When the U.S. Food and Drug Administration (FDA) mandated the use of unique device identification or identifier (UDI), some people voiced concerns over the high cost of the requirement, as well as the technology challenges it posed. What is UDI and why is it important?
The FDA issued the UDI rule in 2013 to establish a system that will identify and track medical devices through distribution and use. The rule, rolled out in phases, requires devices to include a UDI unless it falls under certain exemptions. The labeler must submit product information to the FDA’s Global Unique Device Identification Database (1).
A UDI is a unique numeric or alphanumeric code in human- and machine-readable form. The FDA’s main goal is to reduce medical errors from misidentification of devices and from misunderstanding their use. UDI will make it easier to identify the device, so it should lead to a faster recall if necessary and a more accurate reporting of adverse events.
The industry lauded the UDI rule as an important milestone in promoting device safety. On the flipside, the rule means more stringent and costly requirements for medtech firms, their suppliers, and CROs.
For devices used externally (e.g., CT or MRI machine), a UDI could be easily etched on the item without jeopardizing patient safety, unlike implantable devices (e.g., artificial knee). More complex and high-risk devices that have been approved will require a new 510(k) submission.
Importance of Product Tracking
A good way to look at the UDI system is by comparing it to product tracking in other industries, such as a car’s vehicle identification number (VIN) or a book’s international standard book number (ISBN). Most manufacturers use product tracking software for managing inventories and monitoring purchase orders and product sales.
What’s at stake for medical devices is bigger and more urgent. Tracking down a defective catheter is more serious than monitoring returned hardcover books.
To help ease the implementation burden of the UDI rule, the FDA commissioned the Brookings Institution to create a roadmap for stakeholders, including medtech firms, patients, suppliers, and others (2).
For manufacturers preparing to comply with the rule, the Brookings Institution roadmap could be helpful. Here are the highlights of the report:
Integrate UDIs into provider systems: “Provider systems should automate important safety reporting with UDIs,” according to the report. They should integrate the flow of UDIs across their supply chain, clinical, revenue-cycle management systems to realize the benefits of UDI.
Integrate UDIs into administrative transactions: Among other things, the report recommended including the device identifier portion of the UDI as a situational element at the claim detail level for high-risk, implantable medical devices.
Integrate UDIs into patient-directed tools: The report called for proactive efforts to increase awareness among patients, who should request the UDIs of their medical devices from their providers.
Compliance is a mindset. It’s important for device manufacturers, patients and their advocates, and health-care providers to embrace the UDI system as a necessary part of ensuring device safety and promoting patient welfare. The public has long accepted product tracking for things like cars, books, and hair dryers without resistance; it’s high time we do the same for medical devices.
Cindy Fazzi writes about the life science industry and other regulated environments for MasterControl. She has worked as a journalist in three countries. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York City. She has a master’s degree in journalism from Ohio State University.