Philips has known for a decade at least the foam was degrading. It first popped up in commercial respirators in hospitals. They knew full well this foam was breaking down and they did nothing about it for nearly a decade. They are directly responsible for a lot of cancer in their patients and there needs to be the proper consequences for the executives for corporate manslaughter.
How they have behaved through the recall has been equally appalling. They have spent years telling people to keep using their machines and failing to offer replacements, offering a pittance for the machine not allowing people to reasonable replace them. They have made the situation worse since 2019 and its only not starting to get resolved with appropriate replacement funds in place for people to switch to other manufacturers.
The pro-publica report describes how the machines would cause cancer: The polyurethane foam used to muffle the sound degrades over time, including into some substances that are carcinogenic. The CPAP machine then blows those particles into the lungs of patients every night. [1]
I don't think the reporting proves that the CPAPs caused cancer, but I do think the preponderance of the evidence is that they did. No one is contesting that the foam degraded, or that it was blown into patient's lungs. People would wake up and regularly find black dust in their masks. The pro-publica report does not specify what substance is carcinogenic, but they mention a test report that sounds like a biocompatibility report which found genotoxicity. So it's likely that test also found carcinogenicity. If the machines were blowing carcinogenic particles into people's lungs, that would cause cancer.
A medical device manufacturer must ensure that their device is safe and effective, and provides essential performance and safety, for the service period defined in its instructions for use.
Simple as that. Make sense to me, after working in the industry for 20 years I honestly see no need to change this. There are other things we should change, but certainly not this.
I had a 10 year old CPAP machine, Respironics SystemOne. I kept telling myself that I needed a new one and I should go and get a new one, but I never did because this one was plodding along "fine". Looks like I dodged a bullet by not getting an updated one, because they probably would've given me one of those Dreamstations!
Did a sleep apnea test last year, it came back negative, which was weird because I can't sleep right without a CPAP.
I redid the test a few months ago, which also came back negative, so I asked to look at the full results, not just the summary. The analysis said I didn't have sleep apnea because I was ONLY WAKING UP 10 TIMES AN HOUR.
I insisted on a new machine, they gave me a ResMed AirSense 11 (autopap) and I've been sleeping like a baby for the last 2 weeks. The technology has improved so much:
* No more SD card!
* Results show up in the phone app in < 24 hours. (Machine modem -> cell network -> provider -> app instead of machine -> app, which I think explains the delay)
* The device detects when you've put the mask on and turns itself on automatically.
* The masks themselves are so much better, so easy to put on and remove.
* The app shows if air is leaking so no more endless fiddling with the mask to ensure a good fit.
This is one of those cases where it really does feel like we're living in the future.
> * Results show up in the phone app in < 24 hours. (Machine modem -> cell network -> provider -> app instead of machine -> app, which I think explains the delay)
This seems like a huge downside. What data is being collected? Who else gets access to this data? What will these third parties use it for? How is it secured?
How much is a CPAP without insurance? Could you buy your own to get around this? Or is it some sort of prescription only situation.
Edit: I don't mean buying one without a sleep study etc. But if my doctor were to prescribe one that needed to tell my insurance my sleeping patterns or get taken back, could I just pay full price for a model I'd actually own?
If insurance companies are accessing this data are they selling it too?
I doubt they're selling the records directly, but if they use that data to learn things about you (your hours awake/asleep for example) they could sell that.
> * Results show up in the phone app in < 24 hours. (Machine modem -> cell network -> provider -> app instead of machine -> app, which I think explains the delay)
Unfortunately it doesn't work in Europe :(. I have a second CPAP (airsense) and I can't complete the app syncing/registration because I am not registered with any provider in the US.
edit: I looked at the airsense 11, not the same model so maybe that changed but I doubt it.
edit 2: data can be extracted though, either with official resmed Windows application or third party (see replies).
Sure, they probably enjoy closer ties to the US health care industry this way. https://careers.resmed.com/what-we-do/locations/ is a page listing offices including Atlanta, Halifax, India and China.
By far the best advance in the ResMed Autoset machines is how good the Auto part does. I don't know about your old Respironics device but I do know in the bad old days getting a CPAP set up was an arduous process of trial and error figuring out what static pressure would work best. The auto machines just detect when you're having trouble breathing and increase the pressure a bit. Works amazingly well.
