Making the Most of UDI

The roots of Unique Device Identification date back at least to 1999 when the Institute of Medicine published its report, “To Err is Human.” Fast forward to 2013, FDA released a final rule establishing the inclusion of a unique device identifier (UDI) on labels and packages. When any new initiative is proposed, questions arise. They did during that fourteen year gap and they continue today. What will we need to do to comply? How will it be enforced? How can we find ROI in the regulation? Now that the UDI regulations are mostly upon us, the second two questions remain unanswered.

So, how exactly does FDA plan to enforce these regulations? When I spoke with Jerry Brown, he had serious doubts that the Agency has the resources to consistently crack down on companies that are non-compliant. (Mr. Brown is the former Vice President of Global Supply Chain for X-Spine, and is now a consultant.)

During an email exchange with FDA, I specifically asked, “How will these UDI regulations be enforced?” The response received was, “FDA’s main focus is getting the UDI system implemented correctly and actively helping companies comply with system requirements. However, we expect industry will be able to comply according to specific timetables. If an entity is not in compliance with applicable UDI regulations within the stated timeframe for implementation, FDA may take necessary enforcement action.”

Setting compliance and unknown enforcement aside, then, the question isn’t how UDI will alter your business, because it has already done so. The question is, how can your business benefit from the changes you’ve made, and how will the healthcare system as a whole benefit from UDI, if at all?


View or download the OMTEC 2016
presentation on UDI below.


FDA, for what it’s worth, has repeatedly said that the UDI system should allow industry to more rapidly review and aggregate adverse event reports, identify problems relating to a particular device, more rapidly take corrective action, and reduce medical errors. The Agency also believes that UDI could enhance analysis of devices on the market, provide a more robust postmarket surveillance system and lay the foundation for a more secure, global distribution chain.

The GUDID Database
Whether or not those goals have been achieved is debatable. I spoke with Brad Steger, the Global Project Manager, UDI for Zimmer Biomet. He said that when the rule was first published, it felt like government overreach or another regulation without a useful purpose, a sentiment shared throughout the industry. Steger says he now sees the benefit of successful UDI implementation.

Specifically, Steger called out the possibilities associated with the Global Unique Device Identification Database or GUDID.

“It’s a well–put-together system in which, provided you get good data into the system, the end-users will benefit, be they hospitals looking for reimbursement aid or patients looking for more information on what’s been implanted in them,” he says.

For Zimmer Biomet, the GUDID spurred a clean-up of internal databases and ensured global alignment of all data. Steger also says that the company developed controls for Global Trade Item Number (GTIN) assignment, leading to better supply chain visibility.

GUDID asks inputters to include information like whether or not an instrument or implantable is single-use, whether it uses latex, whether there are human cells in the product, etc. Zimmer Biomet can now direct customers to the GUDID for more information on their products, or even use the database as a type of marketing tool with more than 54,000 devices uploaded to the GUDID.

Steger had previously served as an MRI compatibility expert for Zimmer Biomet, fielding phone calls from providers, payors and even patients seeking to uncover the MRI compatibility of implants. With the GUDID, all of those parties, including patients, can visit the site, plug in implant information and find out if it is compatible with an MRI. There’s an immediate time-savings for a portion of the staff at Zimmer Biomet.

For manufacturers, the database does provide some interesting intelligence on competitor products. You should be able to easily compare notes on MRI compatibility, package sterility and inclusion of human cells or tissue, as well as understand the device description and status. If you’re so inclined, the GUDID provides weekly downloadable data reports that detail each device that has been plugged in to the system.

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.

It’s certainly a sentiment that was echoed by the orthopaedic OEMs I spoke to. Steger believes that many OEMs have not yet realized the full benefit of UDI/GTIN. Most are so concerned with meeting deadlines that they haven’t stepped back to evaluate how internal changes and the collected data can work for them, and there are myriad uses for different divisions within companies of all sizes.

For the supply chain, Steger points out that by placing a unique GTIN on each device in a warehouse, a company could get rid of all part numbers. That could save money on labels. As it currently stands, many OEMs print multi-language labels on their device boxes. With a GTIN, the device could be shipped to a distribution center and then receive a label with only the relevant language and market information. Additionally, such a change would obviate costs associated with large-scale label changes. Distribution centers would use on-demand printing for labels, and changes could be made immediately prior to shipping.

The obstacle to such a system would be adoption by the distribution centers. Adding the task of on-demand printing could disrupt existing shipping schedules and add time to the out-the-door process. Convincing key members of the supply chain and distribution teams to jump on-board with that system could be difficult. That’s why Steger thinks it could still be some time before all OEMs realize the full efficiency offered by UDI compliance.

Labelling has also been a focus for Johnson & Johnson. Rose says the company wanted to utilize GS1’s traceability standards, already in use by Johnson & Johnson’s pharmaceutical division. It was another opportunity for the massive company to align its strategy across all of its business units.

“Internally, we’ve moved to a very consistent format with barcoding,” Rose says. “It’s helped immensely in our distribution centers, because we now have consistent labeling. It’s a source of internal efficiency.”

Tom Jones, Johnson & Johnson’s UDI Program Director, says that the company’s supply chain now has a unique identifier that can identify any products on-hand. By firming the grip on internal efficiency and inventory management, and bringing together a core data grouping, Johnson & Johnson can now grant customers access to the master data, including: MR compatibility, whether or not the device is single-use, the FDA product code, clinically relevant sizes, sterilization requirements and the GMDN.

Ultimately, the true benefit of UDI to the supply chain can only be realized if hospital systems begin utilizing UDI, as well. Industry experts hypothesize that adoption could take five to ten years. Others have suggested that it may never happen without serious incentivization by Centers for Medicare & Medicaid Services. Yet, if adoption can be driven from the manufacturer to the back loading dock of the provider, end-to-end traceability will become a reality—and this could also impact product design.

“We could know what the full lifecycle of the product looks like,” says DePuy Synthes’ Pandiscio. “We can know how different products are performing and can then feed that information back to our development teams, to improve the products we’re putting out for patients.”

To make that leap from simple compliance to improving product development requires advanced data collection. Pandiscio says that’s a tough–to-get-at opportunity, but one with valuable ROI. 

UDI regulations have altered your business. They may have forced some of your products into sterile packaging; you may still be pondering how to handle the direct marking portion of the rule; you may be simply wondering if any of your efforts will make a difference to the overall healthcare system.

Gaining solid ROI from your compliance efforts comes down to internal efficiency, capturing your own master data and learning how to use that data for product development, marketing and logistics. As more hospital systems come online with UDI, the more useful this information will prove to be. Companies like DePuy Synthes and Zimmer Biomet that are attempting to stay ahead of the curve will be able to capitalize on these efforts when the full benefits of UDI become apparent.

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