Stanford Health Care's UDI Journey: 7 Key Takeaways

We at Stanford Health Care have been ahead of the curve when it comes to global data standards adoption. Most recently, the U.S. Food and Drug Administration’s unique device identification (UDI) rule has driven healthcare organizations such as ours to rethink how we standardize and categorize our product data. Understanding that UDI is here to stay, we have positioned ourselves to adopt this data and make it part of our standard work.

Here are seven key takeaways from our UDI journey:

1. Prioritize and agree on a plan: There are multiple ways to approach UDI adoption based on your end goals. For example, you could approach UDI from an operational perspective, leveraging it in supply chain to identify the movement of products from point to point, and even in ordering and communicating with vendors. Our approach was to address the clinical need first. Identifying your focus will help you determine what resources you will need, including stakeholders, systems and data. Even if you start with a clinically focused UDI implementation like we did, once you have the data it can easily be used for supply chain and other operational initiatives as well.
2. Manage cultural change and build muscle memory: This isn’t a project where you collect a massive amount of data and update your systems – this data is constantly changing, such as when new products are introduced into your environment, or a supplier undergoes a merger or acquisition that results in new UDIs. UDI must become part of your core structured standard work where you maintain it. It is not just a process change but also a cultural change. People in your organization need to understand that UDI is not just another data point we are collecting for the item master, but priority information that impacts everything downstream in the delivery of patient care. You must not only get people to understand how to capture UDI data, but the importance of why they are doing it.
3. Ensure no assumptions about ease of finding data: Understand the limitations of the FDA’s Global UDI Database (GUDID). It is a great resource for accessing supplier UDIs, and we use it, but not all suppliers have put all of their data in there yet. You will likely have to reach out to individual suppliers to get their UDI data. It’s also important to note that your supplier’s sales team might not be the right group to help you find product UDIs. Some supplier organizations have ecommerce teams that are focused on UDI but we are finding that they don't always communicate this information down to sales and customer service. Urge your suppliers to educate people throughout their organizations on UDI so they can help their customers adopt it.
4. Understand where and how your ERP stores data: Accessing UDI data is one thing, storing it in your systems is another. You need to understand how and where your ERP system stores this data. We discovered that our Lawson ERP system stores it one way for GS1 Global Trade Item Numbers (GTINs) and another way for HIBCC Labeler Identification Codes (LICs).
5. Understand there isn’t a “one size fits all”: Not all UDI data is available from one source. Access GUDID is a great site and some of our suppliers have robust sites where you can access their UDI data. Our group purchasing organization (GPO) is another source, as is the GHX NuVia content management solution. Be aware that you can’t go to just one site and get one file to load into your item master. It is not that kind of process — at least not yet.
6. Focus on realizing value in a timely manner: Drive UDI as an organization-wide strategic initiative. While our UDI work was initiated by supply chain, it has delivered tremendous clinical value. Our work is not just about using UDI to move products from the dock to the storage unit — it is also about identifying the product when it is used on the patient and eventually leveraging this information to measure the cost and quality of clinical outcomes.
7. Build a strong team with the right skill sets: Have people around you who have the right skill sets and mindsets to look at the data and determine how to navigate it through your processes and systems. You will get data in different formats and will need people who are creative and efficient in gathering and normalizing that information. You also need effective communicators on your team — those individuals who get the message out there on why you are doing this, how you are going to use the data and how it will help them in their day-to-day environments.