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…
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:
Mar 5, 2020
High quality data collected through Point-of-Care Scanning (POC) gives providers more accurate information that will assist in delivering higher quality of care. With unique device identifiers becoming readily available for medical devices due to U.S. FDA UDI requirements, hospitals need to…
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…
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…
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.