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Eye Bank Association of America Medical Advisory
The Eye Bank Association of America's Medical Advisory Board has released a Medical Advisory on November 20th, 2014 that includes changes to the EBAA standards. Changes will become effective January 1st, 2015, except where noted in the advisory.
The full medical advisory can be found, here.
17 December 2014
ST-001 ISBT 128 Standard Technical Specification v5.2.0 DRAFT is now available for public comment.
A draft version of ST-001 ISBT 128 Standard Technical Specification v5.2.0 is now available for public comment. ICCBBA will be accepting comments until January 18th, 2015.
For more information, please view our Documents for Review page.
17 December 2014
The Registered Facilities Database is Now Available
The Registered Facilities Database has been updated and 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 (Registered Facilities.xlsx) and as a tab delimited Text file (Registered Facilities.txt).
Both files are available in the password-protected area of the website. 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 (as it appears in the Registered Facilities Database) should match what appears on your FDA registration or license.]
09 December 2014
Version 6.0.0 of the ISBT 128 Product Description Code Database is now available.
Version 6.0.0 is the first official release of the restructured ISBT 128 Product Description Code Database. To download and/or learn more about the database, click here.
New Product Description Codes for – Blood, Cellular Therapy, Fecal Microbiota, In Vivo Diagnostic MPHO, Milk Banking, Ocular, Organ Transplant, Plasma Derivatives, Reproductive, Tissue, and Topical – products can be requested via their respective request forms found in the Subject Area of the ICCBBA website.
21 November 2014
A guidance document on the use of GS1 and ISBT 128 for the unique device identification of medical devices is now available.
GS1 and ICCBBA, working within the terms of an existing Memorandum of Understanding, have developed a document to clarify the appropriate use of the GS1 and ISBT 128 unique device identifiers, and the interfaces between the standards. The information in this document may also be applied to tissues regulated as biologics.
ICCBBA One World Award Recipient
ICCBBA is pleased to announce Dr. Edwin A. Steane as the recipient of the 2014 One World Award. Dr. Steane was a pioneer in the development of ISBT 128 and a powerful advocate for global standardization. The award recognizes his vision in identifying the need to improve standards for blood transfusion information technology and for his enthusiasm and determination to achieve a well-structured framework on which future generations of technology developers and transfusion specialists could build. The award will be presented at an evening celebration of the 20th anniversary of ICCBBA to be held on October 26th during the AABB annual meeting.
10 October 2014
United States Consensus Guidance for the Uniform Labeling of Cellular Therapy Products Using ISBT 128 v1.3.0 Now Available
Version 1.3.0 of the United States Consensus Guidance for the Uniform Labeling of Cellular Therapy Products Using ISBT 128 is now available on the ICCBBA Website. This will replace version 1.2.0 published in November 2012. You can view the document, here.
29 August 2014
ISBT 128 Technical Specification v5.1.0 Now Available
Version 5.1.0 of the ISBT 128 Technical Specification is now available on the ICCBBA Website. This will replace version 5.0.0 published in April 2014. You can view the document, here.
29 August 2014
Version 3.0.0 of the United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 is Now Available!
The United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 v3.0.0 is now available.
The FDA has published the document on their website. You can also view it, here.
06 June 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
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 email@example.com.
You can also view the FDA website in regards to UDI, here.
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.
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.
28 January 2014
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