CPAPtalk.com

Wulfman wrote:Darn! He didn't say WHICH Thursday......

I won't wait up.

Den

I don't fasten my seat belt either, unless I plan to get in a wreck! Jim

Hey, I was talking Guam time.

I am reading a ton of stuff to try to boil it down. Bottom line up soon.

DMEdaddy,

I've never posted a link to another forum, but I'm going to do it this time to make a point. You could possibly take it as support for YOUR argument, but THIS one was done by the "professionals". It's probably a one-in-a-million happenstance, but it apparently happens.....according to the last poster. BUT, it proves that mistakes can be made by the pros.

http://www.apneasupport.org/about6161.html

How's the Internet connectivity in Guam?
Do ya need a couple more months?

Den

Hey, somebody took my guest username! I guess that is the risk of being a guest. I sullied it anyway. Wonder why anyone would want it.

I spent a few hours trying to find laws that make it illegal for patients to adjust their cpaps contrary to the physician's orders. I talked to physicians, and a RT and did a lot of web searching.

Bottom line: If there are laws against patients changing cpap pressures to those other than prescribed by a physician, I did not find them or references to them. I a fairly comfortable that no such laws exist. If they do exist they are definitely state laws, not federal.

Second Bottom Line: I was wrong. I was taught that it was against the law for anyone to modify an Rx. Those under a physician's authority (Rts for example) cannot deviate. Patients apparently can deviate. All readers, I regret my comments very much. I will strive to give something positive back.

I did find one link that is the minutes of an FDA meeting that talks about how they categorize products and talks specifically about the warnings that are put on products like cpap masks.

I can't post the link directly because I am a guest. Here it is sort of for pasting in browser.

fda.gov/ohrms/dockets/ac/04/transcripts/2004-4071t1.htm


Here is a tibet from the meeting.

" A prescription device ‑‑ and this is the

definition from our regulation ‑‑ is a device which

because of any potentiality for harmful effect or the

method of its use or the collateral measures necessary

to its use, it's not safe except under the supervision

of a practitioner licensed by law to direct the use of

such a device and, hence, for which adequate

directions for use cannot be prepared, again meaning

for a lay person. As I just said, they would be

exempt for a lay person. And, again, they include

those home use devices. That's considered

prescription.

The labeling that we require in our

regulations would be "Caution: Federal law restricts

the device to sale by or on the order of a." And

that's to be filled in with any one licensed by the

state to use that prescription‑type product. Okay?

And, again, the states enforce these

prescriptions, even though the federal law requires

the statements. Normally we allow the states to go

ahead and enforce them because every state, as I'm

sure you are very well‑aware, is different in what

they allow. And also the method of its application

for use has to be addressed.

_________________

CPAPopedia Keywords Contained In This Post (Click For Definition): CPAP, Prescription

DME daddy wrote: I was taught that it was against the law for anyone to modify an Rx. Those under a physician's authority (Rts for example) cannot deviate.

Thank you DME daddy. That explains a lot. Sounds like indoctrination to me. No wonder so many DME's are less than helpful when patients want to assume some control of their own therapy.

DME's are just following physicians orders. Hmm, . . . sigh . . .

Regards,
Bill (just connecting dots)

Guest 22 wrote:Changing the pressure from what is prescribed are there any physical consequences that anyone has experienced?

DME daddy,

The above quote/question was from the person who started this thread. For whatever reason, the thread changed from "physical consequences" (which in extreme cases there might be some) to the "legalities" of doing so (which nobody so far has been able to find).

I appreciate your graciousness in our exchanges and I hope I didn't hurt your feelings with any of my remarks.
As you have probably gathered from my posts, I have a low regard for SOME of the so-called "medical professionals" in the sleep disorder category.

Best wishes and good sleeping,

Den

Here we go again with the prescription myth.

The only thing that requires prescriptions are to be filled in places licensed to dispense PRESCRIPTIONS.
DME are not licensed to dispense a RX nor is one required to change pressure.

These require an ORDER and there is a difference.A docs order may contain a prescription, but the administration is ORDERED.
Call your board of PHARMACY and ask them if they would enforce or bring charges against anyone selling a CPAP?

Bet they say no.

DME's and even some of the mfg may use the prescription terminology, but an ORDER is correct.

I maintain it is not even against the law to sell a PAP since it does not meet the definition of a device in the code.
I could be wrong

Although I am not an expert at anything, and am neither an attorney nor a physician, I assisted in the drafting of Federal regulations (not laws) for several years. If I recall correctly, Rulemaking 101 indicated that a rule (or law) must be:

1) Enforceable on a practical basis,
2) Not arbitrary, capricious, or unreasonable.

Rules failing these tests are frequently found upon judicial review to be void ab initio, even if promulgated (or passed).

It is difficult for me to envision a scenario under which changing a pressure setting on an xPAP device would be a practically enforceable violation. I suppose if you changed a setting and showed that to a DME, they might rat you out to some xPAP Police, but I don't think that would be good for repeat business. I'd research this issue, but I'm tied up researching whether there is a documented case of xPAP-related aspiration of vomitus, and standing on my head stacking greased BBs in my watch pocket.

Regarding the pre-hijack question, I think it may be possible to set a pressure:

(a) so low that you can't breathe comfortably, and therefore are not adequately treated, which is Not Good, or

(b) so high that you blow air, mucous, or blood through your tear ducts, which I have done, and that is Not Good. My supervisor phrased this issue in these terms: "You might want to turn that thing down before you blow the eyeballs out of your head."

cwsanfor wrote:I'd research this issue, but I'm tied up researching whether there is a documented case of xPAP-related aspiration of vomitus, and standing on my head stacking greased BBs in my watch pocket.

ROTFL, cwsanfor! Love it!

cwsanfor wrote:Regarding the pre-hijack question, I think it may be possible to set a pressure:

(a) so low that you can't breathe comfortably, and therefore are not adequately treated, which is Not Good, or

(b) so high that you blow air, mucous, or blood through your tear ducts, which I have done, and that is Not Good. My supervisor phrased this issue in these terms: "You might want to turn that thing down before you blow the eyeballs out of your head."

Atta boy. Getting back on track answering the the original question. Good.

Or "Not Good", or...whatever.