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[Admin Note] Clarification of Rules - small change
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SuperSleeper Offline

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Posts: 9,966
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Machine: PR System One REMstar Auto (DS560)
Mask Type: Nasal pillows
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CPAP Pressure: 12.5 - 18.5 cmH20 (auto range)
CPAP Software: SleepyHead

Other Comments: Have diabetes Type II

Sex: Male
Location: Illinois, USA

Post: #1
Information Clarification of Rules - small change
Apnea Board is not a licensed Durable Medical Equipment provider (DME) and cannot legally facilitate the sale or transfer of prescription-required FDA Class II Medical devices on our websites or forums.

Due to recent changes within the FDA regulations, we are making one small change to further clarify our rules.

One line is changing, from this:

Quote:Prohibited Category 2: Solicitations offering prescription required items (such as CPAP machines or masks) for sale or trade.

To this:

Quote:Prohibited Category 2: Solicitations offering prescription required items (such as CPAP machines, humidifiers, masks or mask parts) for sale, trade or transfer.


The whole reason for this slight change is the poorly worded and obscure FDA regulations that came out in 2009. I don't have all the links handy but a year ago or so I read through all the applicable governmental laws and regulations from FDA.gov and other websites regarding Class II Medical Devices and in one section, it appears as though masks (and/or mask parts) are now considered Class II Medical Devices (requiring a prescription). Then another section seems to indicate that they might be exempt from that classification.

The point is, we really have no clue or clear direction from the FDA or other regulatory agencies with regard to how we're supposed to interpret these new laws. They have simply been silent. This is why many DMEs have taken the safer route of requiring prescriptions for CPAP masks and to a lesser degree, mask parts. For better or worse, Apnea Board is going to take the safe route also for masks and mask parts and any other parts that are likely to be (or could be) considered Class II Medical Devices or Class II Medical Device parts (because such parts are integral to the operation of a CPAP machine).

This revised policy makes it against our rules to offer a CPAP mask or mask parts for sale, trade or transfer anywhere on the forums.

Apnea Board is essentially an information-sharing and educational website and forum. We are not a commercial entity. We exist for the benefit of sleep apnea patients primarily and not for the benefit of commercial entities or those who wish to engage in commercial activity (like selling or trading CPAP mask parts online).

I'd also like to thank our Moderator, Monitors & Master Members who help to shape our rules and policies. They were very helpful in providing solid advice concerning the implications of how these new regulations might affect our forum operations.

If anyone has any questions concerning this policy, free free to ask here in this thread.

Thanks for your understanding.

Coffee

SuperSleeper
Apnea Board Administrator
www.ApneaBoard.com


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.

10-26-2012 01:59 PM
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Ugly Offline

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Other Comments: Hydrocephalus, myopia, depression, chronic ugliness, stupidity, tinnitus, mixed sleep apnea.

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Location: Barrie Ontario Canada

Post: #2
RE: Clarification of Rules - small change
(10-26-2012 01:59 PM)SuperSleeper Wrote:  Apnea Board is not a licensed Durable Medical Equipment provider (DME) and cannot legally facilitate the sale or transfer of prescription-required FDA Class II Medical devices on our websites or forums.

Due to recent changes within the FDA regulations, we are making one small change to further clarify our rules.

One line is changing, from this:

Quote:Prohibited Category 2: Solicitations offering prescription required items (such as CPAP machines or masks) for sale or trade.

WhatEVER. Because my ancient Tranquility Quest is mostly mechanical with few if any electronic components, it probably doesn't qualify for the electronic waste disposal and will end up in the landfill. Huhsign Hey it's not my idea. Sorry but I have no real choice. *I* don't want it and don't know why anyone else would either.
11-10-2012 11:09 PM
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SuperSleeper Offline

Administrators

Posts: 9,966
Joined: Feb 2012

Machine: PR System One REMstar Auto (DS560)
Mask Type: Nasal pillows
Mask Make & Model: ResMed Mirage Swift II
Humidifier: none
CPAP Pressure: 12.5 - 18.5 cmH20 (auto range)
CPAP Software: SleepyHead

Other Comments: Have diabetes Type II

Sex: Male
Location: Illinois, USA

Post: #3
RE: Clarification of Rules - small change
(11-10-2012 11:09 PM)Ugly Wrote:  WhatEVER. Because my ancient Tranquility Quest is mostly mechanical with few if any electronic components, it probably doesn't qualify for the electronic waste disposal and will end up in the landfill. Huhsign Hey it's not my idea. Sorry but I have no real choice. *I* don't want it and don't know why anyone else would either.

