PurSleep gone for now & why I did what I did

General Discussion on any topic relating to CPAP and/or Sleep Apnea.
whatrdreamsmadeof
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100 percent

Post by whatrdreamsmadeof » Wed Apr 04, 2007 7:13 pm

I for one would like to know what in this life is 100 percent. When an adult can sue a large, long standing corporation for millions when they spill hot coffee on themselves.
I truly feel Bret is above board in all he has done and continues to do with this product. I couldn't be in the trial as he asked, for it as I am super sensitive to many, many things. That said I respect those that spoke up, just as I do Bret for doing further studies. The more research, & testing the better. Even then there is potential for the wrong person inhaling the wrong fragrance and having a negative reaction. I've seen a teenager pass out because another student was sitting near him on a bus with an open candy bar containing peanut butter in his back pocket.
Kudos to all those who raised question and to Bret for going the distance to keep all of us as safe as possible.
After all that is all anyone can do.

Good Luck Bret!
Life is not about the amount of breaths you take;
It's about the moments that take your breath away.

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jrfoster
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Post by jrfoster » Wed Apr 04, 2007 9:14 pm

I too admire Bret for making sure, 100% sure, that the Pur-Sleep system is safe for all. Some good questions were being raised by people, some who have never seen or used the Pur-Sleep system, and others who have tried it. I am one who has tried it, and used all of the essential oils in search for my "nirvana"!

I found the diffuser to be well constructed, complete with grates so that the cotton pad cannot get into the hose. In fact, the pad sits in a secure holder that keeps it in place. Even if the diffuser turned upside down in an earthquake and shook the cotton pad loose, it could not enter into the hose and end up in my mask or mouth. I was never worried about that. The only question I had ever wondered about was the safety of enhaling the fragrance of the essential oils during the night. Yet, driving down the road I enhale much worse stuff every day!

I expect to see the Pur-Sleep site up and running in the near future complete with the approval of an independent laboratory, and new and bigger bottles of essential oils! You've got my support, Bret!

Jeff in TN


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Tkuentz
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Post by Tkuentz » Wed Apr 04, 2007 9:17 pm

I am new to cpap, but was very interested in this topic. What an eye-opener. I hope that Brett will find his business knowledge increasing from this very intense debate and will be successful.

However, there will always be those that assume that anything that happens to them is someone else's fault.

I assume that when I carry hot coffee and spill it on myself, it will hurt.
I assume that when I cross the street, I could get hit.
I assume that if I eat too much, I will get fat. (whoops, that's true!)
I assume that if I put anything in my lungs, there could be problems.

But, I will cross the street to get coffee and a scone, hook up to a machine at night and now, unfortunately, don't have the chance to even try for myself the benefits of this device.

I value the debate, welcome the independent testing and applaud Brett for taking the extra steps necessary which will only serve to limit his liability and increase costs. I also thank Christine for making me and others more aware of the choices they are making.

I don't think the comparison of a complete tragedy which involuntarily happened to a community because of an tragic error and the selling of a device which is voluntarily used is warranted. At what point do you take responsibility for your own decisions. I do not assume every product which has passed FDA approval is safe and or effective for me.

But that only my opinion . . . and as we all know . . . opinions are like . .


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Rabid1
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Post by Rabid1 » Wed Apr 04, 2007 9:41 pm

Christine,

People like you totally disgust me! You get on you soap box and spew your crap as though it has some merit. I feel so much safer, knowing I have a twit like you to protect me.

Bret had a great idea, did a reasonable amount of research, and marketed a product that made our CPAP lives a little more tolerable. Good for him!

Then you come along on your white steed and tell us all we're going to die for breathing tangerine. What a freakin' drama queen.

Snoredog,

You don't disgust me, although I disagree with you.

Bret,

Put your product back on the market before I accuse you of having a knee-jerk reaction.

Rick

BTW, Christine, your "concerns" weren't even important enough to merit consideration.
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Last edited by Rabid1 on Wed Apr 04, 2007 10:27 pm, edited 1 time in total.
Wake me up when this is over...

