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[Admin Note] Rules Clarification
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SuperSleeper Offline

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Posts: 9,976
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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: #1
Rules Clarification
We clarified and added some text to the first paragraph of the Apnea Board Forum Rules. The rule against using one's forum account to facilitate the sale of prescription-required items was buried in the "Commercial Links" section. This places that same text in the first paragraph, making it clearer that this policy doesn't only apply to "commercial links". The part that was updated is this color:


Quote:No member may use their forum account to solicit or facilitate the sale, trade or transfer of any prescription-required items (such as CPAP machines, humidifiers, masks or mask parts). Soliciting or facilitating the sale, trade or transfer of commercially-sold or pirated computer software packages or digital media is also prohibited. All posts must be made in the English language.

Please note: While some countries do not require a prescription for CPAP machines, CPAP humidifiers, masks & mask parts, the United States currently does. Since Apnea Board is based in the U.S., we must comply with U.S. regulations and laws regarding prescription-required items, regardless of where our members are physically located.

If anyone has questions regarding this change, please ask.

Thanks

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.

07-12-2014 12:41 PM
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diamaunt Offline

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Posts: 436
Joined: May 2012

Machine: S9 VPAP Auto 36006
Mask Type: Full face mask
Mask Make & Model: mirage quattro/pilairo q
Humidifier: none
CPAP Pressure: 9-20ish
CPAP Software: SleepyHead

Other Comments:

Sex: Male
Location: texas

Post: #2
RE: Rules Clarification
only, mask parts are not rx required. even ebay recognizes this.

on second thought, I should probably delete this and PM it, but I don't see a delete button.
(This post was last modified: 07-12-2014 01:27 PM by diamaunt.)
07-12-2014 01:26 PM
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SuperSleeper Offline

Administrators

Posts: 9,976
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: Rules Clarification
(07-12-2014 01:26 PM)diamaunt Wrote:  only, mask parts are not rx required. even ebay recognizes this.

The regulations are not absolutely clear on this fact. For instance, CPAP masks are definitely FDA Class II medical devices and are now prescription-required (this law changed a few years ago). But some are saying that if they sell you all the parts separately that can be used to make up a complete mask, a prescription isn't required. I have my doubts as to the veracity of that conclusion, and an attorney friend who has helped Apnea Board in the past agrees that an attempt to skirt the regs by selling parts separately could easily get the FDA involved legally. If FDA wanted to start enforcing the regs, they probably have enough wording in the current regs to justify the consideration of mask parts themselves to be integral parts of the masks and therefore prescription-required items. The thing is that they don't seem to be enforcing that right now... but they could at some point in the future.

In any case, Apnea Board is not a licensed DME and we are taking the safer route by not allowing the sale, trade or transfer of prescription-required CPAP masks on the forums, or the parts that make up those masks. We don't have the funds nor a team of attorneys to fight the FDA like eBay does. So, we're not going to tempt fate nor risk the existence of Apnea Board over this particular issue.

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.

07-12-2014 04:58 PM
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diamaunt Offline

Members-b

Posts: 436
Joined: May 2012

Machine: S9 VPAP Auto 36006
Mask Type: Full face mask
Mask Make & Model: mirage quattro/pilairo q
Humidifier: none
CPAP Pressure: 9-20ish
CPAP Software: SleepyHead

Other Comments:

Sex: Male
Location: texas

Post: #4
RE: Rules Clarification
I think understanding the "why" of the boards position is helpful, thanks.
07-12-2014 05:39 PM
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SuperSleeper Offline

Administrators

Posts: 9,976
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: #5
RE: Rules Clarification
One more slight rules clarification with respect to our commercial link policies.... the changes have been outlined in red:



EXCEPTION #1: A member may post a direct link to a CPAP equipment manufacturer website in any forum for the purpose of linking to user manuals, product support documents and similar information-only pages, as long as the manufacturer does not sell equipment directly to patients on their web site.


Thanks

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.

