UDI: The Foundation for MDM in Healthcare

A recent webinar sponsored by the Association for Healthcare Resource & Materials Management (AHRMM) highlighted the need to more effectively and consistently manage data associated with the myriad of products used in healthcare. The webinar, “Identifying Medical Devices with Quality Data,” was presented by the U.S. Food and Drug Administration (FDA) and stems, in part, from work conducted by the AHRMM Learning UDI Community (LUC) to help ensure data in the FDA’s Global UDI Database (GUDID) meets the needs of a variety of healthcare purposes, including supply chain operations, patient care and research.

As background, the FDA UDI rule was created to provide a way for all parties to unambiguously identify medical devices (from syringes to implants) across the medical device lifecycle. The UDI consists of a primary device identifier for a product at a specific unit of measure and a production identifier that includes information such as lot number, serial number and expiration date. In addition to assigning and labelling their products with UDIs, manufacturers are also required to publish additional data attributes for those products to the GUDID. The majority of data in the GUDID is publicly available through a web portal called AccessGUDID that was created by the National Library of Medicine, under a memorandum of understanding with the FDA.

Sounds simple enough, but as with so many things, implementation can present unexpected challenges.

As the FDA and others have learned, it is not just about whether manufacturers have complied with the regulation; it’s also about whether healthcare delivery organizations and other data consumers can use the UDIs and the data available through AccessGUDID effectively.

UDIs can help identify a product no matter where it is in its lifecycle or in the healthcare system. For example,

• Is it for sale in a manufacturer’s warehouse?
• Is it being ordered by a hospital?
• Is it being received and stored at a hospital site?
• Is its use being documented in an electronic health record and/or registry?
• Is its performance being evaluated?
• Is it being paid for by the hospital and/or being charged to a patient?
• Has it been recalled?

These activities are performed by a wide range of healthcare professionals, each of which need different information or attributes about the product. Some of that data will be in the GUDID; other attributes can be obtained from other product content databases. But there is value in all parties calling the same product the same thing, or in other words using the UDI as a reference code to unlock needed data attributes from other sources and still know they are talking about the same product.

Earlier this year, the AHRMM LUC held a series of workshops where providers and manufacturers discussed how to populate the GUDID to make the data as useful as possible for providers. As a result, some manufacturers are interested in updating their records. While this could help improve the quality of data in the GUDID, what about providers and others who may have previously downloaded data from AccessGUDID and loaded it into their various systems. How will they know if a record has changed? One of the potential solutions discussed during the webinar would be for the FDA to include the full history of a record in the GUDID in addition to the most recent version. There was also considerable discussion about the need to retain product records in the GUDID, even for products that have been discontinued, because those products will continue to exist, on hospital shelves and in patients that have had those products previously implanted.

Another topic discussed during the webinar was the value of the catalog number. While optional for manufacturers, many providers said they would like it included in the GUDID. The FDA proposed clarifying the definition of catalog number to be the number used for ordering. This exposed another challenge: for some manufacturers, the number on the label, which is used by clinicians when documenting supply usage, is different than the number used for ordering a product. Ideally, if the UDI were the only way a product is identified, this would not be a problem, but in most cases considerable system and process changes will be necessary before that can happen on a broad scale across healthcare and the many organizations that use product data. The discussion also raised the issue that catalog and other reference numbers often use hyphens to make the numbers easier for the human eye to read, but that can cause problems when using technology that cannot accommodate the extra characters when ordering or recording usage of a product.

Both of these issues demonstrate the importance of master data management (MDM) when it comes to healthcare products and associated attributes. For those not as familiar with MDM, it is typically defined as a means by which an organization creates a master file as a common point of reference to access all of the critical data essential for operations. But because so many different functions and entities in healthcare need accurate and consistent data about products, I would argue that we need MDM across the entire healthcare system, not just individual organizations. Using the UDI as a common reference code and making sure the data in the GUDID is as accurate, accessible and usable as possible are two foundational steps toward this goal. But as mentioned above, there will also be a need to make sure other data attributes not contained in the GUDID are also linked to the UDI to ensure consistency, and for that data, also, to be accurate, accessible and usable. Further, until all of our various systems and processes (manual and automated) are able to use the UDI, we will need business rules engines to make the necessary conversions, e.g., from codes with hyphens to those without, as an example. This truly is an industry wide challenge, with effort required by all parties, but with potential benefits available to all as well.