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The Registered Facilities Database is Now Available

An updated facility identification database is now available to licensed facilities.  The database contains the names and locations of all ICCBBA registered facilities worldwide and their assigned facility identification numbers.  It is available both as an Excel file (collection_facilities.xls) and as a tab delimited Text file (collection_facilities.txt).

Both documents are available in the password-protected area of the web site.  Amendments to entries in these tables should be notified to the ICCBBA office.  (For US facilities registered and/or licensed with the FDA, the name and location of your facility should match what appears on your FDA registration or license.) View it here.

08 April 2014

ISBT 128 Cellular Therapy Webinars Available

The following presentations were made in March 2014.

The presentations focus on ISBT 128 Cellular Therapy label design and product description code selection using the product lookup tool. We have made the webinars available as a helpful reference.

ISBT 128 Cellular Therapy Label Design:


Using the Product Code Look Up Tool for Cellular Therapy product descriptions:


Publication by EBTAG in the International Journal of Eye Banking

The Eye Bank Technical Advisory Group (EBTAG) is pleased to announce that the “Implementation of Standardized Terminology and ISBT 128 Product Codes for Ocular Tissue” has been published in the International Journal of Eye Banking.

The publication can be viewed here

25 March 2014 

New Cardiovascular terminology in Standard Terminology v 4.33

New Cardiovascular terminology has been introduced to the Standard Terminology v 4.33

The terms are found in section 4.1.1 Cardio/Vascular Bounded List and Definitions.

View it here

Registered Users can request new codes using the Tissues Request form on the ICCBBA website.

Log on to view the Request Form 

20 March 2014

Version 4.33.0 of the Product Description Code Database is Now Available

Version 4.33.0 of the ISBT 128 Product Description Code Database is now available to licensed facilities. The new database can be downloaded as a Microsoft Access database or as Text file tables.

Download it here

New product codes for Cellular Therapy, Blood, Ocular, Milk Tissues, and Other Therapies can be requested via their respective request forms found on the ICCBBA website. You must be logged in to view the request forms.

20 March 2014

The ISBT 128 Introductory Booklet for Human Milk is Now Available

The ISBT 128 Introductory Booklet for Human Milk can be found here

17 March 2014

ICCBBA as an FDA-accredited issuing agency for Unique Device Identifiers (UDI)

ICCBBA is now a Food and Drug Administration (FDA)-accredited issuing agency for Unique Device Identifiers (UDI).  A UDI system can improve the efficacy of information in medical device adverse event reports, which can ultimately aid in the identification of product problems more quickly, assist in better target recalls and improve patient safety.  ICCBBA is excited to be a part of this process and will answer questions in regards to the use of ISBT 128 as a UDI.

Please send inquiries to udi@iccbba.org

You can also view the FDA website in regards to UDI, here.

This Pilot Version of the Restructured Product Description Code Database is Now Available to Vendors

This pilot version of the restructured Product Description Code Database allows ISBT 128 software developers to preview and test how their current software handles the tables, fields, and coding values of the new database before it is released for general use.  Software developers should take advantage of this opportunity to understand the general structure of the database and to begin planning the necessary modifications to their systems to accommodate the new format.

You may view it here.  

06 February 2014

Coding and Labeling of Medical Devices Using ISBT 128 v1.2.0 Now Available

Version 1.2.0 of the Coding and Labeling of Medical Devices Using ISBT 128 is now available on the ICCBBA Website. 

The purpose of this document is to provide requirements and guidance for the labeling of medical devices containing a human tissue or cellular component using the ISBT 128 Standard.

View the document here.  

04 February 2014

Action List Strategy and Validation Strategy for Cellular Therapy Facilities Now Available

The Validation Strategy is intended for facilities that:

• Have already implemented ISBT 128 labeling and are seeking to validate only the changes to the terminology, OR

• Have implemented ISBT 128 terminology (not full labeling) and are seeking to validate only the changes to the terminology.

View it here

The Action List Strategy is a suggested list of actions that should be considered when a facility implements new ISBT 128 terminology for cellular therapy.

