Have Vendors of Technologies Begun Modifying Their Systems to Take Advantage of Standardized Unique Device Identification (UDI) and ISBT128 Tracking of Devices?

Yes, technologies have started adapting to automatic IDs and capabilities associated with tissue storage and blood banking. The Eye Bank Association of America has just mandated ISBT 128 for international distribution of products for their accredited facilities beginning in 2017. For many reasons, software development companies are starting to become interested in ISBT 128 and a tracking system that can be built around it. In regards to blood banking systems, there are issues because the FDA 510(k) clearance for blood bank software does not include other uses. Software developers need to use the same principles, but many need to create separate systems for tissue and cells.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.