UDI (barcode, datamatrix) Verification Solutions

[Mark Meer]

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?

 

[SteveK]

We were in a similar boat – had to bite the bullet though with respect to a 2D verifier and purchased an Axicon 1500 Series (as well as a simpler 1D verifier – Axicon 6515 for larger size packaging barcodes). The verifiers are manufactured and certified to ISO/IEC 15415, ISO/IEC 15416, ISO/IEC 15426-1 and ISO/IEC 15426-2. The suppliers of these bits of kit (Weyfringe in the UK) are accredited by GS1 who supply the GTINs to generate our product/packaging barcodes (1D and 2D). Note that UDIs will become a requirement in the EU – as well as already a requirement in the US, and we had to go this route as a supplier to the NHS in the UK.
Have a look at:

http://www.gs1.org/docs/barcodes//2D_Barcode_Verification_Process_Implementation_Guideline.pdf

Basically as you can see from the above, verification is not a simple process, thus the need for these types of verifiers and the associated software. We also needed a thermal printer capable of 300dpi. The combined verification kit grades the printed barcode as indicated in the guideline/standard to show that the output is acceptable (or not) i.e. is verified, not just read.

Steve

 

[Mike S.]

Yep, it is the verification (grading) that costs the big bucks, and is very touchy. Reading (verifying readability) is pretty cheap and easy.

We have had good luck with Microscan products.

 

[Mark Meer]

Yep, it is the verification (grading) that costs the big bucks, and is very touchy. Reading (verifying readability) is pretty cheap and easy. We have had good luck with Microscan products.

Yes, presently looking into Microscan, Axicon, Webscan (TruCheck) and Cognex products. ...unfortunately all very expensive.

Hard to justify the expense, because the encoding is easy to validate, and due to the simplicity of our application, I'm 99.9% sure the IEC/ISO criteria are met.

Curious: What do you mean by "very touchy"?

 

[Mike S.]

We don't do our own verification, but our label vendors and end customer (a major aerospace prime) have both admitted that the grading results can be easily affected by the verification device's settings, ambient light, dust, angle, etc. A pass can become a fail, and vice-versa, depending on these measurement details.

Our customer only requires sampling for verification (grading) so we farm that out, but we do a 100% readability check after the label is applied with the much cheaper reader. This has not been a problem over the years after we and our label suppliers got the initial bugs of label making worked out.

 

[vinodashri]

Had a quick question.

We are using a software to print the UDI labels. Now we are conducting design verification on the labels. I think that the software used to print these labels need to validated prior to design verification. Any thoughts?

TIA

 

[Mark Meer]

I think that the software used to print these labels need to validated prior to design verification. Any thoughts?

Shouldn't be too onerous.
Suggest the following:
1. Document a set of requirements for the software (e.g. intended use, ability to accurately encode strings into AIDC codes,...).
2. Create a quick software validation plan (e.g. Print some labels with various strings that fit the range of your intended use, read them back, and confirm that the inputs were encoded accurately).
3. Execute the test and document.

 

[miken99]

As I read through this thread I can see that there is a fair bit of misunderstanding about verification.

What is it? It is a testing method to determine if a printed barcode can be decoded by your trading partners (customer or suppliers) scanners. It is not simple scanning. It actually is an analog process that measures the reflectivity of the barcode symbol (every pixel!) to create a map of the barcode. It uses the mapped data in ISO defined formulas to grade the label.

It is definitely more complex than simple scanning, but it is the only way you can be sure your barcodes can be decoded by others scanners. Pretty important for most applications. “I can read it!”

On top of that ‘print quality’ layer of standards, there are ‘application layers’ for your specific applications. These application layers usually define the content of the barcode data and how it is formatted. For instance, the application spec may say 13 numeric characters. Any deviation from that may be unacceptable in the application. This is at least as bad as a barcode that was printed poorly. In many applications, the content and formatting can be quite complex and opens the possibility for new sources of errors. UDI is that way. It is a multifield barcode with extensive and complex rules defining how the barcode is to be produced. It is also a variable data barcode where each new lot, serial # or expiry date changes the symbol. Add to that the ‘invisible’ field delimiters and it can be challenging for label printing software. Do it all correctly and you will have “I can read the barcode and I understand what it says!”

And finally, the third layer for UDI. Does it match the regulators database entries for the product? In the US, that is the FDA GUDID (Global UDI Database). Over the next year or 2, healthcare providers will be moving to get tighter control over their respective supply chains. That database includes a lot of information about the products and the barcode data must match the database to be correct. “I can read the barcode, I understand what it says and it is correct!”

Back now to the posts:
• Verification is mandatory. For those participating in most supply chains, it is specified and not something to be decided. In UDI, it is absolutely required from both a regulation standpoint and from a common-sense standpoint. This is your product.
• The importance of doing this correctly will only increase as more providers rely on the data in the barcodes for their patient’s health records and for payment from insurers.
• If you have a ‘touchy’ verification situation, then I would suspect that your barcode is too close to being out of spec. It is not hard to produce a great barcode, an ISO Grade 4 or ANSI Grade A. A good barcode is not touchy, it decodes in a snap. Start with a good design.
• Barcode printing software needs to be tested. There are lots of things that can go wrong and some are still working on fixing some of the newer things. This is true in both the print quality and in the application spec layers (if your software even checks this).

 

[Ronen E]

Thanks Mike for your thorough overview. Most of it makes a lot of sense.

I’m not a barcode expert but I do know a thing or two about FDA UDI regulations, so a couple of comments to keep things accurate (in the context of FDA UDI regulations):

It is also a variable data barcode where each new lot, serial # or expiry date changes the symbol.

This is only partly true. Class I devices don’t require the Production Identifier (PI) portion and thus there won’t be a variable section in their UDI. Further, the UDI is required to include those fields only to the extent that they are included in the labeling in human-readable format. For example, if the device doesn’t have a serial number it won’t show in the labeling and naturally won’t be required in the UDI as well.

• Verification is mandatory. [...] In UDI, it is absolutely required from both a regulation standpoint and from a common-sense standpoint.

In these forums, when we discuss medical devices regulations we don’t normally use the term “required” unless the requirement appears in the regulation itself, in a mandatory published standard or in a legally-binding, officially issued guidance. From that perspective saying that something is “required form a common sense standpoint” (my emphasis) is somewhat meaningless, though I agree that it generally makes sense to verify what you’re doing (needs to make business sense, too, however).

Having stated that verification is mandated by the UDI regulation, could you please provide a pointer to the specific regulatory section?

Thanks,
Ronen.

 

[miken99]

Regarding verification being mandatory, the FDA here in the US has approved GS1, HIBCC and ICCBBA as the issuing authorities for UDI numbers. The FDA requires that the manufacturer follow the issuing authority’s specifications. In their specs, the issuing authorities have a minimum print quality grade of ISO 2. There is a very specific exception given to printing on corrugated kraft type cartons. This is because of ink absorbency and low contrast issues. You are permitted to go as low as ISO 1 on these.