Which law says we can't change our own pressure flow?

[sleep lover]

I had my first visit with my sleep doctor last week after starting cpap 5 weeks ago. He took the card and said he changed my pressure from 12 to 10.5. When I turned on the machine that night, it continued to say 12. I called to ask him about it and he said he'd absolutely changed it. I called Resmed yesterday to see if there was any way the card could be correct with the machine not showing properly, and they said no. I asked if I could fix it and he said there's an FDA law not allowing us to fiddle with it. Does anyone know what this law is? I keep hearing it stated and wonder if it's all a sham. I've read some posts pertaining to this, but nothing specific, and then we all go our own separate ways without any follow through. I have not been at all impressed with my DME or with my sleep doctor. There is a serious lack of information out there and the only help I've gotten is from cpaptalk. but... after 5 weeks I don't feel very good (I could be having some serious REM rebound issues, including a constant eye twitch) and though determined to stick with it, I'm seeing that the whole protocol of the DME and our lack of control over these machines, lack of facilities to check masks out before purchasing, is absurd. What is really going on here?

[Slinky]

He is mistaken. There is no such law. Only doctors and others in the medical profession can change your therapy settings 'on or by order of a physician'. Just as a doctor can script a medication and directions for taking it, you can refuse to take that medication or refuse to take it in the manner prescribed - at your own peril. You can not legally change someone else's therapy settings as that would be practicing medicine w/o a license. But there's no law preventing you from changing your own therapy settings.

[KatieW]

Here's more on that:

http://www.apneaboard.com/CPAP%20Adjustment.htm

[wil]

I don't understand why we even have to have a prescription to buy one... Seems stupid to me.

The point if prescriptions is to keep us from hurting ourselves, right? Who in their right mind that didn't need xpap therapy would go out and buy one? What's more, even if they did, what harm would it do?

I was fortunate. They left the provider instructions in the bag when I picked mine up from the DME. I'm sure they didn't do it on purpose, but I'm still certain they can be found in the wild if you're willing to look for it.

[Julie]

You need a prescription because without more knowledge and a good Apap machine, you need an educated estimate of what pressure level to set your machine at. Without that, you could either end up feeling like you're never getting enough air to breathe, or else endanger yourself using a setting much higher than necessary, which can cause other conditions like central apnea (which you don't want).

[park_ridge_dave]

I don't understand why we even have to have a prescription to buy one... Seems stupid to me.

This is a Very Short Explanation of a very complex set of rules and regulations (that portion of the Congressional Federal Record (CFR)) that governs the FDA.
It took me 25 years to learn the parts of it that I have memorized and this presentation is way oversimplified.
Also, as an additional caveat "Do NOT expect Rules of Logic to prevail in Governmental matters".

The reason that you need a prescription is that, essentially, someone came up with the machine and conducted tests to prove it's efficacy in the treatment of a recognized medical condition. A review panel convinced the FDA that these machines need to be dispensed under prescription so that the efficacy of the treatment is maintained and/or people might do themselves serious harm if used in an unsupervised manner . ( I warned you not to expect logic ). Also, the manufacturer jumps through a lot of hoops to prove and document that the machine and corresponding therapy(ies) are efficacious as stated.

OK but you still say, why? Good question. Let's look at a relatively simple medical appliance the "MAD"(Mandibular Advancement device). If you claim that is therapy for OSA you need to Validate your manufacturing process and prove that it truly treats the medical condition or provides the medical benefit claimed for it. Thus, for this class of device, requiring a prescription. BUT if you call it an "Anti Snoring" device you can sell it in an infomercial on late night TV. Why? Because Snoring (while it most likely is symptomatic of OSA) is not a treatable medical condition as defined by the medical community(OBTW that could change tomorrow ). And if you do not claim a medical benefit for the device (i.e. cures something e.g. OSA) you can sell it all night long with no prescription. Case in point, the Tomar Somnoguard is sold as a medical device for the treatment of Sleep Apnea in the UK and Germany. They are prohibited by law (US) from shipping it to end users in the USA. That same device is sold by at least one Canadian firm as an anti-snoring device and is shipped to the USA Legally (at least so far).

