Pulse Oximeter Prescription

NightHawkeye · Post by **NightHawkeye** » Sat Mar 22, 2008 8:18 am

RipVW wrote: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.

Pretty amazing, isn't it? Here's what has been discovered so far.
- The FDA doesn't require a prescription for oximeters, but allows it.
- A manufacturer/vendor doesn't want liability for anything medical.
- It's apparently not possible to write usage instructions suitable for a "lay" person.
- Physicians are willing to take complete responsibility for proper usage.
- In return, physicians earn a hefty profit for every prescription.

This is an amazing house of cards, me thinks. I'd be willing to bet that what the folks at CPAPauction are struggling with are possible FDA enforcement actions. Even though the FDA doesn't require a prescription for oximeters, if a manufacturer decides that a prescription is required for medical use what are the implications for vendors?

Obviously, given that SPO sells the identical device in both the prescription and non-prescription markets, the manufacturer can sell an oximeter without requiring a prescription for it. SPO calls the same device in one case a "medical" device and the other a "sports" device.

Can a vendor legally sell a device labeled "Rx only" without a prescription? Probably not to the medical market, but can a vendor relabel the device "for non-medical use only" and then sell it without a prescription? Logically, it would seem so. However, there are powerful behind-the-scenes forces which might object (as we've already observed in recent actions of ResMed and Respironics) and those forces could certainly instigate a protracted legal battle.

And so . . ., the absurdity of requiring prescriptions for non-prescription items continues.

Regards,
Bill

sleepycarol · Post by **sleepycarol** » Sat Mar 22, 2008 1:23 pm

I bet my doctor would give me a script for one. I have an appointment next week -- I might check on it. She is impressed by my reports and I literally have to tell her what the various numbers mean.

She is usually pretty good on such matters.

Lots Of Questions · Post by **Lots Of Questions** » Sat Mar 22, 2008 7:54 pm

I was just searching for some information on a pulse oximeter, and I stumbled across this interesting thread.

I have sleep apnea and am wondering if a pulse oximeter would be helpful to me. But I'm having trouble figuring out how I would use the data. I am currently using a CPAP machine, but I don't feel better, and I wonder if I'm getting enough oxygen.

Suppose I buy one of these and record my oxygen levels at night. Would a doctor be able to look at that and say something meaningful, like, "I'm going to start you on oxygen therapy." Or whatever.

What do you all do with the data? How does it help you to tune your therapy?

RipVW · Post by **RipVW** » Sat Mar 22, 2008 8:08 pm

I rely on mine to give me evidence that my therapy is really working as it should. So far, my Ox Saturation has been all good, letting me know that I'm not suffering any damaging apnea events that deplete oxygen in the blood. If I discovered that my O2 saturation was dropping at times during the night, then I would let my doc know about it (especially if I was pretty confident that my CPAP therapy was working up to full potential).

NightHawkeye · Post by **NightHawkeye** » Sat Mar 22, 2008 8:13 pm

Lots Of Questions wrote:What do you all do with the data? How does it help you to tune your therapy?

I was one of the first here to purchase a recording oximeter (perhaps even the first). I bought my oximeter prior to starting xPAP therapy though, and the recorded data showing repeated desaturations helped convince my physician to write me a CPAP prescription. I had previously had two sleep studies done which showed only a small amount of apnea.

My recorded oximeter results while using xPAP generally correlate well with the recorded xPAP machine results. I still experience mouth breathing which results in desaturations which correlate with the xPAP leak data. In general, the oximeter results correlate with the xPAP data. It's redundant, but helps confirm that the xPAP data is correct.

I'd have a hard time telling anyone with a data capable xPAP machine that they needed to buy an oximeter. Nevertheless, I think an oximeter is valuable for anyone who is interested in monitoring the effectiveness of their own therapy. An oximeter can quantify how significant the residual desaturations while on xPAP therapy are.

Just my $0.02.

Regards,
Bill

Gerald · Post by **Gerald** » Sat Mar 22, 2008 8:19 pm

Very nicely written, Hawkeye. You've expressed the "bottom line" in just a few words. I agree....

Gerald

MrGrumpy · Post by **MrGrumpy** » Sat Mar 22, 2008 10:45 pm

After using CPAP for about slightly over half a year now, I have decided a pulse oximeter with memory is nearly essential for thorough sleep apnea treatment. To me, having my own blood pressure machine is essential for truly effective treatment of my hypertension. I dont want to rely upon once in a while checks at my doctor's office and strange, oftentimes uncalibrated blood pressure machines at various places like drug stores. So I buy my own blood pressure cuff to use at home.

