HJNO Jan/Feb 2024

HEALTHCARE JOURNAL OF NEW ORLEANS I  JAN / FEB 2024 31 On the morning of June 14, 2021, Dr. Rad- hika Breaden hurried to a computer in her hushed sleep disorders clinic and tried not to panic. The 52-year-old physician treated patients with heart conditions, cancer and neurological diseases. She cared for veter- ans with compromised lungs and a woman with Down syndrome. In more than a dozen years of helping people breathe through the night, she had never confronted an emer- gency that jeopardized nearly all of her patients at once. Global device maker Philips Respiron- ics was pulling its popular sleep apnea machines and ventilators off the shelves after discovering that an industrial foam built into the devices to reduce noise could release toxic particles and fumes into the masks worn by patients. Breaden scoured the internet for details, certain that Philips had a plan to quickly ship new, safe machines to the thousands of people under her care at the Portland, Oregon, clinic. “It’s a multibillion-dollar, multinational company,” she recalled tell- ing her staff. But as Philips publicly pledged to send out replacements, supervisors inside the company’s headquarters near Pittsburgh were quietly racing to manage a new cri- sis that threatened the massive recall and posed risks to patients all over again. Tests by independent laboratories retained by Philips had found that a differ- ent foam used by the company — material fitted inside the millions of replacement machines — was also emitting danger- ous chemicals, including formaldehyde, a known carcinogen. Though Philips has said the machines are safe, ProPublica and the Pittsburgh Post-Gazette obtained test results and other internal records that reveal for the first time how scientists working for the company grew increasingly alarmed and how infighting broke out as the new threat reached the highest levels of the Pittsburgh operation. The findings also underscore an unchecked pattern of corporate secrecy that began long before Philips decided to use the new foam. The company had previously failed to disclose complaints about the original foam in its profitable breathing machines, a polyester-based polyurethane material that was found to degrade in heat and humidity. Former patients and others have described hundreds of deaths and thousands of cases of cancer in government reports. After the introduction of the new foam in 2021, this one made of silicone, the company again held back details about the problem from the public even as it sent out replace- ment machines with the new material to customers around the world. One of the devices was the DreamSta- tion 2, a newly released continuous posi- tive airway pressure, or CPAP, machine promoted as one of the company’s primary replacements. Federal regulators were alerted to the concern more than two years ago but said in a news release at the time that the com- pany was carrying out additional tests on the foam and that patients should keep using their replacements until more details were available. The Food and Drug Admin- istration has not provided new information on the test results since then, and it is still unclear whether the material is safe. That leaves millions of people in the United States alone caught in the middle, including those with sleep apnea, which causes breathing to stop and start through the night and can lead to heart attacks, strokes and sudden death. Philips “let me down all this time and now they’re just doing it again,” said 56-year- old retired nuclear engineer Richard Cal- lender, who recently started using one of the replacement devices in his home near Pittsburgh. Public health experts interviewed by Pro- Publica and the Post-Gazette said it’s critical that patients using the machines are told about the potential risks. “It’s a question of providing the facts,” said Dr. Robert Steinbrook, director of the health research group at the nonprofit Pub- lic Citizen and an adjunct professor at the Yale School of Medicine. “The assumption is the new machines and the refitted ones are OK, that the foam issue has been 100% resolved. That’s not the case.” The new foam isn’t the only problem: An internal investigation at Philips launched in the months after the recall found that water was condensing in the circuitry of the DreamStation 2, creating a new series of safety risks. “Loss of therapy, thermal events, and shock hazards,”the investigation concluded. The FDA issued an alert about overheat- ing last month, warning that the devices could produce “fire, smoke, burns, and other signs of overheating” and advising patients to keep the machines away from carpet, fab- ric and “other flammable materials.” Philips has said that customers could continue using the devices if they followed safety instructions. In response to concerns about the sili- cone foam, the company said the material was tested against safety limits recognized by the FDAand theWorld Health Organiza- tion and did not emit chemicals at unsafe levels. Philips said formaldehyde, found in common household items, only becomes a risk at high exposure. “The repaired and new replacement devices with the silicone sound abatement foam are safe,” and findings that conclude otherwise are “inaccurate,” the company said in a statement. Philips said additional test results were submitted last year to the FDA, but the