DMN: What can be said about the GUDID, which is operated by the U.S. Food and Drug Administration?
KC: The FDA is telling people to publish sooner rather than later. I actually heard an FDA official say recently: "Don't wait until all your homework is done to show some of it to the teacher." They want to see how it works.

Another thing to note right now: There is a recommendation on the table for meaningful use stage 3 to integrate UDI into the EHR. The proposed language would require eligible physicians and hospitals to record the UDI when patients have devices implanted.
DMN: What are some of the resources out there to guide people through this?
KC: We are working on the supplier side as well as on the hospital and health care system side — because if they can't use the data then all we have done is this regulatory exercise that costs a lot of money and time.

We have services at GHX to help suppliers prepare and get data in the GUDID and then on the other side we have products and services around data management for providers. Most of the data in the GUDID will be publicly available but not necessarily easily consumed by provider technology systems. We are working to incorporate UDI related data into a lot of our products to make it easier for hospitals and health care systems to use the standardized identifiers. Suppliers, meanwhile, need to feed data to lots of organizations, such as the FDA and customers. In the OR, for example, that product data needs to be captured for the purchase order, implant log, electronic health record (EHR) and for charging and reimbursement. On the hospital side, how do you capture that data and get it into different systems for different purposes? The same for manufacturers — how do you publish it once and enable it to get to multiple places?

DMN: How will this data help in the long run?
KC: There are multiple reasons you need to have accurate and timely data on products we are using in health care. Everything from supply chain efficiencies to managing inventory levels. Health care does inventory in a "just-in-case manner" because clinicians don't want to run out, so suppliers produce more product that sometimes ends up expiring before it's used and it's one of the biggest costs in health care. We want UDIs in EHRs so that surgeons know which implants a patient has before they operate. Or wouldn't it be nice to know if a patient has a defibrillator, pacemaker or stent before they show up in the emergency room? It can also be used for comparative effectiveness research but not necessarily to show that one product is better than another. Rather, what are the clinically relevant attributes, and which attributes in these products work better in different types of patients? Then as more countries enact UDI regulation and more information is added to UDI databases, we can really get more robust data to understand the cost and efficacy.

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