Opinion: The Philips CPAP nightmare exposes shortcomings in medical device regulation

STAT February 6, 2024
Kushal T. Kadakia, Joseph S. Ross, Vinay K. Rathi

Millions of Americans’ bedtime routine includes wearing a mask attached to a respiratory machine that pushes air into their lungs, supporting their breathing during sleep. These airway pressure machines, known as CPAP or BiPAP depending on their design, are sophisticated medical devices that have been used for decades by patients with sleep disorders like obstructive sleep apnea. In 2021, Philips Respironics recalled more than 15 million of these machines after it was revealed that internal foam components were degrading into debris and other particulates that propelled into patients’ lungs, exposing them to potentially toxic material.

Three years later, the recall remains ongoing and has prompted investigations by the Food and Drug Administration and the Justice Department. On Jan. 25, the...

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