Is a prescription required for a pulse oximeter?

[kevincoop]

I have read several posts and also bought dozens of pulse oximeters for customers from other suppliers and have never once been asked if I have a prescription. I started selling oximeters and don't want to screw up by not requiring a prescription, but since nobody else is, I don't know why I would have to. Here is the best FDA guidelines I could find:

Pulse Oximeter Issues for May 13th Meeting
Anesthesiology and Respiratory Therapy Devices Panel
Introduction

The agency has traditionally accepted as evidence for clearance of a new pulse oximeter
design, a comparison to a predicate pulse oximeter of similar design (i.e. reflectance,
transmittance) and specifications (i.e. single use or re-usable, accuracy, motion
tolerance), taking into account the area of application (e.g. finger, ear, forehead). The
comparison usually looks at engineering bench testing for basic safety and clinical
performance testing (i.e. desaturation studies) for an assessment of accuracy. The agency
allows new/modified transmittance sensors to be compared to existing transmittance
sensors and accepted accuracies < 3% as substantially equivalent for use on adults.

When this approach is applied to transmittance probes on neonates, we have traditionally
allowed a 1% degradation of this accuracy since collecting controlled clinical studies on
neonates to demonstrate accuracy is not ethical.

Background on Over-the-Counter
The decision to allow a prescription device to be used over-the-counter (OTC) hinges on
whether adequate instructions can be written for the layperson and whether the risks
exceed the benefits. For pulse oximeters, there are existing non medical uses – mountain
climbing and spelunking (high and low altitude) acclimation.

From REI’s web site: an advertisement for a Nonin finger oximeter, a prescription device
advertised for a non-medical use: (see following page)
Product Info See specs below
This is not a medical device. It is intended to be
used by climbers and other individuals enjoying
activities at higher altitudes.
• Individuals who need a pulse oximeter
due to a medical condition should
contact their physician
• Or contact Nonin Medical at 800-356-
8874, or Nonin's website at:
mail@nonin.com for more information
• Mountaineering or trekking at high
altitudes brings with it the potential for
acute mountain sickness; SportStat™
may help alert you to its onset
• SportStat quickly provides accurate
blood oxygen saturation and pulse rate
data; feedback may help to assess the
level of hypoxia at high altitude
• Easy to use instrument automatically
turns on and off with finger insertion
and removal
• Lightweight and compact in size,
SportStat easily fits into a pocket or
pack without sacrificing valuable space
• Bright display is highly visible in the
dark; numeric display flashes once per
second to indicate low batteries
• Durable and built to withstand the
extreme conditions encountered in high
altitude activity
• Moisture resistant; small amounts of
moisture (as from rain) will not damage
the unit
• Operates on two 1.5V AAA-size alkaline
batteries for up to 1,000 spot checks of
45 seconds each (or approximately 12
hours of continuous use)
• Operates up to 30,000 feet (9,144
meters) and between +32 and +122
degrees F
• One year manufacturer's warranty
SportStat™ is ideal for spot-checking blood
oxygen saturation and pulse rate. By simply
inserting a finger into SportStat, you can obtain
your blood oxygen saturation and pulse rate in a
matter of seconds. SportStat takes the
guesswork out of determining these important
parameters, providing data that may alert you to
the potential onset of acute mountain sickness
(AMS).This is a valuable tool for anyone serious
about high altitude mountaineering. Made in
USA.
The instructions for use should be written so that laymen can understand and safely2 and
effectively3 use the device. In order for a pulse oximeter to be marketed OTC, it must
have adequate instructions for use per 21 CFR 801.5 (see following page). This means
there needs to be adequate directions so that:
1. the oximeter can be placed properly,
2. any interferences (e.g. nail polish) or conditions (e.g. EMC) that would lead to
inaccurate reading should be explained along with mitigating activities,
3. how to use the oximeter, including how long to wait, how frequently to measure,
when to measure, what to do with the information, and how long to have the
sensor on, are explained with an appropriate response, and
4. who should/should not use the oximeter is identified (e.g. age ranges).
Other factors to consider: mental and physical abilities of the user, ergonomic issues, the
use environment, by whom will it be installed, the degree of control the user will have
(setting changes), cleaning directions, maintenance.
2 There is a reasonable assurance that a device is safe when it can be determined, based upon valid
scientific evidence3, that the probable benefits to health from the use of the device for its intended uses and
conditions for use, when accompanied by adequate directions and warnings against unsafe use, outweigh
any probable risks. The valid scientific evidence used to determine the safety of the device shall
adequately demonstrate the absence of unreasonable risk associated with the use of the device for its
intended uses and conditions for use.
3 There is a reasonable assurance that a device is effective when it can be determined, based upon valid
scientific evidence3, that in a significant portion of the target population, the use of the device for its
intended uses and conditions of use, when accompanied by adequate directions for use and warnings
against unsafe use, will provide clinically significant results.
Thanks,
Kevin Cooper

