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UDI - barcode & matrix verification options

Discussion in 'Qualification & Validation (21 CFR Part 11)' started by MarkMeer, May 16, 2016.

  1. MarkMeer

    MarkMeer Well-Known Member

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    Seeking some advice on verification solutions for a medical device UDI (presently planning to use 2D DataMatrix format).

    I've done a bit of shopping around, and my god these pieces of equipment are not cheap!
    ...and largely because of how robust they are (resolutions, integrated lighting, variable aperture...etc.).

    Surely there are cheaper solutions given some simplistic considerations as:
    - Only Datamatrix format will be used
    - Only printing black-on-white
    - Only printing on flat surfaces
    - Matrix is never more than 24x24 units, and never smaller than 0.6"x0.6"

    Anyone have any suggestions?
     
  2. Vintage Goose

    Vintage Goose Active Member

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    Hi Mark,

    We have just purchased some Axicom bar code verifiers for each of our EU plants. These were not cheap, but have training, IQ/OQ/PQ and re-calibration procedures available. They also picked up issues we didn't see just using a scanner or mobile phone app. I'm hoping the payback will be the next time we have an FDA inspection and can show we have real verification in place.

    Chris
     
  3. MarkMeer

    MarkMeer Well-Known Member

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    Thanks for the input. I'm looking at a bunch of options (including Axicom), but they all seem to run $5k+!

    Given the simplicity of our application, I'm pretty confident our barcodes are ok, so the expense seem egregious.

    Curious: what are the issues it picked up?
     
  4. ncwalker

    ncwalker Well-Known Member

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    We spend a lot of money on matrix verification. And DataMatrix is our preferred format as well. But we aren't printing them with nice black ink on nice white labels. You should not have any problems if you are printing to labels. They should always be legible.

    Until you have ink problems, or label feed problems.

    So if you could guarantee there would be no ink or feed problems (not sure you can) I think I would be OK with a periodic audit of the matrix.

    The bigger question is what is the failure mode if the matrix is bad? In my world, the part with the matrix cannot be loaded on the assembly line, even if it is a good part. It costs a little time. We scrap the part out to the supplier. If he has a rash of them, he shows up with a hand scanner and sorts them. But even that isn't guranteed. Scanner to scanner there are sometimes quirks. But as I said, this is more due to the fact that we aren't in a high contrast black ink on white label situation.

    So if you make, say, 1 in 1000 bad, what's the cost of that to your company? (The follow on question being how many of those until the verification scanner pays for itself ....)
     
  5. ncwalker

    ncwalker Well-Known Member

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    Oh - and we use DataMatrix because its self correction seems to be better. Our experience is that if a QR code has a problem at all, it crashes and burns. But a DataMatrix label can have a percentage of illegible dots and it can sort out what was supposed to be in there.
     
  6. MarkMeer

    MarkMeer Well-Known Member

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    The cost to the company is nothing. This exercise is, aggravatingly, only to meet regulatory requirements.

    None of the data encoded is new, and not already presented in human-readable format on the present labels.

    ...this is why it's difficult to justify the expense...there is no real value to us, except appeasing the FDA. :(
     
  7. equilibrium

    equilibrium Member

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    The company that sold us our marking machine offers contract marking for those who didn't want to buy a marking machine. They also sell the 2D scanners and yes, they are quite expensive. Perhaps you could contract out the verification of labels to satisfy the FDA?

    I'm not sure of your specific requirements, but with something like AIM-DPM (which I'm learning more about than I ever wanted to) an inexpensive scanner isn't likely to get the job done.
     
  8. ncwalker

    ncwalker Well-Known Member

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    Sounds like you need a machine that flashes a laser, makes a pleasing beep, and turns a green light on. Then you could write "Veritron 3000" on it in sharpie. :)

    If it's to meet a regulatory requirement, you are sort of stuck. Unfortunately not all of those are authored by people who understand. We really don't want to set a precedent of dismissing them as there's a lot of good out there. Just not all good. "Fair" is where you take a pig to win a ribbon, that's not life.
     
    equilibrium likes this.
  9. MarkMeer

    MarkMeer Well-Known Member

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    Question: strictly speaking (FDA regulation wise), where is the requirement that this type of verification actually needs to be done?

    All I can see is from the UDI regulation (21 CFR 830.20) the requirement:
    "(b) Conform to each of the following international standards:
    (1) ISO/IEC 15459-2, which is incorporated by reference at §830.10;
    (2) ISO/IEC 15459-4, which is incorporated by reference at §830.10; and
    (3) ISO/IEC 15459-6, which is incorporated by reference at §830.10."

    Which are part of adopting one of the FDA-accredited systems, no? (e.g. GS1)

    Is it absolutely necessary to verify the codes to, for example, ISO/IEC 15415, 15416, ISO/IEC 15426-1, 15426-2, ISO/IEC TR 29158 (i.e. the standards that a lot of these hardware solutions use...)?
    It seems to me to be total overkill, unless absolutely required...
     

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