BTW your AutoSet 11 should support an SD Card still where you can get a lot more data than ResMed's webapp will show you. OSCAR or SleepHQ can interpret the data.
You have Upper Airway Resistance Syndrome instead of Sleep Apnea now. That it didn't show up on your sleep studies means they didn't score it properly. It means your body is ("correctly") waking up out of airway collapse before any oxygen desaturation can occur, which regrettably destroys sleep quality as bad or often worse than apnea does. This is particularly common in women, younger peopoe in general, and non-obese individuals.
I have an Airsense 11. It is an amazing device. Been using it (and the 10 before getting the 11 beginning of this year) for 2 years. Huge improvement to my sleep.
Nope. I haven't really noticed a difference in sleep quality. I had an issue with my 10, which is why it was replaced. In fact, I think the 11 is slightly louder. The filter on the back is smaller and harder to get to. I like the 10 a little better.
Just yesterday my father's Philips CPAP was replaced after more than a year of complaints to Philips Romania.
Thanks to HN I read an article that said Philips put a lot of money aside for Respironics issues and this made me investigate further.
If it wasn't for HN I wouldn't have found out and most probably Philips Romania would have ignored the issue, so thank you HN!
I’m surprised that foam of any sort of foam would be used in a medical machine with a lifetime or what? 10, 20 years? I struggle to think of any foam in any product I’ve owned that maintained its condition over that amount of time, whether cleaning products got on it or not.
Same in some cars, they will use this foam to pad the insides of the ductwork for ventilation and eventually it spits out tiny particles of foam that you could easily inhale. If you have an older car it may be worth looking around the vent holes if there is any build up of foam particles if so you may well have a problem.
I bought a few Philips Avent dummies (pacifier in US English) for my 1 year old ~2016. Just before we gave one of them to him we noticed a smell black fleck inside the clear chewing section, photoed it and complained to Philips.
Hearing about black flecks now I wonder if it's the manufacturing facilities...
Has anyone else noticed that sleep apnea machines are being over-prescribed in the US? They were a rarity ~10 years ago, but now it seems like anyone who goes to a doctor with sleep complaints are prescribed one.
“Over-prescribed” is an overused phrase that is usually tantamount to little more than “things are different than they were before”
It’s hard to quantify meaningful over-prescribing.
It seems like the majority of people are in support of lowering the barrier to entry for most forms of medicine. Especially those that are non-drug therapies like sleep apnea machines.
The counter point over-prescribing is the idea that restricting these kinds of therapies very likely cause a significant amount of people to have a demonstrably worse quality of life.
Just because something is more common now does not necessarily mean it is overprescribed. It can just as easily be seen as a mistake in the past to under-prescribe, or the cost of treatment was too high, or access to treatment was inadequate
Over-prescription matters with things like opioids or other habit-forming medications, or medications that have a negative effect after sustained use. Getting unobstructed oxygen intake during sleep is not something that should be policed even if the patient doesn't necessarily "need it". Furthermore, as others have mentioned, you need a sleep study to get a prescription for it.
You're looking for a problem where there really isn't one.
Pharma/med are run like a business so there's always in incentive to squeeze in as much as profit as possible. Not saying that CPAP are overprescribed because I really have no evidence of that but it's surely possible.
I mean, it is possible if you take the most cynical outlook and avoid looking at any other evidence.
Now, I would counter that a number of significant changes have occurred, some mentioned in this thread already...
1. Increase in obesity rate... yea, not good for health and is a causation.
2. Increase in user monitoring technology. My watch for example shows wakefullness and blood oxygen levels. Alerts from this may be sending more people to the doctor.
3. More doctor awareness of dangers of sleep apnea leading to more testing.
None of those need a vast conspiracy to cause increase diagnosis.
But doctors do generally get a ton of follow up visits to tune the patient's settings, so there is an incentive there. It doesn't have to be a conspiracy (in the literal sense) if everyone acting in their own interests brings about the same result.
The days of doctor owned practices are largely over. Doctors don't make money from additional visits, they're probably already booked out and over worked.
Isn't your assumption likely flawed? If 40% of Americans are obese and that's highly correlated with sleep apnea, why is it necessary they are over-prescribed?
It's only over-prescription if the prevalence hasn't changed.
Your friends are 10 years older now than they were a decade ago.
There's more awareness of sleep apnea, and when you look at the risk of treatment vs the risk of it going untreated, things strongly favor throwing a CPAP at a patient.
