UDI (barcode, datamatrix) Verification Solutions

Mark Meer

Trusted Information Resource
#1
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?
 
Elsmar Forum Sponsor
S

SteveK

#2
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.

Happy to be Alive
Trusted Information Resource
#3
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

Trusted Information Resource
#4
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.

Happy to be Alive
Trusted Information Resource
#5
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.
 
V

vinodashri

#6
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

Trusted Information Resource
#7
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.
 
M

miken99

#8
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

Problem Solver
Moderator
#9
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.
 
M

miken99

#10
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.
 
Thread starter Similar threads Forum Replies Date
M UDI barcode quality EU Medical Device Regulations 3
C UDI Label Verification - How do we ensure the barcode is correct and prove it? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 18
I UDI requirements vs Japanese Barcode Marking guideline Japan Medical Device Regulations 1
C Labelling and UDI Requirements - Implications of serial numbers US Medical Device Regulations 0
D Basic udi-di to not appear on IFU? EU Medical Device Regulations 4
R Legacy Device UDI Requirements EU Medical Device Regulations 5
R UDI Requirement at home patient use EU Medical Device Regulations 2
P UDI on devices exclusively intended for retail point of sale EU Medical Device Regulations 3
J UDI and Labelling hierarchy and requirements for separate device components EU Medical Device Regulations 7
C How to place software version for SaMD product in HIBC secondary data structure (UDI-PI)? Other US Medical Device Regulations 3
C Issues with UDI-DI and LAA/LUA registration in Eudamed EU Medical Device Regulations 1
Watchcat Mobile app - Different UDI for different smartphones? Other US Medical Device Regulations 7
Watchcat One UDI per country? ISO 13485:2016 - Medical Device Quality Management Systems 3
Watchcat UDI Timeframes? Other US Medical Device Regulations 7
A UDI-PI for IVDs used in house EU Medical Device Regulations 5
G SRN, Basic UDI, Legal Manufacturer EU Medical Device Regulations 6
A Basic UDI and UDI-DI for hip implant systems EU Medical Device Regulations 1
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 2
R UDI Number Identification EU Medical Device Regulations 5
I Eudamed UDI-Module EU Medical Device Regulations 9
L Configurable UDI mdr EU Medical Device Regulations 0
L UDI implementation in Saudi Arabi (KSA) Other Medical Device Regulations World-Wide 0
L UDI-DI - Device will be sold by itself in a box EU Medical Device Regulations 2
P Basic UDI-DI and Legacy Devices EU Medical Device Regulations 19
C UDI for consumable/replacement components under the MDR EU Medical Device Regulations 7
K UDI for two units with different S/N on the same package/case Other US Medical Device Regulations 10
C Validation of process for releasing the UDI EU Medical Device Regulations 4
A MDR requirement where unit of use packaging is too small for UDI carrier EU Medical Device Regulations 1
L UDI needed when we submit to ON? EU Medical Device Regulations 5
S Does a refurbished product required a new UDI? US Food and Drug Administration (FDA) 3
A UDI for product already packed up EU Medical Device Regulations 0
M Brand owner or manufacturer responsible for Basic UDI-DI and UDI-DI? EU Medical Device Regulations 8
Aymaneh UDI-PI Software CE Marking (Conformité Européene) / CB Scheme 0
J UDI-DI how should we interpret Device version or model to determine if a new UDI-DI is needed? EU Medical Device Regulations 0
P UDI-PI requirements on reusable surgical device, do we need serialisation? ISO 13485:2016 - Medical Device Quality Management Systems 3
J UDI - Where to document it? EU Medical Device Regulations 8
N UDI: GS1 or HIBC ??? EU Medical Device Regulations 1
F UDI-PI required on packaging (MDR) EU Medical Device Regulations 4
C UDI Questions on Control Units Other US Medical Device Regulations 6
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
V UDI - OEM or OBL / Legal Manufacturer Responsibility CE Marking (Conformité Européene) / CB Scheme 0
A European UDI-DI CE Marking (Conformité Européene) / CB Scheme 2
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
K Is UDI (Unique Device Identifier) symbol mandatory under EU MDR? EU Medical Device Regulations 3
M UDI procedure/ report 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
R Shall a new UDI-DI be required when stand-alone software device's version is updated? EU Medical Device Regulations 1
D Hospital Decontamination and the MDR - Technical Files, UDI and PMS EU Medical Device Regulations 3
F UDI - Unit of Use and Class I, single-use devices EU Medical Device Regulations 5
F UDI Registration - Who is responsible for Registration of the Device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12

Similar threads

Top Bottom