Currently, the Novalung ILA is listed as a “Class III – Premarket Approval” device by the Food and Drug Administration, the category with the most stringent approval requirements, according to the FDA’s Web database.
“When an Army doctor wants to use the NovaLung on an emergency basis, we ask the manufacturer, NovaLung U.S., to notify the FDA of the device’s use under the FDA NovaLung Investigational Device Exemption requirements,” wrote Cynthia Vaughn, a spokeswoman for the Army surgeon general’s office, in an e-mail to Stars and Stripes.
But despite any after-the-fact scrutiny or investigations made into medical staff over use of the device last spring, doctors said they were simply doing what they could do to save wounded servicemembers. “We tried to do what we would want someone to do if it was our own son, daughter, or spouse; each and every life was precious,” Col. Rhonda Cornum, commander of Landstuhl at the time Mishoe, Phillip and Wong were hurt, wrote in an e-mail to Stars and Stripes.
Doctors did — and continue to do — everything they can to save injured servicemembers, said Col. Mark Ivey, a pulmonary critical care specialist who assisted Boylston with both Phillip and Wong. “We can and will do whatever it takes to return [servicemembers] home in as good of shape as possible,” Ivey said.
And though her son has no recollection of being attached to the Novalung ILA, Julie Mishoe said she knows it helped save his life, and was glad that its success with Joshua may have helped make it available to other servicemembers. “It’s just wonderful to know that machine has been used to save other people’s lives,” she said.
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