Rédaction Africa Links 24 with Kushal T. Kadakia and Joseph S. Ross and Vinay K. Rathi
Published on 2024-02-06 09:30:14
Millions of Americans rely on a CPAP or BiPAP machine to help them breathe during sleep due to conditions like obstructive sleep apnea. However, in 2021, Philips Respironics recalled over 15 million of these machines due to potential health risks. The recall remains ongoing and has prompted investigations by the Food and Drug Administration and the Justice Department. Philips Respironics announced it would discontinue the sale of its breathing devices in the U.S., highlighting major challenges in medical device regulation.
The outdated approach to medical device oversight in America involves limited testing prior to FDA authorization for most devices and patchwork monitoring of patient safety. The Philips Respironics recall, which includes over 100,000 reports of injuries and hundreds of deaths, illustrates the shortcomings of this system.
None of the 14 recalled devices underwent extensive 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 the public despite legal obligations to do so. After finally issuing the recall, Philips struggled to communicate with many affected patients and issued replacement devices that carried new defects, triggering another round of recalls.
Despite efforts to draw attention to the recall and call for the FDA to initiate rigorous real-world studies to assess patient harms associated with the devices, little progress has been made. Patients still have not received replacement devices, and those who have are now faced with new health risks due to additional device defects.
The FDA operates with limitations when it comes to medical device oversight, including limited information it can request from manufacturers and an expectation that manufacturers report problems and conduct recalls. The result is a system that often prioritizes innovation and profits over regulation and patient safety.
The scale of the Philips Respironics recall has prompted calls for change. The Government Accountability Office has accepted a request to investigate the FDA’s oversight of medical device recalls, and the FDA has issued a proposal to begin considering real-world safety reports before permitting new models or similar devices to enter the market.
With medical device recalls reaching record highs, there is an urgent need to strengthen the FDA’s oversight of medical device safety to protect patients. The hope is that meaningful action will result from the catastrophe of the Philips Respironics recall.