I view a good pulse oximeter with memory and software as the sleep apnea equivalent of the above scenario. Because, similar to hypertension, OSA is so serious if untreated, I prefer to have my own oximeter so I can periodically check nocturnal oximetry, at home, in a real world environment. Otherwise, I only get it checked once a year at best in a lab sleep study.

Since the whole entire point of CPAP is to prevent oxygen desaturations, I dont understand why people arent automatically being issued pulse oximeters with memory so they can periodically check their own nocturnal oxygen saturation...or check it when they gain weight or take new medications, etc. You change one thing (weight, new medications) and sometimes, your CPAP pressure requirements change as well.

Eric

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mindy · Post by **mindy** » Sun Mar 23, 2008 8:35 am

I've had some ups and downs with my xPAP therapy and have found my pulse oximeter to be invaluable. I found that I was still having desaturations down to low 80s, in spite of an AHI below 5. I'm due to see my sleep doc next month and plan to have some summary data for her to review.

I agree that it's similar to having a BP monitor for high blood pressure and don't know how I'd substitute anything else for it. The data from my xPAP is not sufficient for me.

Mindy

MrGrumpy · Post by **MrGrumpy** » Sun Mar 23, 2008 12:48 pm

[quote="mindy"]I've had some ups and downs with my xPAP therapy and have found my pulse oximeter to be invaluable. I found that I was still having desaturations down to low 80s, in spite of an AHI below 5. I'm due to see my sleep doc next month and plan to have some summary data for her to review.

I agree that it's similar to having a BP monitor for high blood pressure and don't know how I'd substitute anything else for it. The data from my xPAP is not sufficient for me.

Mindy

Gerald · Post by **Gerald** » Sun Mar 23, 2008 2:23 pm

What Im seeing is that an AHI over 2.5 is not good enough to provide a pretty good certainty that blood O2 saturation level is 93% or higher all night.

The general opinion in the healthcare industry is that an AHI of 5.0 or less is "normal"........and that a person who has an AHI of 2.5 - 4.9 doesn't need CPAP therapy.

I believe this opinion is wrong.

After experimenting with an Oximeter, I've found that AHI can't be over 2.5 or a person will experience O2 depravation.

As more people discover O2 depravation at AHI levels below 5.0, I suspect that more people will realize that they need assistance with CPAP.

An Oximeter is absolutely necessary if a person wants to be sure his/her therapy is effective.

Gerald

mindy · Post by **mindy** » Sun Mar 23, 2008 2:31 pm

I suspect you're probably right, Gerald. I keep seeing desats down to about 80-85% at least a bit of every night even at a pressure of 13. I can't go to 14 because then my breathing apparently becomes unstable (AHI goes way up). I'm going to ask about a bilevel.

With no cpap, my desats go down to about 70%.

Mindy

MrGrumpy · Post by **MrGrumpy** » Sun Mar 23, 2008 3:02 pm

[quote="mindy"]I suspect you're probably right, Gerald. I keep seeing desats down to about 80-85% at least a bit of every night even at a pressure of 13. I can't go to 14 because then my breathing apparently becomes unstable (AHI goes way up). I'm going to ask about a bilevel.

With no cpap, my desats go down to about 70%.

Mindy

MrGrumpy · Post by **MrGrumpy** » Sun Mar 23, 2008 3:06 pm

I consider this act of going out and buying a pulse oximeter with memory and software "taking matters into your own hands." Its an act that truly separates the people who are serious about kicking their OSA in the butt...and those who are willing to just get by or do it cause their doctor wants them on CPAP or their spouse is tired of them snoring all the time.

In this era of managed care health insurance, where you typically only see a doctor for15-30 minutes max, I dont think there is a single thing wrong with "taking matters into your own hands."

Like the guy said, "Git-er-done!"

Eric

Gerald · Post by **Gerald** » Sun Mar 23, 2008 4:00 pm

Well said Eric........

mindy · Post by **mindy** » Sun Mar 23, 2008 4:06 pm

Agreed - except it is a sizable expense and I'm sure there are folks for whom it would be a burden. Hopefully the price will continue to go down so pulse oximeters will be more widely available.

I didn't have any centrals in my sleep study but may be getting them at a higher pressure. At 14 my AHI jumps to about 6 or 7 (from 2-3) so I stay below 14. However I can't get AHI lower than 2.x.

Mindy