HJNO Jan/Feb 2024

BREATHING MACHINES RECALL 34 JAN / FEB 2024 I  HEALTHCARE JOURNAL OF NEW ORLEANS   by scientists, governments and others; the same device can pass one test but fail another depending on the threshold. In his message, Faulk said the lab had accepted the benchmark proposed by Philips. “Great news. … They are updating all of their reports accordingly,” Faulk wrote. “A big win for the team!” In its statement, Philips said it proposed a limit used by theWorld Health Organiza- tion to provide a “harmonized”threshold at the company’s testing labs. That threshold allows for far higher form- aldehyde emissions than benchmarks used by other organizations, including the Envi- ronmental Protection Agency. Neither Faulk nor Majka responded to requests for comment. Pleas for Help As lawmakers call on federal investiga- tors to hold Philips accountable, Connecti- cut Attorney General William Tong said he wants the FDA, not the company, to oversee the testing. “People are suffering,” said Tong, who, along with Sen. Richard Blumenthal, D-Conn., wrote to the agency last year urg- ing aggressive enforcement against Philips. “We don’t know enough about what’s hap- pening with the silicone to make a judgment about it and so we’re still very concerned.” Patients say they have received little or This story was originally published by ProPublica, December 28, 2023. no information about the issue. Hundreds have reported other concerns to the govern- ment, including the delivery of refurbished devices that were missing parts or had foul odors. “Completely unusable,” one customer wrote last year. “It emitted an extremely … nauseating smell. I was so sick I got up and did not sleep the rest of the night.” Others described long waits for their replacements. Hundreds of thousands of people were still waiting on their machines in April, nearly two years after the recall, according to the company’s website. “I wanted to go there and throw the machine right through the window,” said David Campano, 71, a former steelworker who continued to use his recalled CPAP for months while he waited on a replacement from the sprawling Philips factory only miles from his home near Pittsburgh. In the suburbs of Atlanta, retired elemen- tary school teacher Debra Miller emailed Philips last year after endless rounds of automated responses as she tried to figure out when she would get a new machine. A few days later, she said, a package arrived at her home containing the motor of a new machine, but no electrical cord, explanation or instructions for use. “Dumped in a box,” said Miller, 70, who taught for 30 years. “I literally got … half of an old machine.” Miller said she had no idea that the machine she was waiting on came with its own risks. Philips said the recall required the com- pany to reach millions of patients and was complicated by supply chain challenges. In some cases, CPAP motors were delivered without other parts to “enable the easiest and most familiar replacement option,” the company said, adding that the replacement plan for sleep apnea machines is nearly complete in the United States. In the early days of the recall, Breaden and her team at the sleep clinic in Portland were focused only on getting newmachines to the thousands of patients who used them night after night. Just beyond a waiting room with a framed message, “Healthy people get their sleep,”Breaden said she nowworries about an entirely new set of problems. After learning about the test results on the new foam from ProPublica and the Post- Gazette , the sleep medicine doctor who had been personally using a DreamStation 2 said she needs more information from the com- pany and the government. “I’m prescribing air. It’s wonderful to pre- scribe something that has no side effects and can help with your sleep,” she said. “It’s sad not to be able to say that anymore.” n “In its statement, Philips said it proposed a limit used by the World Health Organization to provide a ‘harmonized’ threshold at the company’s testing labs. That threshold allows for far higher formaldehyde emissions than benchmarks used by other organizations, including the Environmental Protection Agency.”