[quote="NightHawkeye"]In order to clear up confusion regarding oximeters and prescriptions I perused the FDA website. The section dealing with oximeters is at the following link location:
http://www.fda.gov/cdrh/ode/guidance/1605.html#6
An oximeter is a device regulated by the FDA for the reasons listed in
Section 6, Table 2. Risks and Mitigation Measures
Inadequate device performance
Electrical and mechanical failure
Electromagnetic interference
Electromagnetic Compatibility
Adverse tissue reactivity
Cross-contamination and infection
Improper use
An oximeter is categorized as a
Class II Medical Device. This puts it, appropriately enough, in the same category as a stethoscope, or a mercury thermometer. I don't believe that either of those requires a prescription. (The FDA categorizes medical devices as Class I, Class II, or Class III.)
IANAL. None of the reasons stated by the FDA would seem to warrant the need for a prescription. As many/most folks here understand, an oximeter is a benign device which, by itself, poses no more risk to health than either a bandage or a television set.
Since SPO medical highlights CE and CSA approvals prominently next to the "Rx requirement", I also checked on those. CE and CSA are simply approvals required before commercial products can be sold in the European Union and Canada, respectively, and have no relevance to medical usage.
OK, I accept that an oximeter used in a clinical setting needs to be reliable if health care workers are depending upon it to alert them, but then something similar can be said of aspirin which requires no prescription. It makes sense that FDA approval (or certification) would be required for an oximeter. That doesn't answer the prescription requirement though.
The only loophole I see which remotely allows the manufacturer to claim a prescription is needed for an oximeter is, interestingly enough, the labeling requirement. It turns out that in lieu of providing clear directions for usage, a manufacturer can simply slap a label on a medical device transfering all responsibility for proper usage to a physician. (Note the recurring theme here.)
Here's the appropriate reference:
http://www.fda.gov/cdrh/ode/guidance/1605.html#14
As a prescription device, under 21 CFR 801.109, the device is exempt from having adequate directions for lay use.
And here is the link to 21 CFR 801.109, along with an excerpt:
http://www.accessdata.fda.gov/scripts/c ... FR=801.109
PART 801 -- LABELING
Subpart D--Exemptions From Adequate Directions for Use
Sec. 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 long list follows)
Nowhere, does the FDA claim that an ordinary oximeter must be classified as a prescription device. It only took a couple of hours following semi circular references around, but the bottom line is that a manufacturer can, at the manufacturer's option, claim an oximeter as a prescription device by not providing directions for proper use and transferring all responsibility for proper use to a physician.
This leaves a very big, very nebulous, gray area in regard to buying (or selling). The device itself does not technically require any prescription. Medical usage of the device requires a prescription, however, if the manufacturer says that it does.
Regards,
Bill (resisting the urge to summarize with cruder terminology than "arbitrary and capricious" ...)
