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[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
The infomercials are already airing in the North Georgia (Atlanta) area market.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
FDA reclassifies positive airway pressure as a Class II medical device:

The FDA generally classifies medical devices based on the risks associated with the device and by evaluating the amount of regulation that provides a reasonable assurance of the device’s safety and effectiveness.

To read more about Class 2 medical devices, you can go to this link:

https://aasm.org/fda-reclassifies-positive-aiway-pressure-class-ii-medical-device/ 

The Foam used by Philips;

Philips has stated that it used polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices. 

Polyurethane (PU) is a composite material made of: (1) one or more layers of polymer resins joined by urethane links; and (2) a woven or non-woven textile backing such as polyester, cotton, nylon, or ground leather. ... This makes the fabric water-resistant, lightweight and flexible.

For a very high level of scientific info on this product, you can go to this link. I found this to be some scary stuff.

https://www.science.gov/topicpages/p/polyester+based+polyurethane.html 

Here is just one teaser quote from this paper;

Polyurethane (PUR) is a polymer derived from the condensation of polyisocyanate and polyol and it is widely used as a base material in various industries. PUR, in particular, polyester PUR, is known to be vulnerable to microbial attack. Recently, environmental pollution by plastic wastes has become a serious issue and polyester PUR had attracted attention because of its biodegradability. There are many reports on the degradation of polyester PUR by microorganisms, especially by fungi. 

 
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
"Polyurethane (PUR) is a polymer derived from the condensation of polyisocyanate and polyol and it is widely used as a base material in various industries. PUR, in particular, polyester PUR, is known to be vulnerable to microbial attack. Recently, environmental pollution by plastic wastes has become a serious issue and polyester PUR had attracted attention because of its biodegradability. There are many reports on the degradation of polyester PUR by microorganisms, especially by fungi."


In other words it has no place in a medical device....

DARN DARN I really do not like ResMed Air Curve 10 ASV....and I do not like that they TOO have some kind of foam in their fans.

SO at this point as I need ASV I am between a rock and a hard place. ONLY Phillips and ResMed make them.

In my book both companies are risking our lives by the use of ANY foam.

So bottom line: I have Dreamstations, I can and have removed the foam with no out of pocket cost. Lucky I found no visible evidence of deteriorating foam in either of my machines.

To get a ResMed Air Curve 10 ASV I have to buy it, even a used refurbished model costs $1300.00. That is too big a hit for a machine I do not get along with. Especially with foam in its fan housing.

Any damage I may suffered has been done, there is no way to undo it.

I can only hope as I am not showing any changes in my health that there were no damage done to me.

Time will tell for all of us.

I will stick to the devil I know.

At least we now know about Phillips danger from their foam.

Rich
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Ok everybody needs to take a deep breath here... Our cpap machines/filters/hoses/masks are obviously made of all sorts of different plastics & metals, any and all of which have some scary-sounding latin chemical name.

The whole purpose of the machine is to take air at room pressure and speed it up and blow it into your mask. In order for that to work the air must be contained somehow. And keeping the machine quiet enough that you can actually SLEEP is a non-negotiable part of the process.

What matters is what particular substance each material is -- not just the fact that there are materials in the system. ("ResMed has foam too!" is not particularly helpful.) What matters is exactly what material is used in which place in the system, and what stresses those materials are under when we use the device.

It may be that -- just like we need to change that 10-cent filter every month -- there are larger parts that last a finite time and start to deteriorate and will need to be replaced on some timeframe of years-in-service or usage-hours. Nothing last forever, we don't expect things to last forever -- and this fundamentally appears to be a case where the engineers didn't realize that a particular component would wear out faster than they planned because they didn't fully and accurately understand the entire range of stresses that the component would be under. That is fundamentally different from the dichotomy of "good" vs "evil" materials.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Well said and rational. Thank you
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Just in case those who have been using ozone-based cleaning methods have not already heard their company's response to the Philips recall, here's a summary from several companies.

