Refurbishing a Medical Device - Any additional information needed

M

markvm68

#1
We sell the bulk of our medical devices through distribution. As such, we have never had a program where we would sell refurbished units direct to customers. However, we routinely get customer returns that have been opened and used a few times, or opened and never used. These come into our repairs department and often times are made into loaners for shipment to customer while their unit is being repaired.

We now have more units than we need for loaners and someone got the idea that we could refurbish them and donate them.

We are currently the manufacturer, and aside from some aesthetic issues, the units would be refurbished to the same state as the unit that are manufactured (minus the consumables that are shipped with the new units). I believe our current Quality System should suffice and that since we are already registered as the manufacturer of the device, we should be able to refurbish it as well.

It just seems like I'm missing something. We don't fit the technical definition of a remanufacturer or reseller as we made the product originally. Any thoughs?
 
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J

JayJay

#2
I would think that if you are already accepting returns, you could classify those as "nonconforming material" or discrepant material, then perform any refurbishing activities and standard inspection / testing on the units as you would anything else. Then, disposition the units as "use as is", while marking any deviations from standard specs, or any special concessions.

You would also most likely need a procedure or work instruction to show how the return inspections are performed, history records which show the activities performed / approving individuals, as well as ensuring that you can maintain a link to the original device history records that applied to the device during its initial release.

Hope that helps!
 

sreenu927

Quite Involved in Discussions
#3
hi..
i have a similar question.

we are a manufacturer of medical devices.

When a device at the customer site is not working, they will send us for repair. during this time problem solving time(say, 2-4 weeks), we wud like to loan other same piece to the customer (for better customer satisfaction).

For this, we wud like to keep 5 devices under loaner program. Initially all 5 will be new ones, later they wil be used ones, once we start this loaner program.
so when dealing with loaner program, what will be the regulatory issues, esp while exporting(??) to US or EU?

Thanks,
Sreenu
 
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