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Indiegogo campaign for a new CPAP hose
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NoamHadas Offline

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Post: #1
Indiegogo campaign for a new CPAP hose
Hi everybody,
If you're traveling a lot, and struggle with packing the hose, you may find this helpful.
This hose shrinks form 6 feet to just 9". Search Indiegogo for Travelhose and you'll find it.


Thanks,
Noam
07-01-2014 09:45 AM
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Terry Offline

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Post: #2
RE: Indiegogo campaign for a new CPAP hose
(07-01-2014 09:45 AM)NoamHadas Wrote:  Hi everybody,
If you're traveling a lot, and struggle with packing the hose, you may find this helpful.
This hose shrinks form 6 feet to just 9". Search Indiegogo for Travelhose and you'll find it.


Thanks,
Noam

Although I generally attempt to not rain on people's parades, your idea, while interesting isn't going to be useful and might actually be dangerous.

The newer "smart" machines require hoses of a particular diameter and length with known pressure characteristics, so they can determine what's going on.

For example, mine checks to see if an apnea is central or obstructive by sending a pressure pulse and watching the waveform. An expandable hose will stretch and absorb some or all of the pulse before it reaches the end and may reflect multiple indistinct pulses. I have no idea how the machine would interpret this, but can pretty much guarantee that it wouldn't be the desired results.

Aside from anything else, because it's "medical equipment" you'll get your butt sued off the first time someone has a problem or dies and your hose is connected.

Terry
(This post was last modified: 07-01-2014 02:12 PM by Terry.)
07-01-2014 02:10 PM
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SuperSleeper Offline

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Post: #3
RE: Indiegogo campaign for a new CPAP hose
In addition to that, at least in the U.S., CPAP parts (hoses, masks, etc) are now considered to be "Durable Medical Equipment" and thereby regulated by FDA. In order to legally sell them here in the U.S. I'm pretty sure you'd have to apply for FDA approval to sell the product, and also have a DME license to do so legally.

There is also some ambiguity in the regulations that now seem to give the impression that even CPAP masks & hoses require the DME to have a customers CPAP prescription on file in order to sell such items. I doubt there's much enforcement of that technicality these days, but given the current regs, it sure looks like that is now the "law", and the FDA could start cracking down on vendors if they so choose - they at least have the legal framework to do that in place now.

That's something that hopefully you have researched and accounted for. If I were an investor in your project, I would demand legally-solid answers on these points before I handed out any money to the project. Even if you "promise" to send investors a CPAP hose, that's not going to happen if the FDA or other regulatory agencies shut you down - and if that happens, investors will lose their money and get no "free" CPAP hose from you.

Because of that, a healthy dose of caveat emptor is probably warranted here.

Eat-popcorn

SuperSleeper
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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.

07-01-2014 06:23 PM
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NoamHadas Offline

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Post: #4
RE: Indiegogo campaign for a new CPAP hose
(07-01-2014 02:10 PM)tcarmen Wrote:  
(07-01-2014 09:45 AM)NoamHadas Wrote:  Hi everybody,
If you're traveling a lot, and struggle with packing the hose, you may find this helpful.
This hose shrinks form 6 feet to just 9". Search Indiegogo for Travelhose and you'll find it.


Thanks,
Noam

Although I generally attempt to not rain on people's parades, your idea, while interesting isn't going to be useful and might actually be dangerous.

The newer "smart" machines require hoses of a particular diameter and length with known pressure characteristics, so they can determine what's going on.

For example, mine checks to see if an apnea is central or obstructive by sending a pressure pulse and watching the waveform. An expandable hose will stretch and absorb some or all of the pulse before it reaches the end and may reflect multiple indistinct pulses. I have no idea how the machine would interpret this, but can pretty much guarantee that it wouldn't be the desired results.

Aside from anything else, because it's "medical equipment" you'll get your butt sued off the first time someone has a problem or dies and your hose is connected.

Terry

Terry, the Travelhose is not that different than your standard one. The main difference is that the stiffening coil is metal, not plastic, so its a lot thinner and the loops can be pressed much closed together for packing. It is not more "elastic" than all other hoses currently on the market. Of course, if you want top performance, you'd use an original hose, but if the manufacturer doesn't specifically forbids use of alternative hoses you should be safe.
Thanks for your comment, but I'm not concerned.
Noam
07-02-2014 12:43 AM
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NoamHadas Offline

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Post: #5
RE: Indiegogo campaign for a new CPAP hose
(07-01-2014 06:23 PM)SuperSleeper Wrote:  In addition to that, at least in the U.S., CPAP parts (hoses, masks, etc) are now considered to be "Durable Medical Equipment" and thereby regulated by FDA. In order to legally sell them here in the U.S. I'm pretty sure you'd have to apply for FDA approval to sell the product, and also have a DME license to do so legally.

There is also some ambiguity in the regulations that now seem to give the impression that even CPAP masks & hoses require the DME to have a customers CPAP prescription on file in order to sell such items. I doubt there's much enforcement of that technicality these days, but given the current regs, it sure looks like that is now the "law", and the FDA could start cracking down on vendors if they so choose - they at least have the legal framework to do that in place now.

