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The importance of the device label to a global UDI system

Posted 30 March 2021 | By Terrie Reed, MS; Dennis Black; Rich Kucera; and Shivum Bharill  | PDF Link PDF | ©

The importance of the device label to a global UDI system

Variance between medical device regulations in different jurisdictions complicates creation of a global unique device identification (UDI) system, causing compliance barriers for manufacturers and adoption barriers for device users. As regulatory agencies advance their UDI initiatives, we reflect on the principles guiding this system not only for regulatory purposes, but as essential to improving the value of healthcare supply chain, clinical, and research data. This article outlines the parameters for recommitment to the vision – including standardization of labeling requirements, coordination across key stakeholders, and end-user engagement – as a way to advance collaborative dialogue among stakeholders.
 
Introduction
A medical device label, like a label on other commercial products, offers an opportunity for manufacturers to directly communicate encoded and human readable information to those who buy and use their products. There have been multiple efforts over the past decade to harmonize global medical device labeling regulations. The International Medical Device Regulators Forum (IMDRF), a voluntary group of medical device regulators from around the world, has played a key role in harmonizing the regulations by convening three cross-jurisdiction workgroups and producing five documents since 2013 to promote more consistency in global labeling requirements.1
 
Among the most ambitious has been defining a global UDI system that would unambiguously identify a device through distribution and use. Rather than waiting for each jurisdiction to individually define the regulatory requirements of a UDI system, IMDRF proactively established the foundation in 2011 to facilitate a globally harmonized system that could be applied as each jurisdiction rolled out its portion of the system. According to the original UDI guidance, the fundamental elements include:
 
  • Developing a standardized system of UDIs;
  • Placing UDIs in human- and machine-readable formats on package labels or the device;
  • Submitting core UDI data elements to a unique device identifier database (UDID); and
  • Setting up “transitional and implementation arrangements” to ensure smooth implementation of the UDI system.2
 
The final rule on the UDI system was implemented in 2013 as part of US Food and Drug Administration (FDA) regulations for safety and surveillance purposes, and since then, UDI has grown in scope and has evolved and been integrated into the US and global medical product landscape.3 Healthcare providers, distributors, group purchasing organizations, payors, researchers, and others are beginning to use UDI for supply chain efficiency, tracking medical devices in the electronic health record, track and trace, comparative effectiveness research, electronic procurement, and a multitude of other purposes.
 
The Association for Health Care Resource & Materials Management’s Learning UDI Community (LUC)4 houses a public repository of white papers documenting the work of 13 cross-stakeholder groups. The topics include, but are not limited to, the positive impact of UDI on recalls, the use of UDI to identify high-risk implants in patient records, and UDI benefits to healthcare supply chain processes. The accomplishments of the LUC illustrate the importance of collaboration between regulators, health systems, and manufacturers to better understand the UDI system from different perspectives and to work together to reduce variation and increase harmonization as a prerequisite to adoption of the system.
 
Multiple jurisdictions have released, or are in the process of considering, UDI system implementations. The European Union has published the EU Medical Device Regulations.5 China, Saudi Arabia, and South Korea have also published reguations,6-8 with similar regulatory requirements being considered in Australia, Canada, and other jurisdictions. In addition to jurisdiction regulations, private and state-owned health systems and ministries of health have set up market requirements for the adoption of UDI in their healthcare system data. To date, the UDI format remains tightly linked to original UDI system guiding principles, but significant variance is being introduced in the specifications of jurisdiction-specific UDIDs and health system requirements.
 
UDIDs and health systems are creating broadly similar, but slightly differing, representations and definitions of the same data elements, variances in data constraints (e.g., optional vs. required fields), and additions of new data elements or removal of agreed upon data elements without global partner consensus. These variances unnecessarily increase compliance complexity for manufacturers that have to submit different data to each jurisdiction and meet the requests of individual health ministries. Variances also reduce the ability to compile master standard device data into a single global repository that would allow evaluations of comparable items from the UDI systems of multiple jurisdictions.
 