[Wulfman]

Five years ago when I started out, I wanted to get a recording pulse oximeter.

CPAP.COM had a prescription requirement for their little finger one. (still do, it appears)

https://www.cpap.com/productpage/digita ... lseox.html

And, every website I checked also wanted a prescription. I asked my doctor for a prescription......he wouldn't write it. So, I never did get one.

The reasoning for a requiring a prescription for one of those things is WAAAAY beyond my comprehension.


Den

[frh]

My wife's Pulmonologist wrote a prescription for an oxymeter for her, but our insurance would not provide it. She frequents a COPD forum and told me this has been talked about a lot in that group. The general concensus is you don't need a prescription to buy an oxymeter online. After talking to Kevin on the phone, I felt comfortable ordering from him.

Seeing this topic reminded me to check the mail box. Guess what? It got here! Thanks, Kevin.

[kevincoop]

Thanks for your comment Wulfman. I have ordered from several sites that "requre" a prescription. They state that it is required but I have not once been asked for one. Once I click to checkout, it doesnt seem to be an issue.
They are also listed on amazon and ebay without prescription. I just don't want to be doing anything wrong. I am just starting this company and want to do things by the book. Unfortunately, the book isnt very clear. It does seem that everyone agrees that it is a prescription item, but nobody actually requires it. I may be shooting myself in the foot if I am the only company that requires that a prescription be received before mailing the oximeter...

[kevincoop]

This was taken from another popular site that sells oximeters without prescription. They state that they require it, but you can checkout and get one without a rx.

Do I need a Prescription to purchase from you?
Many of the products we sell are listed as Class II Medical Devices by the Food and Drug Administration (FDA) and therefore can only be sold either TO or ON THE ORDER OF a physician (i.e; with a Prescription).

Items that fall into this category are: Nebulizers, Pulse Oximeters, Oxygen Concentrators. If you are purchasing one of these items from another company and they do not require a prescription, then they are breaking Federal Law regarding the sale of these products.

If you are purchasing a Class II Medical Device from us and are NOT a Physician, Hospital, School, Health Care Worker or Military Institution, please process and pay for your Item directly on our website and once your order is processed, you will receive an Order #. Simply write that Order # on your Prescription on fax it or email it to us and we will match it with your order and ship it right out to you.

[WearyOne]

kevincoop, I read that same thing, so I know where you found it. I just looked at three other sites selling oximeters and none of them even mentioned a prescription at all. I bought mine about four years ago and didn't need one. Maybe I better get my recording one fast before things change and everybody starts wanting a script. I managed to use mine for four years (it's not recordable) and I'm still alive and unhurt, so I guess it's safe for me to get this one on my own.

[Linus]

No. It is not required. I bought one without a prescription in the United States. Also it falls under medical equipment that can be written of on your taxes (show that you have a need). Consult your tax attorney on this one.

[DreamOn]

Kevin, I sent you a PM.

[Kevin G.]

I think that there are two issues. First is there potential harm to the user by using the equipment and second is it being used to diagnose and treat the user.

Mu understanding is that the devices do not puncture the skin or cause other damage to the user thus there is no reasonable risk to hte user. Note that you can buy blood pressure and other devices without a prescription.

The information provides information on blood oxygen levels. As long as the devices do not come with information telling how to diagnose and treat diseases I do not see a problem. It is not illegal to monitor your body temperature, blood pressure and pulse. We also regularly self diagnose colds, and other medical conditions. In addition we regularly treat our selves for common medical conditions with aspirn and other drugs. I would argue that the selection of what we eat is a form of self medication. Thus I do not see a problem.

