Blog: An Interview with Jay Crowley: An Insider’s Look at Unique Device Identifiers, Part 2

May 14, 2018 by Jay Crowley

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First Databank (FDB) recently talked with Jay Crowley to get his expert perspective on the Unique Device Identification (UDI) system. Crowley developed the framework and authored key requirements for the Food and Drug Administration’s UDI system while working as the Senior Advisor for Patient Safety in the FDA’s Center for Devices and Radiological Health. This is the second of a two-part series where Crowley offers his thoughts on the evolution and future of this emerging identification system. If you missed Part 1, read here.

To what extent do you see analogies between the National Drug Code (NDC) and the Unique Device Identifier ? from both a regulatory and provider standpoint?

The basic ideas are the same. There is a product and it is allowed to be on the U.S. market through some regulatory pathway. The product has a certain form, and the form is referenced by with a standardized identifier. This makes it possible to compile data associated with the product, which can be used throughout the lifecycle of that product, driving activities from supply chain through post market activities. And, some devices tend to look like drugs from a lifecycle perspective. They’re ordered and consumed. They’re very discrete, the healthcare organization gets them, dispenses them and the patient uses them and discards them.

The differences come into play when you start to scratch the surface. There are many devices and accessories that don’t operate like drugs, in that they have a long lifecycle. There are devices that are around for thirty years. The analogy breaks down a little bit when we start getting into some of these complex devices that have long lifecycles, as well as different pieces and accessories.

Is the UDI commonly understood as an “National Drug Code for devices?”

I see it that way, but I don’t think most people do. The UDI just has not become so ingrained in the process. With drugs, professionals routinely prescribe and dispense with an NDC number. We’re not quite there where we’re “prescribing” devices with a UDI.

So, we haven’t really crested to a level where we’re using UDIs in a way that is analogous to the way that NDCs are used for pharmaceutical products. We haven’t gotten to the point where it’s ubiquitous. The industry has different pockets of people who are dealing with their specialized area and using the UDI for their specific purposes.

Like the parable of the blind men and an elephant, each group tends to view their area as the whole “truth,” yet it’s only a partial “truth.” We’re not yet at the point where everyone is stepping back and looking at the entirety of the healthcare continuum in the same way – viewing the whole truth, which is really the goal of the UDI.

Given your history with the UDI initiative what functions do you see the Global Unique Device Identification Database (GUDID) serving for medical device manufacturers, clinicians and healthcare institutions?

The underlying concept of GUDID really is based on what we see in the pharmaceutical space. Although not exactly parallel, our model was, in general, the FDA’s use of a controlled set of data for pharmaceutical products via the NDC.

It was intended to be a resource, just as organizations take the data from the DailyMed and leverage it by adding value and then providing it to various users in various forms. Its primary purpose is to be a repository that others ? whether that’s data resellers, or hospitals, or other groups – can leverage to solve whatever use case or business case they have.

What sort of actions by the FDA or Centers for Medicare and Medicaid Services (CMS) would accelerate UDI implementation?  How about private sector initiatives?

FDA is currently limited in its regulatory authority in this space. In Europe, however, they have UDI requirements for device manufacturers, very much like what we have in the United States, but they went a step further with their regulations, and require various economic operators, distributors, importers, healthcare organizations, at least initially for class III implants, to manage the distribution and receipt of those products at a UDI level.

And obviously, this requirement helps to drive adoption. Having a similar requirement in the United States would require a legislative change, which is not unheard of. CMS could help drive implementation by requiring, at least for certain products, to have UDI as part of the reimbursement requirements. The Office of the National Coordinator for Health IT (ONC) could also drive adoption by requiring the documentation of patient implants in the electronic health record (EHR). So, if we could see FDA really work on some of the supply chain issues, and CMS work on the reimbursement, and ONC work on the implant documentation, that would get this gigantic ball rolling.

What role do you see FDB playing in the medical device knowledge market?

FDB is known as one of the premier providers of pharmaceutical information to both the government and industry and that business model is central to how this needs to work. Hospitals aren’t going to go and download GUDID and incorporate it into their systems. They need a compendia company such as FDB to provide the information they need in the form they need it, and to add whatever value they desire. FDB provides the bridge that we need. GUDID is the foundation and then others, like FDB, takes that foundational information, adds whatever its organizations want, and then provides it to them in the format they need to deliver value for providers.

There’s kind of a “push and pull” going on. Providers have to start to pull and say, “Yes. I need that data.” And, “Oh, it would be very helpful if I had it in this form.” And, we need organizations like FDB to be responding. That’s what’s ultimately going to drive adoption. There has to be value that comes from scanning a product and having all the information associated with it. We spent a long time developing GUDID. Nobody pretends it’s perfect right out of the gate, though. It was a grand compromise. It needs a lot of cleaning and it needs a lot of work, and that’s just not FDA’s domain. It’s really others, like FDB, that are in the right position and have the expertise to provide that to the healthcare industry.

About Jay Crowley
Jay Crowley is Vice President of the Unique Device Identification Services and Solutions at USDM Life Sciences. Crowley recently served as Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. At USDM Life Sciences, Jay focuses exclusively on providing business process, technology and compliance solutions for the regulated life science industry.

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