A device intended to help wean coronavirus patients off of ventilators have been given an “emergency use authorization” by the FDA, which allows doctors to use the device despite it not gaining full FDA approval.
An emergency use authorization stipulates that “the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.”
The device is called a “TransAeris Diaphragm Pacing System,” and it is designed to stimulate the diaphragm muscle and to improve breathing muscle strength. The FDA says that the device may reduce the amount of time needed to get off of ventilator.
“This device may allow patients to wean off of the ventilator in order to meet emergency demands for ventilators, critical care beds, and ICU personnel,” the FDA said.
The devices improve diaphragm muscle strength to promote early weaning from the ventilator while avoiding the risks of being on a ventilator for prolonged periods, which include pneumonia, lung injury, damage to the airway and death, the FDA said.
But the device comes with risks, which include infection, breakage of the device, lung injury, pain due to stimulation, interference with heart rhythm, bleeding, and rarely, implant procedure death.