Unused Service Parts in Newly Manufactured Medical Device?

kchan

Starting to get Involved
#1
Hello all!

We had a situation where a doctor's unit required repair. We sent out a technician with several components that we suspected might have fail. A component was put into the doctor's unit, but it turned out not to be the failed part, so it was removed, returned to HQ, and the technican finished the repair by replacing a different component.

I am arguing that the returned component cannot be used in a new manufactured unit because it was 'used', however briefly, in a service. Therefore it is a used part and can only go into service stock.
My production counterpart argues that it CAN be used in a new manufactured unit, because it never left our possession, can be tested to confirm that it still meets specifications, and is low risk for failure.

There is nothing in our processes that speak to this situation, but my production friends say that we should write something to allow use in these specific situations (item never leaves our possession, can be tested, and is low risk).

I cannot seem to find any regulatory or quality content regarding this situation -- help?
 
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Gisly

Starting to get Involved
#2
I would claim that this is a question of business policy, not regulatory. In other words I agree with your production team.
 
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