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ISBT 128  NEWSLETTER

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ENDORSEMENTS

ISBT 128 Is supported by the following organizations:

ALL MEDICAL PRODUCTS OF HUMAN ORIGIN

​ISBT 128 CONSISTENT CODING SYSTEMS

The WHO Transplantation website carries a page on Harmonization of Standards for Medical Products of Human Origin, which states: 

ISBT 128, managed by ICCBBA, is the sole global standard for the identification and coding of MPHO. It supports global governance by providing a donation numbering system that ensures globally unique identification. It is built upon internationally agreed terminology published in the ISBT 128 Standard Terminology which is a publically available document.

WHO and ICCBBA have been pursuing a joint work program since 2011 in support of the objectives of WHA63.22.

View the page here: 

http://www.who.int/transplantation/tra_isbt/en/index.html

GLOBALLY CONSISTENT CODING SYSTEMS FOR MEDICAL PRODUCTS OF HUMAN ORIGIN 

 

An editorial article published in the Bulletin of the World Health Organization states:

The development of an international coding system for Medical Product of Human Origin (MPHO) requires either creating a new system or ensuring a role for the ICCBBA as provider of the global service for nomenclature and coding. Attaining the WHA63.22 objective of globally consistent coding systems will involve the gradual adoption of ISBT 128 by organizations as an element of their development programs.

View the full bulletin here:

http://www.who.int/bulletin/volumes/91/5/12-116988/en/ - Posted 03 May 2013

GLOBAL HARMONIZATION OF NOMENCLATURE AND TRACEABILITY

The World Health Organization and ICCBBA held a joint workshop in August 2012 to develop a strategy to achieve the World Health Assembly objective of globally consistent coding systems for human cells, tissues, and organs.

See the statement released from the workshop here (28 September 2012).

BLOOD ENDORSEMENTS​​

​​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 labeling-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)

EUROPEAN BLOOD ALLIANCE

Statement of the European Blood Alliance position on the labelling, coding and identification of blood, blood components, tissues, and cells.

At the Board Meeting in Valletta, Malta, the EBA Board has voted to support the universal use of the ISBT 128 for labelling, coding and identification of blood, blood components, tissues and cells.

EBA Position Paper on Coding and Labeling - PDF (01 October 2010)

ISBT POSITION PAPER

This paper contains the Statement of the International Society of Blood Transfusion position on the labelling, coding and identification of blood, blood components, tissues, cells, and organs.

ISBT Position Paper - PDF 

UNITED KINGDOM NATIONAL HEALTH SERVICE

The United Kingdom National Health Service has published two articles regarding ICCBBA and ISBT 128 labeling in their latest online issue of NHS Blood and Transplant Matters. The articles can be found on page 13 and 14. (08 June 2010)

TISSUE ENDORSEMENTS​​

ACBTSA RECOMMENDATION

The Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) of the United States Department of Health and Human Services (HHS) has recommended that the Secretary of HSS take action in a step-wise, risk-based approach to establish use of ISBT 128 code in electronically readable format as a universal standard for mandatory implementation of unique donation numbers for all human tissue products.

To read more click here. (23 April 2015)

BIOTHERAPEUTICS ASSOCIATION OF AUSTRALASIA

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

Read the statement of support here. (12 August 2013)

ORGAN ENDORSEMENTS​​

GLOBALLY CONSISTENT CODING SYSTEMS FOR MEDICAL PRODUCTS OF HUMAN ORIGIN 

 

The World Health Organization (WHO) has released a bulletin acknowledging that: 

"The development of an international coding system for Medical Product of Human Origin (MPHO) requires either creating a new system or ensuring a role for the ICCBBA as provider of the global service for nomenclature and coding. Attaining the WHA63.22 objective of globally consistent coding systems will involve the gradual adoption of ISBT 128 by organizations as an element of their development programmes."

Bulletin of the World Health Organization (03 May 2013)

GLOBAL HARMONIZATION OF NOMENCLATURE AND TRACEABILITY

The World Health Organization and ICCBBA held a joint workshop in August 2012 to develop a strategy to achieve the World Health Assembly objective of globally consistent coding systems for human cells, tissues, and organs. See the statement released from the workshop here. (28 September 2012)

ADVISORY COMMITTEE ON ORGAN TRANSPLANTATION

ACBSA recommends FDA create a task force to identify ways to promote standardized systems for organ transplant. One of the recommendations was to:

“Identify ways to promote adoption of standardized systems (e.g., ISBT 128) for identification and codification of all organ transplants (including country of origin for those acquired abroad) to facilitate tracking and traceability."

View the statement here (23-24 August 2011)

CELLULAR THERAPY ENDORSEMENTS

​WMDA POSITION PAPER STATUS

The World Marrow Donor Association (WMDA) has posted a position paper discussing how to handle facility confidentiality when labeling cellular therapy products from unrelated donors. 

An excerpt from the paper: "WMDA encourages the efforts to adapt ISBT 128 as an effective bar-coded information coding system that supports a globally unique identity, standardized product coding and full traceability of cellular therapy products."

WMDA Position Paper - PDF (12 August 2011)

WBMT LETTER TO THE EUROPEAN COMMISSION SUPPORTING ISBT 128 FOR CELLULAR THERAPY

The World Network for Blood and Marrow Transplantation has submitted a letter to the European Commission (EC) supporting ISBT 128 for cellular therapy products and recommending that the EC provide a clear indication that the implementation of ISBT 128 for cellular therapy products will be compatible with the European Coding System.

See the WBMT letter to the European Commission here: http://www.wbmt.org/ (12 August 2011)

PATIENT ADVISORY FOR STEM CELL THERAPY AND MEDICAL TOURISM

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.

Patient Advisory - PDF  (August 2013)

CTCLAG JOINT STATEMENT

The Boards of AABB, ASBMT, ASFA, EBMT, FACT, ICCBBA, ISBT, ISCT, JACIE, NMDP and WMDA issued a consensus statement in support of the use of ISBT 128 in the coding of hematopoietic progenitor cell and other therapeutic cell products. 

The Boards of the above organizations encourage cell therapy facilities to move forward with the implementation of ISBT 128 coding and labeling.

Joint Statement - PDF (21 March 2011)

OCULAR ENDORSEMENTS

EBTAG JOINT STATEMENT

The Boards of the Association of Eye Banks of Asia, Eye Bank Association of Australia and New Zealand, Eye Bank Association of America, Eye Bank Association of India, European Eye Bank Association, Pan-American Association of Eye Banks, and ICCBBA confirm their support for the international use of ISBT 128 in the coding of ocular tissue.

The Boards of the above organizations encourage Eye Banks to:

  • Adopt this standard terminology for use in communications and in the labeling of ocular tissue grafts;

  • Implement ISBT 128 globally unique donation identification for ocular tissue grafts; and

  • Move towards full implementation of ISBT 128 nomenclature, coding and labeling in accordance with guidance published by the Eye Bank Technical Advisory Group.

View the joint statement here.

HUMAN MILK ENDORSEMENTS​​

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; and

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)