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 had over 30 years experience in sleep testing and treatment. RESMED makes the best devices on the planet. Phillips bought Respironics, which was the pioneering CPAP / BIPAP manufacturer. It was an American company. I’ve distributed thousands of Respironic devices. When Phillips bought them, the quality and reliability took a nose dive. For years I refused to use their equipment despite pressure from my employer. Turns out I was right to do so.
Medicare will only pay for a portion, and you have to rent it forever, at the copay of $215/month. My husband uses it. It’s considered a noninvasive respirator, instead of just a cpap. I’ve been trying to get him to go back to using his regular cpap machine, which we own. We really can’t afford that copay, especially with bidenomics hiking the price of everything.
Been on cpap for 15 years. Respironics appears to be the best. Had a Phillips for a while but switched back.
That’s interesting. I’ve not heard or seen that reported in the news articles I’ve read. I’ve never used any cleaning solutions or machines with my ResMed and I probably won’t. I keep it clean and dry when not in use during the day.
Good information to know. Thanks for sharing that.
Thankfully I have VA health insurance and will have for the rest of my lifetime, so hopefully I won’t run into that scenario. But just in case, even when I get a new machine I’m keeping my current machine as a backup. One can’t be too careful these days.
Similar to those of us who take only one pill of a 2/day Rx and save the rest for... well, so many things could interrupt the supply chain.
(In my case the half dose seems to be adequate, on two different prescriptions)
For about 700 bucks you can buy one.
I stopped using insurance and the “rental” years ago.
Take a look at CPAP.com for prices.
That’s a good website too
I applied for a new machine about 2 years ago. After a year they finally responded, offering me 50 genuine American smackers for my Philips System One machine. I said no, holding out for replacement, and bought a new one (Airsense 10) online out of pocket, paying just a little more than my insurance copay would have been. A few months later they offered me a replacement machine (Dream Machine). So I packaged up the old System One and swapped it. The Dream Machine sits on the shelf unused as a backup.
I never had a problem with the System One - still worked great after 10 years use. The Airsense is much quieter and is a good machine also. I never had a problem with the foam insulation - so I am a bit perturbed that, should I need one, I won’t be able to get another Philips machine.
Well, if you returned your system 1, you can join the class action lawsuit.
I’m getting an extra 100 bucks, plus another 57 bucks for sending the old one back
I had a acute respiratory failure after having a-fib for years. The hospital put me on O2 (it sounded like waves crashing in my head) but I slept through the night and I had been used to getting up 5 times — to pee I thought. I have been told I have an enlarged prostate and everything missed the Sleep Apnea that the hospital discovered after the respiration failure. My cardiologist decided the true cause of all my symptoms was sleep apnea. I was proscribed a test and had 45 events an hour where my airways closed and the test showed that each time I tried to go to sleep the same thing happened. To me I was just not able to fall asleep, They increased the pressure and I went right past the CPAP limit and they moved to a bi-pressure system and I was not able to fall asleep with that system either.
The hopsital wrote a prescription for a Phillips Trilogy 100 and they brought it in and it worked immediately. The Software in this ventilator checks for blocked airways and increases the external pressure until a preset volume is reached Then it drops to a low level so you can exhale. It also changes the level of the drop if the airways block the exhale so it works on inhale and exhale. It is dynamic and changes to match what you need. If the airways are open the pressure is relatively low, However I have airways that block the instant I fall asleep.
The unit I have has worked for two years now and I am getting stronger and only need the machine at night. I have oxygen added at night and and tried to sleep with just the ventilator but my oxygen level stayed below 80 % so the doc has authorized my oxygen as well as the ventilator. It is covered by Medicare (so far),
Mind that I had to stop work because of shortness of breath but everyone just prescribed COPD meds. The breakthrough diagnosis of SA was the thing that should have been found long ago, I now believe a lot of my issues were due to SA being present and undiagnosed for many years. I can play golf and play in a concert band. I could not have done either before the Phillips machine was installed.
BTW, Phillips foam is reactive to Ozone, that is the engineering mistake they made. And the way Ozone gets into the machine is when users use an ozone bath to sanitize their mask and tubes in the circuit. This is because systems like So Clean generate ozone so we can blame William Shatner for the ozone. (And maybe other systems). Anyway, my machine has not been exposed to ozone hence I have used it for years. Phillips may replace it but now I may not give it up because I have one now and I am satisfied with it. My supplier will get any refund, since I have not paid anything for the system .
I wonder though, and it's a question that came to mind late last night, but how many hours a day do CPAP users use their machines? I use mine mostly during the evening hours when I go to bed, but I'll also use it if I lay down during the day as well. I'll sometimes use it 10-12 hours during a 24 hour span of time.
Thoughts?
As I noted earlier, I finally got a replacement for my old ResMed unit. Though it was beyond its estimated useful life it still works, which got me thinking I should set it up downstairs for use when I take my afternoon nap. The new ResMed is upstairs in the bedroom. When I first started on CPAP about 10 years ago, I admit it took some getting used to with the nose pillows and headset. But, now I’m hooked on the device. My dad had severe sleep apnea and died in his sleep, which made me determined to use the device. Now I see it as my friend and I use it every night throughout the night.
ResMed here, sleep like a baby now.
Thanks for your comments.
It took me some time to get used to wearing the mask at night, but now that I have I sleep much better now.
“I don’t understand why a recall to remove the degrading foam in the Phillips units wasn’t the simplest answer to the problem.”
My thought, too. Maybe it is glued in place and impossible to remove.
I can’t believe they chose a material that could degrade, is toxic, and could cause cancer. Of course, me being a huge skeptic of the government, I wonder how overblown this is. Is there REALLY a good chance the material could degrade and enter the airstream? From a product engineering perspective, I wouldn’t expect sound-deadening insulation to be exposed to the air stream. It would be sandwiched between the outer plastic shell and an inner plastic part that directs the airflow.
The skeptic in me says “follow the money.”
I think you should be able to use about any brand of mask with any brand of machine.
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