AARC held virtual discussions with senior officials at the Food and Drug Administration (FDA) to raise concerns about the availability of Avea-compatible disposables following Vyaire Medical’s Chapter 11 bankruptcy filing. These components are essential to the continued operation of Avea ventilators, which remain in widespread use across the country.
During these discussions, AARC emphasized that any disruption in the supply of critical disposables could have serious consequences for patients requiring mechanical ventilation, particularly those with acute or chronic respiratory failure. Zoll Medical Corporation, which is in the process of acquiring Vyaire Medical’s ventilator business, was recognized as a key stakeholder in ensuring supply continuity.
The FDA recently announced that extended availability of Avea-compatible disposables will be maintained for at least one year, allowing hospitals and healthcare systems adequate time to plan for transitions in technology or care delivery. AARC appreciates the FDA’s responsiveness in addressing this matter and its efforts to support uninterrupted patient care during this period of market transition.
“When AARC was made aware of a shortage of Avea ventilator disposables that threatened to disrupt hospital ventilator use and patient care, we immediately engaged with the U.S. Food and Drug Administration. We contacted leadership within the Center for Devices and Radiological Health (CDRH), including the Division Director for Shortage Assessment and Product Authentication in the Office of Supply Chain Resilience, housed within the Office of Strategic Partnerships and Technology Innovation. We are pleased that the FDA responded effectively, taking action that resulted in a resolution to the shortage and ensured continuity of care for patients relying on this life-sustaining technology,” said Miriam O’Day, AARC Senior Vice President of Government.
