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We outsource the repair of our medical devices (Infusion pumps, monitors, etc.) and I believe that the repair facility we use may be switching the serial #s of our units onto those of their inventory to get our "units" back in a timely manner. It was my understanding that the traceability of the unit in regards to the DHR would be compromised if our units are actually their units with our serial # label on them? Not that i think it matters but our permission for this to occur is not solicited.
What is the FDA regulation on this and do I have any responsibility to take action here?
What is the FDA regulation on this and do I have any responsibility to take action here?