Is it Illegal to Change Settings on One's CPAP Machine?

[sleepguide]

i know it's not likely to be enforced, but there seems to be genuine confusion over whether it's legal to change settings on one's cpap machine. i thought the prohibition was only on sales of devices without a prescription, but from a look at my home state's laws (California), looks like something broader. Anyone have a definitive answer on this. See below for more context.

Excerpted from http://www.sleepguide.com/profiles/blog ... ettings-on

In California, under the California Business And Professions Code Section Section 4022, CPAP and other xPAP machines are deemed "Dangerous Medical Devices" because they carry a federally mandated label regarding their prescription status and are viewed as "unsafe for self-use in humans":

"Dangerous drug" or "dangerous device" means any drug or
device unsafe for self-use in humans or animals (emphasis my own), and includes the
following:
(a) Any drug that bears the legend: "Caution: federal law
prohibits dispensing without prescription," "Rx only," or words of
similar import.
(b) Any device that bears the statement: "Caution: federal law
restricts this device to sale by or on the order of a ____," "Rx
only," or words of similar import, the blank to be filled in with the
designation of the practitioner licensed to use or order use of the
device.
(c) Any other drug or device that by federal or state law can be
lawfully dispensed only on prescription or furnished pursuant to
Section 4006.

[dsm]

I don't believe it is illegal for you to change your settings but I believe it is illegal for cpap vendors and DMEs
to tell you how to

Can you imagine the US flooded with cpap police hunting down cpappers who changed their settings

NewsFlash
"A boston man died today in a shootout with FDA agents trying to arrest him for repeatedly adjusting his cpap'
The man, a Mr Airey Breeze, failed to put down his weapon and we had to open fire said the FDA investigator.
Unfortunately the weapon turned out to be an airhose that looked like a shotgun because of how he was holding
it said the unnamed Investigator. We have to weed these trouble makers out and what happens to them is all
their own fault! he added"



DSM

[Wulfman]

Your question pertains to the USERS of XPAP machines changing/adjusting their OWN pressures......however, the body of text you listed pertains to the dispensing and sales of the machines.

If you DON'T use it are you breaking the law, too?
Once you own it, it's YOURS.
I'm not holding my breath that the "CPAP Police" will ever come knocking on my door.

Den

[Debjax]

I've had one RT (not my DME) tell me that it was illegal, after we were discussing the machines and data. While she was fully in support of downloading and reading the data, she bristled more than a bit when I mentioned that I knew how to access the clinical menu...."You know it's illegal to change your own pressures, right? It's like a surgeon cutting on himself." I told her that I personaly would not change pressures without an order from the doctor or to any pressure not prescribed by the doctor, but that if I was in a spot where the pressure needed to be changed and my RT could not get to me to do it....well, then yes, it would get changed or set to the prescribed pressure. I will not be left helpless when my husband's (or my) life depends on it. I was uninformed and unable to insist on the proper treatment ONCE, and it nearly cost my husband his life...and did cost him about 1/3 of his heart muscle, to include most of his left ventricle. That will not happen again.

[Gale Hawkins]

Why would anyone care unless they stood to gain financially? In many states there are laws on the books making some acts done in our bedrooms illegal I have read but I do not think adjusting our CPAP machines is own of them.

Those of us who have purchased used equipment and treated ourselves in the past must be in double trouble I guess.

We have read here how the auto machines are being used for in home sleep studies and some even just sell machines set at 4/20 and forget going for a bulleye number as the setting.

Getting my house blown to bits by the CPAP machines however is a real concern but I fly often enough to have Home Land Security give my CPAP machine the thumbs up that it is not going to explode when I least expect it to happen.

The one I found on Ebay last month will get checked by them soon and then I will sleep much better. They have never told to me what happens if they find it in danger of exploding.

[sleepguide]

no doubt it would preposterous for anyone to actually enforce this, but the question is whether, as a technical legal matter, it's legal to change the settings on one's own machine. I know some very intelligent, honest RTs who claim that it isn't. I know it's clear cut that the machines can't be sold without a RX. But the question of whether adjustments can be made without an RX, by the patient or otherwise, seems more complex. Anyone have an answer to this based on the statutes/regulations themselves, and not just our feelings about what should be the case?