These variances are barriers to standards-based UDI adoption in healthcare systems and will affect the value of real-world device data for the regulatory bodies that are creating UDI systems. Evidence of these barriers to UDI adoption is currently manifested in the US as healthcare systems struggle to address UDI scan failures and data quality issues with the US public portal, AccessGUDID (global unique device identification database), that houses FDA UDID information.9 Technical solutions matching healthcare data to AccessGUDID are available. Some healthcare systems are creating their own proprietary sources of truth associated with UDI – using some aspects of AccessGUDID but supplementing it with proprietary data to fill gaps in public data. Others are using more sophisticated methods, such as artificial intelligence, optical character recognition, and machine learning, to retain public data sources as the source of truth. All health systems and their vendors and the overall success and sustainability of a global UDI system depend on clear identification, recognition, and resolution of data inconsistencies across the public UDIDs governed by regulatory jurisdictions.
 
This article outlines the potential for reducing cross-jurisdiction variance as the global UDI system grows by aiming for a vision of a global medical device data repository (GMDDR), not housed by any one jurisdiction, but created by pulling data from each of the UDIDs into one publicly available source managed by a trusted entity. Although it would be ideal if UDI data could be submitted into a single database and used globally, data rights may vary by jurisdiction and some products may have different requirements in different countries. However, at a minimum, we suggest that agreement on a minimum core set of data available from public UDIDs offers the opportunity for a GMDDR that could be supplemented with country-specific attributes (Figure 1). Again, creation of this master data source would benefit from following guiding UDI system principles that rely on collaboration across jurisdictions. This master data source could not only be used as a global reference for device data but improved over time by offering a connection or way of matching operational, non-UDI regulatory and health system data to harmonized regulatory UDI data.
 
Reed_Figure-1-(1).png
 
Labeling and the label
The label is defined as “written, printed, or graphic information either appearing on a medical device itself, or on the packaging of each unit, or on the packaging of multiple devices.”10 Figure 2 depicts labeling as including the information contained on the label as well as instructions for use and other information.
 
Reed_Figure-2-(2).png
 
IMDRF highlights the general importance of labeling to meet ISO 13485 medical device quality management system and patient safety requirements and the need, across jurisdictions, to define principles for creating and maintaining labeling.12 Labeling requirements consider what specific information should be associated with the device label, including the UDI, which is a key component of the label.
 
The IMDRF’s guidance on the UDI of medical devices (N7) established the principles requiring manufacturers not only to apply UDIs to device labels, but to populate public-facing databases (UDIDs) with required data fields about the device – attributes such as the manufacturer, brand, description, size, model, and key safety information not previously available in other public data sources.2 The device identifier of the UDI (UDI-DI), the part of the UDI associated with the specific manufacturer and model/version of a device, is the key to unlocking more data about that device in the UDID. The production identifier, or UDI-PI, is not stored in the UDID but represents the part of the UDI that contains at least one of the following: lot number, serial number, expiration date, manufacturer date, and/or distinct identification code. Figure 3 shows an example of the UDI-DI and UDI-PI depicted in the UDI system application guide (N48).13 The application guide, as well as accompanying documents on the system requirements for use of UDI in healthcare (N54)14 and use of UDI data elements across different IMDRF jurisdictions (N53),15 were all intended to reinforce the initial UDI guidance and include experiences and lessons learned from initial UDI implementation in the US and other early regulatory adopters.
 
Reed_Figure-3-(1).png
 
Figure 4 offers a more realistic UDI representation as it would appear on specific product label along with other important information the manufacturer communicates to its device users, for example, reference numbers and prescription and sterility information. Improvements to the data in the UDI system rely on matching the UDI and the information on device labels to structured data stored in UDIDs and to converging data in the UDIDs into common representations of the same concepts – a common data model.
 
Reed_Figure-4-(1).png
 
Addressing global UDI system data challenges
Despite global efforts to harmonize on UDI as part of a device label, jurisdictions such as the US, EU, Australia, China, South Korea, and Saudi Arabia are each establishing jurisdiction-specific requirements. This divergence is resulting in the development of siloed UDIDs containing an ever-increasing number of broadly similar, but slightly different, data attributes associated with the UDI-DI. This regulatory, and sometimes health system, variability misses the point of the UDI as a global system for clearly and accurately identifying a device through distribution and use.
 
Even in this relatively early implementation stage involving only a few jurisdictions, manufacturers and healthcare systems are expressing concern over a system that seems to be diverging from its original goals. For example, in the EU, manufacturers are required to assign and submit a European Medical Device Nomenclature code and description to their UDI-DI and basic UDI-DI entry in the European Database on Medical Devices (EUDAMED).16 However, in the US, they are required to assign and submit a Global Medical Device Nomenclature code and select an FDA equivalent term in AccessGUDID. This adds to the number of standard nomenclature codes manufacturers must use to group devices into categories and requires mapping by those consolidating data from the EU and US for clinical or research use.
 
