The FDA Final Rule is enacted. UDI implementation will:

  • Standardize the identification of medical devices in a globally harmonized way
  • Improve public health initiatives to optimize automated systems
  • Reduce medical device-related injuries and deaths via improved device recalls
  • Eliminate (or at least reduce) inaccurate or incomplete reporting of medical device problems
  • By improved tracking of devices implanted in patients, identify usage problems and make recalls quicker and more accurate

Barcode Symbology Designation

The UDI rule specifies that barcodes are the primary tool to be used to mark medical devices. Several barcode types are designated.

During the comment period AIM advocated for adoption of Data Matrix code. All three FDA-approved issuing agencies (GS1, HIBC and ICCBBA) standards  also support the use of Data Matrix code. UDI barcodes created under any of these three standards are differentiated and self-identifying under ISO rules.

Standardized formatting of the UDI mark (barcode) is an important factor in making these improvements real and substantial. The FDA specified the key data elements that must be included in each UDI. And of course the barcode must be readable over the life of the device.

It is concerning to some of us in the barcode industry that although barcode quality is mentioned in the UDI rule, it is not stressed in a way which is commensurate with its importance. Following good barcode practice, barcode verification is assumed as part of the implementation of UDI. Here is what the UDI rule says about barcode quality:

  • All firms subject to the UDI rule are required to establish a standards-based barcode quality verification program
  • All firms subject to the UDI rule are required to record the outcome of verification tests

This is really an extension of FDA Good Manufacturing Practices (GMP). But the UDI rule does not specifically invoke ISO standards as the basis of barcode verification testing, nor the performance standard for the verification device. This is because the FDA did not specify the standards for barcode verification to be used in the implementation of the rule.

 

No Barcode Verification Standards DesignatedBlood Test Device

Furthermore, after the public comments period prior to the enactment of the rule, the requirement to mark implantable devices was removed from the rule. This is because all surgically implantable devices should already be tracked through the patient’s Electronic Health Record.  Post-implantation scanning, if it proves necessary, could be accomplished through use of RFID technology.

Also, the final rule does not require the use of UDI for chain of custody inventory tracking and distribution throughout the supply chain, although many companies will do it to prevent device counterfeiting. As with any major new barcode implementation, glitches and oversights will reveal themselves and fixes will need to be put into place. We also hope that subsequent revisions will include standardizing on a single symbology: we join with AIM and others in the AIDC community and advocate for adoption of Data Matrix code.

What will verification of UDI barcodes involve? As in other non-medical applications, quality measurement of the UDI barcode will depend on how it is created. Direct Part Mark (DPM) technology will be widely used for Class II and III devices. Here again, Data Matrix is the right symbology: 1D barcodes are not designed for DPM applications.  There are ISO standards for the quality of direct marked as well as 1-D and 2-D printed symbols. Verifiers that are not certified ISO compliant devices do not meet the symbol quality verification requirement.

Your comments, experiences and questions are always welcome.

 

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3db Barcode Testimonial

Our company (an advanced software company) recently worked with Barcode Test to source a barcode verifier.  Not long ago, we were awarded a contract requiring products to be marked with IUIDs in accordance with MIL-STD-130.  For that standard, marking labels must pass a verification test that evaluates many variables (contrast, size, clarity, syntax, modularity, and more).  After a thorough search, we reduced our options to a select few.

In our search for a verifier, the Axicon line caught our attention.  Barcode Test is our regional reseller for this product.   From the beginning, they were very prompt with their responses.  We ended up having a quick call with John Nachtrieb to go over our needs.  John was extremely easy to work with and provided a lot of great information.  He was very knowledgeable on the matter and was quick to offer up a demo unit (free of charge).

Upon receiving the demo verifier and testing it, a few questions arose.  John joined a call with us and answered all our questions.  Ultimately, the Axicon verifier wasn’t the best fit for us, so we shipped the demo back.  John was completely understanding.  A few weeks later, Barcode Test reached back out with another possible verifier for us to try.  While they didn’t sell that brand, they just wanted to help us find the best option that met our needs. They even offered to send us the unit that they have in-house to see if it worked to our liking. 

Barcode Test is truly a great company to work with.  Their service and willingness to help the customer are far beyond what you typically get from other companies.  They are experts in barcode quality assurance and seem willing to help in any way they can (even if that means not getting a sale and recommending another option that better fits the customer’s needs).  If anyone is in the market for barcode verification/scanning services or products, I would highly recommend giving Barcode Test a call.

Regards,

Production Manager