WHO WE ARE – We are a global nonprofit organization dedicated to enhancing patient safety by leading the development and management of ISBT 128.

WHAT WE DO – We provide a universal framework for the terminology, coding, and labeling of medical products of human origin, enabling accurate identification, traceability, and safe use across healthcare systems worldwide.

HOW WE DO IT – We collaborate with industry experts, regulatory authorities, and healthcare organizations, ensuring ISBT 128 evolves through rigorous standards, innovative tools, and accessible educational resources.

WHERE WE ARE – We operate on a global scale, uniting diverse healthcare systems across all seven continents to support the universal adoption of ISBT 128.

WHY WE DO IT – We believe in protecting patients by fostering a safer, more standardized, and interconnected global healthcare system, ensuring trust and reliability in every step of medical product handling.

Mission statement

Develop and advance the ISBT 128 Standard for medical products of human origin (MPHO) to enhance global traceability and achieve harmonization for improved healthcare systems efficiency and patient safety.

Vision Statement

A safer world through the global adoption of a universal information standard for all medical products of human origin (MPHO).

CERTIFICATIONS

ICCBBA has been ISO 9001 certified since April of 2011 and received ISO9001:2015 certification in May of 2024. A copy of the certificate of registration can be found here.

Nonprofit Organization

ICCBBA is a tax-exempt, nonprofit organization as described in Section 501(c)(3) of the US Internal Revenue Code. These regulations stipulate that the organization cannot be organized or operated for the benefit of private interests, and no part of the organization’s net earnings may inure to the benefit of any private shareholder or individual. Within its Articles of Association, ICCBBA is required to be organized and operated exclusively for charitable, scientific, and educational purposes.

HOW IS ICCBBA FUNDED?

ICCBBA operations are funded entirely from licensing fees collected from both facilities using the ISBT 128 Standard and from vendors providing equipment or software that incorporates the standard.

History of ICCBBA

ICCBBA, an international non-profit, non-state actor, supported by user fees, was established in 1994 to maintain and develop the ISBT 128 Standard. Thirty years later, ICCBBA continues to maintain the ISBT 128 standards for internationally harmonized terminology, globally unique identification, labeling, and electronic data exchange for medical products of human origin (MPHO).

Volunteers continue to drive the ISBT 128 Standard forward; more than 600 volunteers have contributed to the evolution of the Standard since inception. Both standards and implementation guides are developed with the assistance of ICCBBA’s technical advisory groups.

Our Timeline

2025
2024

ICCBBA Hosts Forum 30 in Rome, Italy.

2023

As of December, 2024, the product code description database includes 16,740 active product description codes covering a wide range of medical products of human origin.

2023

ICCBBA publishes Chain of Identity Identifier (ST-028), which provides a standardized, globally unique identifier to link together donations and products related to patient- specific cellular therapies.

2022

ICCBBA publishes ISBT 128 Standard for Labeling of Reproductive Tissue and Cell Products (ST-019).

2022

ICCBBA and ISBT develop a Memorandum of Understanding to set a framework for future collaborations to enhance blood safety.

2021

ICCBBA publishes ISBT 128 Dictionary of Standard Data Elements (ST-027).

2021

ICCBBA publishes ISBT 128 Standard for XML (ST-020).

2021

ICCBBA introduces the cellular therapy hybrid label with Implementation Guide: Applying ISBT 128 Labels to Collection Products for Further Manufacture (IG-045).

2021

ICCBBA publishes ISBT 128 Standard for the Medical Products of Human Origin (MPHO) Unique Identifier (ST-026).

2021

ICCBBA joins the FHIR Orders & Observations work group to collaborate on enhancing the BiologicallyDerivedProduct resource.

2020

Global Pandemic prompts ICCBA to create new product description codes for Convalescent Plasma COVID-19.

2019

ICCBBA Hosts Forum 25 in Lisbon, Portugal.

2018

AABB, FACT, JACIE, and NMDP require that ISBT 128 terminology be used when labeling cellular therapy products. AABB Standards for Cellular Therapy requires that all facilities shall implement ISBT 128 labeling by 01 July 2018.

