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%.
My supplier doesn’t have a single Phillips machine in their store. I have ResMed as well.
There are You Tube videos on how to take yours apart and remove the foam. I did that to mine. Then they sent me a new one and I stuck that away in a closet for when mine quits.
My Pulmonary Doctor made it a point they provide me a Resmed machine as she didn’t trust the other options. I was always using a Resmed when I had Kaiser for many years, but Medicare/TFL through Apria filled the prescription.
The VA gives me a ResMed machine every couple of years and I’m quite happy with it..
I also got the option, if they will provide me a prescription, that my current supplier of parts, TheCPAPShop.com, will sell me a new ResMed machine.
The Philips CPAP foam flap has caused a spillover backlog for CPAP machines in the field. I had to wait for a ResMed unit for about a year beyond my old machine’s normal five-year replacement date. Fortunately, my old machine kept working in the meantime. I don’t understand why a recall to remove the degrading foam in the Phillips units wasn’t the simplest answer to the problem. The ‘regulators’ got into the picture and mucked up the entire matter.
I’m currently using a React Health Luna G3 CPAP machine. Super quite!
ResMed AirSense 10 AutoSet CPAP Machine with Bluetooth, HumidAir and ClimateLineAir
This is the one I really want to get.
I was tagged up with a local medical device supplier and outfitted with a ResMed Airsense 10. It has a CDMA cellular card to perpetually tattle on your usage. Initially dispensed with an F20i full face mask. Not happy with that. Purchased the N30i. Better, but can slip off the nose. Final config is P30i with the pre-heat hose.
I'm paying $91/month for 13 months of "rental". The payments stop and I own the device on the 13th month. Periodic "supplies" are billed and delivered. Nose pillows. Head frames. Heated hose. Filters. I purchased an ultrasonic cleaner and an ozone sanitizer. Ozone is fast, but stinky. Ultrasonic takes time to haul the device to the kitchen sink, fill with hot water, add sanitizer tablets and equipment, then run for 20 minutes. Drain and dry the equipment and return to storage. Ultrasonic does a better, nice smelling job of cleaning, but takes more effort.
BTW, it appears the penalty for ignoring the sleep apnea is a measurable (by blood test) impact on my left ventricle. I should have acted 10 years ago. My best friend from college was found cold and dead in his favorite chair at home. It appears sleep apnea finally caught up with him.
I forgot to add, my machine is about eight years old, but I didn’t use it much in the first five years I had it. It wasn’t until I got hit with Covid, then Long Covid, that I started using it regularly. Now I use it every night, even during the day at times too.
My latest is the Air Sense 11 and I would not accept anything else the ResMed machines are what the VA contracts for and they have them in stock nationally. I don’t think you would have a problem with getting a Rx as long as you are going to pay for it yourself..
I just recently happened upon a website called SleepHQ.com. It's run by a fellow out of Australia, and he also has a YouTube channel called "CPAP Reviews." I highly recommend it. Since CDMA/3G went bye bye, data is no longer transmitted to ResMed, or anyone else. The only way now to upload data is via the SD card in the machine through your computer, and that's what I do with that website.
When I did, I saw that my early AHI levels were through the roof. It really scared me. Now after a couple of years of using it every night, my levels are regularly between 0.9 to 2.0, though during my hospitalization in Feb 2022 the AHI levels were closer to 10.0, and this past December when I was ill, it was close to 4.0. So I'm now taking this very seriously.
OH, and I forgot, right before I retired last year a co-worker and friend also died from severe sleep apnea. He also was found dead on his couch by his wife one night. Something else I didn’t know is that not only do you stop breathing, but your heart will also stop beating. THAT’S SCARY!
That’s good to know that the VA contracts for ResMed. That should make it easier to get a newer one. Thanks for that information!
I’m down about 45 lbs and my apnea has improved greatly.
Thanks for posting this.
You are very welcome. Sleep apnea is a serious condition, and for the longest time I ignored it. No longer. I am taking it very seriously now.
From what I’ve heard, it was those CPAP cleaning machines that caused the foam to degrade and cause problems. Those who never used those things never had a problem.
That’s what I’ve been lead to believe anyway. I took mine apart before sending the recalled one back and it was like new even after years of use.
I don’t see how Philips could have foreseen this happening.
Be careful using the ozone sanitizer. I was advised that if the ozone is routed through the machine tclean the humidifier, it will destroy the electronic components of the machine. I learned this after trying to have my CPAP repaired when it stopped working. Now I only use the ozone for the hose and mask…
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