The FDA has identified the need to actively engage with a coordinated, action-oriented, and early adopter unique device identifier (UDI) community. To answer this call, AHRMM has organized the Learning UDI Community (LUC), a broad-based coalition comprised of health care leaders across sectors whose goal is to develop a common understanding and approach to UDI adoption within the health care setting. Accelerating UDI adoption across the health care field is essential to meeting the call for Cost, Quality, and Outcomes, the Triple Aim, and evidence-based care.
A memorandum of understanding signed by AHRMM and the FDA formally demonstrates both parties' collaborative support of the LUC.
LUC Work Groups
Cross-functional work groups develop progressive practices, proposed solutions, and resources to focus on topics that can accelerate UDI adoption. More work groups will be established as the LUC Community identifies additional topics specific to UDI adoption.
View a summary of each work group’s project scope and charter. Work group progressive practices and resources will be shared below and in the LUC Resource Listing as they are made available.
|Indicates work groups that have completed their deliverables.|
|Indicates work groups who are working on their deliverables.|
The mission of the UDI Impacts on Recall Process Management workgroup is to: 1) define the value to multiple stakeholders (suppliers, providers, patients, etc.) re: the use of UDIs in the recall process; 2) collect information on current level of usage of UDIs in the recall management process, and 3) make recommendations to increase usage of UDIs to maximize value.
To analyze current communication processes and their implications on all stakeholders related to changes to the UDI-DI. Gain a clear understanding how these changes are documented in affected software systems. Identify gaps between current and desired state and develop recommended practices to improve the process for all stakeholders.
Medical supply/device products typically have more than one barcode on the label. This leads to confusion in the care and procedural settings as to which code is the UDI, negatively impacting scanning compliance and with it, the unrealized benefits and efficiencies that scanning has to offer. This work group will collaborate with representatives from the provider and supplier communities to explore potential alignment, including identifying a standard or set of standards on linear/2D barcode placement, logistics for multiple barcodes and visual queuing.
The mission of the Catalog Number work group is to provide the business case and industry value for requiring catalog number in GUDID submissions. In order to use the information in the GUDID, most stakeholders will need to match existing data sets to the GUDID, and manufacturer catalog number is the key data point that has been used historically for identifying product information.
In order for the UDI Program and broader National Evaluation System for Medical Devices in Health IT (NEST) to bring value to the health care enterprise, all parties along the medical device spectrum (manufacturer/labeler through end user) need to be speaking the same language and terminology. This work group should review the pro’s and con’s of GMDN and SNOMED terminologies and review findings of preliminary pilot exercises (RAPID), while also recognizing that additional vocabularies for medical devices, such as UMDNS, UNSPSC, or others, may provide value to GUDID device data and NEST priorities.
The current implantable device list posted at the AccessGUDID website is based upon an FDA product code query of the Global Unique Device Identification database. The query currently returns all devices that are cleared or approved with a product code that classifies the device as implantable. Since product codes are based upon device approval and not device use, the list includes implants and associated medical devices (e.g. instruments) that are together classified as an implant for device approval. This work group is charged with developing a more user-based set of search criteria that would be run against AccessGUDID and return a search result to document implants in health IT – including those working with the automated billing process – and to be shared publicly.
Human cells, tissues, and cellular and tissue-based products (HCT/P) are widely used in health care. Most of these products are regulated as biologics, but some products fall within the scope of medical devices. An identifier is required to allow tracking from recipient to donor and from donor to recipient. FDA regulation uses the term distinct identification code. The distinct identification code needs to be captured at all point in the supply chain in order to allow rapid tracking and recall of all the products derived from the implicated donor. The UDI Final Rule requires that medical devices containing HCT/P carry a production identifier for the distinct identification code. The 2015 Edition Health Information Technology (Health IT) Certification Criteria Final Rule requires that the distinct identification code be parsed from the UDI when a medical device contains an HCT/P. These requirements have the potential to significantly improve the traceability of medical devices containing HCT/P following distribution from the tissue processor. In addition, improvements in the ability of the supply chain to capture donor related identifiers could help to improve biovigilance and support outcome evaluation. However, the stakeholders involved in handling these particular products need to work together to gain the greatest leverage from the UDI regulation.
The Global UDI Data Base (GUDID) is the source of truth for Device Identifiers (DI). As a result of the recent LUC UDI Capture case studies and Data Quality Initiative, supply chain and clinical users of this data have identified products which have been assigned multiple device identifiers. This is introducing challenges for provider systems that would like to import and use data from the GUDID. The goal of this work group is to establish a forum for open dialogue between providers and suppliers, share use case examples, and review established criteria when a new DI should be allowed for a device, and how to manage the original DI record.
While unique product identification is a standard cost management tool for manufacturers and retailers, health care executives juggle many priorities and they need a clear map showing how UDI will reduce expense in hospitals both immediately and in the long term. This work group will develop five important work flow processes as they currently work without UDI and then contrast these to future work flows where UDI is incorporated in hospital information systems and operations. Savings opportunities will be discussed for each step where they are found. The work group will author an article to be published in a journal respected by hospital CEOs and CFOs.
The ultimate goal of this work group is to identify opportunities for case studies, initiate them and bring answers to the greater Learning UDI Community to foster learning and hopefully, shorten the adoption curve for capturing UDI's within health care.
UDI Capture Work Group Case Studies:University of Tennessee Medical Center
This work group will explore cost effective and sustainable solutions around labeling at the lowest unit of measure/unit of use – where technically feasible – devices that meet the UDI final rule’s SUD packaging exception.
FDA Global Unique Device Identification Database (GUDID) compliance currently requires manufacturers to provide unique device identifiers at the “Unit of Use” (UOU). Many products have multiple discrete items contained within the lowest packaging level. In those instances, the requirement is to provide unique device identification for items that are not intended to be labeled in the product. These identifiers will only be found in the GUDID itself. This work group will develop recommendations and guidance addressing the issues existing with Unit of Use.
Unit of Use (UOU) Webcast Series:
- Part One: The FDA UOU Explained Webcast
Talking points and PowerPoint presentation pdf
- Part Two: Clinical Recognition of the UOU Webcast
Talking points and PowerPoint presentation pdf
- Part Three: Potential UOU Examples Webcast
Talking points and PowerPoint presentation pdf
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Additional UDI ResourcesAHRMM LUC Comments to the FDA’s Communications About the Safety of Medical DevicesAHRMM Comment Letter to FDA RE: “Modernizing FDA’s Data Strategy”General UDI and Health Care Data Standards Information BUILD Report on Implementation of UDI for Implantable Devices at the Point of Care Implementation Roadmap for Point of Care Capture of UDI for Implantable Devices (Excerpt from BUILD Report) Gaps, Challenges and Strategies in Point of Care Capture of UDI for Implantable Devices (Excerpt from BUILD Report) FDA AccessGUDID Medical Device Epidemiology Network Initiative (MDEpiNet) Registry Assessment of Peripheral Interventional Devices (RAPID) Initiative FMOLHS-GS1 US Data Standards Master Process Implementation Plan pdf Report of the MDEpiNet AUDI Workgroup pdf
Alternative names (aka) for the DI of UDI used by each issuing agency:GS1 – Global Trade Identification Number (GTIN) pdf HIBCC – Universal Product Number (UPN) pdf ICCBBA – Processor Product Identification Code (PPIC) pdf