Posted on 01/29/2024 2:33:16 PM PST by ducttape45
Dutch health technology company Philips will not sell new devices to treat sleep apnea in the U.S. in the coming years as it works to comply with a settlement with the Food and Drug Administration (FDA) announced on Monday.
The agreement followed the recall of millions of breathing devices and ventilators used to treat sleep apnea in 2021 because of concerns that foam used to reduce noise from the devices could degrade and become toxic, carrying potential cancer risks.
Philips said it had reached what is known as a consent decree that spells out the improvements it needs to make at its Respironics plants in the U.S.
Until the conditions are met, no new Respironics devices will be sold in the U.S., the company said.
Philips shares traded down 8.5% in afternoon trading in Europe, after news of the agreement, which ING analyst Marc Hesselink said was “very punitive”.
“We believe it will be very difficult for Philips to recover its U.S. Respironics market position,” Hesselink said in a note.
The decree is being finalized and will be submitted to the relevant U.S. court for approval. It was not clear how long that would take.
CEO Roy Jakobs declined to give details on the conditions that Philips will have to meet, but as a general indication said it on average takes between five and seven years to comply with consent decrees in the medical equipment industry.
Philips said the costs of the agreement led to a provision of 363 million euros ($393.5 million) in the fourth quarter of last year, and were expected to be about 1% of total revenues in 2024.
Even after the consent decree, Philips faces numerous cases brought by patients who say their health has suffered due to the use of the devices, and the outcome of an investigation by the U.S. Department of Justice into the handling of the recall.
Philips said the agreement did not change its financial targets for 2025, set out last year.
Due to the provision, Philips core profit in the fourth quarter remained roughly stable at 653 million euros, while comparable sales fell 1%.
Analysts in a company-compiled poll on average had predicted adjusted EBITA would rise to 672 million euros, from 651 million euros a year before, with comparable sales growth of 2.6%.
I've been using ResMed the past five years or so and it definitely has helped. I started with a CPAP but later switched to a BiPAP.
Here are some things I've learned.
1. The "Apnea Board" is just like FReeRepublic -- lots of people helping each other and discussing sleep apnea, machines, therapies, interpretation of data, etc. I highly recommend the board. The people there will help you tweak your machine settings to get the most out of it. There are thousands of discussion threads and all very well organized. To give you an idea, here are the recent topics on the page sidebar right now:
Recent Forum Topics
There's a great Your Personal CPAP Success Story with 1,362 replies. People discuss their experiences like on this thread.
2. At the Apnea Board, I learned about fantastic free software called "OSCAR" ("Open Source CPAP Analysis Reporter"). You put an SD Card in your CPAP machine and periodically take it out and plug it into a card reader attached to your computer. You open OSCAR and import the data. It shows you ALL the details and numbers of your sleep, minute-by-minute all night long, WAY beyond a simple AHI index (which is included, too). Be sure to eject the card from your PC or Mac and put it back into your CPAP machine.
3. There are wearable Pulse-Oximeters you can wear overnight and the data can be imported into OSCAR. You then see your blood oxygen levels aligned with all of your sleep data on the charts. I like the idea that you can directly measure your blood oxygen and pulse all night long -- after all, that's what this is all about, right? I use a Chinese product called the "O2 Ring." It's available on Amazon. They provide their own software "O2 Insight Pro" that provides a summary Sleep Report with graphs of your O2 and pulse overnight. It's the same data that gets imported to OSCAR. You can download the Sleep Reports as pdfs or as txt data. If you are inclined and comfortable programming, you can do all sorts of analytics on your data over time.
Almost the same for me. Up to 10 hours in a given 24 hour period.
When I started using it years ago it was a game changer as far as how rested I felt after a sleep cycle.
I figure I should have been using one for at least 20 years before I started.
It’s too bad Philips won’t be selling them in the US anymore. I imagine whatever stock they have will either be sold until gone or reallocated to different countries. The lawsuit and recall really hurt them and like I said, it wasn’t even their fault. The machines were being cleaned in a way they never intended. I think I’d try to go after those cleaning machine makers if they haven’t already gone to ground. I never see them advertised anymore.
I do not know that information. Maybe someone else here can answer that question.
I very carefully clean his machine with vinegar and water weekly and make sure that we only use distilled water in the machine. The CPAP cleaning systems, which are expensive, are totally unnecessary if you do that.
Same here. I started having episodes back in 1993 (right after I separated from the Air Force) where I would wake up out of breath, or not being able to breath, but I never asked the question about that to my doctor until 2016 and that's when I was diagnosed with moderate obstructive sleep apnea. Now I'm trying to get either a VA or SSA disability based on that diagnosis.
I've been ramping up my usage of my ResMed and I feel it's really making a difference. Like last night, I put the mask on and turned on the machine at 10:30 PM and the next thing I know it's 6:30 AM in the morning. Amazing for me!
Thanks for your input!
I will check out the resources you provided. Thank you!
” I would wake up out of breath, or not being able to breath, but I never asked the question about that to my doctor until 2016 and that’s when I was diagnosed with moderate obstructive sleep apnea.”
Wow, that’s exactly what happened to me. It caused dreams of running and being totally exhausted, then I would wake up out of breath. About the same time frame for me, too. It was horrible!
When I told someone at the seminar about it, he just quipped "old shloofoot is trying to get you." He was talking of the devil of course. But it would happen periodically over the next couple of decades until I finally received my diagnosis.
But I still didn't take it seriously until I caught Covid and pneumonia in Feb 2022, and developed Long Covid later in the year. THEN I took it seriously and lately I've been practically OCD about it. I even check my oxygen levels throughout the day, and I'll probably get an O2 ring to help me monitor that more frequently.
Maybe you and I should compare notes sometime!
My husband uses his all night, and any time he lies down, but he’s on oxygen almost all the time.
(I’ll sometimes use it 10-12 hours during a 24 hour span of time.)
Same here but early this morning around 4am I woke up with my tube filled with condensation and was spitting water everywhere when I removed the nose mask. First time its done that.
I agree with your statement about Phillips.....
Get a SLEEP STUDY...now!
It is sad to see such a great American company be denigrated by a bunch of Euro twits.
I wonder how much more accurate that expensive (to me) “O2 Ring” is than the Pulse Oximeter in my $45 Chinese watch. Could be the exact same chipset? The watch records and phone shows charts. Apple watches (used to) have one too, right?
I’ve had two, and that’s why I have the RedMed I have now. I’ll be having a third one next month.
I have an O2/pulse device but I have to put it on my finger tip whenever I want to use it. I’m going to check into an O2 ring myself soon.
Then, they made some changes... the rest being history.
I'm curious as to whether the original recall was necessary if the patient did not use heated humidification or any type of O3 cleaner. My suspicion is that the foam would be stable if not steamed or nuked.
Sorry........
If by “regulators” you mean lawyers, you got it right!
Don’t get me wrong - my dad was, and one of my brothers is, a lawyer - I don’t blame ALL lawyers for these kinds of problems
HST, there are just enough shady lawyers at work in our society to muck things up!
The shady lawyers get rich, and We the People suffer the consequences.
Maybe someday the shady lawyers will be take out of service?
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