Could Most CPAP/APAP Machines Have Foam Degradation Risk?

[Lane101]

Wondering out loud here if most of the CPAPs out there present a foam degradation risk to users and that perhaps Phillips is the first manufacturer to come clean in acknowledging the risk. The fact that in early 2020 ResMed voided its warranties when ozone based cleaners are used implies that they may have experienced some similar degradation issues to those driving the Phillips recall. The Phillips recall implies that the use of ozone cleaners accelerates what may be a naturally occurring process in all machines as they age as the recall notice also notes that heat and humidity can accelerate the foam deterioration along with a reminder that machines should be replaced after 5 years.

On this last point I just posted regarding foam degradation on a 14 year old Puritan Bennett GoodKnight 420G ( viewtopic/t182290/Warning-Foam-Degradat ... Units.html ). It seems that most machines have foam somewhere in the air flow path - saw recent posts from a ResMed owner who disassembled a unit. When tearing down an old ZzzPap (made by Apex Medical) purchased in 2009 almost all of the air inflow to the blower was via a foam channel. Note that the ZzzPap foam did not appear to have deteriorated, though it was dusty - in the case of this unit the blower failed after roughly 8,000 hours of use over 9 years (travel unit). As implied by the Phillips recall significant risk also comes from gasses given off by the foam prior to any visibly noticeable deterioration. Glad I only used the 420G a few nights a year for camping since 2015.

Surprised that prior to the Philips recall there are very few posts regarding foam degradation/particles from a CPAP. Phillips noted that complaints on this issue were .03 of one percent - roughly 1,200 complaints on four million units sold. Suspect that unless you are one of the few who will tear down a machine, as I did with my old 420G, you would not realize that your foam was bad.

Others thoughts on this? Has anyone else confirmed that the foam in their machine has deteriorated?

[chunkyfrog]

Of course you are concerned.
So far P/R is the only company to alert outside of the ozone interaction.
Spontaneous foam outgassing normally occurs within the first few weeks,
diminishing to undetectable after a short time--until entropy sets in.
This is likely the case with most other brands-they may have access to better foam.
And they all want you to get a new machine as soon as possible.
Is anyone thinking that Respironics got a little greedy?

[Dog Slobber]

The problem isn't (necessarily) that there is foam in these devices, nor that foam may degrade. What is important is causes of degradation of the foam, expected time frame with reasonable use and the byproducts left or created when the foam does degrade.

What we know:

• ResMed's do have foam within them
• ResMed had made a statement indicating it uses a different material for sound abatement
• We can infer that Ozone does accelerate the breakdown of some material with ResMed's
• Philips' foam has known carcinogens
• The foam they use is susceptible to accelerated break down from ozone and high heat and humidity

We do not know:

• If ResMed's foam is susceptible to accelerated break down because of Ozone
• If ResMed's foam is susceptible to accelerated break down because of high heat and humidity
• If ResMed's foam is comprised of a known carcinogen

ResMed is well aware of the circumstances or Philips recall and claims their products are safe, this suggests that the circumstances that are responsible for Philips problems are not present in ResMed's. And yes, I'm aware that companies can be dishonest, but you can be damned sure that *ALL* getting caught lying about this will cause them more problems then lying would.

ResMed specifically singling out Ozone disinfectors and suggesting cleaning according to instructions a while ago, will go a long way to protecting them from expensive recalls and litigation.

There's a reason that Rhilips is forcing everyone to answer whether they have used an Ozone disinfection device when registering for the recall.

I suspect everybody who answers "Yes", will have a financial shock sometime in the future.

[Lane101]

Thank you Dog Slobber, like how you organized what we know.

Just noticed this post on the ResMed Airsense 10 from September 2019. Multiple users of this device reported green particles in the humidifier that appear to be from degradation of the green sound insulation foam. Appears some of those reporting the issue were using an ozone cleaning device (SoClean). Link below. Good evidence that the Ozone cleaners do cause the ResMed foam to deteriorate. Also, per WRX03, other machines including Dreamstation observed with the same problem back then.

viewtopic/t177081/Particles-in-Humidifi ... +particles

[Dog Slobber]

Just noticed this post on the ResMed Airsense 10 from September 2019. Multiple users of this device reported green particles in the humidifier that appear to be from degradation of the green sound insulation foam. Appears some of those reporting the issue were using an ozone cleaning device (SoClean). Link below.

viewtopic/t177081/Particles-in-Humidifi ... +particles

Let's assume that those particles are foam from within the device, and let's assume that Ozone is responsible, which BTW I believe both to be true.

Do you believe ResMed's should be recalled, and at whose cost?

[chunkyfrog]

It remains to be seen whether the ozone scammers can be held liable for damages . . .
Sorry about that.

[zonker]

... and at whose cost?

william shatner, of course.

[amenite]

... and at whose cost?

william shatner, of course.

Why do I hear a disembodied voice of a starship captain saying "it's gonna be big. It's gonna be real big!"

[zonker]

... and at whose cost?

william shatner, of course.

Why do I hear a disembodied voice of a starship captain saying "it's gonna be big. It's gonna be real big!"

[LSAT]

If this was a widespread problem, the FDA would be involved...this is a voluntary precautionary recall. To my knowledge of the 4 million machines out there. no reports of cancer or lung problems.

[chunkyfrog]

But it appears they have caused a lot of PANIC.
Shame on them.

[Firemonkey]

If this was a widespread problem, the FDA would be involved...this is a voluntary precautionary recall. To my knowledge of the 4 million machines out there. no reports of cancer or lung problems.

Reminds me of a discussion I once had with an attorney, because my local water company had routinely (over 2 years straight) had measurements in their water quality reports that were well outside EPA defined limits. Their only action over the 2-3 years of violating maximum levels was to “engage with a consultant regarding the situation”

I wanted to help change the economics for the water company, so I contacted an real estate attorney I knew, and asked if they had a referral for someone that could help me convince the water company to fix the issue. They explained that these sorts of cases were extremely difficult to bring, because while people were certainly being harmed by the water (otherwise max limits wouldn’t exist), there were no dead bodies or sick people that you could attribute specifically to the water as a cause. And because the effects of the toxins was cumulative, it would likely take many years before you had any, which the water company knew. It’s absurd that a company can admit doing damage (delivering water containing compounds that are outside safe standards - or blowing foam and carcinogens into your lungs in this case) but until someone dies you can’t demand relief or remedy.

I’m still using my system one even though it’s affected, but the scale of this thing makes it obvious the risk of doing so is very much real. Real enough that it’s worth upwards of half a billion dollars for PR to make it go away before someone does die - because that changes the economics and legal landscape immediately.

[chunkyfrog]

Water quality is a real estate problem.
Home buyers would think twice if they knew what they might be buying into.
Real estate generates taxes, making it a problem for local government.
The internet can be used to spread the ugly truth without a pile of money.
Everybody uses water.
Not so with cpap--but here we are--on the internet.
We will see what happens . . .

[Lane101]

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.

[klm49]

But it appears they have caused a lot of PANIC.
Shame on them.

You prefer they did nothing?