Philips is making its Philips Respironics DreamStation BiPAP AVAPS devices available for sale in the United States as new setups for obstructive sleep apnea (OSA) patients with respiratory impairment who are over the age of 7 and weigh 40 to 66 lbs.
“The availability of the devices will help address critical care gaps and supply challenges in the U.S.,” Philips said in a March 19 announcement. “The DreamStation BiPAP AVAPS devices provide advanced respiratory support to lower-weight patient populations.”
Philips Respironics is currently under a U.S. Food & Drug Administration (FDA) consent decree, which officially began April 9, 2024. The DreamStation BiPAP AVAPS system will be available for purchase “only to Philips customers who meet certain distribution control and traceability requirements,” the announcement said. “The company is also committed to returning to serving patients who rely on its sleep and respiratory therapy devices in the U.S. when it has fully met the requirements of the Philips Respironics Consent Decree, which the company is diligently working to meet.”
Philips added that the DreamStation BiPAP AVAPS systems “have been subject to comprehensive testing in accordance with the applicable industry testing standards. Philips is confident these devices will help customers support the needs of their lower-weight patients.”
The company recalled certain ventilators, continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) machines in June 2021 due to potential health risks from the breakdown of their polyester-based polyurethane (PE-PUR) foam breaking down and being breathed in or swallowed by patients. The PE-PUR foam in the systems were meant to reduce sound and vibration.
As part of the consent decree, Philips is restricted “with limited exceptions” from producing and selling “new CPAP machines, BiPAP machines and other devices at several Philips Respironics facilities in Pennsylvania and California until certain requirements are met,” the FDA said in an April 2024 update.
“Patient safety is at the heart of everything we do, and expanding access to advanced, reliable care is essential,” said Sam Talya, Philips business category leader, therapy platforms, sleep and respiratory care. “The availability of DreamStation BiPAP AVAPS devices in the U.S. for lower-weight patients supports a limited patient population. It is a signal of our commitment to ensure access to safe, effective respiratory solutions for patients who need them most.”
