The deadline for manufacturers to comply with the U.S. Food and Drug Administration's Unique Device Identification (UDI) will be here sooner than we know it — and there is still a lot of work to do. Karen Conway, executive director of industry relations for the supply chain consulting firm GHX, explains the progress and challenges of the rule so far.

FDA issued the final UDI rule on Sept. 24, 2013 and the first compliance deadline is this year, on Sept. 24. UDI is a two-part system that involves a bar code as well as human-readable text on medical devices, with the aim to manage materials better and improve the quality and safety of existing medical devices and those coming to market.

DMN: The final rule passed, what's the next step for manufacturers?
KC: Manufacturers are very busy — especially those who have class III devices, because they will have to comply with the UDI rules by September 24th [this year]. They need to be assigned a UDI compliant code, like a global trade item number. Manufacturers need to label their products with that code in both a human- and machine-readable form, and they have to have published data to the Global UDI Database (GUDID).

DMN: It sounds like a lot of work.
KC: There are some who have been working on this for a long time and others who got started soon after the rule came out. It's definitely hard work.

A year after this deadline [Sept 24, 2014], the next category of products that will need to comply are those described in the FDA Safety and Innovation Act as "implantable, life-saving, and life sustaining" — mostly class II devices — they will have to comply by Sept. 24 of 2015 and then the rest of the class II devices in 2016, and then in 2018 it is all non-exempt class I devices. Some products — those that are intended to be used more than once and reprocessed before each use, must also have direct part marking (DPM). For most products, the DPM deadline is two years after their initial compliance date, except for products that are "implantable, life-saving, and life sustaining," which must be in full compliance by September 24, 2015.

DMN: What do you think the biggest challenge is right now for everyone involved in this?
KC: First, lots of education needs to happen in various manufacturing functions — it's much more than a labeling exercise. You have to have multiple functions involved and pull the right team members together who can identify which products fall into which compliance deadlines, then publish product attributes to the GUDID. But those attributes often sit in different locations, formats, and systems and they are owned by different functions and people, so you have to figure out where all this data is — one might have some of it in an Excel sheet, or some in the master data management system. You have to figure out where it is and how to harvest it. How are you going to get it ready to publish to the GUDID? And most important, you have to create sustainable processes — it's not something you do once — because if you create new products, significantly enhance them, or acquire new products, they need to have UDIs and be in compliance with the regulation.

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.

DMN: Where do other countries stand in setting up UDI?
KC: Europe is next in line. They planned to have something final early this year but because of parliamentary elections it's probably looking more like later this year. It would be similar to what's being done here except they actually have language in their draft recommendation that would require implantable device UDIs to be documented in the EHR. Other countries including China, Australia, India, Japan, Korea, Brazil and Canada are also looking into UDI, but nothing is formal.

DMN: What other things should be on manufacturer's radars?
KC: If anyone is attending HIMSS 14, AHRMM and HIMSS are collaborating on a pre-conference symposium on Linking Technology and Supply Chain: Cost, Quality and Outcomes. This symposium is designed to show how supply chain has the ability to link all of the various systems, processes and data to understand what drives better cost, quality and outcomes in health care. And there's a great lineup of speakers, including the FDA lead on UDI.