportable, the ILA is used by inserting a pair of heavy-gauge needles into the major blood vessels in a patient’s legs, allowing his heartbeat to push blood through a complicated membrane that filters carbon dioxide out of the blood and infuses cells with oxygen. The blood is then circulated back into the body through the other leg.
For patients like 22-year-old Sgt. Chang Wong, wounded in a bombing in Iraq this May and now recovering at a medical facility in the States, the Novalung ILA was a “miracle,” his father said last month.