INTRODUCTION FOR REGULATORS &
Medical Products of Human Origin (MPHO) are unique in that they are often considered to be products of an exceptional nature. These products require special treatment by industry and their nature highlights the need for a globally consistent traceability system.
ISBT 128 is an ideal system for traceability of MPHO across all product categories including blood, cells, tissues, and organs. The standardization of terminology and identification has been ongoing for over two decades and now comprises over 15,000 unique product codes.
ICCBBA and the ISBT 128 standard are widely endorsed by the professional community. At the international level, ICCBBA has agreements with the World Marrow Donor Association and the European Commission to promote standardization for human cells and tissues, respectively. In addition, ISBT 128 is supported by the founding members of the Global Alliance of Eye Bank Associations as well as the Global Advisory Panel (GAP) on Corporate Governance and Risk Management of Blood Services in Red Cross and Red Crescent Societies.
Now used in 87 countries, an effort to coordinate activities is necessary to fully utilize the effects of the ISBT 128 standard in the context of global traceability. This effort will require a substantial exchange of information by key leaders and influencers across all MPHO fields.
Recognizing the responsibilities of regulatory authorities around the world in healthcare, ICCBBA encourages participation in Technical Advisory Groups by regulatory authorities in the fields of blood transfusion, cellular therapy, tissue banking, and assisted reproductive technology.
Regulatory authority involvement in managing ISBT 128 is important in that:
Harmonization of terminology can be determined and disseminated from a “top-down” method
Regulators will have input into proposals for changes and updates to the standard, such as new labeling requirements
Multinational information exchange of regulations and best practices can improve current systems of traceability