The underlying purpose of the U.S. FDA’s Unique Device Identification (UDI) Rule seems simple enough: to “adequately identify medical devices through distribution and use.”1 But even manufacturers that have been working for years – some even before the initial legislation was passed – are being tested as they move from planning to compliance. UDI compliance requires not only labeling products with UDI compliant codes, but also submitting additional product data to an FDA Global UDI Database (GUDID). Challenges often result from trying to implement a regulatory requirement that touches nearly every aspect of their business, from manufacturing to customer service.
As Melissa Finocchio, director of labeling for bioMérieux, told an audience attending a UDI and traceability conference in Munich this year, “The FDA cares about clinical systems, but I am running an industrial system, too. I want to identify all of my products the same way.” The FDA, too, sees broad application for UDI and plans to use it to improve the visibility and consistency of product identification across the Center for Devices and Radiological Health (CDRH). In other words, it will be the key for master data management (MDM) within the CDRH. As they look toward compliance, many manufacturers have also chosen to leverage UDI to achieve a more consolidated view of product data within their own organizations.
David Brooks, senior project manager, Corporate Project Engineering, for Covidien says the company began working several years on an MDM strategy: “We are creating a true master catalog that we can leverage not only for UDI compliance, but also as a comprehensive resource about our products and their attributes.” Brooks says this eliminates redundant work and potential version control problems with managing multiple databases. Like Finocchio, he wants to be able to identify the same product with the UDI for multiple purposes: regulatory compliance, billing, rebates, e-commerce, inventory management, etc.
Darrell Padilla, a senior UDI consultant with GHX, says because MDM will be tied to regulatory compliance, manufacturers must build quality control systems to validate that the information in their various systems – manufacturing, production, marketing, etc. – are all in sync. This is especially true as products change to the degree that a new UDI-compliant code and updates to the GUDID are required. “This requires cross functional collaboration, as we map every attribute to each of the core groups that are responsible for that data,” explains Dawn Fowler, sr. manager, labeling and documentation with Endologix. Brooks adds that it’s not only important to identify who owns specific data, but also to set up the appropriate data governance structure and ensure other parties also agree to who owns what.
Customers, meanwhile, are also placing demands on manufacturers for UDI-like data. Many want their suppliers to provide both the Global Trade Item Number (GTIN) and additional product data attributes for the items they buy by publishing that information to the Global Data Synchronization Network. The GTIN is the UDI compliant code managed by GS1, one of three standards bodies accredited as a UDI issuing agency by the FDA. The GDSN is also operated by GS1, with many different datapools publishing data on behalf of manufacturers to the GDSN and providing that data to authorized subscribers around the world.
Here’s where some of the challenges manifest. There is a lack of standardization between what regulators and customers want and how they want it provided. This increases the burden on manufacturers who must meet regulatory requirements but also want to be sensitive to customer demands.
Case in point: Because the GDSN was primarily intended to hold trade attributes (it was originally built for retail purposes), it requires packaging information like height, weight, and depth. On the other hand, the FDA requires the clinical dimensions of a product, but there are no attributes for clinical dimensions in the GDSN. Instead, they need to be entered as sets of attributed value peers (AVPs). Neil Farquharson, GHX technical product manager, shared several examples on the July meeting of the GHX Global Data Standards Users Group, including the one below that shows how you need three peers to actually enter a clinical size for a French catheter gauge: 1) the clinical size type (lumen diameter), 2) the actual clinical size value (15) and 3) the unit of measure for that type of value (in this case, millimeters).
Farquharson stresses that logic and business rules are required to get data out of the GDSN, to interpret it, and to transform it into HL7 structured product labeling (SPL) language if you are sending data to the GUDID in a manner other than the FDA’s web portal.
Adding to the complexity of UDI are the potential differences in requirements from regulatory bodies beyond the US FDA seeking to enact their own UDI-like data requirements. We will look at the global nature of UDI in the next installment in this blog series. Watch for it in September.
1 Unique Device Identification rule as published in the Federal Register, Vol. 78, No. 185, Sept. 24, 2013.