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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.
05 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.
Internationally Standardized Terminology for Human Milk Draft
ICCBBA has made the Internationally Standardized Terminology for Human Milk Draft available for public comment. ICCBBA will accept comments until April 1, 2014. Send comments to ICCBBA via email at firstname.lastname@example.org. View the draft here.
Technical Specification v5.0.0 Draft
ICCBBA has made the ISBT 128 Standard Technical Specification v5.0.0 Draft available for public comment. ICCBBA will accept comments until March 21, 2014. Send comments to ICCBBA via email at TScomment@iccbba.org.
View the draft here.
Version 4.32.0 of the Product Description Code Database is Now Available
Version 4.32.0 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.
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.
07 February 2014
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.
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
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
Job Opening For a Global Development Director
ICCBBA is searching for a highly motivated professional to fill its Global Development Director position. This individual will be responsible for managing the promotion of ISBT 128 at the global level and working with stakeholders to ensure the ongoing suitability of the Standard. Key responsibilities will include: identifying key policy makers and encouraging them to adopt and implement ISBT 128; developing and presenting education material; coordinating promotional activities on-line and at international professional meetings; working to improve the stakeholder perception and professional image of ICCBBA; and promoting the importance of ISBT 128 as a patient safety initiative in support of biovigilance and traceability. Knowledge/Education: Bachelor’s Degree or equivalent in transfusion or transplantation related discipline, substantial experience in transfusion/transplantation; information management and standards; quality systems; and use of healthcare IT systems. We offer an excellent benefit package. Candidate must be willing to travel internationally and to relocate to Redlands, CA. For consideration, please submit resume via e-mail by 10/31/2013 to email@example.com. For more information about the position click here.
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
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 firstname.lastname@example.org by 31 August 2013. The advisory group will review all comments prior to finalizing the nomenclature.
View the document here.
21 June 2013
Read ICCBBA's Guest Blog about the use of ISBT 128 for Unique Device Identification (UDI)
This guest blog was contributed by ICCBBA's Technical Director Pat Distler. It explains how ISBT 128 will play in successful implementation of UDI.
Those who use ISBT 128 for Tissues may find particular interest in this blog post.
Read ICCBBA's recent blog post featured on The Healthcare Hub.
21 March 2013