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would like to do a open source mask
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TonyJ Offline

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Post: #11
RE: would like to do a open source mask
(04-05-2014 02:08 PM)SleepWrangler Wrote:  
(04-05-2014 12:39 PM)TonyJ Wrote:  In Canada you do not require a prescription to purchase a CPAP mask. To purchase a CPAP machine will require a prescription. This may vary depending on your Extended Health Insurance provider.

I tried to find a source to help clarify. B.C. government on-line information talks about needing a prescription but only in the context of social assistance (i.e., funding) and not solely in terms of access. Same for Ontario. Your evidence is similar because you mention Health Insurance.

Overall these devices are regulated by the Canadian Food and Drug Act, Canadian Medical Devices Regulations. CPAP is listed as class 2 device which means there are special licensing requirements for the manufacturer but I don't see anything related to the distribution.

The Canadian government publishes the guide "Buying Medical Devices from the Internet" and it says nothing about needing a prescription. A prescription may be best practices code-of-conduct and needed for liability but I don't see any specific criminal laws. I dunno and IANAL.

I think the quote regarding needing a prescription applies in all cases. The reference to insurance providers is regarding masks. I think if you do a google search you will find that any purchase of a cpap machine requires a prescription.This is a quote from a BC provider website:
Q: Do I need a doctor’s prescription to buy a CPAP machine?
A: Yes you do. If you believe that you are experiencing symptoms of sleep apnea, your doctor is the one who will authorize both sleep apnea testing as well as any required sleep apnea treatment. Pacific Sleep Care works with your family doctor to provide a medically supported diagnosis. You can take our online sleep test and have the results sent directly to your family doctor.
04-05-2014 03:37 PM
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space45 Offline

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Post: #12
RE: would like to do a open source mask
fair enough and point taken. I was just saying it would seem I could not that I would manufacture, it now looks like I will have to jump through some hoops and face the chance of law suets by customers and competitors.

the whole point of open source is not in manufacturing, at least till the patents run out, but in being able to make your own for your own use.

the idea was to have downloadable 3D models that could be modded and printed to find the best fit. it was not about my manufacturing them. it was just a way for some to find a way to get good fitting masks at a good price, and being able to mod bought masks for a better and more comfortable fit.

it was never about me manufacturing the masks and my saying I could if I wanted to looks to have been out of line, sorry for that.

(04-05-2014 03:09 PM)PaulaO2 Wrote:  
(04-04-2014 06:58 PM)space45 Wrote:  I live in Canada and I do not need a prescription to get a CPAP unit, just walk in and buy one, same with the masks.
the FDA rules do not apply where I live. I can make masks and machines and sell them with no problems. just problems of being sued is the only worry.

<sarcasm>Oh, well, then if that all you have to worry about, go for it. Rolleyes </sarcasm>

You need to not be so casual about this. If you are serious, then be serious. Like others have said, Canada and its provinces don't allow just anyone to make and sell a medical device.
04-05-2014 04:06 PM
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space45 Offline

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Post: #13
more info about open source masks and what I am thinking
ok, when I first mentioned open source mask I had no idea how to do it just that it should be done and was open to ideas

the masks will be the first open source idea I will do

I have now worked out how any of you can make both the hard and soft sections or a mask and have a extremely good chance at the perfect fit and anyone can mod to fit their face. if the easy way number one does not fly well I have a option 2 that I can not see not working, but for a modded mask will need you to know someone that can work with 3D models

nether way will require you to own a 3D printer, and you can make as many masks as you want, both the soft parts and the hard parts, option 2 when wanting mask different from the standard 3D models will cost more. also soft parts that are not the standard will also cost more as there is custom work needed for all non standard stuff.

every one or anyone can be their own make manufacturer and pump them out. I am assuming it will be for your self and family members and possibly friends, would be not so good a idea to openly sell them and also not the point of this open source project. in places where they are not regulated or if you jump through the hoops and get insurance and what ever else is needed to be legal then you could use this system to make and sell masks.

will try to keep the price down and it will be a one time cost for each style and type of mask. in theory you will have a life times worth of mask with one purchase.

in time I will also offer the equipment for making the stuff to make the masks so others will be able to offer this on a more local level, working with others to customize their masks for a perfect fit.
04-05-2014 09:56 PM
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Bruno2 Offline

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Post: #14
RE: would like to do a open source mask
We don't need a prescription in the US to buy masks, hoses, head gear or even the machines. They are all over CL and Amazon. I have a prescription, but was never asked for it when purchasing equipment and they couldn't know I have one.
04-05-2014 10:21 PM
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Peter_C Offline

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Post: #15
RE: more info about open source masks and what I am thinking
How are you planning to get around/past the requirement of a prescription for said mask?

What base materials do you plan to use? Even if 'we' provide the 'plan' for said mask, I would think (due to government laws, etc) you would have much liability, and must pass FDA rules and trials, etc?

*I* am not a DOCTOR or any type of Health Care Professional. My thoughts/suggestions/ideas are strictly only my opinions.

