ISBT128条码(FDA)ISBT128条码(FDA).pptVIP

Use of ISBT 128 in the Labeling of Cellular Therapy Products Pat Distler Technical Director, ICCBBA pat.distler@iccbba.org Copyright ICCBBA, Inc What is ISBT 128? International standard for the transfer of information associated with tissue, cellular therapy and blood products Provides globally unique donation numbering system Internationally standardized product definitions Standard data structures for bar coding and electronic data interchange Independent of delivery mechanism (linear bar code, 2-D bar codes, RFID, electronic data interchange) Copyright ICCBBA, Inc What is ICCBBA? Formerly International Council for Commonality in Blood Bank Automation Not-for-profit US-based organization Develops and manages ISBT 128 Standard Works with advisory groups of experts in the fields of tissues, cellular therapy and blood Interacts with other standard setting and regulatory organizations to ensure compatibility of the ISBT 128 Standard with existing standards and regulations Copyright ICCBBA, Inc Status of ISBT 128 In use for almost 10 years for cell therapy, blood and tissue Cellular Therapy: Some US and European Cellular Therapy facilities using ISBT 128. Used in cord blood banks all over the world Blood: Blood banks in many countries are using ISBT 128 since 1997 Tissue: UK is using ISBT 128 for tissue banking; being evaluated for use with tissues in the US International standard setting organizations have committed to using ISBT 128 for cellular therapy products Copyright ICCBBA, Inc Organizations Committed to ISBT 128 Standard for Cellular Therapy AABB American Society for Apheresis (ASFA) American Society for Blood and Marrow Transplant (ASBMT) European Group for Blood and Marrow Transplantation (EBMT) Foundation for Accreditation of Cellular Therapy (FACT) International Society for Blood Transfusion (ISBT) International Society for Cellular Therapy (ISCT) ISCT Europe Joint Accreditation Committee for ISCT and EBMT (JACIE) National Marrow Do