Why it IS illegal - sort of - to change your pressure.

[SuperSleeper]

What you believe is one thing, actual law and its practice is another thing all together.
You have the right to believe what you want and you may chose to break these laws but you can still get arrested when you do - this is commonly called political activism and is fine as far as I am concerned - for more then 3 generations my family has participated in this. But don't come whining when the law lays its hand on your shoulder - you make the choice, you take the risk and you pay the price - that is how it works.

Don't confuse the two.

A "law" that is created in direct opposition to the rights of man is no law.

I am fully willing and able to defend myself by all proper and just means should a tyrannical government decide that they must violate my God-given rights. If such an event occurs, I assure you, whining on a public forum will not be among the options that I will exercise. No confusion here at all.

If you choose not to exercise nor to defend your own rights, you have that option open to you. But when more and more of your rights are taken away because you refused to take action, I expect you as well to not "come whining" when all of your freedom is stripped from you because you refused to fight.

Works both ways.

Sleep well...


SuperSleeper

[M.D.Hosehead]

I'm one of those who appreciate the OP's taking time to post a polite, reasoned exposition upon a topic of interest to me. I can't think of any rational thought process that would justify someone's posting a vituperative reply.

I, for one, hope xj220c sticks around. If "nobody" dislikes his posts, he can add xj to his foes list. And vice-versa, ipso facto, mutatis mutandis and res ipsa loquitur.

[xj220c]

A "law" that is created in direct opposition to the rights of man is no law.

I am fully willing and able to defend myself by all proper and just means should a tyrannical government decide that they must violate my God-given rights.

Who would have ever suspected that the second American revolution would have started on an internet message board devoted to CPAP therapy?

Seriously though, I absolutely respect your political philosophy Sleeper. I happen to disagree with it to a large extent and even consider a few parts inherently dangerous, but I don't deny you your right to hold those opinions if you so choose. Thank you for taking the time to spell it out. I'm sure that some here will agree and some will disagree and some will be split down the middle on what you have to say.

As I said at the very beginning, I knew that we'd see posts like this in this thread. I just hope that we can maintain the distinction between a discussion on what the law is and what the law ought to be. Those are two very different subjects even when you invoke Jefferson and natural law.

Cheers,
OPos.

[LinkC]

Who would have ever suspected that the second American revolution would have started on an internet message board devoted to CPAP therapy?

All I can say is that some of us are sleep-deprived... Gotta go prepare my pitchforks and torches now.

[Breathe Jimbo]

The original post is utter rubbish and shows the dangers of someone with no legal training misapplying legal principles that he does not understand. Don't even bother to argue with me unless you have a law degree and have passed a state bar exam. And no RT or sleep study tech can say the same thing back to me because they are not authorized to prescribe machines or pressures or to change a pressure prescribed by a doctor, so there.

It appears that we keep seeing the same person appearing over and over again under different persona for the purpose of discouraging people from being very proactive and taking charge of their own care and treatment, which may include occasional pressure changes for good reason after becoming educated in the matter. That person, whatever his or her real name (I seriously doubt it has ever been used here), is a negative influence hostile to the spirit of this community. Pay that person no heed.

[BlackSpinner]

The original post is utter rubbish and shows the dangers of someone with no legal training misapplying legal principles that he does not understand. .

Uuumh the OP stated he/she is a lawyer.... Great reading comprehension on your part.

[navyvet]

Interesting. But xj displays a fundamental lack of understanding of the FDA, its processes and general philosophy. That's only a comment, not a criticism. That kind of knowledge is hard to come by.

1. Adulterating a Medical Device

Federal law, 21 USC § 331(b) to be precise, prohibits "(t)he adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce."

Ultimate answer: Yes, it's technically illegal under federal law to change your pressures but nobody in Washington is going to care.

Actually, under this criterion the answer is probably no. FDAese is a distinct dialect of both English and Legalese. There are some nuances that it takes one experienced in reading the FDA gibberish to understand it, lawyer or not. Adulteration of a device would entail changing the manner that the machine functions according to the approval documentation. Because it was approved as a device with a feature enabling it to deliver air pressure within a defined range of pressures, changing the setting of the device for pressures within that range is probably fine. However, changing the device so that it delivers a pressure outside of the approved range would be adulteration of the device. Changing the device so that it delivers only one pressure, and not a defined range of pressures, would be adulteraing it.

I'm with howkim here, For example:

1adul·ter·ate
vt \ə-ˈdəl-tə-ˌrāt\
adul·ter·at·edadul·ter·at·ing
Definition of ADULTERATE
: to corrupt, debase, or make impure by the addition of a foreign or inferior substance or element; especially : to prepare for sale by replacing more valuable with less valuable or inert ingredients

Adulteration of food, drugs, cosmetic's, etc. IS adding foreign substances to it for resale. The law clearly says "in interstate commerce":

Interstate commerce - The buying and selling of products and services across state borders.

It is NOT illegal to add substances to any of these things by the consumer. It's not illegal to crush a pill and mix it with milk. How could you prepare food at all if that were the case? I don't see how an attorney could not get that.

Uuumh the OP stated he/she is a lawyer.... Great reading comprehension on your part.

Uuumh....I doubt the op is a lawyer, otherwise they should not have missed the interstate commerce part which is unmistakable. People can claim to be anything on the internet.

