#1
Can someone please help me on this? For active implantable devices where there are double sterile barriers, is it fine to put labels on secondary barrier instead of primary, since the device goes to the OT room with the secondary barrier and traceability is maintained.
In MDR, its quoted as ""Implantable devices shall, at their lowest level of packaging (‘unit packs’), be identified, or marked using AIDC, with a UDI (UDI-DI + UDI-PI)".
Does this mean, the label should appear on the primary sterile barrier?

Thanks.
 
#2
the requirement is for the lowest level of packaing to be identified - this is not necessarily the primary sterile barrier otherwise it would say so. Therefore you could get away with labelling only the secondary barrier.

However you need to consider how the theatre works - would the hospital only ever scan the device when it is being handed to the scrub nurse? or is the scrub nurse likely to scan the packaging before handing the device to the surgeon?
Is there a risk of multiple devices being used simultaneously in the sterile area (thereby necessitating a way to distinguish them)

Despite my comments/questions, in my experience an implant is only handed to a scrub nurse shortly before its use, the scrub nurse will immedaitely break the primary barrier and hand it to the surgeon - I can't see any benefit of labelling the primary barrier

Previously I have used clear pounches so that the label can be applied to the primary barrier but then read through the secondary. - could that be a solution for you?
 
#3
Hi pkost, thank you so much for your reply. I agree with you that the implants will be handed to a scrub nurse shortly before use only.
The term "unit packs" written in regulation confused me and thought will get a clarity with experts like you.
Thanks much.
 

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