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 embattled manufacturer announced it would discontinue the sale of all of its breathing devices in the U.S. In short, a medical device that promised to provide a good night’s sleep became a public health nightmare, one that has exposed major challenges in medical device regulation.
America’s outdated approach to medical device oversight starts with limited testing prior to FDA authorization for the vast majority of marketed devices and ends with patchwork monitoring of patient safety. The tale of Philips Respironics — which has now grown to encompass over 100,000 reports of injuries and hundreds of deaths — illustrates many of these shortcomings.
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