Changing the air pressure on a cpap is NOT adulterating it as it is designed to be changed, if it were not designed to be changed and you went in to modify it that would be "corrupting" it and would be adulterating it. Still, the federal law CLEARLY states IN INTERSTATE COMMERCE which has nothing to do with the end user unless you are selling these.

[SuperSleeper]

As I said at the very beginning, I knew that we'd see posts like this in this thread. I just hope that we can maintain the distinction between a discussion on what the law is and what the law ought to be. Those are two very different subjects even when you invoke Jefferson and natural law.

Cheers,
OPos.

Indeed, there is a distinction between the two, and they are both forever intertwined whenever these subjects are properly discussed.

As we discuss what the laws are, we ought also to discuss what the law ought to be. One cannot permanently divorce the two issues without sacrificing justice.

Regards,

SuperSleeper

[Physician]

How about you prove that anyone ever has been in legal trouble or even had insurance coverage denied solely because they changed the pressure on their own machine.

[ some of the interpretations of them

This is the problem with it, but hey if you want to believe this nonsense feel free. Just remember anybody can claim to be a lawyer online and offer up a bunch of legal sounding bullshit.

And you can prove this? You have the quotes of the laws? and the court rulings?

Remember, we are dealing with HEALTHCARE here, not litigation for a tort of product liability. I enjoy the medical-legal field, so this is a fun topic.


Let's see if anyone here can produce any evidence that Medicare or any other third party carrier has ever denied benefits solely due to a patient modifying values, software, or hardware of any legally-prescribed equipment which is used for effective treatment of a known medical condition.

[SleepingUgly]

Is it just me, or is it irrelevant to most people whether it is or is not legal to change their settings? If I weren't so tired today, I would be able to read the original post, and maybe there is an answer in there that would satisfy my curiosity (very, very minimal curiosity) about whether it's illegal or not. But whether it's legal or not, interesting little tidbit that it is, is not going to impact whether I do it. It's simply not the basis for my decision. For example, I am more likely to consider whether my doctor will be upset if I do it than whether it's legal or not. But maybe there are lots of people out there who are currently changing their settings and would not be doing so if they thought it was illegal. If so, I'd be curious whether it would make any difference whether they thought they could get caught or punished for it vs. that it's technically illegal but no one is going to prosecute.

In any event, I have to go... I always take my uncaged bear out for a drive on Saturdays.

[xj220c]

Adulteration of food, drugs, cosmetic's, etc. IS adding foreign substances to it for resale.

Please see my later post discussing what the legal definition is for adulteration of medical devices. As you will see, the definition of adulteration for a device is set by federal statute, not by a dictionary, and is very, very much different from what you have posted here.

Still, the federal law CLEARLY states IN INTERSTATE COMMERCE which has nothing to do with the end user unless you are selling these.

Please also take the time to read the section of the original post that discusses this. Many, if not most, products remain in interstate commerce even after they are sold to the consumer. The sale to the end user does not extinguish federal regulatory authority. In many cases patients don't even own their machine. There's not even a question that rented units are still in interstate commerce.

Cheers,
XJ.

[navyvet]

Sorry, you are wrong. Otherwise you could not add milk to pancake mix as that would be an adulteration of food.

[Physician]

Sorry, you are wrong. Otherwise you could not add milk to pancake mix as that would be an adulteration of food.

Now this is humorous !! Perhaps it is an adulteration, but a perfectly legal and acceptable one. After all, adding milk is adding a foreign substance to the pure pancake mix. And as the dictionary states:


ADULTERATION : to corrupt, debase, or make impure by the addition of a foreign or inferior substance or element; especially : to prepare for sale by replacing more valuable with less valuable or inert ingredients

[Breathe Jimbo]

@blackspinner, the so-called legal analysis in the original post is superficial nonsense typical of laypersons acting like lawyers. The original poster may claim to be a lawyer, but his reasoning is so misguided and shows such fundamental misunderstanding of the context and purposes of the authorities cited that I doubt he is a lawyer, let alone a graduate of a "top ten law school." He may have used sufficient buzz words to impress laypersons who don't know any better, but his so-called legal reasoning is garbage, for reasons that others have already provided above.

[xj220c]

Is it just me, or is it irrelevant to most people whether it is or is not legal to change their settings?

You're absolutely correct.

I knew when I started this that I was probably going to regret. Sure enough, I do.

I honestly don't think it's a big deal to have patients changing pressures. I do it myself with the help of the clinician's manual I obtained from SuperSleeper's site (and I'm sending along a donation for that, BTW). I also think that educating patients and involving them in their therapy as much as possible is a great, great thing. It's probably THE best thing you can do to improve CPAP compliance. I call my doc - who knows me well and trusts my ability to help manage my care - before I make any changes though. It think that's the sane and sound way to do it.

My intention with this thread was to inject some factual discussion into the "it's illegal - no it's not" debate that's been going on. I had not previously seen a single post that bothered to say why it would be illegal or not. Everybody was just going on what they had heard or been told or decided for themselves. I knew that it would inflame some passion, but I never suspected that such a minor issue would lead to such outright nastiness and name calling. I guess I just need to live and learn.

So you're right. It is a minor point. This community represents about one out of every 10,000 CPAP users out there - and I doubt there's many of them changing their settings who aren't a member of this board. I don't think that we're threatening the human species by having this conversation - and don't think we would threaten it if we didn't. Maybe it's just best to lock the thread and let it die.

Cheers,
XJ.