Likewise, the US established a small set of size dimensions for entry in AccessGUDID, and the EU has identified a separate set of size dimensions. Efforts to standardize these dimensions for current and future jurisdictions would reduce variability and increase the value of each separate UDID to support global harmonization. Manufacturers are encumbered by keeping track of different regulations in each jurisdiction, reducing their ability to maintain and track data quality across jurisdictions. Meanwhile, device consumers are eager to use UDI to improve supply chain transparency, support health data interoperability, and improve patient safety with standard data feeds to registries but have no single source of truth to reference when they want to clearly identify a device in all global markets.
 
One way to reduce variance is by recognizing and enforcing the device label as a source of standard information to populate global UDIDs. Although there is no current standard device label format, manufacturers spend significant regulatory and commercial effort ensuring their labels are conveying complete and accurate information to the device user and meeting basic regulatory requirements. Changes to the label often result in regulatory and commercial actions. In the US, the FDA Data Element Reference Table (DERT)17 contains data entry guidelines for manufacturers to submit data elements to AccessGUDID. The DERT instructs manufacturers to enter the UDI-DI, the model, the size, and the description and other information as they appear “on the device label.” Despite these guidelines, there are often disparities between the information on the label and the same information in an AccessGUDID record.
 
As an example, sizes are placed on a label to assist in device selection and purchasing. However, size is an optional field in AccessGUDID and therefore is not consistently populated by manufacturers, resulting in gaps between what is on the label and what is in AccessGUDID. Manufacturers and regulators should consider the importance of standardizing device labels and enforcing a match between what is on the label and what is in the UDIDs to ensure consistency between how information appears on the label and how it appears to users in each public UDID.
 
UDID systems contain attributes beyond those on the label, such as text in device labeling, device clearance, or approval information. These elements, too, could be more consistent across jurisdictions. General principles, as outlined in IMDRF documents, are not sufficient to drive label and UDI data requirements. Jurisdictions, manufacturers, and device users will all benefit from efforts that increase the consistency of representations of the UDI, the information in UDIDs, the text information on the label, and key information in device labeling. It will also improve the overall quality of UDI data and, ultimately, the value of UDI for achieving the patient safety and economic benefits expected with its use. Continued variation in label and UDI data requirements will necessitate country-specific labeling and UDID data reconciliation that may increase device costs and hinder the use of UDI device performance comparisons and patient outcomes monitoring – a key public health goal of the UDI system.
 
Based on our regulatory and healthcare experience, we suggest the following might help reduce variability and complexity of global UDI regulations and increase the value of the device label as a communication and verification tool of device integrity:
  • Regulators could better coordinate requirements across jurisdictions to increase standardization of device labels by reconvening the IMDRF UDI workgroup. Countries that have implemented UDI and those that will do so soon may be best positioned to lead that coordination.
  • Public-private partnerships could be initiated across stakeholders that value the importance of the label and the potential for UDI to unify information on the label with electronic health information. Standards development organizations concerned with the standardization of symbols, labels, and device attributes associated with the label could be included In those partnership activities.
  • Jurisdictions could contribute to label standardization efforts through incentives and/or enforcement efforts that would ensure data in UDIDs match the contents of the label as much as possible. The FDA does not yet identify the specific elements required on a device label but, per UDI guidance, does express preference that label attributes match what is submitted by manufacturers to AccessGUDID. To validate that manufacturers are matching label data to UDID submissions and to increase the transparency of label information, jurisdictions, including the FDA, could create label repositories where the UDI-DI record in a UDID would include a sample label specification, as is done with medications in the US DailyMed database.18
  • Global users of the UDI system could be encouraged to provide ongoing feedback to the UDI system, especially with regard to scanning issues and variability in public UDID data. A prerequisite for this action and a future GMDDR is for all jurisdictions to make at least a core set of the data in UDIDs publicly available. The US has offered the data in AccessGUDID as a public good and provided multiple means of public access. The EU has committed to providing similar access to the data in the UDI module of EUDAMED.17 However, not all jurisdictions implementing UDI systems have committed to publishing their UDI data. Efforts to harmonize and allow UDI users to provide feedback on real-world experience with the data would be greatly enhanced if all jurisdiction requirements and UDID data were made publicly available to support continuously improving the global UDI system. In addition, the publication by each jurisdiction of its UDID information could ultimately result in better harmonization and convergence toward a single global repository of device data to support global healthcare efforts.
 
