Knowledge Center

68 Results Found

Jan 24, 2022
The AHRMM LUC members submitted comments and recommendations to the FDA's Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices. They recommend that information related to all Class I Medical Devices be included in the GUDID without exception.
Oct 7, 2021
The UDI-DI Change Communication Process Work Group, a part of AHRMM's Learning UDI Community (LUC), recently released a report analyzing current communication processes and their implications on all stakeholders related to changes to the UDI-DI. Gain a clear understanding of how these changes are documented in affected software systems, identify gaps between current and desired states, and develop recommended practices to improve the process for all stakeholders.
Oct 7, 2021
The UDI Impacts on Recall Management Work Group, a part of AHRMM's Learning UDI Community (LUC), has released their recommended practices reports that analyzes the barriers and highlights the benefits to patient safety and key stakeholder groups when utilizing the UDI throughout the recall process. Work group members identified recommended practices for each of these groups underscoring mutual areas for improvement in the safety and efficacy of the recall process. In addition to the two Impact Reports, there is also a comprehensive Regulatory Resource Guide and a Supporting Information document with detailed reports, resource links, surveys and summary presentations that the work group members created, as well as a Recall Time & Cost Collection Tool.
Jan 19, 2021
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.
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.
Dec 31, 2019
As UDI capture and exchange becomes more prevalent across the healthcare ecosystem and as implantable device information is linked to patient outcomes there are a number of expected benefits to look at. Find out how UDI will improve patients safety and supply chain purchasing for years to come.
Dec 31, 2019
Supply chain is in the unique position, working with so many different disciplines within the hospital, that it is natural that they initiate conversations on the proper management of these products. Presented by: Karen Conway, Executive Director, Industry Relations, GHX and Mike Schiller, Senior Supply Chain Director, AHRMM
Dec 31, 2019
Some Human Cellular Tissue Products (HCTP) are considered “devices” and will require their assigned Unique Device Identifiers (UDI) to be tracked within the patient’s Electronic Health Record (EHR) and shared across the healthcare spectrum. Supply chain should be having interdepartmental conversations to determine how they will handle these types of products and their UDIs.
Dec 31, 2019
Get the basics on what healthcare supply chain and manufacturers, together with clinical and IT departments, must do to implement the Unique Device Identifier and adverse event reporting, and the subsequent effects that will trickle-down to individual patients and the global health population.
Dec 31, 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 Ultra high frequency (UHF) radio-frequency identification (RFID) technology. Peter explains why they chose RFID, the success and benefits they have achieved, and lessons learned. Presenters: Peter Fiorentino, Materials Management Cardiology, Beth Israel Deaconess Medical Center and Lana Makhanik, COO, VUEMED, Inc.
Dec 31, 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 Ultra high frequency (UHF) radio-frequency identification (RFID) technology. Peter explains why they chose RFID, the success and benefits they have achieved, and lessons learned. Presenters: Peter Fiorentino, Materials Management Cardiology, Beth Israel Deaconess Medical Center and Lana Makhanik, COO, VUEMED, Inc.
Dec 31, 2019
This session explains the benefits of implementing the UDI such as immediate device status updates through collaboration with manufacturers and suppliers, increased patient care satisfaction, and how the data you collect can turn your analytics into strategic and critical business decisions. Learn the step by step process that FMOLHS used to implement UDI.
Dec 31, 2019
Hear one provider’s ongoing process of UDI implementation, from deciphering acronyms and educating interdepartmental staff, to working with vendors to redesign ERP software to meet FDA data capture and reporting regulations, all while creating procedures for others to follow.
Dec 31, 2019
In order to become data-driven organizations, healthcare providers need to leverage data standards and information technology. In the past, lack of standards across healthcare has been a major roadblock. However, numerous governmental and industry initiatives pursuing the adoption and implementation of supply chain standards across health IT systems are giving providers the opportunity to do just that. Standards lay the foundation for supply chain operations to leverage information technology to help transform healthcare providers into data-driven organizations.
Dec 31, 2019
A short introduction to the CMS Meaningful Use 3 Rule and how implementing UDI within the healthcare setting and moving toward the full GS1 will reduce costs and improve inventory management while providing accurate data reporting and complete patient EHR information. Ultimately, these changes will lead to knowledge-based decision making and improved quality of patient care.
Dec 31, 2019
Tracking surgical supplies is a challenge. Average returns for picked supplies is low, O.R. in-and-out traffic to retrieve items is high, and significant staff hours are spent checking consumption, restocking, and locating supplies. UTMC and DeRoyal have developed a "smart" radio frequency identification trash bin that tracks inventory used during a case, charges for that inventory, and shows where items are located in the room in real time.