Could Most CPAP/APAP Machines Have Foam Degradation Risk?

General Discussion on any topic relating to CPAP and/or Sleep Apnea.
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klm49
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Re: Could Most CPAP/APAP Machines Have Foam Degradation Risk?

Post by klm49 » Sat Jun 26, 2021 2:09 pm

Lane101 wrote:
Sat Jun 26, 2021 1:26 pm
Just found this on the ResMed web site. Relevant to this discussion thread. Link at https://www.resmed.com/en-us/other-manu ... call-2021/ .

Have been researching to figure out the safest option in place of my Dream Station APAPs. Looking at all the details below and experience with foam degradation in other manufacturers units (my old GoodKnight unit's foam disintegrated) noted above there is a strong possibility that there is risk with many of the machines out there regardless of manufacturer. Phillips may be the first to "come clean" about these risks because they can more easily absorb the recall costs since they have much higher corporate sales from a broad range of products. Other manufacturers that are more dependent on sleep therapy sales may be more resistant to a recall that could be more damaging to their bottom line.

Per ResMed under Frequently Asked Questions:

"ResMed devices use two foam materials that are different than the foam material Philips says are in its recalled machines. ResMed devices use polyETHER-urethane or silicone foams for sound abatement; Philips has said it uses PolyESTER-based polyurethane for sound abatement. The foams used by ResMed in its devices are safe for patients when following the device’s instructions for use. ResMed devices are not subject to Philips’ recall."

"ResMed’s AirSense 10 device contains foam located within the device airpath to minimize noise produced by the device during therapy. Based on the AirSense 10 device design, air can safely pass around or through the foam during therapy, with the majority of air passing around the foam. We have not observed the issues that Philips is reporting with its devices;"

Note that ResMed states that the foams used are only safe when "following device's instruction for use" - guessing that could imply they are unsafe if an ozone cleaner, that now voids the warranty, is used. Per above post ozone cleaners caused ResMed machines to generate particles. Second statement by ResMed is somewhat contradicted by posts from ResMed users who found particles and ResMeds action of voiding warranties when ozone cleaners are used.

From the Polymer Properties Database at https://polymerdatabase.com/Elastomers/PUR.html :

AU (PolyESTER) & EU (PolyETHER)– polyurethane

"Properties

Cast polyurethanes can be divided into two main classes; polyester (AU) and polyether urethanes (EU). Many polyurethane elastomers are based on diphenylmethane diisocyanate (MDI). These elastomers have outstanding tensile strength, tear and abrasion resistance. They also have good resistance to oxidation, ozone, aliphatic solvents, and petroleum based fuels and oils. The electrical properties, the compression set and the creep properties are only fair and the heat resistance is poor.

The physical properties of polyester urethanes (AU) are somewhat better than those of polyether urethanes (EU); whereas EU elastomers have better chemical resistance and better low temperature flexibility but are more expensive and are sensitive to ultraviolet light. For example, polyesters can be affected by hot water, high humidity and their resistance to acids and alkalis is rather poor. They are also prone to microbiological attack. EU elastomers, on the other hand, have poor resistance to oxidation and heat."

Per this summary it appears that there are material differences between the two foams and one can draw the following possible conclusions:

1) Both have similar resistance to ozone (resistance for both noted as "good") per the above but per user reports and CPAP manufacturer recommendations not enough resistance to prevent problems when ozone cleaners are used
2) The AU used by Phillips is more susceptible to degradation from high humidity, a risk factor noted in the Phillips recall.
3) The EU, that is the type of foam used by ResMed, is noted as having "poor resistance to heat and oxidation". If Phillips, using the more heat resistant AU, notes that heat is a risk factor for foam degradation couldn't machines with the EU foam have an even higher risk of heat induced foam degradation?
4) ResMed appears to be dancing around the fact that it may have some issues in this area.

If anyone has a technical background on the above please chime in. A quick look at silicone foam indicates that it may be much more resilient/safer than polyurethane per foam manufacturers web sites.

