Responses: E-bay Items

Responses: E-bay Items

Jacqueline Schmit

5/22/2007

I'll include the majority of responses after having eliminated a few at the
request of the senders. The concensus seems to be 'stay away, it's a
liability'. Items that are regulated by the FDA should not be for sale
online, and they are considered a single patient item. I was also under the
impression that we were not able to use used parts on prostheses in the US,
and I got a few of those responses as well, regardless of if it were a C-leg
or a tube clamp.

As far as my patient is concerned, he still thinks his old prosthetist is a
friend who's done him many favors over the years. With friends like that,
who needs enemies, right??

Jacqueline Schmit, MS, CP
Certified Prosthetist


**********
First, the C-Leg is a class two regulated device in the eyes of the FDA. It
is registered as a single patient use device. Use any other way represents
off label use, and puts the practitioner at risk with the FDA.

Second, the warranty for the device, which covers service for full 3 years
is with the original PROSTHETIST, and the original patient, when the device
returns for service. The device is registered to a patient. Only that
patient can get the service. If you buy a C-Leg off E-bay it
is going to be without warranty.

Third, and this is perhaps the most significant issue: If the C-Leg was
already purchased for a specific patient, and it was reimbursed by some
payor, technically that payor has already paid for the device, once.
Positioning the device as new and seeking reimbursement from a payor for the
seocond time around seems very shaky ethics, and certainly not something
that would endear you to the payor community if it were discovered. And it
will eventually be discovered.

High risk, low reward for the patient, and for the prosthetist.
**********
I think away to answer this partially, is to ask the following question. If
a patient fell on a used component, who would be held liable?
**********
Great question. The knee first must visit Uncle Otto's shop. Have it
refurbished at the expense
of the patient or insurance company and purchase the warranty that will now
be in the new owners
name. Three month warranty is a couple of thousand dollars. One year
warranty is like 11, 000.
dollars. Still cheaper if they got a good price from ebay. Talk to Michele
at 800-795-8846 at
ext 5147. There is a form you will need to fill out. Insurance company may
even kick in for the
warranty if you discuss it with them prior to fitting. Good luck.
**********

I have had several families of patients who want to sell the prosthetic
devices after the patient expires. Then they see what the actual monetary
value of used prosthetic parts is, and they are discouraged. An exoskeletal
limb from the WWII era will fetch about $250 and that's it.

The layman does not recognize the craftsmanship and finesse that is
requisite to make such a
thing. They naturally assume that parts are parts, and it doesn't really
matter what goes where.
I came across a woman in Florida whose husband passed away and she wanted to
throw out his
beautiful 3.5 lb exoskeletal outside hinge AK. I mean, the screws were
painted caucasian to match the lamination! This leg was beautiful! She found
out it wasn't worth much, and wanted it gone.

I personally would not knowingly ever fit a used part on a patient,
regardless of what it is and
where it's from. If that part fails, it's your reputation on the line as
well as your patient's safety. Even if they brought the part in for you to
fit into their prosthesis, and even if they swear that it's only barely been
used, they are still depending on your clinical knowledge and experience.

If it fails, odds are that the patient is not going to tell their attorney,
It was my fault. Leave that nice prosthetist alone.
**********
check with your liability ins. company. Used parts on a new patient is
exempt. Check with the manu. and they will tell you single patient use
only. Exempt them from liability
**********
Great question and in absolute haste let me say that liability and the
warranty would be the big issue. The L-Code fee pays for the product, the
skill and knowledge in assembling the product, the cost of maintaining the
facilities to do such work, as well as both our warranty and the
manufacturers warranty of that product. It's a slippery slope when you
start contemplating used parts.
**********
I am aware of a case currently that is being investigated by the FBI for
possible Medicare fraud. The practitioner supplied a used C-Leg but charged
Medicare for new. It came to light when the patient started hearing strange
noises from the unit and on checking with OB was told the unit was used and
there was no warranty.

I believe most of the items we provide are designed by the manufacturer as
single patient use, many are marked that way, and I know for a fact that OB
will not honor a warranty on C-Leg to second use, regardless of age. This
came up when I had a unit donated that was to be put on patient for free,
but I wanted to insure the patient wouldn't be stuck if unit later broke.

