Tips for Successful UDI Implementation for Medical Device Labels


Labeling is a critical element to ensure your product arrives and functions properly in the clinical environment.  The labeling key elements include reference numbers, product descriptions, expiration dates, quantities, and identifiers.  Healthcare professionals rely on all of this information to properly use, store, and locate devices.

Avoiding the nightmare of smudged and torn labels can be as simple as employing proper material testing methods.  Sutherland Rub testing can be a great tool for gathering data and comparing different materials/technologies.

The medical labeling industry is currently undergoing new FDA requirement plans.  Unique Device Identification, also known as, UDI is a soon to be implemented plan where all devices will need to have both computer and human readable labels.  These labels will include reference, lot, and expiration dates all together in a concise manner.  Compliance with UDI requirements will be completely implemented by 2020.

There are four steps for successful UDI implementation:

  1. Identify all sealable SKU’s/ configurations, then obtain “UDI’s” for each.  FDA- accredited issuing agencies include GS1, HIBCC, and ICCBBA.
  2. Add the UDI to product labeling necessary elements are the “Device Identifier” (DI) obtained in the step above + “Production Identifier” (PI) which is usually the lot/ expiration data. This information must appear as a barcode (1-D or 2-D are both acceptable) along with the human readable text. 
  3. Register with the FDA’s Global UDI Database (GUDID). This is a publically searchable repository.
  4. Implement UDI rollout according to established FDA timelines.

The message from a “best practices” standpoint is that there are many considerations to take into account when it comes to labeling.  These considerations need to be thought through and tackled systematically.  The consequences are delays, issues in the field, customer complaints, and recalls.

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