Consignment Sets & Traceability - Orthopedic surgery - Small plates and screws

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ISO tired

I work for a company that manufactures and distributes small plates and screws for orthopedic surgerys. Due to hospital constraints on spending they insist on us providing them with consignments sets(each set has a mixture of sizes contained in racks), the salesman continuallly replenishes the sets as the hospital uses the inventory. The problem is that the screws and plates are too small to be marked and we cannot maintain traceability. I am sure this is prevalent throughout the industry, and woluld like to know if anyone might have come up with a solution to this problem.
 
D

DrM2u

This might sound like a dumb question, but ... Aren't these components supposed to be sterilized? If they are, can you label the packaging with the lot #? Another thought ... How small are these things? I know there are some laser marking systems that can do small prints or codes (bar, 2-D). Did some brief research and Technifor popped up as an option (I'm not associated with them, don't even know where they are).
 
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ISO tired

Hospital is responsible for sterilization, screws can be small as .5 MM.
 
D

DrM2u

That's a small screw! I would say that a potential solution is for your organization to perform lot control while distributing the supplies, but that traceabiltiy would be lost if the hospital does not do the same. You could replenish with a new lot only after the old lot has been depleted or eliminated (disposed of). However, that is where your control ends and your customer needs to understand and accept this. I am interested to see the final solution to this ...
 
C

cavjoc

Hello ISO tired ... did you ever figure out anything to help with this? Is there some exemption for a standard for this situation?
 
S

sshankle

I think that the new UDI requirements are going to put a stop to this common practice in Ortho. No way to meet the proposed requirements with the current practices.

I think EU is headed to sterile for everything. Makes sense, less liability for them, and that seems to trump many other considerations.
 

pkost

Trusted Information Resource
I've had this problem before with loan and consignment kits and didn't come up with a solution other than providing sterile product.

As has been pointed out, there is an increasing trend in the UK to buy sterile product.

[edit] the problem people forget with sterile product is that your 0.5mm screws fit in a small tray...sterile product requires a lot of packaging and a lot of space! This affects transport of your loan kits

With consignment kits, I took the view that we provided traceable product to the hospital, it was the hospitals responsibility to maintain traceability at their own site. When consignment kits were returned I enforced writing it off or using it for workshops/demos
 
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pkost

Trusted Information Resource
What about implant cards.... That's going to be interesting to implement in these circumstances!
 
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