In 2021, Philips pulled 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. "But as Philips publicly pledged to send out replacements, supervisors inside the company's headquarters near Pittsburgh were quietly racing to manage a new crisis that threatened the massive recall and posed risks to patients all over again," reports ProPublica. "Tests by independent laboratories retained by Philips had found that a different foam used by the company -- material fitted inside the millions of replacement machines -- was also emitting dangerous 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." From the report:
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 replacement machines with the new material to customers around the world.
One of the devices was the DreamStation 2, a newly released continuous positive 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 company 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 Administration 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.
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 overheating 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, fabric and "other flammable materials." Philips has said that customers could continue using the devices if they followed safety instructions. ...
