Knowledge Center

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  • Multiple Device Identifier Work Group Report

    March 19, 2019 | Content Areas: Technology | Tags: UDI | Formats: Report/Study

    Read this report on the recommended practices related to the allocation of multiple unique device indicators (UDI-DI) and suggested ways to mitigate the occurrence or negative implication of multiple UDI-DIs.

  • 2018 AHRMM Cost, Quality and Outcomes (CQO) Report on the Clinically Integrated Supply Chain

    August 11, 2018 | Content Areas: Strategic Planning | Tags: CQO | Formats: Report/Study

    The goal of this report is to share best practices, while generating continued dialogue within the AHRMM community and across the broader health care field on clinical integration in the supply chain as a critical component of the CQO Movement. The case studies included in the report provide insights into the evolution of the CQO Movement and create opportunities for you to engage with others across your organization and across the health care field to create leading practices of your own.

  • Business Case for the UDI Work Group Report

    May 03, 2018 | Content Areas: Technology | Tags: UDI | Formats: Report/Study

    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.

  • UDI Guidance Document for Medical Devices Containing HCT/P

    May 03, 2018 | Content Areas: Technology | Tags: UDI | Formats: Report/Study

    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.

  • Low Unit of Measure (LUM) UDI Single Device Work Group Report

    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.

  • Report of the Catalog Number Work Group

    September 20, 2017 | Content Areas: Logistics | Tags: Data Standards, Regulatory, Suppliers, UDI | Formats: Report/Study

    In this report, Catalog Number Work Group provides the value for inclusion of Catalog Number in Global Unique Device Identification Database (GUDID).

  • Report of the GUDID Clinically Relevant Size (CRS) Work Group

    August 31, 2017 | Content Areas: Logistics | Tags: Data Standards, Regulatory, Suppliers, UDI | Formats: Report/Study

    A report from the Clinically Relevant Size Work Group, which was convened to examine the utility of device size data in the FDA GUDID system, provide a framework to facilitate correction of existing device size data in the GUDID, and standardize the accurate capture of device size data for new entries into the GUDID.

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