UDI_LOGO_retGiven the noted benefits of UDI implementation (see The FDA’s UDI Compliance Mandate in Plain English – Who Benefits?), no time is better than the present to begin the process of becoming UDI compliant. The obvious enhancements to patient safety and public health coupled with a far more efficient and cost effective way of doing business are reasons enough to get started right away. That said, the FDA’s mandated UDI compliance deadlines obviously play a role. Companies that are not compliant by those dates may face the grim reality of not being able to continue to ship their respective devices.

The FDA deadlines serve to give medical device companies a target date to shoot for, however, it’s the amount of time it takes to actually become compliant that really deserves some scrutiny. Estimates vary and the timeframe is entirely dependent on the number of devices requiring a UDI, but, it seems that nine months on average is what most companies in the SMB space may experience. This means that manufacturers of Class II implantable, life-supporting, and life-sustaining devices should already be ON IT in order to meet the FDA’s deadline of September 24, 2015 for those devices.

Very basic to the UDI compliance process is knowing what devices must be uniquely identified and being able to create a product’s uniqueness with the understanding that said identity cannot be changed down the road. Every packaging layer of a given device is treated as a distinct UDI. New FDA regulations for the type of information to be displayed on medical device product labels will, in the least, imply modifications to existing product databases or quite possibly require the creation of new databases. This will all need to be carefully planned and mapped out in detail well ahead of time to ensure a smooth path to compliance.

While the scope of work and amount of time required to become UDI compliant will vary from company to company, there are some processes and steps that all companies, regardless of size, will need to complete prior to making submissions to the FDA’s database:

  • As part of laying the groundwork to building a UDI database, a company will need to establish an account with the Global Medical Device Nomenclature Agency, the body responsible for maintaining the Global Medical Device Nomenclature (GMDM). Member companies have access to the GMDM database where standardized, internationally accepted medical device descriptors reside.

  • The Global Unique Device Identification Database (GUDID) is the FDA administered, public database to which UDI submissions are to be made. A company must be registered with GUDID in order to be able to upload product information.

  • In order to become a registered user with GUDID, a company will first need to have an assigned DUNS number.

  • Companies are required to use one of two mandated labeling standards when making submissions to GUDID:

    • The GS1 standard – requires a fee-based membership to GS1 US where companies can obtain a unique company prefix and Global Trade Item Number (GTIN) for every product sold.

    • The HIBC standard – requires a fee-based membership to The Health Industry Business Communications Council (HIBCC) where companies can obtain a unique Labeler Identification Code (LIC).

  • U.S. companies that export medical products of human origin, including blood, blood components, and cellular therapy products will use the ISBT 128 labeling standard, which requires a fee-based license from ICCBBA.

After meeting these very basic requirements, the compliance process will be entirely dependent on the volume of work to be done. It’s important to note that every medical device configuration and packaging layer must bear a UDI label, so it’s entirely possible for a company to have only one device in its product offering yet require hundreds of unique identifiers.

Some questions to consider in estimating the amount of time it will take to become UDI compliant:

  • What will the scope of work be?

  • Are the right systems and processes in place?

  • How much new data will be required to build a UDI label database.

    • Where will it come from?

      • Spreadsheets?

      • ERP system?

        • Will the existing ERP system interface seamlessly with the UDI label database?

          • Will it allow the storage of UDI codes?

          • How will UDI data be sent from the ERP system to printers and report formats?

          • If using a third-party UDI software solution, will it work hand-in-hand with the ERP system?

    • Where will UDI information reside and how will it be accessed for submission to GUDID?

  • Will existing hardware and supplies be good enough to handle the change?

    • Do existing label printers offer: 600 dpi resolution; the speed necessary to print new formats and volumes of labels; and color and graphic capabilities for branding?

    • Are barcode verifiers on hand to test the quality and validity of a UDI barcode?

    • Are the correct label and ribbon materials and configurations in use to meet the FDA’s requirement that a label must remain legible and affixed to a product throughout the product’s lifecycle? This question is key, considering the rigors of a healthcare environment where labels are subject to frequent handling and exposure to a variety of fluids, chemicals and disinfectants.

  • Can the UDI compliance scope of work be completed in-house?

    • What will the staffing requirements be to become UDI compliant?

    • Who will be the “point person” for GUDID submissions? (required by GUDID)

    • Who will code and how will that code be triggered?

  • Will a new budget be required and how long will the budgetary process take?

  • Do assembly and packaging facilities have the capabilities to assure UDI compliant labels are affixed to product packaging?

  • Are the right third-party partners in place to facilitate and simplify the path to UDI Compliance?

Considering these are only some of the more basic steps and questions that come into play when companies consider a timeframe to become UDI compliant, is there any doubt that no time is better than NOW to begin the process?