A recent post on AAMIBlog asked the question, “Will Unique Device Identifiers Live Up to the Hype?” As a self-proclaimed UDI enthusiast, I would argue that, while the UDI program isn’t perfect, it is a giant step in a long-awaited and much-needed direction. I do think it will live up to the hype.
First allow me to clarify that the term “UDI” has two meanings: “unique device identifier” and “unique device identification.”
A unique device identifier is a tool used to mark and identify medical devices within the healthcare supply chain. It is a number assigned by the device manufacturer to each version or model of a device and needs to be in both human readable format and AIDC (i.e., barcode) format.
Unique device identification is a system to adequately identify medical devices through their distribution and use. This system consists of rules for assigning UDI (the tool), the data elements associated with the UDI (the tool), and requirements for the database to contain and control the associated data.
The benefits of UDI noted in the FDA’s Medical Device Safety Action Plan are not predictions. They are statements of what UDI—as a tool—is intended to provide, including mechanisms for:
- Standard and clear ways to document device use.
- More accurate reporting, reviewing, and analyzing of adverse event reports.
- Reducing medical errors.
- Preventing confusion between similar devices.
- Effective management of device recalls.
Medical device manufacturers (MDMs) are required by law (the FDA Regulation) to meet the requirements of UDI—both the tool and the system. This is not a choice for MDMs. It is the new reality.
So, what is the impact of this new reality for healthcare professionals?
By requiring the UDI to contain both the human-readable and AIDC formats, it is hoped that healthcare technology management professionals and other healthcare professionals will realize the efficiency and accuracy of the barcode functionality by scanning the UDI rather than keying in the UDI. Failure to do so should not reflect negatively on the effectivity and performance of the unique device identification program.
The UDI, whether on the label or the device itself, contains data representing the manufacturer and the device. It may also contain lot number, expiration date, serial number, or date of manufacture. That is all the information the UDI provides. UDIs provide information—they are not intended to be a replacement for decision-making or critical-thinking skills.
It’s important to note that UDI is a passive tool. It does not send any data for the user to “receive.” Any information beyond the data embedded in the UDI must be accessed in the publicly accessible AccessGUDID portal. Not all data provided by MDMs are available to the public.
It is true that data limitations are database-related. Of the 62 data elements identified in the FDA UDI regulation (the EU MDR specified 25 data elements), 18 are required and 24 are conditionally required. The remaining 20 data elements may not be applicable to a medical device, so it is reasonable that there may be blanks or fields displaying as “not available.”
And with all databases, junk data in equals junk data out.
Through the GUDID Data Quality Initiative, the FDA is focusing its UDI resources on optimizing the quality and utility of UDI data, and it is committed to working with industry to ensure widespread use and sustainability of the UDI system. In support of this initiative, the FDA is releasing enhancements to GUDID that will improve the quality of the data submitted in order to improve the confidence of healthcare professionals in the accuracy and completeness of the data.
These improvements are not going to happen overnight. It has already taken eight years for the idea of UDI to become a regulation, and another seven years for the regulation to be implemented. In four years, nearly 1.8 million records have been collected in GUDID from over 4,300 labelers around the world distributing their products in the U.S. Now we are in the use phase, which will be followed by the results phase.
UDI as a system or process will only work as intended—and realize its “hyped” benefits—when it is implemented and used by all stakeholders. Responsibility for the success of UDI falls on all those stakeholders: from MDMs entering quality data to distributors, supply chain partners using UDI for product identification, healthcare organizations integrating UDI into electronic health records, and finally the accessibility of information provided to patients.
Several organizations are working to make UDI a success through communication, collaboration, training, and support. These include the AHRMM Learning UDI Community, the MDEpiNet Public Private Partnership (working to build roadmaps for adoption), AAMI, GS1, HL7, IEE, IHE, NCPDP, and ASC X12 (writing standards and providing training opportunities), as well as the software vendors, certified EHR vendors, registry vendors, and supply-chain aggregators who are working with early adopters to implement UDI solutions.
Will UDIs live up to the hype? I say yes, eventually—but only when healthcare organizations develop the practices and systems necessary to utilize them to improve the efficiency and quality of the care they provide. The identifiers perform as expected. The success of the unique device identification process, which is dependent on utilization by all stakeholders, continues to evolve.
Lena Cordie is president of Qualitas Professional Services in Victoria, MN.
Cordie will hold a webinar on this topic on July 31: The Benefits of UDI for Healthcare Technology Management.