Validation of process for releasing the UDI

Cybel

Involved In Discussions
#1
Hi,
my NB asked for the validation of the process for releasing the UDI.
We have a SOP describing how the UDI is assigned and a spreadsheet containing the list of the UDI-DI for each device and configuration. In the same spreadsheet we register the UDI-PI each time. (We are a small company with not so many UDI-DI, but with a number of UDI-PI. We manufacture low risk class IIa devices, a mistake in the UDI may result in a logistic/regulatory issue - no harms to patients/users).
The UDI-DI is indicated in the DMR, while the UDI-PI is defined by the production dep. according to LOT number, manufacturing date, and so on and reviewed. The production dep. has a program for printing the UDI, in the format of GS1 data-matrix, on the stickers that are applied on each device. Finally, GS1 data-matrix codes printed on the stickers are checked by sample with a barcode verifier (verification).

How would you validate this process (= confirm that the data content within a barcode is correct) ?

Thank you for any input you can give me!
 
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Billy Milly

Starting to get Involved
#2
From what you describe, it seems easy ;) Document the chain you described (assigned unique number, transferred to labelling SW, printed, verified) in form of a protocol, then add proof - printscreens, pictures, spreadsheet...
Show evidence that spreadsheet cannot be changed after PIs are recorded.
Side note - have another look at risks. In my opinion, mistake in UDI can trigger the use of unsuitable device, if the whole chain up to the end user reiles on it (which is the long-term intention of UDI) or inadequate reporting on adverse events - just a few.
 

Cybel

Involved In Discussions
#3
Thank you Billy Milly.

From what you describe, it seems easy ;) Document the chain you described (assigned unique number, transferred to labelling SW, printed, verified) in form of a protocol, then add proof - printscreens, pictures, spreadsheet...
This sounds similar to the documented information recorded in the DHR and production reports, isn't it?

Show evidence that spreadsheet cannot be changed after PIs are recorded.
This is the improvement I have thought to. I'm wondering if the spreadsheet validation would satisfy the NB, considering that I think the rest is already implemented in DHR and production reports.

Side note - have another look at risks. In my opinion, mistake in UDI can trigger the use of unsuitable device, if the whole chain up to the end user reiles on it (which is the long-term intention of UDI) or inadequate reporting on adverse events - just a few.
Thank you very much for these inputs!
 

andrei iuganu

Involved In Discussions
#4
Hi,

We have a SOP describing how the UDI is assigned and a spreadsheet containing the list of the UDI-DI for each device and configuration. In the same spreadsheet we register the UDI-PI each time. (We are a small company with not so many UDI-DI, but with a number of UDI-PI. We manufacture low risk class IIa devices, a mistake in the UDI may result in a logistic/regulatory issue - no harms to patients/users).
The UDI-DI is indicated in the DMR, while the UDI-PI is defined by the production dep. according to LOT number, manufacturing date, and so on and reviewed. The production dep. has a program for printing the UDI, in the format of GS1 data-matrix, on the stickers that are applied on each device. Finally, GS1 data-matrix codes printed on the stickers are checked by sample with a barcode verifier (verification).
If you can think that you could give us an example of what your SOP looks like? thx in advance
 

Cybel

Involved In Discussions
#5
Hi,
basically my SOP is structured as follows:

- purpose of the procedure
- reference documents (regulations, guidances)
- responsibilities
- definitions (UDI, DI, PI, EUDAMED, BASIC UDI-DI, GMN. I’ve included the GUDID as well, as per the requirement USA FDA)
- management of the UDI codes:
a) definition of the BASIC UDI-DI
b) definition of the UDI-DI
c) definition of the UDI-PI
d) operative process (how the code is chosen, for example between GS1 vs datamatrix, how it is generated, program used, printing, verification methods, records to be produced)
e) registrations required (EUDAMED - GUDID)
f) specific cases and direct marking

This is mine, but this may not be good for other companies…

Hope it helps.
 
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