Can ISBT 128 be Used for Both Human Cells, Tissues, and Cellular Tissue-Base Product (HTC/Ps) That are Regulated as Biologics and HTC/Ps That are Regulated as Devices? Does It Work the Same Way?

Yes, ISBT 128 may be used for all HCT/Ps regardless of how they are regulated.  When labeling HCT/P regulated as a device, you must follow device labeling guidelines that require a Device Identifier (DI) and a Product Identifier (PI). With biologics, you may use either this format or follow the format used for cellular therapy products and blood. It’s the same information but organized a little differently. Tissue banks can choose between the two systems for biologics.  It’s the same information either way---it’s just organized into different data structures.

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.