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
(a) Any drug that bears the legend: "Caution: federal law
prohibits dispensing without prescription," "Rx only," or words of
(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
(c) Any other drug or device that by federal or state law can be
lawfully dispensed only on prescription or furnished pursuant to
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
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.
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.