Quote:Philips Recalled Breathing Machines in 2021. Chemicals of “Concern” Found in Replacement Machines Raised New Alarm.

Amid a massive recall in 2021, the medical device maker Philips raced to overcome troubling questions about its replacement machines as customers waited for help.

Global device maker Philips Respironics 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 telling 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 crisis that threatened the massive recall and posed risks to patients all over again.

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.

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.

Public health experts interviewed by ProPublica 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 Public 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 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.

In response to concerns about the silicone foam, the company said the material was tested against safety limits recognized by the FDA and the World Health Organization 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 agency has not yet provided a response.

In a statement, the FDA said more tests are needed on the foam before determining if the devices pose “risks to patients.”

Experts who reviewed the test results for the news organizations said the findings revealed troubling markers, including the presence of formaldehyde at levels that exceed safety thresholds established by multiple organizations. Thresholds vary, they said, and those cited by Philips allow for far higher formaldehyde levels than others.

Safety thresholds also do not take into account patients who are already suffering from chronic illnesses and breathing from devices that emit fumes directly into the lungs.

The experts said that one of the most vexing concerns is that formaldehyde — linked to respiratory problems and certain cancers — showed up in multiple tests and at varying levels, at times low and at others higher.

“Who knows what a patient could be exposed to?” said an engineer familiar with the testing who still works in the industry and did not want to be identified for fear of reprisals. “If you had grenades and you’re not sure where they’re going to go off, that’s a problem.”

After questions from ProPublica and the Post-Gazette — and more than two years after the problem surfaced — the company put out a more detailed explanation about the issue late last week.

Documents related to the company’s testing have been turned over to the Department of Justice, which launched an investigation of the recall last year, according to sources familiar with the probe.

Philips has said that it is cooperating with investigators and that the company initially did not believe that complaints dating back more than a decade about the recalled machines needed to be reported. The company said it took action as soon as it learned of the significance of the problem.

Source: https://www.propublica.org/article/philips-recall-machines-chemicals-of-concern