Chemicals of 'Concern' Found In Philips Breathing Machines (propublica.org) 43
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. ...
"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. ...
Other manufactureres also? (Score:3)
My wife, who is highly allergic to formaldehyde had noticed skin issues with her new Resmed CPAP.
Is Resmed going to be the next brand of machines to be shown to be emitting formaldehyde?
Re: (Score:2)
Skin issues? Wouldn't that be more of a contact issue - something in the mask / headset itself?
Re:Other manufactureres also? (Score:4, Informative)
If the skin irritation is at the site of direct contact, that is contact dermatitis, and that of course is a common thing.
But, remote skin reactions from an irritant or allergen exposed elsewhere, that is called atopy, and atopic dermatitis, one form of the broader immune-allergic dermatoses called the eczemas, is also very common. The pathogenesis of remote or atopic sensitization is long (chronic) and complex, but all too real and unfortunate for the MANY people who have it. It is for the same reasons and pathological mechanisms why allergic exposure, even just seasonal hay fever type allergies, can cause rheumatic and rheumatoid joint aches and pains, abdominal and urinary symptoms, and others.
Resmed Air Sense 10 Respond (Score:1)
Re: (Score:2)
Re: WINNING! (Score:2, Offtopic)
Re: WINNING! (Score:1)
Much like the intentional misspellings in spam email, that obvious bit of non-logic serves as a filter.
If the reader is too stupid or ignorant to pick up on it, chances are good that they'll also buy whatever bullshit said scammer is peddling. 60+ court cases and zero proof? Oh that's just part of the conspiracaaaaahhhh. It's all to get you to think the "wrong way" man, WAKE UP SHEEPLE!
Remember folks, teaching your children logic and reason is frowned upon in RepubliKan Kristian MuriKa. It makes it harder t
Polyurethanes (Score:3)
Re:Polyurethanes (Score:4, Interesting)
Just a month or two ago, I dusted off an old backpack I hadn't used in about 10 years. It was just the right size and pockets for some local hikes I wanted to do, and it was a wonderful little pack for about 10 years before that. It was in my bedroom those recent 10 years, not in any extreme environment. When I opened it, the room got dusted with degenerated foam, stinky, and some of it sticky and gooey, just as you described. After a trip through the washing machine, it was okay again, fully rebab'ed but without original padding. I was surprised how thoroughly it had degraded - into nothing but dust, doing nothing but sitting in a room environment for 10 years.
If you use something like that regularly, you may not notice the deterioration as small particles flake off continuously but unnoticed, until one day you realize things are looking ragged. But, sitting unused in the cool dark for 10 years, now there's a chemistry experiment !
The med device makers should already know this.
Re: kek (Score:1)
Re: kek (Score:2)
Because that's the play they've been taught. Someone speaks out about the ills of capitalism? Quick! Get out the bogeymen it's time to scare the ignorant back into compliance!
I appreciate your calling it out directly though, needs to happen everywhere and all the time. None of these ignorant loudmouths should be anywhere near where adult decisions are being made, much less included in them. Give them some actual education and some deprogramming.
I'd wager the vast majority are misinformed and would hand a di
Re: kek (Score:2)
No, thatâ(TM)s fear of government regulation. If companies were afraid of the consumers, they would do everything to make sure their products are better than their competition, rather than skirting around the laws that give them immunity for producing faulty products,
Sigh, formaldehyde. (Score:2)
Formaldehyde is a natural substance. A result of much fermentation, and lots of stuff we eat is broken down to formaldehyde, and the body metabolites it, to methanol and finally formic acid, which is excreted.
You'd have to take in a fair bit of formaldehyde for it to be a problem. Small amounts leached out of foam aren't going to be a problem. Drinking yesterday's orange juice would give you a whole lot more.
Re: (Score:3)
You'd have to take in a fair bit of formaldehyde for it to be a problem.
For the average person, yes, but some people can be highly allergic to formaldehyde.
Re: (Score:1)
You'd have to take in a fair bit of formaldehyde for it to be a problem.
For the average person, yes, but some people can be highly allergic to formaldehyde.
No, no, you don't understand. Formaldehyde is natural so there is no issue for anyone. It can't be harmful if it's natural. Like water.
Re: (Score:2)
No, no, you don't understand. Formaldehyde is natural so there is no issue for anyone. It can't be harmful if it's natural. Like water.
Exactly, because no one has ever been harmed by water. What's all the fuss about?
Re: (Score:3)
There's a world of difference between eating a substance and inhaling it.
Re:Sigh, formaldehyde. (Score:5, Informative)
You are right, but wrong.