[vapat75]

To me it no difference then purchasing a blood pressure monitor or a blood sugar monitor. With the pulse ox meter you cannot harm yourself with the meter, you only get readings as with a blood pressure monitor or a blood sugar monitor. So what is the big deal with having a prescription , other than more hoops and more bucks.

[djr1215]

I think the difference is whether it is being advertised/used as a medical device or non-medical. Are you using it under orders from your doctor to treat an ongoing health issue? Medical device, need a prescription. Using it while performing specialized activities and not to treat a health issue? non-medical, no prescription. What the mfg gave the FDA as the product intent and how they were approved fits in to this as well - was it approved and marked as a medical device or not?

Here's what I found on the Nonin site:
You need a prescription oximeter if:
You are a patient working with a doctor and need to monitor blood oxygen saturation for a chronic disease such as COPD. Prescription devices are FDA cleared for medical monitoring and required to meet certain criteria such as level of accuracy. Nonin’s GO2 and GO2 LED are prescription devices.
(Note: GO2 and GO2 LED are not intended to diagnose, treat, cure or prevent any chronic lung or other disease.)

You can use a non-prescription oximeter if:
You are a sports or fitness enthusiast interested in managing your intensity level while exercising or training. Non-prescription oximeters are also great to check for the onset of in-flight hypoxia during air travel. Nonin’s GO2 Achieve and GO2 LED Achieve provide near-instant and accurate biofeedback such as pulse rate and blood oxygen saturation.
(Note: GO2 Achieve and GO2 LED Achieve are not medical devices and are not intended to diagnose, treat, cure or prevent any chronic lung or other disease.)

[SleepyTiger]

After seeing the depth of my desats I asked my sleep doc if I could borrow an oximeter to self-monitor for a couple days to make sure the CPAP treatment was addressing them.

He didn't have any to lend, but gave me a prescription instead. No hassle.

He's a good chap.

Sleepy Tiger

[dtsm]

I just don't want to be doing anything wrong. I am just starting this company and want to do things by the book. Unfortunately, the book isnt very clear.

With all due respect, this is not the place to ask for legal office when setting up a business....

https://www.cpap.com requires a Rx
http://www.semedicalsupply.com does not require a Rx - so I bought from them even though I knew my doc would give me one

Maybe a lawyer would be the place to go?

[Slinky]

I've purchased a non-recording oximeter (Nonin Onyx) probably close to 10 years ago. I've purchased two recording oximeters. I didn't need a script for any of them.

[mattman]

Here's how various DME providers I've worked for have approached questions like these, and the way I personally tend to agree with and feel is the best.

If a device normally says somewhere "For sale by or on the order of a physician" or something similar, we will require a prescription for it.

This goes for virtually anything. Oximeters to Suction Catheters to nebulizer filters. If the typical example of that item has that statement somewhere on it, we require a prescription.

Some people may say it's stupid to require that for a filter. I tend to agree. However the problem comes down to what happens on the wild chance something comes of it.

Well, as anyone who has been in the DME business can tell you - all too often these things come down to a legal opinion. There are dozens of stories of people who have been indicted for Insurance Fraud simply because their interpretation of a rule was on one side, and the Judges was on the other.

A great example is back in the early days of Fax Machines there was confusion over wether or not a faxed copy of a CMN counted as filling the requirement that read 'A signed copy of a CMN must remain on file at all times'. Guess what, some judges disagreed that a fax copy counted as 'signature' and yes - there were hundreds of thousands of dollars pulled back from providers over the issue.

So - since it can boil down to the opinion of a Judge or a review panel, and since those same generally err on the side of caution... so do we. Because it's our business going bankrupt if we wind up with the wrong opinion. And since it's ME going to jail over it then I'm going to take the extra 5-10 minutes to get a prescription.

One last note - when I say we require a prescription by the way. That does not mean we tell someone 'No go away you can't have it without a prescription'. It means we find out who their doctor is, we call them up and we stand there while they fax us over a prescription for the thing.

mattman

Edited to add: I intended all along to add: What I'm getting at with all this is that even if a specific item in my hand does NOT say it requires a prescription, if the same item typically does say 'By or on the order of an MD' we will require the Rx. If 7 of 10 oximeters have that blurb, even if the one in my hand does not say so, we would require an Rx.