Transition to UDI: Get Ready!

The UDI (Unique Device Identification) is a global identification system replacing the NHRIC or NDC number used with medical devices. Manufacturers establish the device identification (DI) portion of the UDI using standard codes like the GTIN (Global Trade Item Number), which is a 12, 13 and 14-digit identifier. The FDA UDI regulations require that medical device packaging labels have a UDI and the device have a permanent marking bearing the UDI, if it can be used more than once.

Device manufacturers must also submit UDI data to the FDA’s Global Unique Device Identification Database (GUDID). The National Library of Medicine provides public access to the GUDID via this website: https://accessgudid.nlm.nih.gov.

All medical devices are subject to the UDI regulation unless an exception or alternative applies.  High risk devices (Class III) and devices licensed under the PHS Act, were to comply with the labeling regulation by September 24, 2014.  Medium risk devices (Class II) were to comply by September 24, 2016.  Class I and unclassified devices were originally required to comply by September 24, 2018.  However, the FDA extended its enforcement discretion for Class I and unclassified devices to September 24, 2020.

The UDI regulation states that on the date a device must bear a UDI the manufacturer/labeler may no longer provide an NHRIC (National Health Related Item Code or HRI) or NDC (National Drug Code) number on the label of the device or on any device package. This situation creates transition issues if all supply chain participants are not prepared. To further complicate this issue, beginning on September 24, 2018, the manufacturer/labeler may no longer provide an NHRIC or NDC number on the label of the device or on any device package regardless of the class of device.  Recognizing market challenges presented, the FDA stated that it “does not intend to enforce the prohibition against providing NHRIC and NDC numbers on device labels and device packages, with respect to finished devices that are manufactured and labeled prior to September 24, 2021.”

The labeling portion of the regulation can be found at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=801.57.

Pharmacies need to consider how the implementation of the UDI will affect their business systems and workflow. Organizations need to ask the following questions:

  • Does your organization fully understand the implications of the UDI regulation and guidance on your systems and business processes? The deadline for the transition from NHRIC and NDC numbers for devices is September 24, 2021.
  • How is your pharmacy IT team or software vendor addressing the implementation of UDI so that systems will be ready to use the UDI before the compliance date?
    • How are they addressing the transition from using a pseudo-NDC or NHRIC (a.k.a., HRI) number to the Device Identifier (DI) part of the UDI? When will the pharmacy system’s product file (i.e., drug file, item file, etc.) be updated to handle an identifier that is not in an NDC format? What provisions are the drug compendia making in their product database to utilize UDI? When will the pharmacy system be ready to submit UDI on insurance claims?
  • Do your pharmacies have bar code scanners that can read bar codes associated with the UDI? Will bar code scanners need to be updated or replaced to read a UDI bar code, which may be in a different bar code format? What are the costs associated with these options?
  • Will your pharmacy system be ready to use a UDI bar code if a manufacturer/labeler converts before the compliance date?
  • When will your PBM partners be ready to accept claim transactions with UDI numbers?
  • How will implementation of the UDI affect:
    • Inventory management systems?
    • Downstream data collection, such as third party claims reconciliation systems and data warehouses?
    • Interfacing systems, such as POS?
  • What training is required for pharmacy staff for the transition to UDI numbers and the technology changes that will be needed?
  • Has your organization assigned a “point person” for understanding UDI regulations, the implementation timeline and how to use and understand the GUDID database?

PHSI recommends that you begin proactive planning to help prepare your organization and minimize the potential disruption to your business practices. Now is the time to begin discussions with internal resources and external partners that will be impacted by these changes or you will end up reacting to these changes on an external timeline.

 

Published February 2018

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