Bottom line the above details imply to me that there are risks with air flow going through either of these polyurethane foams. It seems that most of the major manufacturers designed air flow paths that run through some type of foam. Phillips, ResMed, ApexMedical/ZZZPap, old Puritan Bennett GoodKnight 420 units. Devilbiss Intellipap also does this. Perhaps an independent third party needs to further evaluate machine safety in this area and future machine designs should at least isolate any foam behind a more resilient/solid air flow path material?

In my case I happen to also own a 2 year old fixed pressure Intellipap CPAP purchased 6 months before my doctor moved me to APAP. Since either CPAP or APAP works for me I've switched back to the Intellipap until Phillips can repair or replace my Dream Stations based on my doctors advice. Don't plan to buy a Dream Station replacement from another manufacturer given that my Intellipap works and I suspect that the eventual Phillips recall repair/replacement could be safer than any replacement machine I could buy today given the above information. Realize that calculus will be different for others given personal needs/situation.

P.S. I called the Phillips 1-877 number yesterday. Pending regulatory approval they can't provide any additional information on recall next steps and timing beyond registration of our affected machines.

Could it be that Resmed's lawyers decided their statements about Ozone and cleaners is enough to cover any liabilities and Philips' lawyers decided it best to come out on the matter and do the recall? My first Sleep Dr. told me they were dishonest.

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zonker
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Re: Could Most CPAP/APAP Machines Have Foam Degradation Risk?

Post by zonker » Sat Jun 26, 2021 4:01 pm

Lane101 wrote:
Sat Jun 26, 2021 1:26 pm
Just found this on the ResMed web site. Relevant to this discussion thread. Link at https://www.resmed.com/en-us/other-manu ... call-2021/ .

thank you for this!

i just cross posted your ps about the next steps. and i put a link there to this thread, just in case folks aren't reading this.

good work, lane101.
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Re: Could Most CPAP/APAP Machines Have Foam Degradation Risk?

Post by Coffee Man » Mon Jul 05, 2021 6:18 am

The foam in the ResMed AirSense 10 is really easy to remove. It is not glued in place. I removed it after watching a YouTube video. Despite being called "sound abatement foam", I don't think there is any noticeable difference in sound since I've been using the machine without the foam.

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Re: Could Most CPAP/APAP Machines Have Foam Degradation Risk?

Post by Dog Slobber » Mon Jul 05, 2021 8:30 am

Coffee Man wrote:
Mon Jul 05, 2021 6:18 am
Despite being called "sound abatement foam", I don't think there is any noticeable difference in sound since I've been using the machine without the foam.
The sound abatement foam may not have any noticeable difference in sound, now. On relatively new machines with nicely aligned parts, smooth bearings, and little shifting due to expansion and contraction, machines are a lot quieter.

As the devices age, vibrations start to present, the foam is likely to become increasingly important.

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Re: Could Most CPAP/APAP Machines Have Foam Degradation Risk?

Post by Coffee Man » Mon Jul 05, 2021 12:12 pm

Dog Slobber wrote:
Mon Jul 05, 2021 8:30 am

The sound abatement foam may not have any noticeable difference in sound, now. On relatively new machines with nicely aligned parts, smooth bearings, and little shifting due to expansion and contraction, machines are a lot quieter.

As the devices age, vibrations start to present, the foam is likely to become increasingly important.
Judging by the size and location of the piece of foam in the ResMed AirSense 10, I am skeptical that it provides any sound abatement at all. In a new machine, or an old one.

I just wanted to let people know that it is easy to remove the foam from the ResMed AirSense 10. I know ResMed is saying the foam is safe, and that it reassuring. I personally feel better that I removed the foam from my machine.

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Re: Could Most CPAP/APAP Machines Have Foam Degradation Risk?

Post by palerider » Mon Jul 05, 2021 5:07 pm

Coffee Man wrote:
Mon Jul 05, 2021 12:12 pm
Dog Slobber wrote:
Mon Jul 05, 2021 8:30 am

The sound abatement foam may not have any noticeable difference in sound, now. On relatively new machines with nicely aligned parts, smooth bearings, and little shifting due to expansion and contraction, machines are a lot quieter.