The other thing that's happened over the last decade is American obesity rates have continued to climb. Overweight is correlated with sleep apnea, so all things equal you'd expect to see a corresponding rise in sleep apnea rates too.
>It's only over-prescription if the prevalence hasn't changed.
Actually you've missed one other classification.
Was it previously under diagnosed?
So we have underdiagnosis, increase in base rate, increase in fraudulent diagnosis. At least anecdotally based on the older people in my family that seem to snore hard and have poor sleep habits, underdiagnosis seems pretty likely to me, but I guess we'd need to see studies of randomly selected patients to know for sure.
I posted directly to the original comment, but there is very strong evidence that sleep apnea was severely (~90%!) undiagnosed in 2008. 10 years ago was 2013, so hopefully that number improved between 2008 and 2013, but I'd imagine it was still a large problem.
Yes, it was very very undergianosed, and still is in some populations (read: women). Men are diagnosed at a rate several times higher, but there is no physiological reason that would support there being anywhere close to that much.
I'm fairly certain that you have to undergo a sleep study wherein they monitor your breathing and your blood oxygen levels. If your blood oxygen falls to levels that seem dangerous you will be prescribed. So my understanding is it's not as simple as going to the doctor and saying "I slept funny last night".
Breathing and blood oxygen at a minimum, for the take-home tests. If you go into a sleep lab, they also wire you up to an EEG as well to monitor your brain activity.
They're not just looking for blood oxygen to drop. They're also looking at how many times you wake up due to airway obstructions. Even if you wake yourself up before your blood oxygen drops, waking up 50+ times/night (this would be considered "mild", btw) is not good for your brain either.
But yes, you need a sleep study to be diagnosed with sleep apnea.
> waking up 50+ times/night (this would be considered "mild", btw)
50+ a night is mild? I thought I had it bad at 2 or 3. 50 times a night is every couple of minutes, do people who have it even worse than this actually manage to sleep at all?
When I did my study they said it as >90 times an hour when sleeping on one side and something like >60 on the other. I did a pulse ox test first and the results recommended a sleep study (which was not all that conducive to a good sleep they way it's performed)
Note, you don't actually regain consciousness that often (but if you wake up every 90-120 minutes to pee, and/or snore a lot, your body is telling you something) but it does keep you from getting a deeper sleep. I hadn't dreamed in years because I'd never drop into REM state.
I used to sleep 4-6 hours a night (but rarely felt tired) now I sleep 5.5 - 7 and am much better rested.
> do people who have it even worse than this actually manage to sleep at all?
It's sleep as in their eyes are closed and they are somehow unconscious but they are drifting on and off between falling asleep and being knocked out. There are no recollections of the events so it seems like sleep but very bad sleep (think: more tired when waking up than when going to bed).
From what I remember an apnea/hypopnia index of up to 5 is considered normal, 5-15 is mild, 15-30 is medium, and 30+ is severe. That's what I learned when I had severe sleep apnea, but it spontaneously resolved years ago so perhaps definitions have shifted. I'd be pretty shocked if 50 were "mild" now, though.
I had an AHI of ~90 at diagnosis, and I couldn't figure out why I was so damn tired all the time. My sleep was very badly disrupted, but since an apnea doesn't typically bring you all the way awake it can be hard to notice.
Outside the edit window: I just realized that I missed the mention of the timescale. The apnea/hypopnea index is measured in terms of events per hour, and my doctors never discussed it in any other terms, so I automatically interpreted those numbers as per hour.
Let's send in as many people as profi...er possible to have that test. Probably helps to start a few print and TV campaigns to Ask Your Doctor If CPAP Is Right For You.
Then, over a few decades, let's gradually move the goalposts so that more positive tests continually maximize our shareh...healthcare values.
"Dad died of a heart attack last night, guess we'll never know why"
Health is something that is not just in the doctors purview these days. You can personally buy any number of electronic devices that monitor things like blood oxygen and how often you're waking up that will give you some idea of your sleep quality and likelihood of having apena.
Or, you can be a cynical old fart and continue accepting that dying at 60 of a heart attack is perfectly normal.
I don't know about "vast conspiracy" and as a techie, I fully support testing in order to diagnose and repair.
