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Background Methods Results Conclusion U.S. FDA's Center for Biologics Evaluation and Research (CBER) Biologics Effectiveness and Safety (BEST) Initiative leverages large electronic health records and administrative claims data to conduct active surveillance for CBER‐regulated products. Improved hemovigilance of platelet transfusions provides exposure data for future outcome studies and can identify opportunities to improve management of the limited platelet supply.Platelet utilization in three hospital networks (2012–2018) is summarized from data obtained using Information Standard for Blood and Transplant (ISBT) 128 platelet codes. Transfusion episodes, the number of units transfused, and component characteristics are described.Most platelet‐transfused patients (range 59.6%–62.2% across study years for all sites) received platelets once per year and used a small proportion of the total platelets transfused per year (range 18.4%–22.5%). In contrast, a minority of patients were transfused 12 or more times in a given study year (range 4.4%–6.3%) and used a plurality of transfused platelets (range 32.2%–44.4%) per year. The overall ratio of platelets transfused to the number of patients receiving any platelet transfusion was stable over the study period (range 3.9–4.5 platelets/patient) and similar among participating data sources. For all data sources, most transfusion episodes (78%) involved one component per transfusion episode.ISBT 128 coding in the BEST Initiative was used to capture platelet transfusion events, component modifications, and characterize aspects of platelet use patterns. These data can be leveraged to identify opportunities for improved management of the platelet supply and provide granular exposure information for future studies of transfusion‐related adverse events. [ABSTRACT FROM AUTHOR]

The 1990s saw rapid growth in international activity in hematopoietic cell transplantation. As national donor registries were established and international collaboration increased, a need to transfer cellular therapy products across national borders emerged. A lack of international standards for identification, terminology and labeling resulted in significant challenges for import and export. Twenty years of effort by a large group of experts supported by professional societies and accreditation bodies has today achieved a high degree of standardization. This review highlights the main landmarks in this journey and serves as a reminder of the importance of taking the "long view" when working toward international standardization. It demonstrates the need for continual maintenance and enhancement of standards to meet the changing needs of the cell therapy industry and highlights recent developments in ISBT 128. [ABSTRACT FROM AUTHOR]

Abstract: ISO/IEC 18000-3 mode 1 standard 13.56 MHz RFID tags have been accepted by the International Society for Blood Transfusion (ISBT) and the United States Food and Drug Administration (FDA) as data carriers to integrate with and augment ISBT 128 barcode data carried on blood products. The use of 13.56 MHz RFID carrying ISBT 128 data structures allows the global deployment and use of RFID, supporting both international transfer of blood and international disaster relief. The deployment in process at the BloodCenter of Wisconsin and testing at the University of Iowa Health Center is the first FDA-permitted implementation of RFID throughout in all phases of blood banking, donation through transfusion. RFID technology and equipment selection will be discussed along with FDA-required RF safety testing; integration with the blood enterprise computing system and required RFID tag performance. Tag design and survivability is an issue due to blood bag centrifugation and irradiation. Deployment issues will be discussed. Use of RFID results in significant return on investment over the use of barcodes in the blood center operations through labor savings and error reduction. [Copyright &y& Elsevier]

Modern transplantation of cells, tissues and organs has been practiced within the last century achieving both life saving and enhancing results. Associated risks have been recognized including infectious disease transmission, malignancy, immune mediated disease and graft failure. This has resulted in establishment of government regulation, professional standard setting and establishment of vigilance and surveillance systems for early detection and prevention and to improve patient safety. The increased transportation of grafts across national boundaries has made traceability difficult and sometimes impossible. Experience during the first Gulf War with mis-identification of blood units coming from multiple countries without standardized coding and labeling has led international organizations to develop standardized nomenclature and coding for blood. Following this example, cell therapy and tissue transplant practitioners have also moved to standardization of coding systems. Establishment of an international coding system has progressed rapidly and implementation for blood has demonstrated multiple advantages. WHO has held two global consultations on human cells and tissues for transplantation, which recognized the global circulation of cells and tissues and growing commercialization and the need for means of coding to identify tissues and cells used in transplantation, are essential for full traceability. There is currently a wide diversity in the identification and coding of tissue and cell products. For tissues, with a few exceptions, product terminology has not been standardized even at the national level. Progress has been made in blood and cell therapies with a slow and steady trend towards implementation of the international code ISBT 128. Across all fields, there are now 3,700 licensed facilities in 66 countries. Efforts are necessary to encourage the introduction of a standardized international coding system for donation identification numbers, such as ISBT 128, for all donated biologic products. [ABSTRACT FROM AUTHOR]

ISBT 128 is the global standard for the identification, labeling and information transfer of human blood, cell, tissue and organ products across international borders and disparate health care systems. The system has been designed and perfected over almost two decades to ensure accuracy, safety and efficiency for the benefit of donors, patients and health care workers worldwide. The use of the ISBT 128 standard has grown steadily since a blood bank in Estonia first implemented it in 1997. Today, more than 3,500 facility identifiers for the use of ISBT 128 have been assigned to organizations in 67 countries on six continents. The standard has been accepted by a variety of international standard setting organizations and government regulators. It is managed by ICCBBA, a not-for-profit organization based in the USA that is governed by an international volunteer board of directors. Members of the Board of Directors represent the fields of practice affected by the standard. Advisory groups comprising international experts guide the ongoing development of the ISBT 128 standard to ensure it continues to meet the needs of its users. While there is a cost associated with the implementation and use of the standard, the clear benefits in terms of improved patient safety and ability to meet regulatory traceability requirements justify the costs. [ABSTRACT FROM AUTHOR]

The publication of new standards for terminology and labeling marks an important step in ensuring consistency and traceability of cellular therapies at the global level. However, it is only with the widespread implementation of the standard that the benefits can be truly realized. This paper provides guidance on the practical aspects of adopting these new standards for organizations with differing current levels of computerization. It discusses project management, equipment, licensing, and validation topics.Bone Marrow Transplantation (2007) 40, 1085–1090; doi:10.1038/sj.bmt.1705859; published online 1 October 2007 [ABSTRACT FROM AUTHOR]

This paper desires to explore the role of barcode technology in blood bank information systems via addressing its upgrade and the consequent impact. Firstly, it briefs the application and effect of barcode technology in blood donation and transfusion service. In the second, the barcode paradigms of Macau Codabar and ISBT 128 are carefully examined and compared in accordance with the procedure and specifications of barcode upgrade. Then, the impact due to upgrade is assessed from the perspectives of blood bank information system, blood banks, and even blood donation and transfusion service. It finally discusses the considerations on implementing the upgrade of barcode technology in blood bank information systems. [ABSTRACT FROM AUTHOR]

A survey of blood centre organizations was carried out to establish the degree of progress towards the implementation of global standards for coding and labelling blood components. The survey was performed through questionnaires completed by blood organizations. Of nearly 32 million blood donations collected annually by the participants, 43% are identified with ISBT 128 donation numbers and 36% are fully compliant with the ISBT 128 Standard. Planned implementations indicate that 85% of donations will be identified by ISBT 128 donation numbers by 2011. [ABSTRACT FROM AUTHOR]