Motoapco25
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Post by Motoapco25 » Wed Apr 04, 2007 10:17 pm

Well there goes my chance of getting one

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dsm
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Post by dsm » Wed Apr 04, 2007 10:38 pm

Sleepless_in_LM wrote:To borrow a saying from old Col. Potter "Horse Hockey!" Please don't take this as a personal attack. It is not meant as such, but I think you have made this personal against Brett.

You have have every right to question this product and air your concerns. Good discussion is what this board is about. But for you to compare this to "automobile manufacturers taking short cuts" or "a drug manufacturer that falsifies data" is over the line. To question his integrity and put him in the same boat as lying/cheating companies is just unfair and unwarranted. Brett spent a lot of time and money to come up with a product that he thought was safe and would help people. I know it is a product that he used personally for a long time before he offered it for sale, so that is maybe where actions speak louder than words. I personally feel his intentions were above board and to personally attack him is just plain wrong.

Then to compare this to the pet food problem or the Michigan beef problem is also unfair. Those are cases where there was evidence of something being wrong. Then it makes sense to keep questioning until you figure out what is wrong. In this case, all evidence, so far, was pointing to this being a product that was helping people cope with their therapy. Were there some possible risks? Yeah. Is it good to make people aware of those risks? Yeah. But to make it a personal crusade to shut him down, calling the FDA to "turn him in"... that also strikes me as bit much for something that had no evidence of causing problems. There is a big difference between fighting a known problem, and fighting the possibility that there might be a problem.

Lastly, to claim that your successful crusade to shut him down proves he has safety concerns about his own product is an assumption I doubt is true. It is my guess that you have forced Brett to play an expensive game of CYA. I work for an educational institution, and I can't tell you how many plain stupid things we do, or good things we have stopped doing, just because of the minute risk that puts in the CYA mode. It drives me nuts.

So, you are certainly welcome and encouraged to question products and have healthy discussion. It is good to point out risks. It is good to point out possible problems. Then "adults" can weigh the risk and benefits and make informed decisions. It might turn out that there are some risks with Bret's product. It might also turnout that it is 100% safe. It might also turnout that a product that could have helped countless OSA sufferers will never be available to them because the expense to prove "100%" safe will make it beyond affordable to offer.

I am glad you are sleeping better, but the fact that you were losing sleep over this and the fact that you chose to post such a lengthy claim of victory and explanation of your reasons, would indicate to me that this issue became much too personal.


Sleepless, I have to add that my reactions were somewhat along your lines. Christine, I am sure you meant well (I haven't actually followed too much of the posting on this product) but I will add a few what seem to me obvious points ...

1) That Brett did in shutting down sales proves absolutely nothing other than he was pressured to do so, Christine, your words on this point tend to come across as a self justification. It wasn't needed. Your issues stand on their own.

2) Also, introducing unrelated events (cars, food) to justify your concerns with Brett's product was, to be kind, unfair, unneeded & unwarranted. There is a 'tar-brush' aspect to doing so.

Please don't take offence to my comments, am just calling this as I saw it.

Cheers

DSM
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christinequilts
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Post by christinequilts » Wed Apr 04, 2007 11:42 pm

So several of you have no problem using a non-approved medical device then? I contacted the FDA to inquire if an in-line diffuser for essential oils, when marketed for use with CPAP or BiPAP, would be considered a cosmetic or not, since Brett had suggested I obtain more information on the classification of such devices. The FDA asked me to describe the device, which I stated was a sealed diffuser attached between the heated humidifier and hose or between the machine and hose, with a small cotton pad suspended which various essential oils would be applied.

I was informed any device that becomes part of the air circuit from the machine to the mask would need to be approved as a medical device, not as a cosmetic. They went on to search for any indication of an application or approval of the PurSleep In Line Diffuser, which there was no evidence of. They asked for additional information from the website, which I provided.

