Medical Device, Identification and Data Management
An implementation panel discussion session was held to share best practices, experiences and offer advice for those using GS1 standard to implement UDI regulation.
This session provided an in-depth look at identification, marking and master data management of high risk medical devices. Terrie Reed of the U.S. FDA spoke about the value of the UDI regulation and how it provides a National Evaluation System for active surveillance and collection of data during routine clinical care. Georg Keller of B.Braun shared best practices for labelling medical devices using GTINs, DataMatrix plus GS1-128 for encoding additional information on the label. Georg also demonstrated their process for marking directly on a device with a GS1 DataMatrix barcode.