The AHRMM LUC members submitted public comments and recommendations at the FDA's November 2020 meeting related to the need to include the UDI in the recall process. They highlighted the prototype recall database and electronic submission form, as well as survey data supporting its creation.
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Jan 19, 2021
Jan 11, 2021
Building UDI into Longitudinal Data for Medical Device Evaluation (BUILD) Point of Care Capture of UDI for Implantable Devices final summary report and roadmap.
Jul 24, 2020
In September 2019, FDA announced its Technology Modernization Action Plan (TMAP). The TMAP describes important near-term actions that FDA is taking to modernize use of technology—computer hardware, software, data and analytics—to advance FDA’s public health mission. The TMAP will provide a foundation for developing a more fluid, agile, and efficient FDA that is scaled to respond to novel technologies and a rapidly increasing workload.
Mar 31, 2020
The Unique Device Identifier (UDI) is comprised of 2 segments: UDI-DI (device identifier) – which identifies the make and model of the device PI (production identifier) – which includes lot, serial number and expiration date At a minimum, your Item Master should include:
Feb 20, 2020
Karen Conway, Vice President, Healthcare Value at GHX and Mike Schiller, Senior Director of Supply Chain at AHRMM discuss the value of UDI beyond regulations highlighting recall management and how manufacturers can help. Also available as a podcast.
Nov 3, 2019
The rapid advancement of barcode scanning and RFID technologies coupled with improved interoperability has enabled a new level of data analytics that will impact the entire health care field. This webinar focuses on how automated capture of the UDI serves as the basis for improving current operations and predicting which devices will be the most effective.
Oct 23, 2019
Lana Makhanik and Peter Fiorentino discuss discus why Beth Israel Deaconess Medical Center is breathing easier after they overhauled their inventory management system using UHF RFID technology. Peter explains why they chose RFID, the success and benefits they have achieved, and lessons learned.
Oct 22, 2019
Management of inventory turns, reducing waste due to product expiration, and reducing annual audit shortfalls are all possible thanks to the UDI barcode. In this first webinar of a three-part series, leading field experts focus on the immense benefits of using scanning technology to document medical device usage.
Oct 22, 2019
In this informational session, Karen Conway discusses her research with the FDA on value and the UDI. Mike Schiller joins the conversation by adding the actions AHRMM is taking with the Learning UDI Community to identify adoption practices and move beyond compliance.
Oct 22, 2019
Management of inventory turns, reducing waste due to product expiration, and reducing inventory reconciliation adjustments are all possible thanks to the UDI barcode. In this webinar, leading experts discuss best practices for data capture and the approaches that achieve the best outcomes based on potential use case scenarios.
Oct 21, 2019
In this short video, explore what UDI is, why you should capture UDI through barcode scanning, and how to unlock the many benefits of UDI.
Apr 10, 2019
AHRMM has compiled a list of health care organizations utilizing the UDI or planning to implement UDI adoption within the next 12 months. Download the UDI Adoption Reference List and connect with other health care leaders to discuss the UDI adoption initiatives and obtain advice from colleagues who are further along the adoption curve.
Mar 19, 2019
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. Download Report
Jul 6, 2018
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.
The Critical Link Between Cost, Quality, and Outcomes (CQO) and Unique Device Identification (UDI) White Paper
Jul 4, 2018
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.
May 12, 2018
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.
May 3, 2018
May 3, 2018
Overview: The Business Case for the UDI work group, a formal work group of the Association for Healthcare Resource & Materials Management’s (AHRMM) Learning UDI Community (LUC) is comprised of more than 75 members representing the association, manufacturing/supplier, hospital, regulatory, consulting, group purchasing organizations (GPOs), and solution provider communities. Within this group are five sub groups that are addressing one of five process flows that could potentially change following healthcare organizations’ adoption of the UDI.
Apr 17, 2018
In this AHRMM webcast, Karen Conway, executive director of industry relations and value at GHX discusses her research with the FDA on the value of UDI adoption in health care organizations. AHRMM’s Mike Schiller, senior director of supply chain, joins the conversation by describing the actions AHRMM is taking with the Learning UDI Community (LUC) to identify adoption practices and move beyond compliance.
Apr 9, 2018
GUDID Release 2.2 was successfully deployed. The enhancements will allow for additional functionality as noted below.