2017

ICCBBA releases version 1.0 of the Cellular Therapy Audit Tool, intended for auditors to help assess compliance to ISBT 128 requirements for cellular therapy products.

2016

ICCBBA creates the Enterprise Grant aimed at supporting organizations working in resource limited countries that develop initiatives that have an impact on information management or traceability.

2016

The Eye Bank Association of American (EBAA) requires ISBT 128 barcoding for international shipments for eye banks in North America. ICCBBA releases a guidance (IG-040) document in relation to this.

2015

The European Commission publishes directive that recognizes ISBT 128 to be compatible with the SEC.

2015

FDA’s Center for Devices and Radiologic Health (CDRH) approves ICCBBA as one of only three issuing agencies for medical device Unique Device Identifiers (UDI) in the US.

2014

Dr. Edwin A. Steane is presented with the One World Award. Dr. Steane was previously the first Executive Director of ICCBBA as well as one of the original creators of the ISBT 128 Standard.

2012

First conference call for Milk Banking Technical Advisory Group (MBTAG).

2012

5,000th facility registers with ICCBBA.

2011

ICCBBA’s quality management system becomes ISO certified.

2011

ICCBBA enters into official relations with the World Health Organization.

2010

The World Health Assembly passes resolution WHA63.22 which urges Member States to encourage the implementation of globally consistent coding systems for human cells, tissues, and organs.

2009

ICCBBA partners with the International Blood Emergency Planning Action Group (IBEPAG) to carry out a survey that tabulated which blood institutions had implemented or were planning on implementing ISBT 128.

2008

ICCBBA creates One World Award to acknowledge professionals who contribute to the understanding and application of international information standards in transfusion and transplantation medicine.

2008

AABB requires its accredited blood banks to implement ISBT 128 by May of 2008.

2007

The CT advisory group publishes standards for the terminology and labeling of cellular therapy products, further expanding the role of ISBT 128 as a standardized terminology system.

2007

A memorandum was signed with GS1 to cooperate in the area of automatic identification standards to determine how to best handle potential overlap in products coded.

2006

The Cellular Therapy Coding and Labeling Advisory Group (CTCLAG) is formally established to develop terminology and labeling standards for Cell Therapy applications.

2006

ICCBBA updates the Product Description Code database by adding 74 product codes for the following countries: US, UK, Canada, Sweden, China, and Singapore.

2005

Hospitals in Norway start to use secure wristband identification using ISBT 128 data structures.

2004

Kuwait implements ISBT 128 as a national solution in blood banking.

2003

St. Luke’s Episcopal Hospital in Houston, Texas becomes the first facility in the United States to implement ISBT 128 in its blood bank.

2002

The United Kingdom and Switzerland implement ISBT 128 nationally for blood transfusions.

2000

In the United Kingdom, NHS Blood & Transplant is the first tissue facility that registers with ICCBBA.

1999

ICCBBA publishes ISBT 128 US Consensus Standard (IG-002) as a guidance document.

1998

ICCBBA Technical Advisory Groups (TAGs) are formed to provide stakeholder input to the ongoing development of the ISBT 128 Standard and to provide educational and technical support to facilities implementing ISBT 128.

1997

1,000th facility registers with ICCBBA.

1996

First Product Description Codes were added to the Product Description Code Database in the category of whole blood in July.

1995

The first edition of the ISBT 128 Technical Specification is approved.

1995

The Blood Products Advisory Committee of the FDA votes in March of this year to recommend the use of ISBT 128 in the US according to a timetable presented by ICCBBA, Inc.

1995

In February, ICCBBA’s Board of Directors meet, writes bylaws, establishes a budget, and prepares Articles of Incorporation for the subsequent incorporation of ICCBBA in the Commonwealth of Virginia.

1994

In November the first full Board of Directors meeting commences. The Americas Technical Advisory Group (ATAG) is established to advise ICCBBA on needs of users in the Americas.

1994

AABB and American Red Cross appoint members to form a Board of Directors for new office. The ISBT Council approves the ISBT 128 Standard and agrees in principle to form ICCBBA by adding members to the CoCBBA Board of directors. CoCBBA was the original Council for Commonality in Blood Banking Automation, a committee established by the AABB, before evolving into ICCBBA.