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August 2009

Cells and Tissue Traceability and ISBT 128

There are 30 million blood products; 2.2 million tissue products and 18,000 stem cells collected each year in the United States. Biological products may be collected in one country and distributed in another. Cellular therapy and tissue products are particularly likely to cross an international border because of both availability issues and the need for products that are precisely matched. The recent highly publicized scandal with illegally procured and distributed tissues showed that over 2,000 tissue grafts, distributed around the world, could not be traced.

A critical requirement for such products is the need for traceability, which becomes more challenging when products must be traced through completely different environments (regulatory, health care delivery systems, levels of automation, etc). Additionally, there is a need to label the product in a way that can transcend language barriers.

The key to satisfying these requirements lies in standardization: globally unique identifiers for products, standardized terminology and a means to convey information electronically that is recognized by computer systems throughout the world. Towards this end, ISBT 128 had been developed.

ISBT 128 is an international standard for the transfer of information about blood, cellular therapy, or tissue products. This transfer can be through bar codes on labels (both linear and two-dimensional), Radio Frequency Identification (RFID) tags, or electronic messaging. In support of traceability, ISBT 128 creates a system for assignment of identifiers for products that are globally unique for a period of 100 years.

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