Joint Documents

GS1 and ICCBBA - Medical Devices and Biologics

GS1 and ICCBBA Guidance: Identification of medical devices containing an HCT/P in the United States  PDF

This guidance document applies to the identification of human cells, tissues and cellular and tissue-based products (HCT/Ps) that are regulated as medical devices using a Unique Device Identifier (UDI) as required under the US Food and Drug Administration’s (FDA’s) Unique Device Identification System Final Rule (78 FR 58785; September 24, 2013).

The rationale that applies to the use of ISBT 128 for tissues regulated as medical devices applies equally to its use for traditional tissues. Therefore, ICCBBA also encourages the use of ISBT 128 for tissues regulated as biologics to provide a consistent means of coding all tissue for transplantation.   

GS1 and ICCBBA, working within the terms of an existing Memorandum of Understanding, have developed this document to clarify the appropriate use of the GS1 and ISBT 128 unique device identifiers, and the interfaces between the standards.


GS1 and ICCBBA - Plasma Derivatives

Bar Coding Plasma Derivatives, Implementation Guide, Issue #1.0 – PDF

ISBT 128 defines Plasma Derivatives as, "A product that contains concentrated fractions of plasma proteins that have been separated using physico-chemical or other fractionation processes. It is made from pooling plasma from large numbers of donors and is traced based on the lot or batch number of the pooled product.”

It is recommended that those products for which ABO blood groups is not relevant (e.g., Rh Immune Globulin or Gamma Globulin) be labeled with GS1 bar codes. Conversely, plasma derivatives for which the ABO blood group is relevant should be labeled with ISBT 128. 


Assigning a Patient Identification Number

JP-004 Assigning a Patient Identification Number v1.0.0 – PDF

This document visits two mechanisms for assigning patient identification numbers – a globally unique option using the GS1 Global Service Relation Number (GSRN) and a locally assigned number using the ISBT 128 data structure.