Are Clinician Manuals Illegal

[RN Ricky]

A quick question for the Forum Folk! Does anyone know for a fact that it is illegal in Florida for a person who uses a CPAP to have a clinician manual? Or does the FDA control that on a national leval? Just received a new machine & the RT told me that. Guess where I got that info?? The Big "A". My MD actually wrote a script for a specific unit AND a clinician manual. I suppose that the MD doesn't know me well enough to let me have a manual

Also the other "RT" didn't quite know how to place a cover from the unit into the humidifier so that it would not get lost. Then she tightened the mask headgear so tight that I had to tell her -- her response -- fix it when you get home. No wonder new cpapers quit!

Another question-- if the pressure is adjusted too high will it damage the lungs or just explode them?

[foxhunter]

Frankly, I don't give a damn whether it's legal or not. This is my life and i will protect it with whatever tools i can get and from wherever I get them.

[ScrappinMom]

No, it's not. However, it is illegal for licensed medical professionals to lie to their patients. But, that doesn't stop many of them.

[-SWS]

Another question-- if the pressure is adjusted too high will it damage the lungs or just explode them?

I'm not a medical professional or even an expert about the subject matter at hand... But my understanding is that say 20 cmH2O or even 30 cmH2O is not enough pressure to damage lungs. That kind of low pressure is more suitable for stenting the upper airway rather than inflating lungs. Hospital ventilators can be set to generate much more pressure toward lung inflation.

However, the most common side effects of too much CPAP pressure include the induction of central apneas (somewhat common), aerophagia, mouth leaks, and mask seal breaches. Probably others that I can't think of off the top of my head...

Dunno the legality issues regarding clinician manuals. The FDA has been pretty funky lately about enforcing prescriptions for ancillary items like masks, humidifiers, etc. Heaven knows what those federal legal weenies would do about clinician manuals these days...

Good luck!

[scrapper]

I tend not to worry about the big issues like whether or not the clinician's manuals I have are legal or not..........I'm more into the little details like world peace, freedom of religion, and dwi's....... it all keeps me on my knees.

[JohnBFisher]

... Does anyone know for a fact that it is illegal in Florida for a person who uses a CPAP to have a clinician manual? ...

It is probably illegal (by contract and by the state licenscing agency) for them to provide it to you. I seriously doubt if it is illegal for you to have a copy of it. Those are different beasts.

... Or does the FDA control that on a national leval? ...

Probably. They control the use of medical equipment. Healthcare companies (ResMed and Respironics) must provde to the satisfaction of the FDA that the device is safe and does what it says it does. But I doubt they regulate providing the manual to the patient.

... Just received a new machine & the RT told me that. Guess where I got that info?? ...

You might have gotten the answer because it is easier for some people to make it sound as if it is illegal, when the law actually pertains to them. But even so, they probably are not allowed to provide it - regardless of the doctors prescription. The contract between them and the xPAP device provider would trump the prescription. Sorry.

... if the pressure is adjusted too high will it damage the lungs or just explode them? ...

Nope. The pressures with a traditional CPAP/BiPAP/ASV unit are well below pressures that can damage your lungs. However, if the pressure goes over 15cm H2O (just a rough number), you will feel as if you are breathing into a hurricane. Not really, but hey, it's a LOT of pressure if you are not used to it. But it certainly will not damage your lungs. (Unless of course you have some wierd unkown lung problem and any titration study would have already found that).

[-SWS]

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

And several more here:
http://www.internetage.ws/cpaphelp/manuals/

[RN Ricky]

My question regarding the pressure was for the purpose of people having damaged themselves with a home cpap machine. What is the big deal? I was given a script for a very strong pain medication. I was expected to use this on my own and I did Many folks have ended up in the hospital with overdoses accidental and intentional but with disastrous results. Yet we are still given a bottle of pills. I have not heard of a cpaper dying from a machine unless they were throwing it in the direction of the DME and it bounced back and killed them

You do realise of course that nurses back in the 1920's & 30's could not take a blood pressure, only MD's could. I hope we don't have to wait so long that we can legally change our own pressures.

[Wulfman]

This is what's printed in the Respironics provider manuals (in some form or other).

IMPORTANT! Remove this guide before giving the device to the patient. Only medical professionals should adjust pressure settings.


Doesn't say anything about "legality".
To me, it's like any other item you purchase.....it should have an owner's manual with ALL the information about the item.


Den

[harry33]

I was at another apnea board where they refused to mention any clinical manuals or to tell anyone how to adjust their pressure, that board was mainly to protect the CPAP professionals, this board is mainly for the CPAP users

I have a long wait for a sleep doc appointment but recently had severe fatigue, luckily I found out how to adjust the pressure and increased it, curing the fatigue

[Disneymama]

sws, thanks for those links. Very helpful.

