Medical Devices in a new world│#AdoptUDI

by Patrick Lupinetti

Here’s a thought experiment: imagine that everything is just as we know it now, except there are no NDCs for drugs. There are numbers, to be sure, but a dizzying array of them – UPC codes, GTIN-14s, one set of unique alphanumerics from manufacturers and entirely different sets from wholesalers.

It’s the same with drug names, and are all different in this world. You’d have “amoxicillin powder for suspension,” “amoxicillin for oral suspension,” “amoxicillin suspension,” and “amox, oral, powd., susp.”  Supply chain management would be trickier – sometimes you would be duplicating drug orders, and sometimes you would order something that wasn’t what you intended. Claims processing wouldn’t be a picnic either, since cross-walking all those numbers and descriptions to a reimbursement code would be a tedious process on both ends. And, what you recorded in an EHR would be just as accurate as clinicians were consistent in how they identified drugs, which is to say not very. Things would be very, very messy.

Now return from that vision, back to the world of NDCs, where there’s a single, universally-recognized identifier that lets two people talking about a drug know with certainty that they’re talking about the same thing. The nightmare is over. Or, it is for drugs. For medical devices, not so much.

In this world, devices still have multiple names, variable identifiers, inventory management challenges, limited identifiability, and only a rudimentary amenability to classification. You could fairly say that, until now, devices are where drugs were back in the 1960s. But that’s all changing and you’ll need to add “UDI” to your list of commonly-used acronyms because of the introduction of the Unique Device Identifier (UDI).

Required by federal legislation in 2007, the concept of distinctive UDIs assigned to medical devices first became a reality last September, with the inaugural filing of these new identifiers for high-risk Class III devices such as pacemakers and stents. The next milestone in UDI history arrives today, September 24, for Class II implantable/life sustaining/life supporting devices, to be followed next September by the other Class IIs; then by the Class I products in 2018.

You can read all about it – how you get a UDI, the structure of the number, the FDA’s GUDID database and more – on the FDA’s CDRH Learn website here.

Let’s go back to the thought experiment for a moment. If you had found yourself in that benighted, unenlightened, pre-NDC environment, and the FDA had just come out with a five-year timetable during which this new, unique drug identifier would be rolled out, what would you do?

Let me ask that again. Knowing what you know now about all the use cases to which an NDC can be productively applied what would you do? Wouldn’t you want to use it…everywhere? Wouldn’t you want them in EHRs for clinical documentation and outcomes research; in purchasing to control your inventory and conduct materials management more effectively; and in claims adjudication, to streamline the process and ensure that billers and payers had a common understanding? There would be effort in the transition, but again, with the benefit of your experience with NDCs, wouldn’t you see it as worth the effort?

That’s precisely where we are with the UDI. Yes, there are other reasons for widespread adoption—from MU3 and EHR certification requirements, to the scheduled phase out of NDCs and NHRICs for devices—but the foreseeable benefits make a compelling argument by themselves.

You don’t often get a chance to take advantage of hindsight before something happens, but maybe thinking about NDCs as UDI ancestors can enable us to do just that.

About Patrick Lupinetti, JD
Patrick Lupinetti is senior vice president and editorial director for FDB’s Knowledge Base Services Department, where he has responsibility for drug descriptive data acquisition, government pricing, data structure and clinical content for all of FDB’s product modules.

 

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The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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