07-20-2014 05:28 PM
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justMongo Offline

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Machine: ResMed VPAP Auto (S9)
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CPAP Pressure: 18 IPAPmax - 11 EPAPmin, PS=5
CPAP Software: Other Software

Other Comments: μολὼν λαβέ

Sex: Male
Location: Калифорния

Post: #6
RE: Rules Clarification
(07-12-2014 04:58 PM)SuperSleeper Wrote:  ... But some are saying that if they sell you all the parts separately that can be used to make up a complete mask, a prescription isn't required. I have my doubts as to the veracity of that conclusion, and an attorney friend who has helped Apnea Board in the past agrees that an attempt to skirt the regs by selling parts separately could easily get the FDA involved legally. If FDA wanted to start enforcing the regs, they probably have enough wording in the current regs to justify the consideration of mask parts themselves to be integral parts of the masks and therefore prescription-required items. The thing is that they don't seem to be enforcing that right now... but they could at some point in the future.

I am not a lawyer. I believe what you describe is called "structuring." It is a legal concept where a series of transactions are done with intent to "skirt" regulations. Federal law forbids structuring in areas such as banking and firearms transactions... they would likely extend it to medical devices.

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.
07-20-2014 05:42 PM
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SuperSleeper Offline

Administrators

Posts: 9,976
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: #7
RE: Rules Clarification
(07-20-2014 05:42 PM)justMongo Wrote:  I am not a lawyer. I believe what you describe is called "structuring."

Thanks Mongo... I was trying to remember that word and for the life of me I couldn't.

Old age and sleep deprivation helping me yet again... Oh-jeez

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.

07-20-2014 06:32 PM
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Moriarty Offline

Advisory Members

Posts: 270
Joined: Jul 2012

Machine: Respironics REMStar 50 Series Auto
Mask Type: Nasal pillows
Mask Make & Model: Fisher & Pakel Pilairo Q
Humidifier: Respironics System One
CPAP Pressure: 8.5-20 (average 9.4)
CPAP Software: SleepyHead

Other Comments: Image above is my CPAP machine...

Sex: Male
Location: Toowoomba - Qld - Australia

Post: #8
RE: Rules Clarification
FWIW - I have never needed a prescription for any mask or mask parts I have bought at retail in Australia...
(This post was last modified: 07-21-2014 05:37 AM by Moriarty.)
07-21-2014 05:37 AM
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DeepBreathing Offline
Wiki Editor
Moderators

Posts: 2,297
Joined: Sep 2013

Machine: Resmed S9 VPAP Adapt
Mask Type: Full face mask
Mask Make & Model: F&P Simplus
Humidifier: Resmed H5i
CPAP Pressure: EPAP: 9 - 15 PS: 3 - 10
CPAP Software: ResScan SleepyHead

Other Comments:

Sex: Male
Location: Perth, Western Australia

Post: #9
RE: Rules Clarification
(07-21-2014 05:37 AM)Moriarty Wrote:  FWIW - I have never needed a prescription for any mask or mask parts I have bought at retail in Australia...

Yes, but Apnea Board is based in the US and needs to comply with US laws, regardless of where individual members might be located.

DeepBreathing
Apnea Board Moderator
www.ApneaBoard.com


Bed

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.
07-21-2014 07:04 AM
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me50 Offline

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Posts: 2,559
Joined: Aug 2013

Machine: resmed S9 VPAP Auto
Mask Type: Nasal mask
Mask Make & Model: Wisp and Silicone Head gear
Humidifier: resmed H5i
CPAP Pressure: 18/8
CPAP Software: SleepyHead

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Sex: Undisclosed
Location: USA

Post: #10
RE: Rules Clarification
Even if it is legal, and it isn't, at least that I am aware of, in the US, if the Apnea Board moderators have a rule against it, then we need to follow those rules as members of this board. Just my 2 cents worth. I am glad it got posted here because I was not aware of the rule. Hope all of you have a blessed and safe week. Thank you all for this board and all the help and information we can get here.
07-21-2014 07:14 AM
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