How do you try a new mask if they cannot be returned?

[sthnreb]

Respironics purchases the Comfort Gel from China. You are right Rock and Roll, no one polices them, it is self policing. The Comfort Gel mask was distributed by Respironics without a exhalation port. The report says, " The user instructions inform the patient that the mask contains an exhalation port and does not require the use of a separate exhalation device." As you read, However, the product was distributed without the exhalation port. It is likely that the patient will experience increased CO2 re-breathing and associated oxygen deficiency. In some cases, suffocation may result.
This is a direct quote from the FDA site. So, if it was distributed without the port, where was the FDA inspecting it as some insist? As you state, it is self policing, henceforth Respironics did place a recall on the mask. BTW, if anybody purchased one, you may want to check on it. I believe the dates were around September.
(Does this mean the FDA controls what China produces and sells in China?)

[MaskedMan]

Perhaps they don't say they are the best thing since sliced bread, but they do state things like:

"the most comfortable mask ever"
"virtually leak free"
"sleep in almost any position"

now, I understand fully - buyer beware and don't believe everything you read. However, when the claim turns out not to be true, we should have a recourse to return. Also, we all keep citing that we're talking about medical devices that have we say have to pass this rigorous design, testing, possibly FDA, etc - shouldn't that mean we should have a higher expectation from them? ie, they aren't $4.99 plastic bowls from Target. They are medical devices, expensive, supposedly tested, etc so their advertising, claims, and performance have an expectation of being more on target than that $4.99 plastic bowl. Perhaps they aren't doing anything unethical or illegal since they toss the words like "almost" and "virtually" and such in there, but definately there needs to be a recourse of returning the product.

[rock and roll]

You have to wonder if anybody at these companies actually sleeps wearing these things with a cpap testing them. Or are they supposed to work in theory?

[Janelle]

Rick, I don't have a lot of money lying around to buy a bunch of different masks, either. My insurance bought the first one which I couldn't stand, so I bought my own second one a month later, and have been quite satisfied with it. My insurance will buy me a second one now, and will continue to do so every 3 months. My DME TOLD me it would be cheaper to buy additional supplies online. But first I have to have the money to do it, right?
And I'm still trying to decide exactly which mask I want to buy. My 5 month old Swift is still working fine, although I'm beginning to detect that the pillows don't seem to inflate as well as when it was new, so I probably need to replace them, at the very least. BUT, do I want a different model or the same one?

When I expressed my displeasure with my first mask to my DME they said "They cannot be sterilized to be re-used". And she sincerely believed this. When it "broke" they offered to fix it, not replace it under warranty. I fixed it myself instead.

[sthnreb]

Hi Janelle,
I wasn't going to post anymore on the subject, but yours was so nice I had to. I'm retired and my insurance is not doing the best. For OSA, it had a $2500 lifetime limit. I guess they didn't see that as being very important. I had to have 2 sleep test because I didn't sleep much the first. They say they normally test the first half and try a mask the second. Well, I had to come back again for the mask and settings for a machine. Here they charged about $1000 per test, using $2000 of my limit. I was assigned a DME that rented me a machine and used the rest of the $$ in less than 2 months, wanting me to pay extra. They wanted $3400 for the bipap Duet that was discontinued that I had. I cancelled and got the bipap pro from cpap out of pocket ($1569). I have since bought 3 more masks searching for one I can sleep with (About $250). I have 5 more years until medicare will kick in. I bought another bipap pro II ($1569) to be sure to make it until then. What happened then? It would stop and start in the middle of the night, choking and waking me. When I finally got a RMA and returned it, they wanted to give me a used (refurbished) machine because over 30 days had passed. Now, if you bought a new car and it had 500 miles and the engine blowed out, would you want a replacement demo version with 15,000 miles and dings and maybe a smokers car? Not me. I had mine repaired as an option and long wait, not knowing how long it will last. I will use it the remainder of the warranty and then until it quits. I still have my bipap pro for backup. So, as you see, cost means a lot to me too. I'm near $4000 out of pocket now. I have one mask that is to big and one that is bulky, both uncomfortable. People telling me what a steal some of the masks are at $125 and all the FDA regulations, marketing, research, etc that goes into a piece of plastic and a strap just rubs me. If they work and do what they say, no problem. And what about the ones put up in the drawer never used but the package opened? Have you stuck your nose through a hole in a plastic wrapper yet? Bottom line is I can't just keep up with the "buy to try" philosophy.
I wouldn't be afraid to soak a mask in hot soapy water and use the cpap disinfectant cleaner on it and use it, provided it wasn't already worn out. I know new is best but sometimes you have to even wonder about those.

[Janelle]

And what about the people with no insurance, or like you who have a yearly or lifetime cap? How can the DMEs justify having you pay their entire charge?

There is Awake in America which takes used machines and masks and provides people free of charge with what they need. But the machines are almost always several years old, even though they refurbish and recondition them. But at least it is *there* for those who have no other choice.

There are also many people on this forum who would probably be willing to do mask trades. What else are they doing with those drawsful of masks. But I don't see them offering them up for loaners for tryouts and potential discount purchases.

Personally, I have a Breeze I'd practically give away!

I'd thought about the Comfort Curve but I'd have to readapt the hose to fit my 420E's sensor line. And I'm not even sure I could get it to fit. The Aura is out. I can't stand the midline headgear thought after the Breeze. I like the idea of the Activa and now that I don't mouth breathe anymore it is an option. But nothing else has touched my fancy. So I guess I'll just wait a little longer and see what else comes out, and wait and let those who can afford to buy everything new see how it works for them.