Summary and conclusions
Millions of dollars and hundreds of hours have been spent by the FDA and across the US device industry to create the US UDI system, AccessGUDID, that currently includes UDI appearing on the label of most medical devices and nearly 3 million records. In addition, regulatory requirements and health IT standards are in place to support UDI adoption by the US health system. Challenges in the quality of AccessGUDID are being addressed by health systems and their IT vendors, but even those solutions can include sources of variance from public UDIDs.
 
As the EU and other jurisdictions plan and execute their UDI regulations, the entire UDI system and all those using it would benefit if jurisdictions were to ensure that the UDI and data in the UDIDs matched information on the device label and additional UDID metadata were represented as consistently as possible across jurisdictions, especially for a core set of commonly used and important device identification data elements. These efforts would significantly decrease the complexity of the system, reducing the burden on manufacturers, regulators, and device users. If manufacturers and regulators use the label as a consistent point of reference for populating UDIDs, the variability between existing and new UDI systems would decrease and the resulting UDID data could be used to standardize the labels, as has been accomplished for other medical products and foods.
 
In addition, using the label to populate each UDID will increase the consistency of data elements and the likelihood of a future GMDDR built by matching up all UDI-DIs and associated data across all public jurisdiction UDIDs. It is only when such a repository exists and contains data that is consistent with device label and labeling information and is available to all global users, that the benefits of a global UDI system will be sustainable and constantly improving for the betterment of the global healthcare system.
 
Abbreviations
DERT, [US FDA] Data Elements Reference Table; EUDAMED, European Database on Medical Devices; GMDDR, global medical device data repository [concept only]; IMDRF, International Medical Device Regulators Forum; ISO, International Organization for Standardization; LUC, Learning UDI Community; UDI, unique device identifier; UDID, unique device identification database; UDI-DI, device identifier of unique device identifier; UDI-PI, production identifier of unique device identifier.
 
About the authors
Terrie Reed, MS, is director of partner relationships at Symmetric Health Solutions, where she advances the original vision of the UDI system. She was formerly with the FDA, where she was associate director of informatics at the Center for Devices and Radiological Health and a senior advisor for UDI adoption. Reed led the FDA cross-disciplinary UDI team that established the initial UDI regulatory policy. In addition to supporting individual health systems, Reed participates in multiple public private partnerships supporting patient safety and improved patient outcomes. Reed has a master of science degree in industrial engineering from the University of Illinois, Urbana-Champaign. She can be contacted at terrie.reed@symmetrichs.com.
 
Dennis Black, BBA, is the UDI program director at Becton Dickinson & Co, focusing on implementing UDI regulations in the US and globally. He presently serves on the GS1 Healthcare Global Leadership Team, the GS1 US Executive Leadership Committee, and the board of directors for the Strategic Marketplace Initiative. He is also involved in multiple work groups focused on UDI adoption and execution. Black has a bachelor’s degree in business administration from Eastern Michigan University. He can be contacted at dennis_black@bd.com.
 
Rich Kucera, BS, BBA, is the CEO and a co-founder of Symmetric Health Solutions. He has a Lean Six Sigma green belt certification and experience leading several business-transformation and analytics teams at US hospitals as a manager in Accenture’s health and public services practice. Kucera has a bachelor of science degree in physics and business administration from Carnegie Mellon University, Pittsburgh. He can be contacted at rich.kucera@symmetrichs.com.
 
Shivum Bharill, BA, is a manager at Symmetric Health Solutions, where his responsibilities include educating healthcare professionals about UDI, federal policies, and global regulatory changes. He also participates in the HL7 Patient Empowerment Workgroup and is investigating ways to improve the device implant recall notification process for patients. Beyond public health data pertaining to medical devices and pharmaceuticals, Bharill’s academic interests include the Affordable Care Act, telehealth law and competition policy. He previously worked in digital therapeutics. Bharill has a bachelor of arts degree in political economy from Georgetown University, Washington DC. He can be contacted at shivum.bharill@symmetrichs.com.

Citation Reed T et al. The importance of the device label to a global UDI system. Regulatory Focus. March 2021. Regulatory Affairs Professionals Society.
 
References
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