Pulse Oximeter Prescription

sleepycarol · Post by **sleepycarol** » Wed Mar 19, 2008 5:46 pm

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?

mindy · Post by **mindy** » Wed Mar 19, 2008 5:52 pm

I didn't need a script nor have most others. I'd check to see if that's a mistake!

Mindy

RipVW · Post by **RipVW** » Wed Mar 19, 2008 7:55 pm

Yep, that has to be a mistake. Prescriptions are not required to purchase pulse oximeters.

Wulfman · Post by **Wulfman** » Wed Mar 19, 2008 9:05 pm

From my inquiries about 3 years ago, a prescription WAS REQUIRED for one from just about every place I checked. The only types that didn't require one were the "sports" models that spot-checked your oxygen levels......all of the recording models required one and the ones that CPAP.COM sold did, too.

Den

Gerald · Post by **Gerald** » Wed Mar 19, 2008 9:13 pm

I purchased my SPO 7500 from turnermedical.com and the only prescription required was my VISA number.

Gerald

Slinky · Post by **Slinky** » Thu Mar 20, 2008 5:47 am

Yup, me too, Gerald. No script needed when I bought my SPO 7500 from Turner Medical. I found them a good supplier to do business with. No complaints at all, I was very satisfied w/their service!

sleepycarol · Post by **sleepycarol** » Thu Mar 20, 2008 7:00 am

I emailed cpapauction for a clarification on their policy regarding a script to bid on one.

Will post their reply when I get it.

TuckNRoll · Post by **TuckNRoll** » Thu Mar 20, 2008 7:10 am

It depends on the pulse oximeter that the company is providing to you. Some Oximeters do indeed require an Rx while others do not. Prior to about a year ago, they all did and several manufacturers found a way around the requirement and started producing models that do not require an Rx.
The company that I work for has 2 different models available. One requires and Rx and is priced at $699.00, while the other does not and goes for $199.00. It is the craziest thing since they both do the exact same thing, but as per the Federal Government, one requires the Rx.

Slinky · Post by **Slinky** » Thu Mar 20, 2008 7:47 am

Thanks, TuckNRoll! I hope you are not tuckin 'n rollin' 'cause any of US have given you any grief!!

NightHawkeye · Post by **NightHawkeye** » Thu Mar 20, 2008 8:40 am

TuckNRoll wrote:It is the craziest thing since they both do the exact same thing, but as per the Federal Government, one requires the Rx.

I'm not sure it's fair to blame the the federal government. It looks to me like the choice of whether or not to require a prescription is entirely up to the manufacturer. I found the following wording from the SPO website interesting.
"The PulseOx 5500 pulse oximeter is a FDA regulated device. Like all oximeters sold in the medical market, the PulseOx 5500 requires a prescription. All regulations regarding dispensing of prescription devices must be followed. Product insert has complete information on the PulseOx 5500 portable finger unit."

SPO makes two identical oximeters (at least according to their specifications) which sell for the same price, the CheckMate and the SPO5500. The specs for each are provided below:

Check Mate Finger Oximeter
Battery Continuous Usage 1,000 hrs or 40 days
Battery Indication Full Power, One-third, Near Empty
Dimensions (display) 2.91 x 1.57 x 1.61 inches (74x40x41mm)
Heart Pulse Rate 3 Characters
Heart Pulse Rate 40 to 250 bpm
Heart Pulse Rate Accuracy +/- 3% or +/- 3% Digits
Power Requirements 3.6V Lithium Battery
Resolution 1 Digit
Saturation 2 Characters
Saturation 40 to 99%
Saturation Accuracy +/- 2% or +/- 2% Digits
Signal Indicators Sensor Off, Weak Signal, Flashing Heart Icon
Total Weight 1.8 oz. (50g)Including battery

PulseOx 5500 Portable Pulse Oximeter
Battery Continuous Usage 1,000 hrs or 40 days
Battery Indication Full Power, One-third, Near Empty
Dimensions (display) 2.91 x 1.57 x 1.61 inches (74 x 40 x 41mm)
Heart Pulse Rate 3 Characters
Heart Pulse Rate 40 to 250 bpm
Heart Pulse Rate Accuracy +/- 3% or +/- 3% Digits
Power Requirements 3.6V Lithium Battery
Resolution 1 Digit
Saturation 2 Characters
Saturation 40 to 99%
Saturation Accuracy +/- 2% or +/- 2% Digits
Signal Indicators Sensor Off, Weak Signal, Flashing Heart Icon
Total Weight 1.8 oz. (50g) Including battery

Side-by-side pictures of these two identical oximeters can be seen at the following link:
http://www.quickmedical.com/spo_medical/index.html

IANAL. Bottom line appears to be that if the manufacturer wants to claim it's a medical device then a prescription is required. If not, then no prescription is required. Draw your own conclusions as to why.

Regards,
Bill

DreamStalker · Post by **DreamStalker** » Thu Mar 20, 2008 8:45 am

It's probably not even a manufacturer decision either ... but rather a vendor decision. Some of us got the SPO7500 w/o an Rx.

NightHawkeye · Post by **NightHawkeye** » Thu Mar 20, 2008 8:51 am

DreamStalker wrote:It's probably not even a manufacturer decision either ... but rather a vendor decision. Some of us got the SPO7500 w/o an Rx.

I got my oximeter from Ebay without a prescription. (Of course, that was a little over two years ago.)

If a vendor decision, then there can't be a federal regulation requiring a prescription for any pulse oximeters (at least logically). Otherwise, vendors would be violating the law.

DreamStalker · Post by **DreamStalker** » Thu Mar 20, 2008 8:57 am

NightHawkeye wrote:
DreamStalker wrote:It's probably not even a manufacturer decision either ... but rather a vendor decision. Some of us got the SPO7500 w/o an Rx.
I got my oximeter from Ebay without a prescription. (Of course, that was a little over two years ago.)

If a vendor decision, then there can't be a federal regulation requiring a prescription for any pulse oximeters (at least logically). Otherwise, vendors would be violating the law.

I agree.

I notice the same thing for TENS units ... some require Rx and some don't even when it is the same brand and model and yet none of these vendors are being shut down.

TuckNRoll · Post by **TuckNRoll** » Thu Mar 20, 2008 9:27 am

Being employed in the DME industry for over 20 years, I have learned that regardless of whomever has regulations, some providers will sell whatever it may be, even if it does require an Rx.
Even a hand held nebulizer kit (tubing, cup and mouthpiece) states on the packaging "U.S. Federal law restricts this device to sale by or on the order of a physician". So technically, they should not be selling this item without an Rx, but many places will.
I guess it really depends on the integrity of the selling source. The company that I work for is accredited by JHACO and will not, for any reason sell these items without the Rx.

NightHawkeye · Post by **NightHawkeye** » Thu Mar 20, 2008 10:04 am

TuckNRoll wrote:So technically, they should not be selling this item without an Rx, but many places will.

Hmm . . ., doesn't seem sufficient to me. The places selling this stuff are not shady enterprises.

From the definition of "prescription" at medscrips.com:
"A prescription is a legal document which not only instructs in the preparation and provision of the medicine or device but indicates that the prescriber takes responsibility for the clinical care of the patient and the outcomes that may or may not be achieved."

Taken at face value, the definition explains what we are seeing. Pulse oximeters can be freely sold (as we've observed), but when doing so the sellers make no claims for medical suitability of their devices.

In other words, you can't sue 'em. If you want to hold someone accountable, then first get a prescription. With that, then you can sue your local physician.

Regards,
Bill

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