It is a common, almost ubiquitous biochemical, but as a matter of innate metabolism or dietary ingestion, it is never present in harmful concentrations. As a very reactive compound, and as one subject to handling by several enzymes, any most individual molecules mostly not going to survive beyond milliseconds-to-second range. It is a metabolic intermediary to be sure, but it is rapidly metabolized in mitochondria, cytosol, and erythrocytes, with measurable blood concentrations in low micromolar range.
But, its bio-adverse properties are well known. It cross-links amino acids, pickling tissue, why it is used for embalming and as the "universal" preservative for biopsy specimens to be looked at under the microscope. It causes leukemias and other cancers with high or constant exposure. It is a potent irritant of eyes and upper aero-digestive mucous membranes. Inhalation exposure can cause a full spectrum from transient irritation to chronic bronchitis and derivative pathologies. Outgassing of foam mattresses is a common complaint among people buying and returning them for respiratory irritation. Keep in mind that although the body has many mechanisms for metabolizing or detoxifying CH2O, they are generally cytosolic, not membrane bound, so the conjuctivas and tracheobronchial mucosas are not resistant or resilient to the irritating effects. In that kind of exposure, just a little is irritating and toxic, why formaldehyde is considered a highly toxic substance in any of the industrial forms that we can work with it.
It is used as a preservative in vaccines and cosmetics. Conjugated with ammonia as methenamine, it is one of the most useful drugs we have, as a urinary antiseptic, where it is metabolized in the urine back to microbial-toxic formaldehyde. Etc. - it is useful in medicine. But that is in regulated well devised doses. As an inhalational contaminant, it is not tolerated. To have it in the airway circuit of a medical device used for pulmonary care is just wrong.
Re:Sigh, formaldehyde. (Score:5, Insightful)
Define "fair bit."
Does the outgassing from petrochemical foam, force-fed through your nasal cavities and into your lungs for eight hours every night, constitute a "fair bit?"
Re: (Score:3)
Formaldehyde is a natural substance.
So are cyanide, asbestos, botulism, and anthrax, and they're not good for you either, even in small amounts.
Formaldehyde? (Score:2)
They've been forcing formaldehyde into cigarettes for decades. Because its totally ok to intentionally give cancer causing agents to smokers. They're only upset because they got caught putting in something that doesn't necessarily kill the people they were intending.
Always Avoid Philips! (Score:2)
It is the one major brand that I have considered the laughinstock of the industry and to be avoided whenever possible. For decades their incompetence and hubris when doing business has gradually downgraded them to that status.
Two examples from the video game era:
_Videopac Philips
_Philips CD-I
The amount of bad faith for the latter is the stuff of legends.
And whenever I read the customer reviews of Philips products, I get vindicated.
Oh also: Philips has sold its brand name to chinese companies in a lot of dom
Re: (Score:2)
1978? How old are you? Philips of today has very little to do with the Philips of back then . They don't even make consumer electronics anymore. The CPAP business (especially these older models with the foam issues) is effectively just Respironics. This Pittsburg plant is literally a Respironics plant with a Philips logo slapped on top.
Philips is a medical company now and you are going to get weird looks from your doctor if you say you don't want MRI scans from Philips machines.
Of course if you buy a compan
Not even the same company (Score:3)
Philips Healthcare is the former HP/Agilent medical devices division after it was spun off and Philips acquired a majority stake. It has nothing to do with other divisions of Philips.
Uh oh! (Score:3)
I have one of the recalled Philips CPAP machines. It's 10 years old and is not showing the signs of the internal foam degenerating, probably because I live in California where it's only hot, not humid, and even then it resides inside an air conditioned house. Nevertheless, I just got my HMO send me a new one. I have yet to open the box and set it up because I caught the flu and I feel like shit but this latest story about potential problems with Philips CPAP machines concerns me. If it is a Philips machine, am I going to potentially run into a different problem? I feel doomed because I need a CPAP machine to sleep properly.
Re: (Score:1)
Look into dental devices as an alternative. I have sleep Apnea and never went the CPAP route. I use a SomnoMed Advant device (https://somnomed.com/en/) and it has worked well so far. They don't work for everyone but I like that there's nothing hanging off my face every night.
Re: (Score:2)
It's worse than that (Score:5, Interesting)
I know someone who's worked at Phillips for ~15 years, and he says this 'issue' is considerably worse than reported. The entire company is on the line and it's not good. Unofficially, "Phillips is guilty as shit."
Basically, certain parts in the CPAP machines were made of a lower-grade plastic than they should have been.
As the parts move, they rub against other parts and the resulting sanding action creates millions of micro-particles with each stroke of the breathing mechanism.
To make a long story short, a constant stream of plastic micro-particles gets fed into your lungs, where they eventually find their way into your bloodstream.
Could Phillips have made better parts that didn't create a fire hose of micro-particles? I'm so glad you asked.
Yes, they could have but they would have cost more, so of course they went for the less expensive plastic material. I know, I'm shocked too.
Re: (Score:2)