All medical devices need to be tested for safety before they can be sold, its as simple as that. If the hose connector or quick connects have to have FDA approval, even though they are a very minor and optional accessory, why would an in-line diffuser be any different? Only time will tell now if it is able to obtain proper approval before being reintroduced.

I never did anything to suggest Brett remove his product from market at any point in time. He did that on his own, as he has stated himself. I did ask questions, many of which were never answered to this day. Many of my questions are the same ones I would have asked a friend who had opened a business to provide constructive criticism. What is wrong with asking him if if would work with a VPAP AdaptSV, when his marketing material stated it would work with all forms of CPAP and BiPAP? It was something he needed to consider, isn't? Maybe there are limits of types of machines it may work with- even Brett has admitted he hasn't done any testing with types of machines yet, that's something I would expect before a product was brought to market.


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rested gal
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Post by rested gal » Thu Apr 05, 2007 12:14 am

I think Christine did right to ask questions and make inquiries of the FDA. The effect of a diffuser added to the breathing circuit of xpap machines -- especially those more complicated than a straight cpap -- is something that should be independently tested, imho.

I admire Bret's entrepreneurship and sincerely hope his invention passes every test beautifully.
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Snoredog
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Post by Snoredog » Thu Apr 05, 2007 2:29 am

[quote="Rabid1"]Christine,

People like you totally disgust me! You get on you soap box and spew your crap as though it has some merit. I feel so much safer, knowing I have a twit like you to protect me.

Bret had a great idea, did a reasonable amount of research, and marketed a product that made our CPAP lives a little more tolerable. Good for him!

Then you come along on your white steed and tell us all we're going to die for breathing tangerine. What a freakin' drama queen.

Snoredog,

You don't disgust me, although I disagree with you.

Bret,

Put your product back on the market before I accuse you of having a knee-jerk reaction.

Rick

BTW, Christine, your "concerns" weren't even important enough to merit consideration.
someday science will catch up to what I'm saying...

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dsm
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Post by dsm » Thu Apr 05, 2007 2:38 am

[quote="christinequilts"]So several of you have no problem using a non-approved medical device then? I contacted the FDA to inquire if an in-line diffuser for essential oils, when marketed for use with CPAP or BiPAP, would be considered a cosmetic or not, since Brett had suggested I obtain more information on the classification of such devices. The FDA asked me to describe the device, which I stated was a sealed diffuser attached between the heated humidifier and hose or between the machine and hose, with a small cotton pad suspended which various essential oils would be applied.

I was informed any device that becomes part of the air circuit from the machine to the mask would need to be approved as a medical device, not as a cosmetic. They went on to search for any indication of an application or approval of the PurSleep In Line Diffuser, which there was no evidence of. They asked for additional information from the website, which I provided.

All medical devices need to be tested for safety before they can be sold, its as simple as that. If the hose connector or quick connects have to have FDA approval, even though they are a very minor and optional accessory, why would an in-line diffuser be any different? Only time will tell now if it is able to obtain proper approval before being reintroduced.

I never did anything to suggest Brett remove his product from market at any point in time. He did that on his own, as he has stated himself. I did ask questions, many of which were never answered to this day. Many of my questions are the same ones I would have asked a friend who had opened a business to provide constructive criticism. What is wrong with asking him if if would work with a VPAP AdaptSV, when his marketing material stated it would work with all forms of CPAP and BiPAP? It was something he needed to consider, isn't? Maybe there are limits of types of machines it may work with- even Brett has admitted he hasn't done any testing with types of machines yet, that's something I would expect before a product was brought to market.

Last edited by dsm on Thu Apr 05, 2007 4:09 am, edited 1 time in total.
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telly
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Post by telly » Thu Apr 05, 2007 2:48 am

Christine,
I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU).

Just joking darlin'....

Come Baaaaaaaaack Pur-Sleep. An' jus' when I was fixin' ta buy me sum ArOOOOOMAs. Dang dude.

Pur-Sleep: MAKE IT SO!

