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Improving UDI Barcode Quality and Verification

UDI_DeviceOne of the largest labeling regulations in recent history; UDI (Unique Device Identifier) labeling has been at the forefront of any medical companies agenda to not only implement new information but to also properly display this critical information in a proper fashion. provided simple yet resourceful list of common issues that they have seen so far in UDI implementations and also solutions to these issues:

  1. Overprinting: Print head temperatures reach too high in thermal, thermal transfer and inkjet viscosity leading to nonequivalent dimensions in Data Matrix barcodes.
  2. Infusion bags not producing enough high reflectance values that can confuse a scanner.
  3. Background graphics and text behind a barcode on a clear pouch altering scanability.  Easy solution would be to print the barcode over a white patch on the pouch.
  4. Quiet zone encroachment on 2D Symbols such as Data Matrix. Quiet zones are often ignored when printing a small barcode in a small area; ensure you are leaving enough room for quiet zones to be scanned properly.
  5. The use of a 1D barcode to encode a large amount of data leading to decreased scanability and accuracy; suggested solution would be to replace the 1D barcode with a Data Matrix barcode that can hold much more information in a smaller space.
  6. Data structure within a UDI barcode has very specific requirements.  Some fields are a fixed length, others are variable.  Having a current and updated label design software tool provides that insurance that the barcode structure is compliant and accurate.

Pragmatyxs has partnered with many large medical supply organizations in implementing UDI best practices.  If you are facing any of the challenges listed above or have other questions please reach out as we would look forward to assisting in any way possible.