[-SWS]

You do realise of course that nurses back in the 1920's & 30's could not take a blood pressure, only MD's could.

Speaking of utterly silly nonsense, I love that prescription requirement for pulse ox purchases...

Consulting coroner to FDA bureaucrat: "Ooops! Looks like another case of fatal SpO2 measurement."

[JohnBFisher]

... My question regarding the pressure was for the purpose of people having damaged themselves with a home cpap machine. What is the big deal? ...

Several factors.

First, sleep medicine is relatively new (compared to many other branches of medicine). So, some of the practioners are very protective of their turf. Just the way this sort of thing goes.

Second, your lungs are part of the "cardio-pulmonary" system. They are intertwined. If someone has heart problems changing CPAP pressure can in fact be a very bad thing. I've talked with sleep technicians who had some bad experiences due to this.

Third, with the propensity for people to sue their healthcare providers for their own stupidity (pardon me for being blunt), the healthcare providers will tend to take a "nanny" approach. I won't let you hurt yourself, so you don't sue me.

Fourth, more likely of a factor is that many people experience central apneas when the pressure is increased too high. And that can lead to very ugly problems. I would not wish my joy ride with central apneas on my worst enemy! (Not self induced in my case, but rather due to problems with my brain stem). But remember item 3. If I overdo it, hurt myself, I'll blame it on you, rather than accepting responsibility for my own actions.

... I have not heard of a cpaper dying from a machine unless they were throwing it in the direction of the DME and it bounced back and killed them ...

Nor have I. However, what if someone increases the pressure too much. They then have lots of central apneas. It makes them dangerous to drive. They drive anyway. The patient dies. The family sues the DME, the equipment provider and the doctor ... because they can. And don't think it won't happen. Okay, add in the fact that the accident killed someone else. Suddenly, it's a no-win situation. So, the provider manuals are "off limits".

That's why you see stupid warning stickers on products. Or example, the following warning label appears on a clothes iron:

Warning: Never iron clothes on the body.

There's even a site for this stuff: http://www.dumbwarnings.com/.

... You do realise of course that nurses back in the 1920's & 30's could not take a blood pressure, only MD's could. I hope we don't have to wait so long that we can legally change our own pressures. ...

Hmm... Discuss it with your sleep doctor. If you have your healthcare team on-board, there is no problem with you adjusting (if you CAREFULLY monitor the progress). But remember, you need to validate it with two things - how you feel and what the numbers appear to say.

Hope that helps.

[Hose_Head]

A quick question for the Forum Folk! Does anyone know for a fact that it is illegal in Florida for a person who uses a CPAP to have a clinician manual? Or does the FDA control that on a national leval? Just received a new machine & the RT told me that. Guess where I got that info?? The Big "A". My MD actually wrote a script for a specific unit AND a clinician manual. I suppose that the MD doesn't know me well enough to let me have a manual

Also the other "RT" didn't quite know how to place a cover from the unit into the humidifier so that it would not get lost. Then she tightened the mask headgear so tight that I had to tell her -- her response -- fix it when you get home. No wonder new cpapers quit!

Another question-- if the pressure is adjusted too high will it damage the lungs or just explode them?

I'm certainly no expert on laws in your state. However, I'll bet a buck that it's illegal for your RT not to dispense as ordered by your MD. While your RT refused to break the law (as s/he understands it) regarding giving you the clinician manual, h/she broke the law by refusing to dispense as ordered.

If my interpretation is correct for your state, you may wish to remind the RT that the Rx must be filled as written by the MD.

You also might ask the RT for the precise reference for the law that was quoted re the clinician manual. Others in this forum have asked this same question, numerous times. I am unaware of anyone being able to find such a law. I'm of the conclusion that it's a law that's written by the DME and/or the manufacturer of the product (i.e. it's not a law at all, it's a corporate policy, perhaps based on a contractual arrangement between the two)

[JohnBFisher]

... I am unaware of anyone being able to find such a law. I'm of the conclusion that it's a law that's written by the DME and/or the manufacturer of the product (i.e. it's not a law at all, it's a corporate policy, perhaps based on a contractual arrangement between the two) ...

That is what is known as a contract. To the best of my knowledge a prescription can not trump a legally binding contract. If they could then a doctor could write a prescription to allow me to see company proprietary information about the device that I use for my therapy. I doubt it would not stand up in a court. While the device should be provided as written, the contract between the DME and the manufacturer probably requires removal of the manual. The device can be prescribed. But the prescription can not circumvent the contractural obligations between the parties. In that case, neither the doctor nor the patient has any standing to challenge the contract or those obligations. Unless you can prove that it would harm either party ... and in fact the evidence is that improper use could cause harm.

At least that's the way I read the situation. I may be mistaken. Trust me, it happens all the time. Hope it makes sense.