UDI (Unique Device Identification) Verification Requirements

Mark Meer

Trusted Information Resource
#1
Hi All,

Verification of UDI's was mentioned briefly in this thread.

Bar code verifiers test print quality. The quality measurements should be per ISO/IEC 15416 for linear symbols and ISO/IEC 15415 for 2D symbols.
For linear bar codes, ISO/IEC 15416 specifies that the minimum symbol grade shall be 1.5/10/660 where:
• minimum print quality grade at point of production = 1.5 (C)
• measurement aperture = 0.254 mm = 0.010 inches (that is what the "10" above signifies)
• inspection wavelength = 660 nanometers +/- 10 nanometers
I thought I'd spin out another thread as I think this warrants some discussion.

The above criteria seem highly technical. Can anyone enlighten me as to what these actually mean? Are these requirements quite strict (i.e. in most printing situations is there actually a concern that you might not meet these requirements)?

I'm tinkering with the 2D GS1 DataMatrix format, and the system seems to me to be incredibly robust. I can print out a 0.8cm x 0.8cm (24x24 dots) matrix on a cheap $30 label maker (180dpi) and my phone can read it just fine.

It seems to me that the only 2 concerns should be:
1. Ability of the UDI to be scanned. If it can be scanned easily with a free cell-phone app, isn't that verification enough?
2. Indelibility of the marking. (I'm going with the 60601-1 marking durability test for this).

Other than that, is it really necessary to consider "quality grade", "aperture" and "wavelength"?
 
Last edited:
Elsmar Forum Sponsor

Mark Meer

Trusted Information Resource
#2
Bump.

Bottom-line question:

In terms of printed UDI labels, is it sufficient to verify:

1. Indelibility - scratch resistant & passes water, isopropyl and ethanol rubbing tests.
2. Scanability - check if it can be scanned with a cell phone in reasonably low light (this following test #1).

...or are more thorough/complicated tests recommended?

Any input much appreciated...
 

dzurn

Starting to get Involved
#3
Just because it's technical doesn't mean you can ignore it.

The parameters are just there so that the verifiers are comparing apples to apples. The best 2.5" wide barcode in the world would never verify if the it's eight feet away and lit by a 10W bulb. The parameters of the verifier allow a repeatable grade to be assigned, which the customers can use to ding you if your barcodes don't measure up.

The ability to print barcodes that will be usable by the customer is the entire point of Unique Device Identification. There are three FDA-accredited issuing agencies that have their own standards for the barcodes to qualify as meeting the standard, referring to the ISO standards.

In other words, if your printed barcodes don't meet the grading standards, then they aren't compliant barcodes.

We also have used 2D codes, and they are quite robust. However the standard is not "can my phone scan them", but "do they meet the minimum grading standards".

Scanability is not the same as meeting the standards. For example there's specific data formatting requirements to be followed on how to interpret the dates in the barcode, otherwise your Use-by date (which you intended to be December of 2018) would be read, by following the presumptive standard, as expiring in the Year 2020, Month 18 (!) and Day 12. The barcode needs to convey to the customers the data you intend, so both you and they can interpret the data the same way.

Unless you have a barcode expert personally checking the labels for the morning's run of isotope 217, you should be using a verifier at some (or multiple, preferably) points in the labeling process.

Most medical-device distributors and customers are not using cell phones to scan the barcodes, they actually intend to use the data for important purposes so your barcodes should reflect the data you wanted them to contain.
 

Mark Meer

Trusted Information Resource
#4
Thanks for replying to this old thread dzurn. Had given up on the discussion...

Scanability is not the same as meeting the standards. For example there's specific data formatting requirements to be followed on how to interpret the dates in the barcode...
In terms of content, the (freely available) specifications of, for example, GS1, are pretty comprehensive. I'm not too concerned about content data formatting, my inquiry was more to do with the ISO/IEC standards.

Most medical-device distributors and customers are not using cell phones to scan the barcodes...
True. Presumably they use more robust (dedicated) scanners.

...Which is why I'm proposing that being able to scan with an old cell-phone in relatively low-light might give reasonable worst-case evidence that the bar-codes (or matrices) are acceptable in terms of their "scanability".
 
G

gholland

#5
Maybe I misunderstood the question so ignore this if you were just asking about scanability after printing... My first question would be what are the requirements for the label? For verification you should be establishing what your use cases are and then figure out what the worst case scanning scenarios are. If you ship the device and establish a shelf life you should be shaking/baking/aging some devices with barcodes and make sure you can scan them. There are also standards for some types of medical devices (TPN bags, IV transfer sets, etc) that have specific labeling tests which would also be done after aging/shelf life. You have to have an idea what your use cases/requirements are before you can go into verification.

gh
 

Mark Meer

Trusted Information Resource
#6
Reviving this thread because, unfortunately, I'm still not clear as to what's absolutely necessary.

Since starting this thread (and reading through Sam Lazzara's 12 Steps to Compliance), I've explored several hardware solutions, and am finding it difficult to justify the cost.

Now, I'm re-reading the FDA's UDI requirements , and Small Entity UDI Guidance, and can't see any requirement for this kind of extensive verification (e.g. to ISO 15416, ANSI X3.182, ISO/IEC 15426-1, ISO/IEC TR 29158, ...etc.).

