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Is Changing CPAP Settings on One's Own Machine Illegal?
I don't know. And that's the point. While never likely to be enforced, this article is to highlight that there is confusion over whether it's legal to change the settings on one's own CPAP machine. The CPAP community seems divided on the question of whether changing the settings should be legal, with most doctors, respiratory therapists and Durable Medical Equipment providers feeling we patients should not be able to change the settings of our own machines, at least not without their supervision, and most patients believing we should be able to control our own therapy, much like diabetics do with their own treatment. The question of "should" is one that I'd like to put aside for the moment as we consider what is, in fact, the current state of play.
Going to the law books themselves, I have to say, I can see some zealous prosecutor somewhere making a case that changing the settings on a CPAP machine is illegal. I do not think they would have a winner of an argument, because the law, as set forth below, seems to be regulating those who sell and distribute the machines, not the people who actually use them. But I think their reasoning would be that the sale of a CPAP requires a prescription for a certain setting, and re-jiggering each pressure setting would require a separate prescription.
A lot of the applicable law here is on the state level. I'll take my own state, California, as an example. Now, California isn't quite typical because it tends to go overboard in its regulatory zeal, being a lot more "hands on" and in your face as a general rule than other states. That said, here are the two statutes (one state and the other federal) which I think are relevant:
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.
Federal Law (Title 21, Part 801, Section 109 of the Code of Federal Regulations) requires CPAPs and other xPAPS to carry a federal legend regarding their prescription status:
21 C.F.R. § 801.109 Prescription devices.
Title 21: Food and Drugs
PART 801-LABELING
Subpart D-Exemptions From Adequate Directions for Use
§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which "adequate directions for use" cannot be prepared, shall be exempt from section 502(f)(1) of the act if all the following conditions are met:
(a) The device is:
(1)(i) In the possession of a person, or his agents or employees, regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device; or
(ii) In the possession of a practitioner, such as physicians, dentists, and veterinarians, licensed by law to use or order the use of such device; and
(2) Is to be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice.
(b) The label of the device, other than surgical instruments, bears:
(1) The statement "Caution: Federal law restricts this device to sale by or on the order of a ____", the blank to be filled with the word "physician", "dentist", "veterinarian", or with the descriptive designation of any other practitioner licensed by the law of the State in which he practices to use or order the use of the device (my emphasis); and
(2) The method of its application or use.
(c) Labeling on or within the package from which the device is to be dispensed bears information for use, including indications, effects, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the device can use the device safely and for the purpose for which it is intended, including all purposes for which it is advertised or represented: Provided, however, That such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. Upon written request, stating reasonable grounds therefor, the Commissioner will offer an opinion on a proposal to omit such information from the dispensing package under this proviso.
(d) Any labeling, as defined in section 201(m) of the act, whether or not it is on or within a package from which the device is to be dispensed, distributed by or on behalf of the manufacturer, packer, or distributor of the device, that furnishes or purports to furnish information for use of the device contains adequate information for such use, including indications, effects, routes, methods, and frequency and duration of administration and any relevant hazards, contraindications, side effects, and precautions, under which practitioners licensed by law to employ the device can use the device safely and for the purposes for which it is intended, including all purposes for which it is advertised or represented. This information will not be required on so-called reminder-piece labeling which calls attention to the name of the device but does not include indications or other use information.
(e) All labeling, except labels and cartons, bearing information for use of the device also bears the date of the issuance or the date of the latest revision of such labeling.
Conclusion
Although the law on CPAP is clear that it's illegal to sell or distribute it without a prescription, it's less clear whether patients can modify their CPAP settings on their own. The California statute defines a CPAP as a "Dangerous Device" that is unfit for self-use. What that means is an open question.
Going to the law books themselves, I have to say, I can see some zealous prosecutor somewhere making a case that changing the settings on a CPAP machine is illegal. I do not think they would have a winner of an argument, because the law, as set forth below, seems to be regulating those who sell and distribute the machines, not the people who actually use them. But I think their reasoning would be that the sale of a CPAP requires a prescription for a certain setting, and re-jiggering each pressure setting would require a separate prescription.
A lot of the applicable law here is on the state level. I'll take my own state, California, as an example. Now, California isn't quite typical because it tends to go overboard in its regulatory zeal, being a lot more "hands on" and in your face as a general rule than other states. That said, here are the two statutes (one state and the other federal) which I think are relevant:
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.
