UDI report: what’s next for unique device identification (UDI)?
Guest post with Karen Conway and Mike Schiller
As we are a month past the date when the FDA’s unique device identifier regulation for class II products took effect, we thought it would be helpful to start a UDI report with industry experts. We’ve talked with Mike Schiller, senior director of Supply Chain, AHRMM, and Karen Conway, executive director, Industry Relations, GHX, for an interactive UDI overview.
Q: Karen, what should we know about UDI?
A: The FDA regulation requires medical device manufacturers to assign and label their products with a unique device identifier (UDI). Additional data about those products must also be uploaded to the FDA’s Global UDI Database (GUDID). UDI lays the foundation for creating better visibility into which products are used on which patients, by which clinicians, in what facility, at what cost, and to what clinical and financial outcomes.
While the initial UDI regulation was focused on manufacturers, it is important to remember that UDI is for all stakeholders. Electronic health records (EHR) technology will soon be required to hold UDIs for patients’ implantable devices and pull data from the GUDID. Providers will need to share those UDIs as part of the common clinical data set with other providers caring for the same patients. Manufacturers can play a very important role in providing accurate, relevant and complete data to the GUDID to help providers better use and manage that data.
Q: Karen, how do we start thinking about how to manage this data?
A: All of us in healthcare use product data; we just use it for different purposes, be that clinical, supply chain, or financial. Depending on who you are and what you are trying to do—i.e., buy, source, receive, use, or evaluate a product—you will need different kinds of data attributes, such as price, unit of measure, lot number, expiration date, etc. As a manufacturer and as a provider, you will need to think about how to access, store, and update that data. Many providers use their supply chain item master as the source of truth for their various data systems and will need to think about how they are sourcing UDIs and related data attributes.
It is important to think about this change holistically. Both manufacturers and providers need to develop their own strategies for data acquisition and management and create a supporting data infrastructure. It is important to focus on the full potential of UDI versus just what is required to meet regulatory requirements. Rather than simply checking the regulation box, think about the value you can gain from taking a more holistic approach to managing data.
Q: Mike, how can we work together to solve some of these challenges?
A: The FDA identified the need to engage with a coordinated and early adopter UDI community. As a result, AHRMM began organizing and hosting the Learning UDI Community (LUC). This community, made up of healthcare leaders including those from clinical, distribution, financial, IT, regulatory, physician, standards organizations, and supplier/manufacturing sectors, focuses on identifying issues that impact UDI adoption within the healthcare industry. The Learning UDI Community has established a number of work groups to help identify adoption hurdles and adoption solutions that are then shared through the Learning UDI Resource Center.
Q: Mike, tell us more about the Learning UDI Community work groups.
A: Currently, there are five active work groups; these are UDI capture, Unit of Use, Clinically Relevant Size, Catalog Number Field in the GUDID, and Human Cell Tissue Products (HCT/P). These work groups develop resolutions and draft guidance for LUC review. There are more work groups pending with the potential to have up to ten work groups up and running within the next few months. Follow our series to hear more about what we are discovering. To learn more or to join the growing Learning UDI Community, visit the AHRMM website.
The LUC is open to all those who are interested in advancing UDI adoption in the healthcare field. By providing public access and sharing knowledge regarding UDI adoption we hope to accelerate the likelihood of success and shorten the learning curve for UDI implementation. Remember, UDI is for all stakeholders; develop your data strategy, and there is a Learning UDI Community to help you in your journey.