View it here  

28 January 2014

United States Consensus Standard for the Uniform Labeling of Cellular Therapy Products Draft version 1.3.0

The Unites States Consensus Standard for the Uniform Labeling of Cellular Therapy Products Draft version 1.3.0. has undergone FDA and public comment periods but is still available for your convenience. 

View the document here.

19 November 2013

Red Cross and Red Crescent Support the use of ISBT 128

The Executive Board of the Global Advisory Panel (GAP) on Corporate Governance and Risk Management of Blood Services in Red Cross and Red Crescent Societies endorses the use of ISBT 128 product coding as a risk mitigation strategy to reduce the incidence of labelling-related transfusion errors and will, where appropriate, promote the use of ISBT 128 as a means to minimize risk in the blood collection, processing, testing and transfusion setting.

View the statement here

24 October 2013

International Consensus Statement on the Terminology, Coding and Labeling of Human Milk Donations

The Boards of the European Milk Bank Association, Human Milk Banking Association of North America and ICCBBA  support the use of the ISBT 128 international coding standard for the bar coding and labeling of human milk donations.

To achieve this objective the above associations will form an international advisory group to:

a) develop a standard terminology to describe milk donations;

b) provide guidance on standard labeling of milk donations;

c) provide advice and support to milk banks introducing the standard;

d) advise on the ongoing development of the ISBT 128 standard to support new developments in milk banking.

Milk banks should take note of this initiative and plan for adoption of ISBT 128 coding and labeling of their products once the standard has been published.

 View the full statement here.

 10 October 2013

Hemphill-Jordan Leadership Award

Please join us in congratulating ICCBBA’s Technical Director, Pat Distler, as the 2013 recipient of the Hemphill-Jordan Leadership Award! This prestigious award honors leaders from the transfusion medicine and cellular therapy community and recognizes individuals who have made significant contributions in the areas of administration, quality programs, law and/or government affairs.  

Pat will be speaking on October 13th from 10:30 to noon. Her lecture titled “Beyond Blood - Globally Consistent Coding for Medical Products of Human Origin” will explore the rationale for, and the global status of, ISBT 128 as the single globally consistent coding system for medical products of human origin.

09 October 2013

New Cellular Therapy Terminology Available Now!

New terminology for cellular therapy has been approved and implemented into ISBT 128. Previous terminology was re-evaluated due to regulatory concerns about the use of TC (“therapeutic cell”) terminology.  As a result of this review, terminology was revised to eliminate the “TC” class designation and to create a more consistent format for cellular therapy class terms.

View it here.

23 August 2013

Technical Specification v 4.5.0. Now Available

Version 4.5.0 of the ISBT 128 Technical Specification is now available on the ICCBBA Website. This will replace version 4.4.0 published in December 2012.  The major changes in this version:

New Data Structures are now available:

  • Flexible Date and Time [Data Structure 031]
  • Product Divisions [Data Structure 032]

  • Processing Facility Information Code [Data Structure 033]
  • Processor Product Identification Code [Data Structure 034]

View it here

23 August 2013

The Biotherapeutics Association of Australasia Supports Use of ISBT 128

The Biotherapeutics Association of Australasia supports the concept of global standardization using ISBT 128.

Read the statement of support here.

12 August 2013

Cellular Therapy Patient Advisory

Patient Advisory

Professional Cellular Therapy Societies have issued a patient advisory.  ICCBBA along with several other organizations have endorsed this joint statement regarding Stem Cell Therapy and Medical Tourism. 

View the document here.

19 August 2013

View the Survey Results for Red Cell Antigen Labeling

ICCBBA would like to thank those facilities that participated in the recent survey.

View the results here - PDF

18 July 2013

ICCBBA to sponsor the 2013 UDI Conference

ICCBBA one of the sponsors for the 2013 UDI Conference, for more information regarding registration and promotional discount click here.  

Visit the official UDI Conference website to register http://www.udiconference.com 

10 July 2013

The Cardiovascular Tissue Terminology is Now Available for Public Comment

The International Cardiovascular Terminology Working Group has released the proposed Cardiovascular Tissue Nomenclature for review and public comment.

Feedback should be submitted via email to tissues@isbt128.org by 31 August 2013. The advisory group will review all comments prior to finalizing the nomenclature.

View the document here.

21 June 2013