FDA/Philips Dispute on CPAP Safety Revealed: Report

A new ProPublica/Pittsburgh Post-Gazette article reveals that in the early days of the 2021 recalls by Philips Respironics of its troubled CPAP breathing machines, the company began touting new safety studies that found the foam used in the devices, which was breaking apart and being discharged into patients’ breathing masks, did not present a major health threat to users. FDA reportedly pushed back on the safety claims, according to emails obtained by the news groups, saying that Respironics’ new tests did not account for the impact on patients who had been using the devices for years.

The agency told the company it still considered the machines a significant health threat that could inflict severe injury or even death, according to the article. “These tests are preliminary,” the agency said, adding that “definitive conclusions cannot yet be drawn in support of reduction in hazards.”

In emails to Philips, FDA described its many concerns, specifically that the company’s analysis did not consider “real world” device use (e.g., sending air directly into the noses, mouths and lungs of patients for hours at a time), according to the article. “Philips had brought on independent testing labs to assess whether the chemicals and particles released into the masks of patients reached dangerous levels, but the government in its emails said the testing program was ‘limited in its utility and does not fully assess or account for all risks,’” it says.

However, the article continues, FDA did not publicize this assessment, “even though patients across the country were at risk and an untold number continued using their recalled machines while they waited on Philips to send replacements. At the time, the FDA made only one public reference to the dispute — on the fourth page of a 14-page letter to Philips in May 2022. To see it, customers would have had to find it on the agency’s Web site and then wade through scientific language about ‘cytotoxicity failure,’ ‘novel continuous sampling’ and other complex concepts.”

The FDA and Respironics’ email exchanges “reveal a startling lack of transparency by both Philips and the government while patients and their doctors struggled to make sense of one of the largest and most tumultuous medical device recalls in years,” the article says.

Two years after Respironics promoted the new safety studies, FDA released a public statement about its concerns, saying that testing and analysis were not “adequate” and that Philips had agreed to conduct additional studies. “Richard Callender, a former mayor in Pennsylvania who used his sleep apnea machine for six months after the recall, said patients should have been given details far earlier,” the article says.

In statements to the news organizations, FDA defended its oversight, saying it released the 10/2023 statement after completing an analysis of the company’s test results. “Any health determination made by the FDA is science-driven and based on thorough analysis of the information presented to the agency,” it said. The agency said it “has been clear” about the government’s concerns with the foam in public alerts and other communications and has maintained its position about the potential health risks.

The article noted that Philips Respironics continues to defend the devices’ safety, yet it recently agreed to enter into a consent decree and stop selling them until it corrects related manufacturing issues (see earlier story).