Philips has put a lot of blame for its recall on ozone cleaning companies, however SoClean has mentioned a significant flaw in that blame: 

80% of PAP users DO NOT use an ozone cleaning method,
so why is Philips recalling all their machines too?  

SoClean is therefore implying that the problem is solely to do with Philips' design, composition and placement of its foam - and perhaps not realizing that users might continue to use their systems well past five years.

It's highly doubtful that Philips (or any other company) would spend US$600+ Million (to start) because it's a nice cautionary thing to do, just in case their might be a problem for an end-user.  But that is certainly good "corporate speak", highly influenced by Philips' in-house legal department.


Quote:SoClean is standing by its CPAP cleaning device, after Philips said “unapproved cleaning methods, such as ozone,” may be exacerbating the degradation of sound abatement foam in its first-generation DreamStation product family.  Philips made the claim as part of a voluntary recall announced June 14 to address identified potential health risks related to the polyester-based polyurethane foam in certain Bi-Level CPAP, CPAP and mechanical ventilator devices.  “Almost all the machines affected by this recall have no connection to an ozone cleaning device,” the company [SoClean] said in a statement. “SoClean stands behind its product and its use. SoClean will continue to monitor the situation and will provide further updates as needed.”

Philips says potential health risks include that the foam may degrade into particles that may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals.

SoClean points out that, based on its market share data and the number of installed CPAP devices, the large majority of patients do not use the company’s cleaning device.  “While SoClean would love for all CPAP users to use a cleaning device, nearly 80% of all CPAP users do not,” the company said. “Philips also notes that high heat and humidity environments may contribute to foam degradation.”  

Additionally, SoClean points out the recall also impacts certain vents, and SoClean does not make a cleaning device for vents.  “Clearly this recall, by Philips’ own admission, was not precipitated due to the use of cleaning devices,” the company said.

It’s not the first time SoClean and Philips have crossed paths over the use of ozone to clean CPAP devices. In early 2020, Philips said in a letter responding to a customer’s request for written guidance on the use of CPAP cleaning devices that using SoClean on its DreamStation would not automatically void the warranty, but that the company “reserved the right to void a warranty if it is determined that the use of SoClean caused a defect for which a device otherwise under warranty was returned.”


Kyle Miko, vice president and chief marketing officer for VirtuOx [VirtuClean], says Philips’ comments about the use of ozone do not apply to the company’s CPAP cleaning device, because its device does not attach to the CPAP. 

PJ Ruflin, vice president of business development for Sunset Healthcare Solutions, which launched a CPAP cleaning device last year, says the company is “listening to customers to ensure we understand the situation as best as possible and are doing what we can to assist them in managing it.” 

Jackson Buchanon, director of business development for Sleep8, says its cleaning device does not flow ozone over the foam in the CPAP. “We have been in contact with all of our DME partners and are focused on supporting them as they navigate this challenge.”

Responsive Respiratory Inc. says its Purify O3 and Purify O3 Elite are designed for disinfecting and deodorizing accessories like masks, tubing and humidification chambers and not CPAP devices. “This recall does not correlate to RRI’s family of Purify O3 devices,” it says. 
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
That is fundamentally different from the dichotomy of "good" vs "evil" materials. I have never read anybody on this thread using that language. I think for the most part all we care about are real facts, based on real science. and saying Sh.. just happens does not serve to help or explain anything.

Please see the following statement:


Amsterdam, the Netherlands – Following the company update on April 26, 2021, Royal Philips(NYSE: PHG; AEX: PHIA) today provides an update on the recall notification* for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices. The majority of the affected devices within the advised 5-year service life are in the first-generation DreamStation product family.


To date, Philips has produced millions of Bi-Level PAP, CPAP, and mechanical ventilator devices using the PE-PUR sound abatement foam. Despite a low complaint rate (0.03% in 2020), Philips determined based on testing that there are possible risks to users related to this type of foam. The risks include that the PE-PUR foam may degrade into particles that 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 the use of unapproved cleaning methods, such as ozone,** and high heat and high humidity environments may also contribute to foam degradation. 
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Well, THAT doesn't surprise me. My (industrial chemist) mother did say it was probably that type of foam.