As to charges, you can charge whatever you want, that's between you and
patient. The ethical point is you must disclose to the patient the state of
the component (new, used, refurbished) and under Florida law must provide a
written notice of warranty. You can not charge Medicare for used parts,
private insurance policies don't specify new but I would wager that if you
contact them and inquire they will not pay you for used parts.
**********
In my practice, my prosthetist came across this. A young guy, very
mechanical, who was buying parts on e-bay and assembling them himself. He
came to us after running into some problem he couldn't repair. We refused
to work on it. Instead, we ended up making a new prosthesis with all new
components. Very mirky waters here. I wouldn't touch it if I were you. Good
luck.
**********
Technically this is a violation of ebay's terms of use. Prescription only
items are not to be sold on ebay. In practice they are sold in large
numbers and everyday. Ebay seems to little real interest in policing this
kind of stuff. Regarding O&P items there are some buyers whose user names
imply that they are in O&P but there is no way to find out where in the
world they practice unless you sell something and they buy it. If I
practiced in the developing world I would use ebay as a discount source for
lightly used parts and pass the saving on to my patients. In the USA it is
a violation of both ethical and legal standards to bill for new and deliver
used..

The only barrier that I can see to someone using this as a source for parts
would be the legal liability they are accepting by purchasing and using a
product with an unknown history. I know my insurance would not cover me in
that situation, nor should they.
**********
As far as I know, practitioners are not allowed to use any used components
in the USA. I'm not sure where I heard this, but in the past when I had used
items to donate I was told that we were not allowed to even give used
components/prostheses away in the USA, but that we could send them to a
foreign country.
**********
I would refuse to service the unit or install it due to the liability you
are accepting. Ebay's policy doesn't allow the selling of used medical
devices so I would report anything you see for sale on their site. I tried
to sell a used TNS unit once that was like new and I was told it was a used
medical device. I have seen AK's listed with a C Leg unit listed on their
site.
**********
You should talk with the lawyers at Bock and be aware of the following:

1. It is against FDA regulations to sell any medical device, which the C-Leg
is, by anyone except an authorized FDA approved company. Therefore, the
sale of a C-leg on E-Bay violates FDA regulations as the seller in not
registered nor authorized to sell this device.
2. The seller needs to inform the purchaser that the knee is an FDA
monitored device and they must tell the purchaser that the warranty is
non-transferable and that there is no warranty on the item they are
purchasing. On the ads that have been on e-bay this requirement is never
met.
3. The warranty of a C-Leg is not transferable, this is another FDA
regulation, and therefore, a C-Leg purchased on E-Bay has no warranty.
4. You, as a certified practitioner, are aware that this leg is used and not
sold to this patient as an original device; therefore, you expose yourself
to extreme liability. You have no knowledge if this knee is working
correctly, and therefore, if there is anything wrong with the knee
internally, and you fit it, and the patient falls and has an injury, you
will be a fault and possible malpractice. (How do you know the previous
owner did not fall in a pool and damage the knee?)
5. What we do is tell the patient we will be happy to fit the knee they
purchased on e-Bay, but before we can, we need to send the knee to Otto Bock
to have it evaluated and refurbished, that will bring the knee up to
manufactures specs and give it a one year warranty to the new owner.
However, the cost from Otto Bock to have a knee refurbished and re-issued a
one year warranty is a little over $16,000. On all occasions when the
patient learned this little detail, they went back to e-Bay and returned the
knee to the seller and got their money back. And in all instances, they got
their money back because as per the e-bay regulations, there is a very
specific clause that states that it is against e-Bay rules to sell FDA
monitored items on e-Bay, and therefore the seller broke the rules and the
sale has to be refunded.
**********
This is an interesting dilemma, and one that will come up more and more as
components get more expensive. Personally, I would not provide a device or
knowingly work with a device that was obtained in this manner, simply for
liability issues, if nothing else. I once had a C-leg patient transfer his
care to me after being dissatisfied w/ his original prosthetist. When his
supposedly 1 year old C-leg malfunctioned, we sent it to OB for warranty
repair. It turned out to be more than 3 years old, and originally sold to
the previous practitioner under a different patient name. We couldn�t prove
it, but it was clear that the device had probably been reused by the
providing facility, and billed as new twice! The repairs were out of
warranty and ended up costing the insurance co. approx. $8000.00
**********

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