Learning UDI Community Resources
The Learning UDI Community (LUC) focuses on developing common understanding and approach to UDI adoption for supply chain and clinical care through progressive practices, proposed solutions, and resources. In addition to the work group progressive practices, AHRMM will share applicable resources through the Learning UDI Resource listing.
Check back soon for LUC progressive practices and resources published by work groups. Learn more about the LUC.
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AHRMM’s Learning UDI Community (LUC) is a health care collaborative effort, in collaboration with the U.S. Food and Drug Administration’s Center for Devices and Radiological Health, established to address issues impacting the adoption and implementation of the Unique Device Identifier by developing a common understanding and approach within the health care setting. LUC work groups are comprised of a diverse group of health care supply chain professionals, who work together to develop progressive practices, proposed solutions, and resources to focus on topics that can accelerate UDI adoption. This document is a comprehensive listing of LUC resources and deliverables developed by the LUC work groups and includes best recommended practices, case studies, and power point content templates, with the goal of promoting and accelerating UDI adoption.
The Critical Link Between Cost, Quality, and Outcomes (CQO) and Unique Device Identification (UDI) White PaperJuly 04, 2018 | Content Areas: Technology | Tags: CQO, Data Standards, Regulatory, UDI | Formats: White Paper
In an effort to capture broader insights on UDI adoption from across the health care field, AHRMM, with participation by the FDA, held LUC Data Quality Workshops during four conferences in 2017. During these workshops, conference attendees had the opportunity to voice their opinions on the state of UDI data quality, hurdles to UDI adoption and what recommended practices are necessary for providers and suppliers to effectively capture the UDI and use it in meaningful ways.
A clear message has emerged from health care stakeholders – the only way to drive greater UDI adoption across the health care field is for the individuals and groups engaged in UDI efforts to collaborate, share their experiences, and learn from each other. In this paper, we leverage these collective insights to present challenges faced by providers and manufacturers today with regards to UDI adoption, and highlight potential solutions that have emerged from the work of the LUC and other health care participants.
With significant pressures on hospitals and healthcare systems, it is incumbent upon those who recognize the benefits of UDI to build the business case for UDI adoption in the healthcare delivery environment. As the one discipline that works with operational, clinical, financial and technical leaders, supply chain professionals can help build the business case that documents value for multiple stakeholders.
Download the Business Case for UDI work group presentation and share it with your organization and other stakeholders. By identifying current and future workflows around key hospital processes, the workgroup has provided insights that can help identify areas of investment necessary and corresponding benefits. Healthcare systems can take the current state workflows and adjust them as necessary to match their specific processes and also make any necessary adjustments to the future state to align with their vision for UDI adoption.
The report from the Business Case for the UDI work group, a formal work group of AHRMM's Learning UDI Community (LUC) is intended to close the knowledge gap between the current realities of supply chain workflow processes, and offer a vision for how UDI adoption will allow for a smoothly functioning supply chain based upon reliable product information. The report addresses five process flows that could potentially change following healthcare organizations’ adoption of the UDI. Descriptions of workflow processes highlight the redundancies in today’s environment and where changes using UDI will lead to streamlined future operations and potential savings opportunities. The report also contains recommendations on what hospitals need to do to effectively adopt UDI and incorporate it into ongoing clinical and supply chain operations.
Human cells, tissues, or cellular or tissue-based products (HCT/Ps) are a precious resource often provided by deceased donors and/or acutely grieving family members. Living donors also provide HCT/Ps that can improve and save lives of recipients in need. Tissue banks, eye banks and cellular therapy laboratories handle these products of human origin with care and respect, understanding the special gift of donation. It is important this care and respect is followed from the time of donation and recovery to the moment of implant, transplant, infusion, or transfer to a human recipient. This guidance document, developed by a work group of the AHRMM Learning UDI Community (LUC) provides information on HCT/Ps, HCT/Ps regulation as a medical device, traceability of HCT/Ps, and the U.S. Food and Drug Administration (FDA) Unique Device Identification (UDI) Rule and its effects on HCT/Ps regulated as a medical device.
The FDA announcement of GUDID Release 2.2 explains the details of the enhancements aimed at reducing the burden on manufacturers wishing to corrections or improvements to GUDID. At the same time, FDA UDI Team has also enhanced AccessGUDID, providing users with more transparency on the updates to each DI record.
February 25, 2018 | Content Areas: Logistics | Tags: Data Standards, Regulatory, Suppliers, UDI | Formats: Report/Study
The goal of this document is to provide a guide for supply chain partners to begin a dialogue to ensure that medical devices comply with FDA’s Unique Device Identification (UDI) requirements as well as meet the FDA’s goal of enhancing patient safety. Low Unit of Measure (LUM) programs are complex and the steps outlined in this best practices document are a critical first step. We expect this to be an ongoing process as additional opportunities for stakeholder collaboration continue to arise.