Federal Law (Title 21, Part 801, Section 109 of the Code of Federal Regulations) requires CPAPs and other xPAPS to carry a federal legend regarding their prescription status:
21 C.F.R. § 801.109 Prescription devices.
Title 21: Food and Drugs
PART 801-LABELING
Subpart D-Exemptions From Adequate Directions for Use
§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which "adequate directions for use" cannot be prepared, shall be exempt from section 502(f)(1) of the act if all the following conditions are met:
(a) The device is:
(1)(i) In the possession of a person, or his agents or employees, regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device; or
(ii) In the possession of a practitioner, such as physicians, dentists, and veterinarians, licensed by law to use or order the use of such device; and
(2) Is to be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice.
(b) The label of the device, other than surgical instruments, bears:
(1) The statement "Caution: Federal law restricts this device to sale by or on the order of a ____", the blank to be filled with the word "physician", "dentist", "veterinarian", or with the descriptive designation of any other practitioner licensed by the law of the State in which he practices to use or order the use of the device (my emphasis); and
(2) The method of its application or use.
(c) Labeling on or within the package from which the device is to be dispensed bears information for use, including indications, effects, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the device can use the device safely and for the purpose for which it is intended, including all purposes for which it is advertised or represented: Provided, however, That such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. Upon written request, stating reasonable grounds therefor, the Commissioner will offer an opinion on a proposal to omit such information from the dispensing package under this proviso.
(d) Any labeling, as defined in section 201(m) of the act, whether or not it is on or within a package from which the device is to be dispensed, distributed by or on behalf of the manufacturer, packer, or distributor of the device, that furnishes or purports to furnish information for use of the device contains adequate information for such use, including indications, effects, routes, methods, and frequency and duration of administration and any relevant hazards, contraindications, side effects, and precautions, under which practitioners licensed by law to employ the device can use the device safely and for the purposes for which it is intended, including all purposes for which it is advertised or represented. This information will not be required on so-called reminder-piece labeling which calls attention to the name of the device but does not include indications or other use information.
(e) All labeling, except labels and cartons, bearing information for use of the device also bears the date of the issuance or the date of the latest revision of such labeling.
Conclusion
Although the law on CPAP is clear that it's illegal to sell or distribute it without a prescription, it's less clear whether patients can modify their CPAP settings on their own. The California statute defines a CPAP as a "Dangerous Device" that is unfit for self-use. What that means is an open question.
Views: 6419
Comment
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Comment by Neal Buckner, LRCP on October 27, 2010 at 2:44pm
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Ok. A practitioners 2 cents here.
For the most part. Simple OSA is just that. Simple. As we age and medical conditions change, changes in PAP may need to occur. Either increase or decreased. For those who are proactive about their treatment and understand what kind of sleep apnea they have, making small changes is probably no big deal.
However, having said that. There is some danger in making changes to your PAP pressure if you don't have a clear understanding of the possible outcomes. Too high of a pressure can be just as bad as a pressure that is too low. More so in some cases.
Central sleep apnea's can be worsened if too much CO2 is blown off due to the increase in ventilation when pressures are too high. Plus the number of sleep disturbances can increase from mask leak and swallowing air. Increasing CPAP pressure in turn creates a higher PEEP. Positive end expiratory pressure. Increased PEEP increases the lung surface area participating in respiration. This increased respiration can lower CO2 levels causing the central chemoreceptor to delay sending a signal to the diphragm to contract. This can cause increased central apneas and hypopneas in turn causing O2 sats to drop due to the decrease in ventilation. Desats cause disturbances.
In patients who have later stages of COPD the increase will increase the oxygen levels. Advanced stage of COPD the central chemoreceptor is no longer the receptor used in regulating the respiratory rate. The peripheral chemoreceptor takes over. The peripheral receptor measures blood oxygen. Increasing the O2 levels by way of increased ventilation and respiration also tells the brain the diaphragm does not need to contract. Hyponeas and central apneas increase thus causing the blood CO2 levels to increase.
In short. Please always inform your physician of any changes you have made and get a download done after 2 weeks at the new pressure to ensure the change didn't make things worse.
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Comment by Peggy B. on October 9, 2010 at 10:23am
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I did find out what I needed to do to raise it back to the original settings, THANKS Sleepguide!!. I will call the doctors office on Monday to make sure this is okay with them.
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This is very interesting because due to sinus issues the dr had the tech lower my setting, and since I have been using it at the lowered rate, I find myself waking up because of lack of O2. Anyways, their office is over 2 hours away, and I am searching for a way to increase it myself. It is the weekend or I would call them, but I am not wanting to wait 2 more days. I have a Fisher and Paykel 600 and when I see the setting there is a key(locked) symbol, I am sure. UHHHGGGG!!