Another thing that I am curious about. How many people have "killed" their livers using "Over The Counter" (OTC) drugs like Ibuprophen and Acetamenophin? (OBTW it is really easy to do).

An example that things can change Look at Claritin and Zyrtec. They are no longer prescription medications, both are now (OTC) and they can do major damage if used improperly (And I am discounting using the Sudafed in the Claritin to make "Meth").

And last but not least, VITAMINS! Some yokels decided that you can hurt yourself by overdosing on certain Vitamins. So now they limit the dosages that can be sold (I guess they never heard of taking a lot of pills at once??) I am taking a Vitamin D supplement right now. It is 50,000unit strength. I take it once a week. Yep, you guessed it! PRESCRIPTION!

As I said, this is a gross simplification, but it is essentially correct (IMHO)

Final answer "It depends"!

It's as good an answer as I could give in a few minutes. (and God I am glad I am retired )

Disclaimer: These opinions are mine and do not represent the forum administration's editorial position.

Cheers,

Dave

P.S. SRI for being so "long winded" but this is the short answer

[allen476]

I had my first visit with my sleep doctor last week after starting cpap 5 weeks ago. He took the card and said he changed my pressure from 12 to 10.5. When I turned on the machine that night, it continued to say 12. I called to ask him about it and he said he'd absolutely changed it. I called Resmed yesterday to see if there was any way the card could be correct with the machine not showing properly, and they said no. I asked if I could fix it and he said there's an FDA law not allowing us to fiddle with it. Does anyone know what this law is? I keep hearing it stated and wonder if it's all a sham. I've read some posts pertaining to this, but nothing specific, and then we all go our own separate ways without any follow through. I have not been at all impressed with my DME or with my sleep doctor. There is a serious lack of information out there and the only help I've gotten is from cpaptalk. but... after 5 weeks I don't feel very good (I could be having some serious REM rebound issues, including a constant eye twitch) and though determined to stick with it, I'm seeing that the whole protocol of the DME and our lack of control over these machines, lack of facilities to check masks out before purchasing, is absurd. What is really going on here?

From what I understand, the law he is stating is the FDA prohibits the manufacturers to allow patients to change clinical settings (hence why you aren't to get the clinicians manual with your machine and why the menu is hidden). The person at the other end of the phone was doing his job and for him to tell you on how to make the change would have been practicing medicine without a license. However there is no law that prohibits you changing your own pressure or if your doctor shows you how to make the changes. The greedy DME's aren't going to show you because they couldn't bill you for the service call.

Allen

[mrstevegross]

I had my first visit with my sleep doctor last week after starting cpap 5 weeks ago. He took the card and said he changed my pressure from 12 to 10.5. When I turned on the machine that night, it continued to say 12. I called to ask him about it and he said he'd absolutely changed it. I called Resmed yesterday to see if there was any way the card could be correct with the machine not showing properly, and they said no. I asked if I could fix it and he said there's an FDA law not allowing us to fiddle with it. Does anyone know what this law is? I keep hearing it stated and wonder if it's all a sham. I've read some posts pertaining to this, but nothing specific, and then we all go our own separate ways without any follow through. I have not been at all impressed with my DME or with my sleep doctor. There is a serious lack of information out there and the only help I've gotten is from cpaptalk. but... after 5 weeks I don't feel very good (I could be having some serious REM rebound issues, including a constant eye twitch) and though determined to stick with it, I'm seeing that the whole protocol of the DME and our lack of control over these machines, lack of facilities to check masks out before purchasing, is absurd. What is really going on here?

I'm not sure about the law, but I can comment on medical device development. I work for a medical device manufacturer, and we are SUPER CRAZY CAREFUL about our device and its settings. Basically, it's not good enough to just say "buyer beware" on settings. If a setting poses a risk (a "hazard" in industry parlance), we have to mitigate it somehow. The FDA would give us a seriously hard time if we didn't.

