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Call it a forever project, program, capability—unique device identification (UDI) is gaining adoption globally and cementing its role as a normal business practice for orthopaedic companies. In theory, the ability to track a device throughout its lifecycle seems smart and necessary. In execution, the requirement of UDI has led to layers of regulatory decoding, data collection and dissemination, additional costs and moments of confusion, annoyance and disapproval.
The U.S. is the largest orthopaedic device market and, therefore, the rollout of UDI systems worldwide will be on a smaller scale in other geographic regions. But once you decipher, understand and execute on different countries’ regulations, you’ll realize that it is a mammoth undertaking. With the EU and other Middle Eastern and Asian countries preparing to require UDI, experts say that now is the time to take a step back and examine your compliance process—specifically, your data.
In December 2013, the International Medical Device Regulators Forum (IMDRF) issued its final UDI guidance. Most countries have used this 19-page document as the foundation for their regulation, so similarities exist from country to country.
“The one area that naturally will have to differ is the data,” says Jay Crowley, OMTEC® 2018 speaker and Vice President & Practice Lead of Unique Device Identification Services and Solutions at USDM Life Sciences, as well as the architect of FDA’s system. “Different countries regulate devices differently. They have different data needs.”
For example, FDA’s Global UDI Database (GUDID) requires companies to enter information on sterilization methods and packaging type, while EU’s European Database on Medical Devices (EUDAMED) doesn’t require either of these product attributes.
Crowley chaired the MDR&IVDR EU Conference 2017, and during his presentation on UDI pointed out multiple aspects about data that are important to consider as UDI expands globally.
There’s A Lot of Data
Think about the number of devices your company launches and modifies in a year. Now, in how many countries is that product on the market? Even just considering countries with UDI regulations, or on the brink of regulations, the data adds up fast.
“If I make a change to a device, that [change] has to come back into my data and then populate back out again to all those places where you keep and manage that data. This becomes a data management challenge,” Crowley says. “We talk about tools and processes that you might have to look at in order to really manage your UDI data efficiently and effectively. A lot of people manage UDI requirements in a spreadsheet—big companies and big spreadsheets. A lot of manual data entry. It’s just not sustainable. You can’t do that. The data becomes too big, too broad and needs to be managed in a very precise way. This is regulatory data. It needs to be correct.”
Deeper Reach
FDA established its UDI system to identify medical devices throughout their distribution and use. Other regions and countries are taking a broader approach. For instance, the EU expects benefits of UDI to include traceability of devices and improvement of purchasing, waste disposal policies and stock-management by health institutions.
“A lot of these countries are looking to solve other problems at the same time, whether that’s a traceability requirement, a cost or reimbursement issue, import control,” Crowley says. “When you look at Saudi Arabia, for example, we start to get into import control applications, ‘I want to know what your product is, and I want to know all of the players associated with it before I let your product on the market.’ All of the data has to be tied together. So it’s not just a premarket concept, but a registration and listing concept all tied together so that regulators have complete visibility into your products.”
Overnight Launch
FDA released UDI draft guidance more than five years ago and the regulation still isn’t completely rolled out. Smaller countries are taking a shorter approach to implementation.
“The interesting part about these other regulatory regions is that when it comes, it comes fast,” Crowley says of UDI. “In the U.S. we talked about this for a decade; we had a draft rule; we had a final rule; implementation. Europe, the same thing—we’ve been talking about this for a while, and we have [compliance in] 2020 [and then] phased in. You go to Korea or Taiwan and there isn’t this long implementation timeframe. You need to be ready with a good, solid infrastructure in place and good visibility into your products and data in order to respond to these requirements.”
What does all of this mean? You need a solid and ideally single- source system for tracking your product development and postmarket information. An organized system, of course, is only successful if well managed by people.
Jonathan Bretz, President of RSQM Associates LLC, spoke after Crowley at the MDR conference. Hearing him speak was a reminder of the words he wrote in BONEZONE four years ago when he was warning industry to prepare a well-thought-out game plan that involves cross-functional teams (IT, regulatory, manufacturing/packaging, purchasing/supply chain and sales/marketing) and owners of crucial decisions and timelines.
“Creating a playbook or strategic plan is an absolutely necessary step,” Bretz wrote. “Without one, your hope of ever successfully implementing UDI requirements will be severely reduced.”
A major component of the playbook, Bretz wrote, is to acquire missing data attributes and create a data management process. That should include: “Develop protocol for obtaining missing attributes; determine who is responsible for amassing the information; determine who is responsible for managing the collected information.”
It’s likely that you’re already taking the steps that Bretz outlined. If you are, ask yourself this: Is my process scalable? As UDI requirements expand, what gaps do you anticipate in your data collection? How will your tracking infrastructure need to change? What would happen to your process if a crucial member of the team leaves the company or transitions to a new position?
“I encourage you to take this time to take half a step back, look at what you’ve done, why you’ve done it and decide if it’s really the most robust, defensible way to go,” Crowley says. “Go through and develop criteria, go through and put things into one bucket or another with rationale to support your decision.”