That's something that hopefully you have researched and accounted for. If I were an investor in your project, I would demand legally-solid answers on these points before I handed out any money to the project. Even if you "promise" to send investors a CPAP hose, that's not going to happen if the FDA or other regulatory agencies shut you down - and if that happens, investors will lose their money and get no "free" CPAP hose from you.

Because of that, a healthy dose of caveat emptor is probably warranted here.

Eat-popcorn

Supersleepper, Thanks for your comment. CPAP hoses are class I, so they need to be listed, but do not require 510K. Naturally, all shipments to supporters will go through a US DME. By the way, I think Indiegogo insures supporters for such cases.
Noam
07-02-2014 12:47 AM
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PaulaO2 Offline
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Post: #6
RE: Indiegogo campaign for a new CPAP hose
OH! I went and looked at the product. It's an interesting concept! At 10", it would easily fit in the bag for the S9s.

I wish you luck with it and hope to see it on the market soon.

PaulaO2
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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.
07-02-2014 10:50 AM
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PaulaO2 Offline
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Post: #7
RE: Indiegogo campaign for a new CPAP hose



PaulaO2
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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.
07-02-2014 10:54 AM
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SuperSleeper Offline

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Post: #8
RE: Indiegogo campaign for a new CPAP hose
(07-02-2014 12:47 AM)NoamHadas Wrote:  Supersleepper, Thanks for your comment. CPAP hoses are class I, so they need to be listed, but do not require 510K. Naturally, all shipments to supporters will go through a US DME. By the way, I think Indiegogo insures supporters for such cases.
Noam

Hi Noam,

The FDA documents (links below) make it pretty clear that CPAPs, CPAP Humidifiers and CPAP masks are all now considered Class II (Prescription-required) devices that are subject to 510k approval, as described here:

http://www.accessdata.fda.gov/cdrh_docs/pdf4/k041309.pdf (Mask: Page 4 Class II, Page 6 Prescription Use Per 21 CFR 801 Subpart D)

http://www.accessdata.fda.gov/cdrh_docs/pdf5/K050359.pdf (Mask: Page 3 Class II, Page 5 Prescription Use Required)

http://www.accessdata.fda.gov/cdrh_docs/pdf8/K082605.pdf (Machine: Page 3 Class II, Page 5 Prescription Use Required)

http://www.accessdata.fda.gov/cdrh_docs/pdf8/K080797.pdf (Humidifier: Page 1 Class II, Page 5 Prescription Use Required)

The question I would have if I were a manufacturer is: Does the FDA consider CPAP hoses equivalent to CPAP masks as far as the regs are concerned? They are substantially an integral part of the CPAP system, just like a mask is, after all. I've heard folks (as you have done) claim that CPAP hoses are only Class I devices, needing no prescription and no 510k approval, but I have yet to find any FDA document that clearly says this and can't find CPAP tubing or hoses on any of the FDA's exemption lists... sure wish someone would link to an official FDA document that makes it clear either way - maybe I'm not looking in the right spot.

If I were a manufacturer, I'd want to make absolutely sure that FDA isn't classifying the CPAP hose or tubing as being integral to the CPAP system (making it a Class II device, just like a mask) - it would be horrible to go through the entire research & development and initial manufacturing & distribution costs to find out later on that FDA required 510k approval first. That could ruin your whole day.

One thing I know for sure and that is masks and humidifiers now require a prescription.

SuperSleeper
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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.

07-02-2014 11:01 AM
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NoamHadas Offline

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Post: #9
RE: Indiegogo campaign for a new CPAP hose
SuperSleeper, Indeed the hose is part of the CPAP system, but even you will agree that it is the least complex or risky part. The FDA apparently thinks so, and classified ventilatory support hoses (note - also these hoses used for life support... ) as class I. See here: C:\Users\Noam\Documents\INNOTECH\3_Projects\HOSE\Regulatory\Ventilator tubing.mht
Of course, there is always the duty to comply with GMP, QSR, general quality requirements and several ISO standards such as ISO13485, ISO10993, ISO14971 and others. Being aware of all that after 25 years of doing this kind of work, I'm happy to say the Travelhose meets all requirements.
07-03-2014 02:00 AM
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SuperSleeper Offline

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Post: #10
RE: Indiegogo campaign for a new CPAP hose
(07-03-2014 02:00 AM)NoamHadas Wrote:  See here: C:\Users\Noam\Documents\INNOTECH\3_Projects\HOSE\Regulatory\Ventilator tubing.mht

Noam, do you have a link that leads to the FDA website article? The link you gave was to a file on your personal computer, which we can't access.

Since brand new members can't post direct links, simply remove the "www.fda.gov" part of the address and the software will allow you to post it (since it's a government website link, not a commercial link). I think we have folks who might be interested in this project, but some of us are a bit careful to make sure of things like FDA regs and such before they commit funds to such a project.

SuperSleeper
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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.

07-03-2014 11:03 AM
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