5 Things We Learned From ‘UDI, Wave One'
By Doug Roe, Chief Editor
Most of the unique device identifier (UDI) wave one rollout is behind Class III med device companies, so what did we learn to avoid getting washed away by waves two and three?
For those who have had the pleasure of hearing Jay Crowley — better known as the godfather of UDI — speak about his baby, there is one reoccurring theme: “UDI is not a project, it is a program.”
Crowley, formerly CDRH’s Senior Advisor at the FDA, explains that UDI “was developed for the adequate identification of medical devices through their distribution and use - the entire product life cycle.” The key word in his definition is program; the program is here to stay.
For some, this necessitates a change in mindset. UDI is not a short-term compliance process with a window to complete. Its reach is expanding, both to additional device classes and, soon, through global regulatory harmonization.
So, how should your company prepare for the next waves of UDI? Crowley, now VP of the Unique Device Identification Practice at USDM Life Science, took some time to discuss with me the lessons med device manufacturers can take from ‘UDI, Wave One:’
Med Device Online (MDO): How has product portfolio management created challenges for companies related to UDI implementation?
Jay Crowley: Our first question we ask a client is, “how many products do you sell?” Nobody can answer that question — nobody. We still have some clients finding Class III products they didn’t know they had. The challenge is not with the UDI rule. The rule is relatively straight forward. The challenge is with how a company organizes itself, its basic infrastructure and systems.
For companies that are relatively small or have not been in business long, UDI implementation is not complicated. As a company gets older, it starts morphing. As it grows, other companies are acquired. With those purchases come new or different enterprise resource planning (ERP), product lifecycle management (PLM), stock keeping units (SKU), and other IT systems — not to mention the growing contract manufacturer supply chain. This is where UDI starts to become a challenge. How much visibility do you have into how many devices you actually manufacture, or who manufactures them for you?
The first step to take is to wrap your arms around all the things you actually make. Then, define which are subject to UDI. This is the really difficult part, so start now.
MDO: What challenges have you found related to FDA product classifications?
Crowley: After you define what exactly you sell, it becomes interesting to ask yourself “how is this device on the market?” Is it a PMA, a 510(k), or is it exempt? What is its product code?
The product may not be distributed the way it was originally approved. When you start digging into distribution, you will find that some things have evolved over the years. Also, with some devices, there isn’t always an independent path to market. Maybe it was part of a combination product. The issue isn’t that anything is wrong with the device, or that anything is illegal, you just need to understand how it got to market.
This and other information is required to submit data to the Global UDI Database (GUDID). There is an Excel spreadsheet on the FDA’s website — GUDID Data Elements — outlining all the information required for a device. Start there and work through what data you have and what you need to locate. Make sure you understand what items are required and what is optional. A good rule-of-thumb is that, if it is on the device label, it should be in the GUDID.
MDO: How are companies interpreting the FDA’s definition of “Labeler”?
Crowley: The typical question is “who is the Labeler?” The UDI rule chose the term “Labeler,” instead of “manufacturer,” which was considered too broad. The Labeler is the entity responsible for UDI requirements.
The confusion at companies arises in the supply chain. Is the Labeler the OEM, contract manufacturer, packager, or distributor? All can play a role in labeling. The existing names on labels may be misinterpreted or incorrect. The key to understanding Labeler is understanding the concept of brand owner. Whose name is associated with the device? Who initiates its commercial distribution in the US?
By following this interpretation, a med device company could have the same product manufactured by multiple suppliers and have the same device identifier associated with them.
Take this opportunity to find all of your contracts and supplier agreements. Understand who is going to do what, when, and where. You need to know these things and be able to line them up going forward for each device. As the Labeler, develop a process to make sure that each of these players will know when a change has been made that affects UDI labeling. Then, any required adjustments will be implemented throughout the entire system.
MDO: What should be understood about barcodes and barcode verifiers?
Crowley: A barcode verifier is not a scanner. It is a machine that judges the quality of a barcode. A quality grade of C or better is required for UDI labels. What that grade means is that, as the package moves through distribution and gets roughed-up or dirty, its barcode will remain “reliably” readable over the product’s lifetime. Many companies are surprised to learn that their current barcodes may not meet the standard. This level of quality will have to be implemented for all UDI-related product labels.
MDO: What other issue has been the most prevalent in the first wave of UDI rollout?
Crowley: Many companies are adding layers of change that are not required by the UDI rule. Some companies are using UDI to drive change in IT infrastructure systems. Others are completely rebranding. Instead of a relatively small label alteration, complete changes are being made. My argument against these approaches is that they can increase the complexity, duration, and cost of execution. Implementing UDI is going to be a challenge for your company, why make it harder?
In summary, ‘UDI, Wave One’ has taught us:
- Define what devices, exactly, your company manufactures, and which are subject to UDI labeling regulations.
- Plot out your device’s exact path to market.
- As the Labeler, you must develop a process ensure compliance among all your suppliers concerning changes that affect UDI labeling.
- Confirm that your barcode quality meets UDI standards.
- Do not implement unnecessary changes.
Look for Part Two of Jay Crowley’s series on UDI wave one challenges, featuring insight on Component vs. Accessory, Convenience Kits, and Single-use Devices.
About Mr. Crowley
Jay Crowley is the VP of the Unique Device Identification Practice at USDM Life Sciences.
Jay was most recently Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for FDA’s Unique Device Identification system.
At USDM Life Sciences, Jay focuses exclusively on providing business process, technology and compliance solutions for the regulated life science industry.
Jay held a variety of positions over his nearly 27 years at FDA, including work with design control regulations to reduce the chance of human errors with medical devices, patient safety and adverse event reporting. Jay also worked in the Office of the Commissioner of FDA, and the Office of Compliance at FDA.