"Only two defining forces have ever offered to die for you. Jesus Christ and the American Soldier. One died for your Soul, the other for your Freedom."
04-05-2014 11:45 PM
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SuperSleeper Offline

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Post: #16
RE: would like to do a open source mask
(04-05-2014 10:21 PM)Bruno2 Wrote:  We don't need a prescription in the US to buy masks, hoses, head gear or even the machines.

That is incorrect. CPAP machines have for many years now been a prescription-required item in the U.S. and it is illegal for anyone except a licensed Durable Medical Equipment provider (DME) to offer them for sale, trade or transfer. CPAP masks now require a prescription by law as well-- That has been the case for a few years now.

Quote:They are all over CL and Amazon. I have a prescription, but was never asked for it when purchasing equipment and they couldn't know I have one.

What you're seeing on Amazon is the selling of CPAP mask parts. These companies are claiming that they're not selling CPAP masks per se, but rather "mask parts", which (they claim) are not specifically subject to the prescription requirement. This supposed "loophole" has yet to be challenged as far as I know, but it could very well be challenged in the future. Current law requires the seller to be a licensed DME and they must have the patient's prescription for CPAP on file for a complete mask.

What they're doing is offering nearly the entire mask, but take out one part (headgear or the hose attachment or the nasal pillows, etc which can be purchased separately) and then it qualifies as "mask parts", not a complete [or assembled] CPAP mask.

If a company sells a complete mask on Amazon or any other website or in a brick-and-mortar store in the U.S., they must be a licensed DME and they must have a copy of the patient's prescription on file.

What you're seeing on Craigslist (if indeed full complete masks are offered for sale) is illegal activity according to current law, unless the selling party is a licensed DME and the recipient has a prescription for CPAP. The government is not currently "going after" sellers on such sites, but the law is still on the books.

That said, I personally think the entire prescription requirement for CPAP masks is ridiculous.... and I'm not really fond of the prescription requirement for the machines, either.

Coffee

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INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.

04-06-2014 12:32 AM
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space45 Offline

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Post: #17
RE: more info about open source masks and what I am thinking
I think have worked out the best way to go and that is to make a special 3D printer and use it to make molds.

you guys use the molds to make the masks, as far as I know that is not a problem.

the molds will be cheap and you guys can make molds from my molds so you can make and sell molds as well. I may also make molds of my master mold and cast the molds I sell in a hope to lower costs still more.

castable material will be used to pour into the molds, cost per mask will depend on where you get the casting stuff and what type you choose and if you use filler material.

the cost per mask should be real cheap.

I will make the machine I use for making mask molds available soon after I have the bugs worked out so others and make master molds as well as custom fitted mask molds

the plan is to release the code for making the mold of each standard mask so there will be no problems making master mask molds

if your making masks for your self I would doubt the gov would get involved.
making mask molds should not be a problem ether

(04-05-2014 11:45 PM)Peter_C Wrote:  How are you planning to get around/past the requirement of a prescription for said mask?

What base materials do you plan to use? Even if 'we' provide the 'plan' for said mask, I would think (due to government laws, etc) you would have much liability, and must pass FDA rules and trials, etc?
04-06-2014 12:44 AM
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SuperSleeper Offline

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Post: #18
RE: more info about open source masks and what I am thinking
(04-06-2014 12:44 AM)space45 Wrote:  if your making masks for your self I would doubt the gov would get involved.
making mask molds should not be a problem ether

Oh my... the chances of the government not getting involved when someone wants to manufacture a CPAP mask or "mask mold" via any method is very close to zero, IMHO. [At least here in the states, where we have a Nanny-state government that loves to stick their nose into our lives and to "protect us from ourselves"]. CPAP masks are currently prescription-required items here in the U.S.

Sure, if it's extremely small scale and off the government's radar screen, they might not even notice. But once they do notice, I guarantee you they will be getting intimately involved with anyone who wants to manufacture a CPAP mask via conventional or non-conventional means. Cool

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INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.

04-06-2014 12:55 AM
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zonk Offline

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Post: #19
RE: would like to do a open source mask
(04-05-2014 10:21 PM)Bruno2 Wrote:  We don't need a prescription in the US to buy masks, hoses, head gear or even the machines.
In US, by law a prescription is required to purchase CPAP machines/humidifiers and complete assembled masks

No prescription is required for masks without headgear (include everything except the headgear)
You can add the headgear to make a complete mask .... the law is donkey (sorry donkey)
Also for masks parts, cushions, headgear, hoses, filters, water tank, hose cover, pads, etc
04-06-2014 01:32 AM
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space45 Offline

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Post: #20
RE: would like to do a open source mask
ok so this is cool, the open source thing is all about parts, each mold is for one part, and anyone involved this open source mask thing is only making mask parts so one could mass product mask parts at home and sell them, cool

did some quick math and the casting stuff to make the soft part of a mask should run around $5 or so, very cheap, $10 tops if your messy and wasteful

that was for a $54 part off the net. ebay maybe less, did not look.
04-06-2014 01:43 AM
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