However I just believe that the incentives are perverse and not improving, and it's begetting corruption. Doctors do not order tests out of personal concern for patient's well-being to start healing them; doctors are mandated top-down to tick boxes on a checklist and improve customer engagement.
As a techie, I also recognize how teched-up they are, and question why they need all that. I was shoved into a giant MRI and went through the whole theatrical adventure, and guess what - nobody touched that report. Nobody would read it, nobody would tell me what it meant, nobody would use it for treatment. It was hilarious. So glad it wasn't my pocketbook that time. And I had a real concern, not just a suspicion; my shoulder was bad, and fractures had already been ruled-out by a good old X-ray.
High-tech is able to supplant "safe, inexpensive and effective" by virtue of profit margins, patents, marketing, and customer perception. I've been honestly rather shocked once in a while, to see a nurse wearing a stethoscope, or checking BP by sphig.
I mean, do you realize how much of a fortune those guys are making by selling adhesive nasal strips, after we all developed a huge concern for apnea? What's that line about the American Space Pen and the Russian pencil???
>Doctors do not order tests out of personal concern for patient's well-being to start healing them
I don't order server rebuilds because out of personal concerns for a companies well-being. WTF kind of standard is this. Maybe if we had 10x as many doctors we could afford some personalism with our healthcare workers.
>High-tech is able to supplant "safe, inexpensive and effective" by virtue of profit margins, patents, marketing, and customer perception.
No, again, 40 years ago, you just would have died of your ailment, or had life long suffering. With increased insurance coverage along with increased treatment offerings more people want and are willing to get what affects them diagnosed. Meanwhile we've not increased the number of healthcare workers at the same rate, and increasing with individual workers is very difficult and expensive.
Honestly your post history is concerning. It appears everything is a vast conspiracy against you.
It's almost that simple. There are many online medical equipment providers that will send you an at home sleep study kit. Their goal is basically to sell you a PAP machine (plus ongoing related supplies), pretty much anyone can get one if they make a minimum of effort.
There was a study done in 2008 where surgeons wanted to find out how many surgical patients were undiagnosed with sleep apnea, presumably because it had an impact on the operating table.
The results were that 20% of patients had sleep apnea and 90% of them were not diagnosed.
That means in 2008, when the population of the US was about 300 million, there were between 8.1 million and 54 million people undiagnosed with sleep apnea. The range being dependent on how representative the surgical patient study is on the general population (from assuming ALL people with sleep apnea are also surgical patients to assuming surgery is completely independent of apnea), so likely closer to 50 million than 8 million imo.
20% of today's population is 68million.
Informal Google searching puts yearly CPAP sales at 8million per year in the US. Recommended use is for 5 years. This puts 8million sales per year in line for treating 40 million people with sleep apnea.
Looks to me like we actually might have room to increase our prescription rate still.
Fun fact, I am part of that diagnosis statistic. I was diagnosed in 2016, and estimated to have had it pretty much my whole life, so I was undiagnosed in 2008 and I also never had surgery. Turns out you don't need to be medically obese to have sleep apnea either.
I'd say we are actually fixing one of the countries major medical problems and not overprescribing CPAP machines at all.
As a user, I think you have two factors going on here:
1) They work. They help a LOT of people. It's just really hard to argue against "getting more oxygen and waking up less when you sleep."
2) They're horribly and outrageously gatekept. I'm sure I'm going to hear from many people who say you have to be careful because they're medical equipment -- and having used them for literal decades, I just don't believe that (as in, compared to what other dangerous medical stuff you can get OTC, obviously there's SOME hazards, just not enough to justify this level of gatekeeping.)
I would love to see what this industry could look like if you just let people get them OTC; I strongly predict you'd get across the board better and cheaper results with minimal danger to patients.
1. Aging population. Sleep apnea's effects are more noticed in older folks.
2. Better awareness of sleep apnea's detrimental effects to one's health. It's not just "obnoxious snoring." It's having serious impacts on your cardiovascular health.
I've been using a CPAP since April of this year and OMFG! I had no idea I felt bad. The effects are so gradual you think it's all just a part of getting old. The CPAP has been a complete game-changer that I didn't know I needed!
How they have behaved through the recall has been equally appalling. They have spent years telling people to keep using their machines and failing to offer replacements, offering a pittance for the machine not allowing people to reasonable replace them. They have made the situation worse since 2019 and its only not starting to get resolved with appropriate replacement funds in place for people to switch to other manufacturers.