[ahujudybear]

Janelle?

Your DME person seriously needs to read the information that is packed with the Swift: Disinfection/Sterilization Guide, dated 3 04 06: (i think that's a date?, printed by ResMed in Australia)

"CLEAN the mask components by scrubbing with a soft bristle brush for one minute while soaking them in detergent (eg, Alconox). Pay particular attention to all crevices and cavities.
RINSE the components by agitating them vigorously in water and allow them to air dry out of direct sunlight."

Then follows three different procedures that can be used: Chemical Disinfection, Thermal Disinfection, and the STERRAD 100S Sterilization Process.

It also notes that ResMed testing has shown that the components can withstand 15 cycles of this disinfection or sterilization process.

"Note: the mask must be disassembled and cleaned prior to disinfection or sterilization.

Option 1: Chemical Disinfection:

SOAK the disinfectable components of the mask in a commercially available solution of glutaraldehyde 3.4% (eg, CIDEX Plus) or
ortho-phthaladehyde 0.55% (eg, CIDEX OPA) as described in the manufacturer's instructions.

RINSE mask components as described in the manufacturer's instructions and allow them to air dry out of direct sunlight.

Option 2: Thermal Disinfection

Using a certified hot water disinfection system, soak the disinfectable mask components for one of the following times:
- 158° F (70°C) for 100 minutes, or
- 167°F (75°C) for 30 minutes, or
- 176°F (80°C) for 10 minutes, or
- 194°F (90°C) for one minute."

[My own note: remember that that temperature must be maintained throughout the soaking time]

Option 3: STERRAD 100S Process requires the purchase of the Sterrad system.

In all cases it says to inspect the mask components. If there is any crazing, tears or cracking it says to replace that component. "Slight discoloration of the silicone components may occur and is acceptable."

Again, what do they think sleep labs do, throw out the mask after a person uses it for the night?

- JB

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CPAPopedia Keywords Contained In This Post (Click For Definition): resmed, swift, DME

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CPAPopedia Keywords Contained In This Post (Click For Definition): resmed, swift, DME

[ozij]

It also notes that ResMed testing has shown that the components can withstand 15 cycles of this disinfection or sterilization process.

I had a Swift with instructions that said something like "not yet FDA approved for multiperson use". Which I take to mean that in order to be used on more than one person, in the US without incurring liabilities, the masks have to have an FDA approval for that as well...

I was one of multi users on that mask... thinking Oh, well, we're not in the US, and maybe that instruction manual was old... it might well have been.

By now the Swift might have this approval, as, I am sure, other masks do.

Do you know that my PB hose says "not approved for multi person use"?
O.

[sthnreb]

I had a Swift with instructions that said something like "not yet FDA approved for multiperson use". Which I take to mean that in order to be used on more than one person, in the US without incurring liabilities, the masks have to have an FDA approval for that as well...

Just wondering, when I had my sleep test and titration, what about the masks they use? Are they disposable? I don't think so, at least not the one I used. I assume they disinfect them and use them over and over, otherwise it would be quite expensive. I know they didn't offer the one to me to keep as they would have to toss it anyway. One can only assume they reuse them.

[Guest]

I had a Swift with instructions that said something like "not yet FDA approved for multiperson use". Which I take to mean that in order to be used on more than one person, in the US without incurring liabilities, the masks have to have an FDA approval for that as well...

Just wondering, when I had my sleep test and titration, what about the masks they use? Are they disposable? I don't think so, at least not the one I used. I assume they disinfect them and use them over and over, otherwise it would be quite expensive. I know they didn't offer the one to me to keep as they would have to toss it anyway. One can only assume they reuse them.

[Guest]

Janelle?

Your DME person seriously needs to read the information that is packed with the Swift: Disinfection/Sterilization Guide, dated 3 04 06: (i think that's a date?, printed by ResMed in Australia)

There is a tremendous difference between being able to clean or even sterilize an item and it being okay to sell to another person.

Needles can be sterilized. Do you want someone elses needle?

If the FDA states that an item is single use only, then it doesn't matter how much it can be sterilized - it can not be dispensed once it is opened. It could be used as a demo model or it could possibly be given away although that raises a lot of legal issues if it's caught but it cannot be sold at all.

[sthnreb]

The masks are single use only and they do not reuse them.

So, I guess some of the cost of my titration then...$100 or so dollars was for a mask they threw away and never offered to me. (I guess they pay 5 bucks for them...a more realistic cost.)

[Guest]

The masks are single use only and they do not reuse them.

So, I guess some of the cost of my titration then...$100 or so dollars was for a mask they threw away and never offered to me. (I guess they pay 5 bucks for them...a more realistic cost.)

[sthnreb]

Yeah, it's just a piece of plastic with a strap attached. Can produce cheap. Look at plastic toys.... They get you by calling it medical. Medical plastic, latex, straps. It's still plastic and cloth with velcro. Once a mold is made, they can be mass produced. Surgicial and Medical grade plastic and straps (add $100)!!! FDA approved....cost...over $100. If sold near a real cost, yes, everyone could try different masks to find one that works well. And hey, Resmed thinks they are still to cheap to sell on internet. Just my opinion...and everyone has one Mr/Mrs Guest

[babamamagogodede]

I do not want to use my comfortable curve .I only used it 3 nights!
I think that a classical mask is more suitable for me
If you want to exchange your mask
You can mail to
babamamagogodede@yahoo.com.tw
Thanks!