And of course, the ozone cleaning companies would say that - because admitting it publicly would be suicide for them. The fact is that ozone is KNOWN to hasten the breakdown of certain plastics and other materials, for the exact same reason it's used to "clean" things - Ozone is very reactive, even with things that are normally NOT very reactive. The fact is, they're an unnecessary risk at best and potentially harmful to you and the machine at worst. Ozone is ALSO known to cause lung damage and so on and has been demonstrated to be present in harmful levels in and around CPAP devices even after supposedly being "vented" out.

Also, seconding CathyF's post. Not all foam is the same. Also, the foam doesn't contain "toxic gases". You can't go and tear up the foam and release gases from it. It can be chemically broken down to form a gas, yes, but the foam doesn't contain any gases, just in the same way that salt doesn't "contain" chlorine gas. Sure, if you broke down the salt in the right way, you might get some chlorine gas, eventually - but day to day, salt is not only safe for most people, it's necessary for life. If the ResMed isn't using PE-PUR foam, then it's absolutely not the same risk. Especially if you don't pump ozone or ultraviolet down into your machine!


See my comparison of Viatom/Wellue and CMS50F oximeters here.

Not a doctor, definitely not your doctor, all advice is given as-is and represents simply my own understanding as a fellow patient and OSCAR user.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Worth watching again...

TheLankyLefty27's YouTube video putting Ozone CPAP Cleaners to the test.
I Changed my Mind About Ozone CPAP Cleaners: SoClean 2, VirtuClean...etc.

My thoughts...
Ozone cleaner - convenience or laziness? Laziness in my book.
Ozone cleaners don't remove bodily fluids and particulate residue from your equipment. Yuck!
No way am I going to run poison through my CPAP equipment that I breathe through every night.
No way am I going to run ozone that's known to degrade certain plastics through my $2,300 (out of pocket) CPAP equipment.
No way am I going to run an ozone cleaner through my equipment that can void my factory warranty.

Ozone cleaners run ozone through parts of the CPAP equipment where it is completely unnecessary to do so. It's a closed circuit flow which in my book, means it will be regurgitating airborne schmutz into parts of the machine that would otherwise be pristine if left alone.

I have little doubt that ozone cleaners are the biggest culprit behind the Philips foam debacle resulting in major health problems. I have no doubt that the finger will be pointing back and forth between Philips and the ozone machine manufacturers, and the one with the deepest pocked lawyers will probably win.

On a side note: Our dear friend who was suffering severe health reactions from her SoClean sanitized DreamStation is experiencing great sleep again with the REMstar machine I was able to find for her. She is so thankful to get some good sleep without worry.

Technically I don't directly have a dog in this fight. But I do have very high interest due to our friend who has suffered greatly.
RayBee

~ Self-Treatment - via ApneaBoard experts.
~ Self-Pay - no help from Kaiser other than getting my script, then a pat on the butt and out the door.
~ Self-Educated - via ApneaBoard experts and its many users.
~ Using a 2018 MacBook Pro running Mojave.
~ Pay no attention to the dog behind the cup, he ain't a docta, and does not give medical advise.

I-love-Apnea-Board
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Remember what Philips has said;

Philips determined based on testing that there are possible risks to users related to this type of foam. The risks include that the PE-PUR foam may degrade into particles that may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals.

The majority of the affected devices within the advised 5-year service life are in the first-generation DreamStation product family.

They recreated the problem in their lab, they were not using any cleaners at that time. If they were that would be their lead story.

They did say that " The foam degradation may be exacerbated by the use of unapproved cleaning methods, such as ozone,** and high heat and high humidity environments may also contribute to foam degradation.  

This problem goes back at least 5 years, who really knows.

Philips has decided to voluntarily issue a recall notification. I personally think they were being squeezed to do that or the government would step in and issue a mandatory recall order. No proof, just thinking out loud.


As far as cleaning, I am back to where I started, using soap and water, and air drying.
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