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Philips CPAP Foam Degredation Issues May Be Linked To Ozone Cleaning Devices

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Manufacturers of devices used to clean CPAP machines are trying to put distance between themselves and a massive recall of Philips’ DreamStation devices, after the manufacturer suggested problems with sound abatement foam may be linked to ozone cleaning devices, like SoClean.

Earlier this month, a massive Philips CPAP machine recall was issued for millions of devices used by individuals with sleep apnea, as well as Bi-PAP and ventilator devices, due to foam degradation issues where particles from the polyester-based polyurethane (PE-PUR) sound abatement foam may cause respiratory and other health problems.

Philips has indicated problems with the CPAP foam breaking down could be exacerbated by unapproved cleaning products, which use ozone and high heat.

The recall also came just a few months after the FDA issued a warning to CPAP users and healthcare professionals not to use illegally marketed ozone gas or ultraviolet (UV) light cleaning products to disinfect or sanitize CPAP machines.

These two events have raised questions as to whether there was a connection between the CPAP and ventilator recall and CPAP cleaning devices.

“The risks include that the PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone, and high heat and high humidity environments may also contribute to foam degradation,” Philips’ recall notice warned.

In a report published last week by HME News, which covers the medical equipment industry, interviews with multiple CPAP cleaning device manufacturers indicated they had no indication the recall was connected to any of their products.

Executives from SoClean, VirtuOx, Sleep8, Sunset Healthcare Solutions and others all said in the report that a connection to their devices is unlikely for a variety of reasons, or indicated they are still investigating the issue, but have not been informed there’s a problem.

CPAP devices provide steady air pressure through a mask or nosepiece, granting continuous positive airway pressure to prevent the user’s airway from collapsing, thus preventing constant broken sleep.

The devices are often used by those diagnosed with obstructive sleep apnea, which is a condition which causes a person’s airway to collapse during sleep, resulting in short periods of time where the individual stops breathing. Individuals suffering from sleep apnea have a greater risk of experiencing adverse health and heart problems. Typically, these individuals have a higher risk of suffering hypertension, stroke, heart disease and daytime sleepiness.

The FDA indicates it has received at least 11 reports of CPAP cleaning problems involving use of ozone or UV light products from 2017 through 2019, involving individuals who experienced coughing, difficult breathing, nasal irritation, headaches, asthma attacks and other breathing problems after using the unapproved products.

Meanwhile, Philips has received several complaints involving the recalled devices, 80% of which were DreamStation CPAP machines, causing patients headache, irritation, inflammation and respiratory issues after inhaling the polyester-based polyurethane foam, representing approximately 0.03 percent of devices sold in 2020.

Philips cited the FDA warning about cleaning methods in its recall notice. The company indicates it is working closely with regulatory agencies to determine the extent of the problems, and to provide customers a resolution which will include the deployment of updated instructions for use and a comprehensive repair and replacement program for the affected devices.

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17 comments

  1. Ed Reply

    this has def been an on going problem with me.

  2. Russell Reply

    I use both pieces of equipment and over the past year have developed a cough. My doctor has not been able to figure out what is causing the problem.

  3. George Reply

    I have been using Phillips CPAP’s for about 25 years. I have had 7 sinus surgeries, cluster headaches, asthma and stage 3 kidney disease. If all this was caused by my Phillips CPAP machine I WILL be getting a lawyer!

  4. Lydia Reply

    I have Been using this machine for 4-5 years and have developed breathing problems some shortness of breath and wheezing at times. I have sleep apnea and snored . After this I will discontinue both products

  5. Harold Reply

    I have used the philips dream station CPAP machine since 2016. I have used the SoCleanFilterKit machine since 2017. Neither company nor my CPAP doctor have ever brought to my attention any safety concerns about either product in these almost 5 years. The federal health saving account approved the purchase of the socleann machine as well as the CPAP machine. I have faithfully used the CPAP machine every night for at least 7 hours . The soclean machine has been used at least 99 % of the time since 2017.

  6. William Reply

    A month ago I woke up with the worst nasal irritation I have ever had. I sneezed and blew my nose for several hours that morning. The discharge from nose was clear and filled up paper towels I was using. Discharge was too much for tissue or TP. I was amazed at how much was coming out of nasal passages. Since then, I awake several times each night with an extremely dry mouth and throat. I do not use mask. I use the nose cushions!
    Any advice? My providers and doctors seem to be evasive and paranoid about discussing this with me!!!

