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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
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 (collection_facilities.xlsx) and as a tab delimited Text file (collection_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 should match what appears on your FDA registration or license.)
05 August 2014
Version 5.2.0 of the Product Description Codes Database is Now Available
Version 5.2.0 of the ISBT 128 Product Description Codes Database is now available to licensed facilities. The updated database can be downloaded as a Microsoft Access database or as Text file tables.
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.
04 August 2014
Development of the guidance document on the use of GS1 and ISBT 128 for the unique device identification of medical devices
Since the approval of GS1 and ICCBBA (ISBT 128) as issuing agencies for unique device identifiers by the U.S. Food and Drug Administration (FDA), both GS1 and ICCBBA are developing a guidance document to clarify the appropriate use of the GS1 and ISBT 128 unique device identifiers, and the interfaces between the standards.
A brief announcement has been prepared, which provides an overview of each issuing agency (and their standard), and an outline of what information the guidance document will convey.
31 July 2014
ICCBBA Website Survey
Below is a link to take a short survey regarding your experience with the ICCBBA Website. Completing the survey provides us with your feedback and would help us in determining how to improve our website. We greatly appreciate your time.
14 July 2014
UDI Implementation Workshop and UDI Conference for 2014
As one of the Associated Sponsors for UDI 2014, ICCBBA would like to announce that the UDI Conference will take place on October 28-29 in Baltimore, MD.
For registration and details regarding the conference, please visit the UDI Conference website.
10 June 2014
ICCBBA's Plasma Derivative Group
ICCBBA is looking to form the Plasma Derivative Group for evaluating ways of coding plasma for further manufacture.
ICCBBA encourages ISBT 128 users and Technical Advisory Group members with operational experience with products intended for plasma fractionation to join the Plasma Derivative Group. ICCBBA plans for the group to be geographically balanced. The group will meet through conference calls only.
Participation is limited, so if you are interested in joining this group, please email ICCBBA’s Technical Director by June 23, 2014.
09 June 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
A pilot version of the restructured Product Description Code Database is available for preview
The greatest change for Version 5.0.0 of the Technical Specification is a restructuring of the Product Description Code Database. Details of this change may be found in the new publication, ISBT 128 Standard Product Description Code Database v1.0.0 (ST-010). A pilot version of the restructured Product Description Code Database is available for preview.
You can view the Product Description Code Database v1.0.0 (ST-010) document, here.
You can view the pilot version of the restructured Product Description Code Database, here.
Users 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.
08 May 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.
Registered Users can request new codes using the Tissues Request form on the ICCBBA website.
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 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
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
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