The UDI world gets bigger (and more complicated)

Those in charge of UDI compliance for global medical device manufacturers are busy these days, not just because more countries and regions have or plan to publish their UDI regulations, but also as manufacturers try to sort through the myriad similarities and differences between the various regulations. One medical device manufacturer leader told me recently that he fears he will miss something simply given the rate of activity and the complexity of the regulations. This may sound like a manufacturer’s problem, but if you are a hospital or other user of UDI-related data, the complexity and challenges of compliance could have downstream implications for you as well.

The International Medical Device Regulatory Forum (IMDRF) published a framework in 2013 to help regulators around the world develop a globally harmonized approach to UDI. Some of the key recommendations call for:

• A unique device identifier (UDI) at each packaging level using international standards
• Most UDIs to consist of both a device identifier and relevant production data, e.g., lot, serial number, expiry date
• The UDI to appear on the label in machine and human readable format.
• Publication of a recommended list of attributes in a UDI database (UDID)

But even regulators that have or plan to follow the IMDRF guidelines have seemingly simple differences in their regulations (published or draft) that could have significant implications for how a UDI system is implemented and utilized. For example, different regulators may require different global standards, e.g., GS1, HIBCC and/or ICCBBA; which auto id and capture (AIDC) carriers, e.g., linear and 2D matrix barcodes, RFID, etc., must be used and on which products, and which attributes are required and how they must be published in the UDIDs.

So far, only the United States and Europe have published UDI regulations but many more are in the works. Here is just a partial list of what’s coming:

• Brazil: has published a resolution but only for cardiac stents and hip and knee implants.
• China: has published draft regulations.
• India: requires UDI on all licensed devices by January 1, 2022.
• Taiwan: current voluntary program to become mandatory in 2020.
• Saudi Arabia: expected to be similar to Taiwan.
• South Korea: plans to phase in UDI by risk class between 2019 and 2022.
• Turkey: expected to reinstate requirements to support its traceability system soon.

Other parts of the world have also implemented regulations to identify medical devices, but not necessarily UDI regulations, which are primarily designed to improve patient safety and post market surveillance. For example, Japan, Argentina and the United Kingdom all require the use of GS1 standards exclusively to identify medical devices, but there are differences as to the primary purpose. For example, Japan has required Global Trade Item Numbers on all reimbursable products for nearly two decades. The U.K. requirements are primarily for procurement purposes, although the Department of Health has also funded the Scan4Safety program at select NHS trusts to use GS1 barcodes for traceability. Argentina’s program, meanwhile, only focuses on implants, primarily for traceability.

Why does the global complexity matter to region or country specific hospitals? Here are just a few examples of the potential downstream implications.

Labelling — Different requirements for different regions could force manufacturers to create inventory that can only be used in specific regions. This could make it difficult to use those products in different regions in the event of shortages, such as those experienced as the result of natural disasters.

Auto ID and capture (AIDC) carrier — Which AIDC carrier a manufacturer uses could impact the ability of healthcare providers to scan the barcodes. For example, many manufacturers prefer the 2D data matrix barcode because it can hold more information in a smaller space but it requires use of specific scanners that must be held much more closely than when reading linear barcodes.

Database attributes differences — Different UDIDs around the world sometimes require different product attributes, but even when they are the same, the way manufacturers need to publish the data could be different. For example, both the US and Turkey require information on MRI compatibility, but FDA requires specific values (safe, unsafe, conditional), while Turkey simply asks yes or no.

Direct marking — Both the U.S. and Europe require UDIs to be directly marked on reusable devices but the U.S. requirement is limited to devices that must be reprocessed between uses and allows either text or a barcode. Europe, on the other hand, mandates a 2D matrix. Also, while the technology exists to direct mark extremely small medical devices, the capability may not be readily available to read the marks.

Perhaps the most significant impact of the variation could be on the ability to garner real world evidence on the performance of medical devices in routine clinical practice. Both the U.S. and Europe have requirements for healthcare providers to capture UDIs on implantable devices in electronic health records. When data is harmonized, it can help us identify adverse events associated with the same device more quickly because data would be available from more data sources. The same is true as we are trying to understand which devices perform better or worse for specific populations of patients, e.g., those with similar co-morbidities. Harmonization of attributes are also important because sometimes we want to understand which product characteristics, vs. which devices, are associated with better or worse outcomes. This information can help inform future product development and regulatory decisions. The IMDRF hopes to finalize a guide by the end of the year to harmonize how UDI regulations are implemented which could address some of these issues.