So, let's consider the CPAP pressure setting. What is the risk of setting it too high for someone? I'm not a pulmonologist, but I would guess that bad things could happen. How bad? I don't know. But probably bad, anyway. So CPAP manufacturers are being careful and restricting who can change pressure settings. The manufacturers always have to keep the FDA happy. If you really want to change the regulations, write to the FDA.

--Steve

[Uncle_Bob]

I've had my doctor authorize a couple of pressure changes when i first started out, the on site DME actually showed me how to do it at the office before i left with the machine.

After a while i got fed up with calling the doctor, leaving a message and waiting up to 2 days for a reply.

So i started being naughty and changed the pressure my self, i got a great rush out of not doing things properly. And an even bigger rush in knowing that the doctor will eventually find out once he reads my data card and sees it on the reports

[sleep lover]

uncle bob,
come to berkeley and show me how to mess with the doc. I love what you wrote... thanks, Lisa

[finchy]

Hello, While its a good thing to monitor your own treatment, it can be dangerous to try to treat yourself. Lowering and or increasing pressures, obviously lowering pressures may lead to insufficent PAP for an individual, wearing CPAP 8 hrs a night, essentially may be doing nothing. Too much PAP can cause pneumothorax, bloody nose, aerophagia. So sorry many people have had bad experiences with DME, I am a RT/SDS, Respiratory Therapist/ Sleep Disorders Specialist currently at a DME provider with 3 yrs experience in performing PSG's. And joined in order to help people with CPAP, it can be very difficult for some to become compliant, and it is very important to be with a Physician and DME provider you can trust and who can give you support. If you have any questions about PAP settings and why they are important not to change, please IM me.

[GumbyCT]

I asked if I could fix it and he said there's an FDA law not allowing us to fiddle with it. Does anyone know what this law is? I keep hearing it stated and wonder if it's all a sham. I've read some posts pertaining to this, but nothing specific, and then we all go our own separate ways without any follow through.

lmao...law? Ask to see this law, in writing. Then watch his face... Laws are written are they not?

Then you can ask to see a list of names of those recently convicted of breaking this law. Don't you want to know what the punishment is for breaking this law?

oh and Good luck with the law - see usually when they say there is a law against something, people just obey, thinking they may end up in jail.

RT's are not used to people using logic. If they can use logic, they won't need CPAP. So they use fear.

Ever seen a STOP sign stop a car? lmao

[howkim]

This is a Very Short Explanation of a very complex set of rules and regulations (that portion of the Congressional Federal Record (CFR)) that governs the FDA.

Nope. It's the "Code of Federal Regulations." 21CFR is the portion that covers FDA. You can find it online at http://ecfr.gpoaccess.gov/cgi/t/text/te ... tab_02.tpl. The device regulations are in Sections 800 through 898.

[DoriC]

When I realized the sleep dr and DME would be useless and I needed to be in charge of my husband's therapy, I came to this forum and got the help and friendship I needed. But their suggestions for pressure changes were never radical or strayed very far from his titration pressure. The logic behind their recommendations was always explained to me in detail so I could make my own decisions. They also taught me to be patient. Where would my husband be if I had accepted the sleep dr's order to "leave the settings at 5-18 and let the machine find the right pressure"! Knowledge is Power!

[park_ridge_dave]

This is a Very Short Explanation of a very complex set of rules and regulations (that portion of the Congressional Federal Record (CFR)) that governs the FDA.

Nope. It's the "Code of Federal Regulations." 21CFR is the portion that covers FDA. You can find it online at http://ecfr.gpoaccess.gov/cgi/t/text/te ... tab_02.tpl. The device regulations are in Sections 800 through 898.

Yes, Howkim, you are most certainly correct! In my haste I typed the Congressional Federal Register when I should have typed the "Code of Federal Regulations" Thanks for catching that. I think it's because I have been reading the register lately (trying to see what new punishments the congress has in store for us ). Or really, I had a Senior moment (that's my story and I'm sticking to it ).

Cheers,

Dave