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Labeling requirements when selling demo Medical Device equipment

craiglab

Involved In Discussions
#1
I seem to recall a consultant (CFR or 13485) that said there needs to be a label near the nameplate showing the device was previously a demonstration unit if that unit is later sold. I'm having a hard time finding/interpreting a requirement to place such labeling on the device (Class II). Is it from the position that we must control the process?
 
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M

MIREGMGR

#2
Re: Labeling when selling demo equipment

Does "demo" equate to it having been used in one or more patient procedures?

If so, in the US it may be subject to the various device re-use regulations, which of course are much more extensive than just labeling.

Other countries have their own regulations regarding used or refurbished devices, in some cases banning import of such equipment.

If it's only been used in simulated procedures, whether it's regulated as "used" might involve some precise reading of particular regulations.
 

AnaMariaVR2

Trusted Information Resource
#3
Could using a loophole help?
As for example adding to your label: "for R&D use only"

...that way it won't be subject to regulations. Would your client mind if that language is in the label? Just a thought.
Is there another loophole to explore?

Good luck,
Ana
 

craiglab

Involved In Discussions
#4
Re: Labeling when selling demo equipment

It is very common for certain qualified medical device sales reps to demonstrate a unit in a department setting and on patients. One company I worked for required registered respiratory therapists for applications people and many went into sales, so they had the qualifications.
There are two sources of equipment here: 1) always company owned units, such as sales demonstration (demo) units, service loaners (for hospital use while their unit is being serviced), rental or lease-return units, and 2) customer returns for whatever reason – maybe dissatisfaction. All these items are commonly sold off.
Agree that many countries do not allow importation of used devices, and there are brokers galore to sell old/used items to. But in the US this scenario is not uncommon: 1. Sales or applications rep show equipment, 2. hospital gets proposal, 3. it's too much money, 4. company discounts but not enough, 5. previously used device is offered at a substantial discount 6. hospital accepts proposal.
So the hospital knows what they are buying, and I am just trying to understand if there are labeling requirements for the device. These are not singe-use devices being re-used.
 
J

JodiRaus

#5
Re: Labeling when selling demo equipment

It is very common for certain qualified medical device sales reps to demonstrate a unit in a department setting and on patients. One company I worked for required registered respiratory therapists for applications people and many went into sales, so they had the qualifications.
There are two sources of equipment here: 1) always company owned units, such as sales demonstration (demo) units, service loaners (for hospital use while their unit is being serviced), rental or lease-return units, and 2) customer returns for whatever reason – maybe dissatisfaction. All these items are commonly sold off.
Agree that many countries do not allow importation of used devices, and there are brokers galore to sell old/used items to. But in the US this scenario is not uncommon: 1. Sales or applications rep show equipment, 2. hospital gets proposal, 3. it's too much money, 4. company discounts but not enough, 5. previously used device is offered at a substantial discount 6. hospital accepts proposal.
So the hospital knows what they are buying, and I am just trying to understand if there are labeling requirements for the device. These are not singe-use devices being re-used.
I now have the very same question on selling demo units and what the requirements are for labeling these units. We have the agreement that product needs to meet original spec, yadda yadda yadda; however I can't help but feel we are missing something from the "disclosure" to the buyer... Can anyone point me in the right direction? (This product is a piece of equipment; no direct patient contact; etc.)
Thanks
 
D

Deep Krothapalli

#6
If it's being used for Human Use in procedures, then I view this not much different from regular product being sold. You would need to prove/establish that product met predetermined acceptance criteria, manufactured per respective regulations and guidance, and is traceable. You are just changing product status from 'non-human use' to 'human use'.
 
M

MIREGMGR

#7
Re: Labeling when selling demo equipment

however I can't help but feel we are missing something from the "disclosure" to the buyer...
That comment sounds as if you know, or feel, that the used equipment is not objectively equal to new equipment. Is that because the equipment-type is perceived to "wear out" or die for no apparent reason other than accumulated use effects, after some amount of use? Do you have a way of estimating that likely life and the use that the equipment has had already, and have you included that in the disclosure to the customer?
 
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