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Don't be a wuss! Make it SO!....and HuuuuuuuuRRRY
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telly

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dsm
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Post by dsm » Thu Apr 05, 2007 4:10 am

telly wrote:Christine,
I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU) I LOVE YOU (I HATE YOU).

Just joking darlin'....

Come Baaaaaaaaack Pur-Sleep. An' jus' when I was fixin' ta buy me sum ArOOOOOMAs. Dang dude.

Pur-Sleep: MAKE IT SO!

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Don't be a wuss! Make it SO!....and HuuuuuuuuRRRY
So what is your point (was there one ???)

DSM
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StillAnotherGuest
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Expressions of Remorse

Post by StillAnotherGuest » Thu Apr 05, 2007 5:38 am

Yeah, I feel bad about this, too.

So, while we're waiting for Brett's Bong to get back on the market, here's a idea. Get a load of this website, ain't it appropriate?

http://www.hippiepower.com/74/
Surrounding yourself with gentle candlelight and sinking into a hot bath laced with aromatherapy oils or herbal sachets can go a long way to soothe and prepare your body for sleep.
This incorporates a couple of Sleep Hygiene facets, and we're still talking 6 bucks for a 10 ml bottle of Lavender from Amazon.

And check this out:
A study of percutaneous absorption of lavender oil in massage found that within 5 minutes after application, main constituents of the oil were detected in the blood.
More Fun With Lavender

Just rub it in, this way you don't have to inhale it in directly (seems like there'd still be plenty of indirect as well, anyway).

Or if you want to spend a few extra bucks, these guys have some higher end "Room" models.

Just Do The Room

Cause CPAP machines simply suck up the air around them, so doing it this way will avoid the "shotgun" effect of an an in-line device (seriously, why do you need to increase the application by a factor of 50?).

So now we have:

A few inhalations before bedtime (medically documented).
Simply aromatherapize the room.
Sprinkle on pillow or use sachet
Take a bath in it.
Massage it in.

The next round of "R&D" should test these methods in re: sleep architecture, including whether or not continuous infusion is necessary vs single application. And also against the different types of insomnia (sleep onset, sleep maintenance, early awakening, etc.)

Hey, I believe there's some science involved here, so fine, let's do some science.
SAG

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Aromatherapy may help CPAP compliance. Lavender, Mandarin, Chamomile, and Sweet Marjoram aid in relaxation and sleep. Nature's Gift has these and a blend of all four called SleepEase.

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WearyOne
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Post by WearyOne » Thu Apr 05, 2007 7:51 am

Christine, thank you for your persistance and willingness to undergo the pressure to help provide a better tested and researched product.

Bret, thank you for deciding, for whatever reason, to do further R&D. Hope we'll see your site selling again soon.

dsm: If I were Christine, I would feel the need to respond to comments made to/about me, not as a defense, but just to let us know why/what she did and her reasons.

Rabid1: You should be ashamed. Play nice.

SAG: As always, great constructive suggestions! Thanks!

The more testing is done, the less chance of something negative happening in the long run. This will not only further protect the consumer, but also Brett.

Just set the lavendar outside the air intake and smell the results.

Pam

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Nenetx2004
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Post by Nenetx2004 » Thu Apr 05, 2007 9:00 am

Crap, crap, crap, crap.......okay, now that I have that off my chest.....

Christine, no idea why you got so rabid about this......not really interested. When I first saw this product (a while back), I vehemently said I wouldn't purchase the unit. I spoke to my doctor, showed him the website and he said it didn't seem to him to be a problem. I bought it, showed it to him with my machine and he said go for it.

Brett, I'm glad and sorry you're having to go through this process. As I said earlier, we're all adults, we can all make decisions based on what we read/know.

My father was one of the top environmental chemists in the country. I grew up hearing about what we were breathing and drinking......I hope Christine plans on living in a plastic bubble and purifying every liquid she consumes.....

Sorry if I offended anyone, but I'm a little miffed about this. My intention is not to hurt anyone's feelings but ya know what? I am highly offended that this product was taken off the market.

Jeanne

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