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America’s outdated approach to medical device oversight starts with limited testing prior to FDA authorization for the vast majority of marketed devices and ends with patchwork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.
None of the 14 recalled devices underwent more than limited testing in humans before reaching the market. In the decade preceding the recall, Philips received thousands of reports of device malfunction but failed to disclose these complaints to the FDA and public despite legal obligations to do so. After finally issuing the recall, Philips struggled to identify and communicate with many affected patients, prompting a rare rebuke from the FDA. And when Philips Respironics ultimately offered patients replacements, regulators discovered that these devices carried new defects that posed additional health risks, triggering another round of recalls.
As clinicians and experts in medical device regulation, we sought to draw the medical community’s attention to the recall when it began and highlighted the need for the FDA to initiate rigorous real-world studies to assess patient harms associated with Philips’ devices and called for the agency to accelerate resolutions for patients. Nonetheless, progress remains lacking to date. The FDA still has not issued requirements for follow-up safety studies, and patients are no closer to understanding what long-term consequences they may suffer. Many still have not received replacement devices, and the news that Philips Respironics is now exiting the sleep medicine industry only makes things worse. The company controls nearly one-third of the market, so this ignominious retreat risks exacerbating supply chain shortages and spurring price increases in a consolidated industry where competition has been stifled.
The FDA might be America’s original consumer protection agency, but it’s operating with a handicap when it comes to medical device oversight. By law, the FDA is limited in the amount of information it can request from manufacturers to evaluate medical devices’ safety and effectiveness. And if safety issues occur, it is typically manufacturers, not the FDA, that are expected to police themselves by reporting problems and conducting recalls. The result is a system that all too often puts innovation and profits over regulation and patients. In the case of Philips Respironics, patients were left between a rock and a hard place — either stopping use of a device that provided necessary respiratory support, or continuing to expose themselves to potentially serious health risks.
In American medicine, catastrophe is often a catalyst for change. The scale of the Philips Respironics recall and the tragedy of the company’s dysfunctional response should motivate meaningful action. There is reason for hope. The Government Accountability Office recently accepted a request by Sens. Richard Blumenthal and Dick Durbin to investigate the FDA’s oversight of medical device recalls. Moreover, the FDA last fall issued a proposal to begin considering real-world safety reports — like those submitted for Philips Respironics’ devices — before permitting new models or similar devices to enter the market.
With medical device recalls reaching record highs, the need for action has never been more urgent. Strengthening the FDA’s oversight of medical device safety will help patients everywhere to breathe a sigh of relief.
Kushal T. Kadakia is a Rhodes scholar and medical student at Harvard. Joseph S. Ross is a professor and internal medicine physician at Yale. Vinay K. Rathi is a surgical fellow at the Medical University of South Carolina.