As the devices age, vibrations start to present, the foam is likely to become increasingly important.
Judging by the size and location of the piece of foam in the ResMed AirSense 10, I am skeptical that it provides any sound abatement at all. In a new machine, or an old one.
Resmed didn't spend the money to have that bit of foam manufactured, added to the Bill of Materials, and have it inserted in manufacturing just to increase expense, they did it for a REASON, you may not understand what that reason was, but they had a reason. Resmed spends time engineering their devices, and they are some of the better, if not best, engineered machines.

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Re: Could Most CPAP/APAP Machines Have Foam Degradation Risk?

Post by Coffee Man » Mon Jul 05, 2021 5:52 pm

If the reason they added the foam was sound abatement, and it does not perceptibly abate sound, then I don't see the point of the foam being there in the first place.

I just said I'm more comfortable having removed the foam. All it took was a screwdriver, after all. I don't see why this is generating so much ire!

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Re: Could Most CPAP/APAP Machines Have Foam Degradation Risk?

Post by palerider » Mon Jul 05, 2021 8:23 pm

Coffee Man wrote:
Mon Jul 05, 2021 5:52 pm
If the reason they added the foam was sound abatement, and it does not perceptibly abate sound, then I don't see the point of the foam being there in the first place.

I just said I'm more comfortable having removed the foam. All it took was a screwdriver, after all. I don't see why this is generating so much ire!
Because just because you don't hear anything doesn't mean that there isn't something there, if you'd stopped at saying "I didn't notice any difference" then it's doubtful that anyone would have bothered to reply.

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Re: Could Most CPAP/APAP Machines Have Foam Degradation Risk?

Post by Dog Slobber » Tue Jul 06, 2021 6:41 am

Coffee Man wrote:
Mon Jul 05, 2021 5:52 pm
If the reason they added the foam was sound abatement, and it does not perceptibly abate sound, then I don't see the point of the foam being there in the first place.
This was explained to you. The foam may not be necessary on relatively new machines, but important on old machines.

This is why old cars make more noise than new cars, old shop tools make more noise than new shop tools, old computer fans and hard drives make more noise than new fans and hard drives.
I just said I'm more comfortable having removed the foam. All it took was a screwdriver, after all. I don't see why this is generating so much ire!
And nobody here has a problem with it, We're not trying to get you to put the foam pack in. But you're telling others that it's not doing anything, and doesn't have a role. Before others try it they should know all the facts.

There is no ire, you just don't want your opinion challenged.

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Re: Could Most CPAP/APAP Machines Have Foam Degradation Risk?

Post by MartinGuitars » Fri Aug 27, 2021 5:01 pm

This was a very good post. I sit here confused, often angry, mostly worried. I have had cancer twice, lost my dad to it and I am two years from his age.

Aside from my moaning - here is my wonder - - - - why in the hell would anyone use anything for sound? Why not make the unit thicker huh? I was just about to have to buy a ResMed because it will take six months to get though the hoops at Medicare and I was waking the first night gasping for air.

So Resmed says they use polyETHER-urethane or silicone foams - - - OK I am not genius but there has to be a possibility this will do the same thing in time. I do not want to replace my unit every 5 years because it could start giving me cancer. I want to change the unit cause you just need a new one in five years. Better tech.

We need a doctor on here - someone who can talk about polyETHER-urethane or silicone foams and why anything is needed when we have to take air 10,000 times per night.

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Re: Could Most CPAP/APAP Machines Have Foam Degradation Risk?

Post by rdfry » Fri Aug 27, 2021 5:40 pm

Are you using an ozone cleaner? That is what is causing the damage. Resmed does not use the same foam as Philips and is not and will not be having the same problem. I have been using resmed xpaps for over 20 years. They are the best machines on the market.
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Re: Could Most CPAP/APAP Machines Have Foam Degradation Risk?

Post by chunkyfrog » Fri Aug 27, 2021 6:53 pm

There are hundreds of unique formulas for foam plastics.
Many are engineered to function inside the human body as part of a medical device.
Some of those are in the polyurethane family; others are not.
Responsible companies will research and test every material they use.
I guess Respironics is not one of those companies . . .

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Re: Could Most CPAP/APAP Machines Have Foam Degradation Risk?