Can someone please let me know were requirements to verify UDI's (as per specific standards) for purposes of FDA compliance are specified?

Thanks.
 

Sam Lazzara

Trusted Information Resource
#7
As a basic quality control measure I believe it is important to at least inspect each run of printed labels to make sure the the barcode can be correctly read using a simple "scanner" (USD $50 - $400) if you do not have the budget to use a real "verifier" (USD $3000-5000). My recommendation would be to either scan or verify at least 1 label printed for each unique production batch/lot.

Use a scanner is infinitely better than doing nothing. Using a verifier instead of a scanner does buy you assurance, but nowhere near the gain achieved when you go from nothing to a scanner.
 

Mark Meer

Trusted Information Resource
#8
Thanks Sam, I agree.

Do you think that a dedicated scanner is necessary? I was thinking of just using a cheap, old cell phone - the reasoning being that if a cheap, old cell phone can reliably scan the code, that surely the dedicated scanners used in industry will be able to scan it as well.

What do you think of this approach/justification?
 

Chrisx

Involved In Discussions
#9
FDA recently issued draft guidance on form and content of the UDI. It "recommends" bar code testing to various ISO standards cited in the guidance. I believe these tests can only be performed with a dedicated bar code verifier and not a cell phone or bar code scanner. It seems unlikely that they would remove this from the final guidance.
 
#10
As a basic quality control measure I believe it is important to at least inspect each run of printed labels to make sure the the barcode can be correctly read using a simple "scanner" (USD $50 - $400) if you do not have the budget to use a real "verifier" (USD $3000-5000). My recommendation would be to either scan or verify at least 1 label printed for each unique production batch/lot.

Use a scanner is infinitely better than doing nothing. Using a verifier instead of a scanner does buy you assurance, but nowhere near the gain achieved when you go from nothing to a scanner.
Hi! Do you have the verification procedure? What is the frequency of verification? every time start print job for each printing machine?
 
Thread starter Similar threads Forum Replies Date
K Is UDI (Unique Device Identifier) symbol mandatory under EU MDR? EU Medical Device Regulations 3
M Informational EU – Unique Device Identification (UDI) System – FAQs Medical Device and FDA Regulations and Standards News 0
S Looking for procedure on UDI (Unique Device Identification) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S UDI (Unique Device Identification) Requirements for Remanufactured devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Edward Reesor UDI (Unique Device Identification): HIBCC or GS1? ISO 13485:2016 - Medical Device Quality Management Systems 39
H UDI (Unique Device Identification) Requirements for IVD Software EU Medical Device Regulations 2
Pmarszal UDI (Unique Device Identification) Transition Period - Packaging Labeling Other US Medical Device Regulations 5
B Class II Medical Device UDI (Unique Device Identification) Question(s) Other US Medical Device Regulations 8
D 820.120 UDI (Unique Device Identification) Labeling Verification Requirements Other US Medical Device Regulations 11
S Understanding UDI (Unique Device Identification) Other US Medical Device Regulations 10
M UDI (Unique Device Identification) for Convenience Kits with several options Other US Medical Device Regulations 3
M UDI (Unique Device Identifier) ISO/IEC 15459 (Unique Identifiers) Requirements Other US Medical Device Regulations 4
J UDI (Unique Device Identification) and Reprocessing Medical Devices Other Medical Device Regulations World-Wide 10
K UDI (Unique Device Identification) requirements of US FDA US Food and Drug Administration (FDA) 4
Ajit Basrur ICCBBA Is Now an FDA-Accredited Issuing Agency for Unique Device Identifiers (UDI) Other US Medical Device Regulations 1
C UDI (Unique Device Identifier) Definition of Labeler Other US Medical Device Regulations 1
M Official EU Unique Device Identifier (UDI) Requirements EU Medical Device Regulations 3
Sam Lazzara 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013 - 2015) Other US Medical Device Regulations 45
W Class II Medical Device Unique Device Identifier (UDI) Requirements US Food and Drug Administration (FDA) 8
S US FDA Unique Device Identification (UDI) Proposed Rule 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 18
X FDA UDI (Unique Identification) amendment on 19 Nov 2012 - Date of 'final rule'? US Food and Drug Administration (FDA) 4
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 0
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 2
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
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 4
F UDI Registration - Who is responsible for Registration of the Device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
M UDI Database and EUDAMED - Will there be two separate databases? EU Medical Device Regulations 4
Q Must product name be listed the same name in FURLS, UDI, GUDID and Company Website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Q LOT or Serial Number Symbol not used when the information is contained in the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Looking for a template SOP for UDI implementation for EU Medical Devices EU Medical Device Regulations 1
M Basic UDI and technical documentation EU Medical Device Regulations 1
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M MDR Requirements - UDI/Barcodes/QR codes on IFUs EU Medical Device Regulations 4
M UDI transition period and implementation EU Medical Device Regulations 6
M UDI size on packaging EU Medical Device Regulations 3
R UDI for US - Third Party device Repackager Other US Medical Device Regulations 9
M UDI placement - Packaging levels EU Medical Device Regulations 2
L UDI Requirments Gap Analysis - EU MDR vs FDA CFR EU Medical Device Regulations 8
M DI format for UDI after we have registered it with GS1 Other US Medical Device Regulations 0

Similar threads

Top Bottom