[sleepguide]

no doubt it would preposterous for anyone to actually enforce this, but the question is whether, as a technical legal matter, it's legal to change the settings on one's own machine. I know some very intelligent, honest RTs who claim that it isn't. I know it's clear cut that the machines can't be sold without a RX. But the question of whether adjustments can be made without an RX, by the patient or otherwise, seems more complex. Anyone have an answer to this based on the statutes/regulations themselves, and not just our feelings about what should be the case?

[SharkBait]

I've had one RT (not my DME) tell me that it was illegal, after we were discussing the machines and data. While she was fully in support of downloading and reading the data, she bristled more than a bit when I mentioned that I knew how to access the clinical menu...."You know it's illegal to change your own pressures, right? It's like a surgeon cutting on himself." I told her that I personaly would not change pressures without an order from the doctor or to any pressure not prescribed by the doctor, but that if I was in a spot where the pressure needed to be changed and my RT could not get to me to do it....well, then yes, it would get changed or set to the prescribed pressure. I will not be left helpless when my husband's (or my) life depends on it. I was uninformed and unable to insist on the proper treatment ONCE, and it nearly cost my husband his life...and did cost him about 1/3 of his heart muscle, to include most of his left ventricle. That will not happen again.

People are silly little beings. Don't you know it made her feel all special and powerful telling you that load of crap. And that's all it was. Surgeons cutting on themselves. Yeah, that's a pretty accurate parallel...

[ozij]

I know some very intelligent, honest RTs who claim that it isn't.

And none of them, despite their intelligence or honesty have managed to show you those statutes. So you come here to ask us.

Are they not intelligent enough to find the info? Are they not honest enought to admit they can't supply it - because it is simply an RT urban legend?

Search this forum - never has any RT making it managed to supply proof for that preposterous statement - which has been brought here by RTs more than once.
O.

[sleeplessinaz]

Are these the same people who believe that we are not allowed to cut the tags off of our matress and pillows????? LOL!!! For pete's sake --once you own the machine--you can do what you want with it. Just like people with diabetes can regulate and change their meds on their own,
C

[LoQ]

In California, under the California Business And Professions Code Section Section 4022, CPAP and other xPAP machines are deemed "Dangerous Medical Devices" because they carry a federally mandated label regarding their prescription status and are viewed as "unsafe for self-use in humans":

Alright, so that says it's "unsafe for self-use in humans." What the heck does that mean? Sounds like it's unsafe for you to put on a mask and use a PAP machine every night. It doesn't sound to me like it means illegal to change the pressure. Possibly "unsafe" to change the pressure. Where do you get the illegal part?

Are you an RT? If not, then let me just say that there is a motive for RTs to tell their patients it's illegal for them to change their own settings. RTs are being squeezed out of business by the "take responsibility for your own health" crowd, and I'm sure they don't like it. Many of them, for example, will not help you with equipment you acquire from some place other than their business. It's not about the patients, as far as I can tell, it's about the money.

It's like a surgeon cutting on himself.

That's illegal?? I'm not even a medical doctor, and I do surgery on myself all the time. Is it illegal for me to do that, or just surgeons?

[SharkBait]

I think we all know the score here. "CPAP machines require prescriptions to make people a lot of money". Are there risks? Of course, just as there is with any over the counter drug. Just keep playing the game and ignore the people that try to make themselves feel like they matter by lying to you about laws and statutes...

[TSSleepy]

And if you're prescribed "one tablet daily, with food" for some pill, will they arrest me if I take two or forget to eat?

[sleepguide]

I'm not an RT. I'm a patient who has heard conflicting things about the legality of pressure setting changes, and just trying to sort out fact from fiction.

[ozij]

And if you're prescribed "one tablet daily, with food" for some pill, will they arrest me if I take two or forget to eat?

Not to mention medication prescribed for you to take at your discretion.

I'm not an RT. I'm a patient who has heard conflicting things about the legality of pressure setting changes, and just trying to sort out fact from fiction.

Accordign to your site, " you've got a diverse group of sleep pros here to bounce ideas off of". And, yet your honest intelligent informants and sleep pros are doing nothing to help you sort that out. Don't you consider that weird?

O.