Post by Lane101 » Sun Sep 05, 2021 12:18 pm

Adding a link to LSATs post "Could this be Foamgate 2" regarding use of Polyester foam by Devilbiss in it's DV5 Intellipap machines as this further supports concerns in this post that foam risk could be endemic to most machines manufactured and that Philips is the only manufacturer to really address the issue so far. Useful to have all information regarding possible manufacturer foam risks in one place. In my case my Devilbiss Intellipap is the Dreamstation backup I've been using since the recall so this is of direct concern.

Bottom line message from these posts/videos is that Devilbiss DV5 Intellipap machines use a lot of Polyester foam in the airflow pathway, the foam does appear to degrade when exposed to Ozone and Devilbiss just announced that it is withdrawing from the CPAP machine market. Devilbiss posted a notification that states its Polyester foam is OK because it hasn't seen complaints from users but also acknowledges that it hasn't tested the foam for Ozone degradation to be sure. CPAP reviews did see Devilbiss Polyester foam deterioration when it was exposed to Ozone. Per Devilbiss the DV6 (Intellipap2) line uses silicone foam so should be more resilient. Interesting that they decided to upgrade the foam quality in the newer model machines as have other manufacturers.

This adds to mounting evidence that many machines from manufactures other than Philips may present a similar foam degradation risk. Thank you to LSAT. Has anyone who uses a Devilbiss DV5 Intellipap experienced any foam degradation issues?

https://www.cpaptalk.com/viewtopic/t182 ... TE-2-.html

youtube video in the above post:
https://www.youtube.com/watch?v=ZXw3UwmHPc8

CPAP Reviews video regarding foam in Devilbiss machines and Devilbiss exit from CPAP market:
https://www.youtube.com/watch?v=lMrX6QEysJY&t=0s

Drive-Devilbiss 6/29/21 Notification on It's Use of Foam in CPAP machines:
https://www.drivemedical.com/medias/sys ... erica-.pdf

Paste of above Drive-Devilbiss notification text:

JUNE 29, 2021 STATEMENT ON DRIVE DEVILBISS HEALTHCARE’S
RESPONSE TO PHILIPS CPAP RECALL

On June 14, 2021, Philips issued a formal recall notification and field safety notice for
various models of its CPAP, BiLevel and Mechanical Ventilation devices, due to potential health
risks related to sound abatement foam used in the products. Philips reported that the
polyester/polyurethane foam used in its devices may degrade into particles that may enter the
device’s air pathway and be ingested or inhaled by the user, and that the degradation of the foam
may cause an off-gassing of certain chemicals. Philips also reported that the foam degradation
and potential off-gassing may be caused or exacerbated by the use of unapproved cleaning
methods, such as ozone devices, and from prolonged use in high heat and humidity
environments.

Drive DeVilbiss Healthcare has not identified any issues similar to the ones identified by
Philips. Our DV6 series CPAP devices use a silicone foam for sound abatement. This foam is
not related in material or design to polyester/polyurethane foams. In addition, although our DV5
series CPAP devices do use a polyester/polyurethane foam for sound abatement, there is a wide
variance in the mechanical and chemical properties of these foams based on their specific
formulations, the processes used to manufacture them, and the unique design and performance
characteristics of the devices in which they are used. Drive DeVilbiss performs constant,
continuous post-market surveillance and analysis of sales, service and repair data, which has not
detected any problems similar to the ones identified by Philips since the DV5 series was
introduced in 2007.

Drive DeVilbiss Healthcare notes that ozone cleaning devices are not approved or
regulated by the FDA (see the below links to FDA statements on these devices). We have not
performed any clinical, safety or validation testing of these devices, and we advise against using
ozone or UV cleaning with any of our CPAP devices. We recommend following only the
cleaning and disinfection instructions outlined in the device-specific user manuals.

FDA Public Notice: Ozone & UV CPAP Cleaning https://www.fda.gov/consumers/consumer-
updates/cpap-machine-cleaning-ozone-uv-light-products-are-not-fda-approved

FDA Public Notice: Risks of using Ozone & UV CPAP Cleaning Devices
https://www.fda.gov/medical-devices/saf ... iated-use-
ozone-and-ultraviolet-uv-light-products-cleaning-cpap-machines-and

Drive DeVilbiss Healthcare takes this situation very seriously, and will continue to
analyze and monitor the issues very closely.