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Making the Most of UDI

I’ve heard mixed reviews on the actual process of uploading data to GUDID. Smaller OEMs have said that it’s extremely labor intensive, requiring hours of manual work by dedicated staff. Steger says that his team set up an HL7, an interface that allowed automation of batch uploading, which essentially allows Zimmer Biomet to act as its own third-party uploader. Additionally, because they’re acting as their own third party uploader, they can include data for any of the various Zimmer Biomet units. For OEMs that have their business spread across different franchises or business lines, an HL7 could centralize your uploading, allowing a single unit to do all GUDID uploading for the entire company. Without the third-party uploader status, your individual units would be responsible for uploading their own data into the GUDID.

Beneficial Barcodes
There are three UDI-issuing agencies that have been accredited by FDA: the International Council for Commonality in Blood Bank Automation (ICCBBA), the Health Industry Business Communications Council (HIBCC) and GS1. All three organizations are non-profits.

ICCBBA isn’t applicable to most orthopaedic companies. While either HIBCC or GS1 are acceptable labelers for orthopaedic device companies, only GS1 is partnering with the Big 5 orthopaedic companies (DePuy Synthes, Zimmer Biomet, Stryker, Smith & Nephew and Medtronic). In fact, GS1 seems to account for the vast majority of devices currently entered in the GUDID.

According to Greg Bylo, Vice President of Healthcare, GS1 US, about 90% of all devices registered in FDA’s database contain a GS1 identifier. That’s more than 480,000 devices.

Johnson & Johnson, parent company of DePuy Synthes, has used GS1 Standards for many of its retail product lines. Until recently, however, DePuy Synthes employed HIBCC. Mike Rose, Vice President of Supply Chain Visibility for Johnson & Johnson, told me that the company was already familiar with many of the services that GS1 provided because of its relationship, so when UDI came down the pike, it made sense to create a common standard across all of the company’s product lines and businesses. The commonality aided internal Johnson & Johnson efficiency and responded to what Johnson & Johnson was hearing from its customers.

“From a customer perspective, it would make it easier for them to scan barcodes,” Rose says.

Some large hospital systems and some thought-leader systems are incorporating parts of the UDI regulations into their own inventory management. For Johnson & Johnson, their large customers were saying mostly the same thing.

“Listening to the voices of our customers, even earlier than 2013, we started to hear and feel that some of the big hospital systems, particularly in the U.S., were strongly suggesting they would require GS1 in the future,” said Paul Pandiscio, Vice President of Supply Chain Product Management at DePuy Synthes.

Rose specifically cited Mercy, Mayo Clinic and Kaiser Permanente as entities making strong pushes for GS1 standards. It is also worth noting the call for international harmonization of standards, and that has largely meant the utilization of GS1. The UK’s National Health Service now requires GS1 standards; rumblings from China suggest acceptance of issuing agencies that are already in place internationally, meaning GS1 and potentially HIBCC.

“When [U.S. hospital systems] looked at efficiencies and operations, they felt it was important to have a common standard so they could set up their own scanners and do so in a consistent way,” Rose says. “If you go back prior to seven or eight years ago, you had HIBCC, you had GS1 and you also had proprietary systems of barcodes. It was a mess.”

As a result, many of DePuy Synthes’ customers weren’t employing any type of barcode scanning, because they couldn’t depend on the consistency of the barcode.

Which issuer do your customers use? Understanding which agency your hospitals or GPOs prefer will help you coordinate your barcodes with their scanning systems, improve your end-to-end traceability and create a better dialogue between you and your customer. If your target customers are U.S.-based, they either prefer HIBCC to GS1 or have an entirely different system of utilizing UDI.

Industry Benefits
One of the obvious areas of benefit from UDI is the supply chain. Josh Cannon, the Marketing Strategy Director for UPS, has seen immense benefit emerging from the regulations.

“You can make decisions based on two things: good data and good visibility. If you have good data and good visibility and provide that data to all of your key stakeholders (providers, 3PLs, service reps), and give them complete visibility, then the supply chain can make decisions,” he says.


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