Pulse Oximeter Prescription

I have received a reply from cpapauction and I am putting it below.

There are two types of pulse oximeters, one is of medical accuracy and requires a prescription, and the other is used by athletes and others and it does not. Our categories were set up to sell the medical pulse oximeters that require prescriptions, but we are working on the issue of how to handle both.

Here is information about the phrasing of a prescription for a pulse oximeter:
http://www.cpapauction.com/cpap-help/26 ... ments.html

Regards,
Becky Polk
CPAPAuction

Well that's easy! ... Just tell 'em you need it to train for a marathon

sleepycarol wrote:I have received a reply from cpapauction and I am putting it below.

There are two types of pulse oximeters, one is of medical accuracy and requires a prescription, and the other is used by athletes and others and it does not. Our categories were set up to sell the medical pulse oximeters that require prescriptions, but we are working on the issue of how to handle both.

ROTFL!!!

In other words, they know perfectly well that they can sell oximeters without a prescription! We've already established that there's not only no difference in accuracy between "medical" oximeters and "athletic" oximeters, they are exactly the same designs. Nevertheless, CPAPauction.com is intimidated about selling them without a prescription, either for liability reasons or (insert reason of your own choice here).

... or tell 'em you're not a doctor and you don't intend to play on on TV

I was hoping to be able to bid on one but will wait and maybe if I can get some extra money just buy one from one of the other online dealers.

While all this dialogue was going on yesterday, I took Bill's examples and wrote an inquiry to SPO Medical:

To whom it may concern:

Could you please answer the question as to what/who determines
whether a pulse-oximetry device requires a prescription?

Thank you,

Dennis


And, received this answer:


Dennis,

The SPO Medical PulseOX 5500 is an FDA approved device that requires a prescrition to purchase.

Should you have further questions please visit our website at http://www.spomedical.com[1].

Thank you
Greg Cummings
SPO Medical Support


Not satisfied with their answer, I wrote the following:


Greg,

I realize that the model you mentioned is supposed to require a prescription. However, I've seen the CheckMate Finger Oximeter listed as NOT requiring a prescription......yet, according to the specs, they're practically identical.
What is the determination whether one device requires an Rx and another does not?

Thanks,

Dennis


I finally got this answer back:


Dennis,
In the United States a pulse oximeter used by individuals with medical conditions (e.g. asthma, heart disease, COPD or any other medical condition) require a prescription or Rx. Oximeters used for sports or aviation do not require an Rx. Hope this clarifies your queries.
With kind regards and a Happy Easter Holiday.
Doni

~~~~~~~~~~~~~~~~~~~~~~~

Doni Mayerfeld
Director Product Marketing

SPO Medical
Tel: + 972-9-764-3570
Fax: + 972-9-764-3571

------------------------------------------------------------------------------

So, as TuckNRoll said, the decision is made at the manufacturer's level.
How much do they want to make for selling a "medical device" or a "sports device"?

Den

I did not have a prescription when I bought my SPO 7500 from a popular online vendor, but when I went to sell a spare one I had at cpapauction.com, at least one bidder emailed me and cpap.com complaining of not being able to bid on it because he had no prescription. I understand that the Goodmans need to avoid even the appearance of impropriety, and very much respect what they are doing at cpap.com, cpaptalk.com, and cpapauction.com, but in this case it appears to have cost me about $150, since the seller said he would have paid $300, and I sold for $152.

So if this is a prescription item, it seems not to be sold as one uniformly.

[quote="sleepycarol"]I went to bid on a pulse oximeter on cpapauction and was told I need a prescription for it on file.

I thought you could order these without a script.

Do you need a script or not?

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" ...)

[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" ...)

MrGrumpy wrote:We'd probably have to hire a lawyer to do the legal research to really find the complete answer here.

Good grief! Don't fall into the same trap with lawyers, treating them as all knowledgeable. In actuality, the law is more like varying shades of gray. You have to go to court, and through several appeals to get a definitive ruling sometimes.

The website Groklaw is kinda like a serial movie following legal maneuvers (and shenanigans) regarding the free software movement. Interesting stuff. The lawyers themselves often don't know what the outcomes are going to be. We need a site like that for the free healthcare movement.

Regards,
Bill

The idea that a prescription is needed before I can shine a little light on my finger to determine (for myself) how much O2 I have in my bloodstream is completely rediculous.

My prescription is written by "Larry the Cable Guy"......and it reads, "Git 'er done!"

Tell 'em whatever they want to hear....and buy the thing. Your health is far more important than what some silly bureaucrat says you have to do.

Gerald

NightHawkeye wrote: 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.

Also in the same class as CPAP machines!

(I found that out today while trying to find out if Respironics could be forced into fixing the lost data problem by the FDA. I am still searching.)

sparky2 wrote:(I found that out today while trying to find out if Respironics could be forced into fixing the lost data problem by the FDA. I am still searching.)

I think that one's a lost cause ... the data loss is more of an inconvenience than a medical crisis. It's not a disaster to lose an occasional day although I admit it is frustrating for us and is avoidable if you erase every night. The cost to fix would likely be so high that we might not like the results of that either -- e.g. higher prices for future machines.

Mindy

Well, I just don't get it. All of us (I think) purchased our pulse oximeters without a prescription--they are offered by companies all over the Internet with no prescription requirements.