  7. William Reply

    I have used Phillips CPAP machines for over ten years. I have used the So Clean device since 2017. I have experienced coughing, shortness of breath and headaches this past year. I have COPD and Asthma. The So Clean model I have, did not have advise to seek a Physicians opinion if you have COPD or Asthma. The 2018 So Clean booklet advises to seek a Physicians advice if you have COPD or Asthma prior to using the machine. I have been in contact with So Clean Corporate office and they know I have the manual without the warning. They asked if I had the receipt for the So Clean purchase in 2017, I do and they said they would get back to me. I had to purchase a new machine out of pocket, Medicare currently only replaces every 5 years. I have the Dream Station. I would like to be part of any class action suit. I am also looking for an attorney to address the So Clean issue.

  8. James Reply

    I have used the different cpap machines for the last 20 years with no problem.since I purchased the soclean unit approximatly three years ago my face masks end up with a dingy gray color and I can actually scrap scum from the inside of the mask

  9. Robert Reply

    Over the last 6 months I had a cough feeling like something is my throat, doctors can’t figure it out

  10. BONNIE Reply

    I have just learned about all the issues and terrible problems with the Dreamstation and soclean machine both of which my husband use, he just got off the phone with his sleep apnea Doctor and guess where this leaves him, in very concerning trouble, she is calling the company that supplied his machine to try to replace his but she said there is now a shortage on sleep apnea machines (the good ones) and it puts him at serious risk he stops breathing over 400 times in 8hours without the machine, even she is very worried about him without it, he already has heart problems, 2 stints, just been prescribed nitroglycerin for breathing issues, now the breathing issues may not even be his heart but these machines, oh my goodness what a mess this leaves so many people in, my heart goes out to everyone

  11. Albert Reply

    I use the Philips machine and the Sleep 8 cleaning device . I was wondering if the fact that the Cpap isn’t included in the cleaning process , just the mask , head gear , hose and water tank if the sleep 8 , would be the culprit or is it in the Philips machine itself .

  12. Natividad Reply

    I use both the dreamstation and soclean for the last 4-5 years and would not have added the soclean if this information would have been told to me. For the last 2 years I have nasal irritations, headaches, coughing and sore and scratchy throat I attribute to the CPAP as I am otherwise a healthy person.

  13. Timothy Reply

    For the past 2 to 3 years I’ve been using the Phillips Dreamstation, I got diagnosed with severe OSA and it was imperative according to the nurses after my sleep study that I needed to be on a CPAP and to consult with a doctor right away. And I did right away, he explained I stopped breathing many times a night and if I don’t get on a CPAP immediately I could have a heart attack or other major health issues.

    So I did my due diligence and research, and I got the best sleep apnea machine out on the market. Which was the good ole Phillips Dreamstation. I started feeling really sick in Dec of 2020 short of breath, severe headaches, chronic coughing, chest pains, high blood pressure, nausea, and just a real bad feeling something was wrong. On Dec 30th of 2020 I went to the ER, I couldn’t breathe, the headaches and cough were so severe that they admitted me. I spent 5 days in the hospital they told me I was possible suffering from mold exposure in my house and that I should move immediately. They discharged me on Jan 4th 2021 and they could not give me a definitive answer on what was actually wrong, beyond frustrating. Since then I’ve been very sick and still no answers. Now I think I realize what the problem was the whole time. I wish all of you the best and this is just so upsetting to hear the news of this today. But at least we know now, before it killed us. Best of luck to all of you and your health, register your device on http://www.phillips/src immediately, and obviously consult with an attorney and a doctor right away.
    Sincerely, -Tim

  14. DIane Reply

    Who ever thought of using ozone with plastic parts knows nothing about O3 where are the designers. Ozone is only used with glass parts due to the nature of the element O3 dissolves plastic and reacts dangerously with metal I wondered how So clean used Ozone as the fisenfectantdu to plastic materials. 0O3 is extremely good to disinfect air and water so muc more safe than any chemical cleaner I did not know ozone was the disinfectant until after purchasing I Expect a full refund of my $400 st the very least snd am feeling very fortunate the gaskets providing the seal immediately popped off rendering the do so clean unusable plastics degrade regularly I will follow through with the CPAP replacement. I pray not too many people we’re affected du to the so Clean. peace all

  15. Frank Reply

    I have used my CPAP for one year, at first i could smell chemical when taking my mask off in the morning. I mentioned to my wife and we just passed it off. Now we have a recall and no one can tell me when they will fix or replace it.
    I wish the medical field would tell me just what percentage of chance to have a health issue with it. That way I can determine if I need to buy a new one or not.

  16. Mike Reply

    Had the Dreamstation for a few years . Noticed a chemical smell . Thought it was from cleaning it. I discontinued using it . Three weeks latter they came out with their recall on the machine.. Had a sleep study done and found out my sleep was interrupted 35 times . I did register the machine for the recall. My new machine is on back order . What a disaster for a good night sleep

  17. David Reply

    I have been on my CPAP for 8 years, I purchased a soclean a couple of years ago because I kept getting infections. Now I find out the soclean is making or worse.

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