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Comment by Richard Morgan on May 30, 2010 at 6:42pm
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Glad I saw this. Just the other day I went to my PCP to get my rx for a new mask (Swift FX) which I think is the greatest, and for a new cpap. We got into a short discussion about settings. I told her I wish there was a dial on the front so we could adjust it to what felt comfortable and allowed us to breathe the easiest. Which I did once when hospitalized for a non related illness. I set it on 14 instead of the usual 12 cm and it felt much easier to breathe. She said if oxygen was part of the treatment, too much could be toxic, but she wasn't sure if too much plain old compressed air might also be dangerous. She thought it would be a good question to post here. What do you all think?
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If the doctor saw to it or assisted you in being provided w/a fully data capable xPAP getting feedback would NOT be a problem! There are doctors such as you suggest you would be. And WAY TOO MANY OF THEM don't provide the patient w/any feedback. Then there are the wiser, more progressive doctors who see to it that those patients who are interested in taking an active part in their healthcare and therapy are provided w/the education, support, advice and monitoring to do so.
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My original pressure was reduced, mask difficulties. When I saw DME, he was shocked my pressure was increased. Asked, had I seen Dr. No, but told him had asked Nurse if Dr would object to .02 increments back to original pressure. She sd wd tell Dr. DME not approve. Dr not make comment at office visit. Took record of all data She commented was the first time a patient had shown that much interest in data. If I had not taken option,of increassing pressure, my treatment would have been delayed 6 weeks until my next appointment. I want to have cordial relationship with Dr. that is why I asked nurse if I could change pressure.
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Treatment for diabetics has matured over many years. Diabetics now have a much better life since they have been trained to make the necessary adjustments to maintain proper blood/sugar levels. Sleep apnea treatment is relatively new and it will also take some time for the medical community to evaluate proper treatment. Out of necessity, I have made some minor changes that have greatly improved my sleep. As an engineer, I know how to evaluate data, make reasonable changes, evaluate the results, etc. There are others that would make wild changes that defy common sense, and they could hurt themselves. Let's face it; there are some people that cannot adjust their room thermostat properly. But, should all of us be lumped together in one big group and all have to adhere to rules simply because a few need strict guidance?
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Comment by sleepycarol on March 9, 2009 at 8:21am
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I have a very open relationship with my primary care doctor. I openly admit to her about any self-treatment that I do, including changing my own pressure. She supports me and is not against me changing my pressure. Of course, she also knows I am very proactive in my treatment. I often take my printouts to her for her to review.
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Comment by Mike on March 9, 2009 at 12:13am
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Another good question: "can you actually hurt yourself by mismanaging your settings?" Along with the question "is it illegal to change one's own settings", we have a couple of very good questions. I as a patient don't know the answers, but if Respiratory Therapists and other professionals are going to answer these things in the affirmative, I agree with Sleepy Carol that I want to see proof in the law/statutes. Otherwise we'll have to believe it's some convenient myth that the pros want us to believe, but which is not really based in fact.
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Comment by Anne Pf on March 8, 2009 at 11:32pm
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Mike,
This is a complex issue. It's also considered to be abusing prescription medications if you take them in ways not prescribed. For instance, if you have Percocet prescribed for a tooth extraction and you save it and later take it for some other reason (sprained ankle, for instance) someone out there could say you abused your medication. But the fact is, unless you take the medication in such a way that it makes you high or impaired, or you give it to someone else for whom it is NOT prescribed, I can't imagine you would be prosecuted for it.
I see diabetes self care compared to sleep apnea a lot on these boards. Perhaps they are similar -- but there are certainly major differences. First of all, diabetics do not really supervise their own treatment. Their physicians give them parameters and tell them what actions to take. Many have a "sliding scale" -- this tells them what dose of insulin to take for their blood sugar. So if their blood sugar is over 150, for instance, they are to self-administer 1 unit of regular insulin, for over 200, 2 units, etc. Others have insulin "coverage" ordered for carbohydrate intake. They are taught to carb count, and are to take 1 unit of insulin for every 15 grams of carbohydrate they consume. They are in charge of their own care in a sense, but they are closely monitored and guided by their physicians.
Sleep apnea care seems to be different. The mask is titrated in a lab setting and the device comes with the settings in place -- some patients don't even know how to change their settings. Other do change their settings based on information from the smart card in the device, but it seems that they are doing this on their own.
I would much rather see patients changing their settings with the close supervision of their medical provider, similar to the way diabetics are managed, than have people changing their settings on their own. Are there physicians out there who are supportive of this practice? Or are patients doing this on their own without medical guidance?
And this is an important question: can you actually hurt yourself by mismanaging your settings?
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