FDA’s Unique Device Identifier Program is a Prince Masquerading as a Frog

In popular lore, the princess kissed the frog to break the spell that had once transformed a handsome prince to that hideous creature.

In the device world, manufacturers need only to embrace FDA’s onerous unique device identifier (UDI) program to know that a golden opportunity lies within.

 Under this program, most medical devices will bear a unique label/ID that will contain a host of vendor and provider-inputed data that will reside in an FDA database. The UDI system, FDA hopes, will ultimately boost patient safety and help in recall efforts.

If that doesn’t sound too exciting, then feast on this: if developed correctly, the UDI system can also help device makers have better inventory control, save on regulatory costs and develop better products. And that is the proverbial frog turning into the handsome prince.

The final regulation is expected sometime in mid 2013. Waiting later than now – some would argue it is quite late already - to develop the processes and indeed the culture needed to successfully develop a UDI program would be unwise.

But first, one impression of the program needs to be immediately dispelled: that it is a mere labeling project.

“Complying with UDI is not a labeling exercise,” declared Karen Conway, executive director, industry relations at GHX Inc., a healthcare supply chain management company.

So how should one approach it? Conway provided some pointers.

For one, getting different parts of your organization talking. The graphic created by GHX to the left shows developing UDI standards needs input from a cross-functional team involving everyone from legal to IT and marketing to process engineering.

The big question that needs to be answered is: Where and how is data stored within the organization and who owns the data? That’s because UDI isn’t simply slapping on a machine and human-readable barcode. It involves submitting product and usage information to a FDA database, so having consistent data about a product is crucial.

But just imagine the benefit of achieving this Herculean task? If providers are using the UDI appropriately, then manufacturers can know when a particular product was used and how. If the UDI gets captured in the medical record, then providers can have better understanding of how the products are being used, so they can make better, more timely purchasing decisions.

And that in turn means that device makers will have improved inventory control and there won’t be that excessive waste in the medical device industry where products that get made expire before they can be used. Conway described that as a “huge cost.”

The other advantage is simply saving money in the area of compliance because now device manufacturers will have a standardized internal process. Conway said that many organizations identify a product and therefore its attendant data and processes differently through its entire lifecycle.

The UDI data captured in a medical record for instance can tell product development experts which product has better outcomes. That could be leveraged to conduct comparative effectiveness research and thereby build better products.

“If a manufacturer approaches the UDI in a very holistic fashion and approaches this as an opportunity to get its regulatory master data in order, it can actually deliver value for them.”

In other words, immerse yourself in the frog’s world and then muster up the courage to embrace it. You might be surprised.

—Arundhati Parmar, Senior Editor, MD+DI

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