Season 6 | Episode 10
DRS. PETER GAY, ANEESA DAS, AND ROBERT OWENS, GUESTS
After nearly three years, the Department of Justice and the Food and Drug Administration have finally agreed to the terms of a consent decree with Philips. It states that Philips Respironics cannot manufacture or distribute new sleep and respiratory care devices in the U.S. market until certain criteria are met, unless the devices are classified by the FDA as “medically necessary.” The scope of the recall is far larger than just consumer PAP devices. This impacts sleep diagnostics – including Alice polysomnography systems, home sleep apnea test platforms, and in-lab titration devices. Here to help us understand the specifics of the consent decree are Drs. Peter Gay, Aneesa Das, and Robert Owens.
Dr. Peter Gay is a professor of medicine at Mayo Clinic in Rochester, Minnesota, where he has served for more than three decades. He earned his medical degree from the University of Hawaii in Honolulu, where he grew up. Dr. Gay received all graduate training at Mayo Clinic and is board-certified in internal medicine with subspecialty certification in pulmonary disease, critical care medicine, and sleep medicine.
Dr. Aneesa Das is a professor in the division of pulmonary, critical care and sleep at The Ohio State University. She is the director of the home sleep apnea testing program and assistant director of the sleep disorders program. She currently serves on the Board of Regents for CHEST. Dr. Das earned her medical degree from the University of Virginia School of Medicine in Charlottesville and completed her training at University of North Carolina Healthcare in Chapel Hill. She is board-certified in pulmonary disease and sleep medicine.
Dr. Robert Owens is a critical care and sleep medicine physician-scientist at the University of California San Diego. He attends in the ICU and the sleep medicine clinic. His research interest is in upper airway physiology and obstructive sleep apnea pathogenesis. Dr. Owens currently serves as chair of the American Thoracic Society Sleep and Respiratory Neurobiology Assembly. He earned his medical degree from Columbia University in New York, and he completed his training at Massachusetts General Hospital and Harvard in Boston.
Resources
- American Academy of Sleep Medicine. AASM guidance in response to Philips recall of PAP devices. Updated Apr. 29, 2024. https://aasm.org/clinical-resources/guidance-philips-recall-pap-devices/
- Nokes B, Sarmiento KF, Owens RL. Philips leaving the United States: what does that mean for physicians, patients and everyone in between? J Clin Sleep Med. 2024 Apr 24.
https://doi.org/10.5664/jcsm.11188 - Owens RL, Wilson KC, Gurubhagavatula I, Mehra R. Philips Respironics recall of positive airway pressure and noninvasive ventilation devices: a brief statement to inform response efforts and identify key steps forward. Am J Respir Crit Care Med. 2021;204(8):887-890. https://doi.org/10.1164/rccm.202107-1666ed