Hi Ugly,

I don't think the U.S. FDA regulations apply to you since you are in Canada. Apnea Board is located in the U.S. and therefore subject to U.S. regulations and laws. But if you'd like to give away or sell your old CPAP, you'd have to take a look at your Canadian regulations.

Just can't do it on Apnea Board, since we are subject to the U.S. FDA regulations here.

Good luck and sleep well.. Coffee

SuperSleeper
Apnea Board Administrator
www.ApneaBoard.com


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.

11-11-2012 09:57 AM
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Bernie Offline

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Posts: 23
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Machine: Resmed Autoset Spirit, ResMed S9 autoset
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CPAP Pressure: 7-15
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Location: Texas

Post: #4
RE: Clarification of Rules - small change
What if someone already has a machine with defective or missing parts and wants to repair it him/her self. If someone else has an old machine from which they can remove the needed parts, would it be legal to provide those parts to the person that wants to do the repair?
11-16-2012 02:04 PM
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PaulaO2 Offline
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CPAP Software: SleepyHead

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Location: western NC, USA

Post: #5
RE: Clarification of Rules - small change
Whether or not it could or could not be defended in a court of law is not an issue in regards to ApneaBoard.

In my interpretation of the ApneaBoard rules, machine parts are the same as mask parts. You would not be able to list those parts for sale, trade, or for free in a post here on this site. Not that it is or is not legal, but that it is a can of worms this site is not interested in opening.

PaulaO2
Apnea Board Moderator
www.ApneaBoard.com


Breathe deeply and count to zen.

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.
11-16-2012 02:21 PM
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Bernie Offline

Preferred Members

Posts: 23
Joined: Aug 2012

Machine: Resmed Autoset Spirit, ResMed S9 autoset
Mask Type: Nasal pillows
Mask Make & Model: ResMed Swift LT
Humidifier: ResMed H5i
CPAP Pressure: 7-15
CPAP Software: ResScan SleepyHead Other Software

Other Comments:

Sex: Male
Location: Texas

Post: #6
RE: Clarification of Rules - small change
Thanks for that clarification.
11-16-2012 02:27 PM
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jdireton Offline

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Location: Florida

Post: #7
RE: Clarification of Rules - small change
I'll throw in a short war story.

Many years ago I worked at a Scuba Diving Shop in the service department. There are absolutely no laws regulating much of anything in Scuba equipment except the high pressure cylinders. That said, we were clearly informed that we could not provide parts, equipment diagrams, or any other advice on servicing Scuba equipment to customers. I went through factory training to be a certified technician for most of the major brands. There was just too much liability concern to allow someone to work on his/her own equipment. After all, this is life support stuff that will kill you dead if it stops working when you're at 100 feet deep.

Now, xPAP machines are not going to kill you, but they are a medical device and medical malpractice, in the US at least, is a growth industry. Same thing, just not worth the risk.

Okay, story not that short. Hope I made my point.
11-16-2012 03:31 PM
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archangle Offline
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Post: #8
RE: Clarification of Rules - small change
The medical mafia also has a big financial incentive to keep people from trespassing on their turf.

Capice?

Get the free SleepyHead software here.
Useful links.
Click here for information on the main alternative to CPAP.
If it's midnight and a DME tells you it's dark outside, go and check it yourself.
11-16-2012 06:15 PM
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zonk Offline

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Location: Australia

Post: #9
RE: Clarification of Rules - small change
(11-16-2012 06:15 PM)archangle Wrote:  The medical mafia also has a big financial incentive to keep people from trespassing on their turf.

Capice?
Si signore Rolling laugh
[Image: 220px-Godfather_ver1.jpg]
11-16-2012 06:22 PM
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SuperSleeper Offline

Administrators

Posts: 9,966
Joined: Feb 2012

Machine: PR System One REMstar Auto (DS560)
Mask Type: Nasal pillows
Mask Make & Model: ResMed Mirage Swift II
Humidifier: none
CPAP Pressure: 12.5 - 18.5 cmH20 (auto range)
CPAP Software: SleepyHead

Other Comments: Have diabetes Type II

Sex: Male
Location: Illinois, USA

Post: #10
RE: Clarification of Rules - small change
(11-16-2012 02:21 PM)PaulaO2 Wrote:  Whether or not it could or could not be defended in a court of law is not an issue in regards to ApneaBoard.

In my interpretation of the ApneaBoard rules, machine parts are the same as mask parts. You would not be able to list those parts for sale, trade, or for free in a post here on this site. Not that it is or is not legal, but that it is a can of worms this site is not interested in opening.

Yep, that's my take also. Well said. Coffee

SuperSleeper
Apnea Board Administrator
www.ApneaBoard.com


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.

11-16-2012 07:21 PM
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