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United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128

Revised Standard for Blood and Blood Components Recognized by US Industry Consensus



The International Council for Commonality in Blood Banking Automation (ICCBBA) prepared and submitted IG-002 v4 to the FDA for review. This submission aimed to replace the older version of IG-002 v3.


In 2024 April a new guidance document, released by the FDA's Center for Biologics Evaluation and Research (CBER) announced the acceptance and immediate implementation of the United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128, IG-002 v4, dated 2024 January.


Following a thorough review, the Director of CBER has approved the updated standard for use on such container labels and “believes that conformance to the updated version 4.0.0 Standard will help facilitate the use of a uniform container label for blood or blood components in the United States and internationally” (U.S. Department of Health and Human Services Food and Drug Administration, Center for Biologics Evaluation and Research - Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels; Guidance for Industry (fda.gov) April 2024).


ICCBBA’s Technical Director, Karen Moniz, recently stated, “The FDA’s engagement with ICCBBA’s standards development process over the decades and repeated recognition of collaboratively developed updates to the United Statues Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 has helped ensure a safer blood supply for all.”


Updates to IG-002 v4


The recently updated IG-002 v4 continues to provide a system of uniform container labels for blood and blood components intended for transfusion or further manufacturing.


This update includes the following:


  • Current references to applicable FDA regulations 

  • Expands the list of ISBT 128 data structures 

  • Includes the revised labeling guidance for bacterially monitored platelets 

  • Encourages the use of 2-D Data Matrix symbols now that scanners are more common


This update builds upon the FDA's recognition of previous versions in the past and is designed to help manufacturers comply with container label requirements under Title 21 of the Code of Federal Regulations 606.121 (21 CFR 606.121).


Availability of IG-002 v4


IG-002 v4 can be obtained from ICCBBA. It is accessible online at https://www.isbt128.org/standard-terminology. If you are interested in implementing ISBT 128 please visit our dedicated how-to page, https://www.isbt128.org/how-to-register.


 

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About ICCBBA:  

ICCBBA is the international standards organization responsible for the management and development of the ISBT 128 Standard.  


The acronym ISBT was originally derived from the important role played by the International Society of Blood Transfusion in the development of the Standard. Today it expands as Information Standard for Blood and Transplantation. The number 128 reflects the 128 characters of the ISO/IEC 646 7-bit character set.  


The acronym ICCBBA is derived from the International Council for Commonality in Blood Banking Automation.


For More Information About ICCBBA: 

 

Media Contact:

Christina Salinas 


 

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Global Development Manager, ICCBBA

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