Cell Notes: Safety and Traceability: Put a Label on It With ISBT 128

In her monthly column "Cell Notes," AABB's Christina Celluzzi, PhD, MS, CABP(H), shares insights, findings and commentary on emerging topics in biotherapies. Subscribe to CellSource, AABB's biotherapies newsletter, to receive "Cell Notes" and the latest news directly in your inbox. 

When does labeling become exciting? When we realize how crucial it is for safety and efficiency in health care. Imagine receiving a blood product without a label. The risks are immense—mismatched transfusions, unknown origins and compromised patient safety. ISBT 128 prevents such scenarios, aligning perfectly with AABB's mission to advance transfusion medicine and biotherapies. By adopting ISBT 128, AABB-accredited institutions demonstrate their commitment to safety, quality and innovation, ensuring the best possible care for patients.

Think about how we track packages from the moment they leave the warehouse until they arrive at our doorstep. Each step is meticulously recorded to ensure the package reaches the right destination safely and efficiently. Applying this level of precision and traceability to medical products like blood, tissues and cells is where ISBT 128 comes into play. As the global standard for labeling medical products of human origin, ISBT 128 ensures consistency, safety and efficiency across institutions worldwide, making a significant impact in transfusion medicine, cell and gene therapies, and biotherapies.

While many of our readers are already familiar with ISBT 128, it is essential to remind ourselves of what it is and it’s benefits. AABB is committed to furthering awareness and helping our members stay informed about the latest developments in ISBT 128 so they can meet the needs of an evolving landscape. Regular updates and continuous education help ensure that stakeholders are aware of the latest best practices and regulatory requirements.

ISBT 128 reduces labeling errors, preventing adverse events like transfusion reactions and transplantation complications. Accurate labeling is crucial for patient safety. The system enhances traceability from donor to recipient, ensuring product safety and quality. Standardized labels and barcodes streamline processes, improving operational efficiency. ISBT 128 helps institutions meet legal requirements and maintain high standards of practice. Used in more than 80 countries, ISBT 128 facilitates international collaboration and product exchange, contributing to better patient outcomes. It supports data sharing across health care systems, enhancing patient care and research, and is crucial for tracking advanced therapies like CAR-T cells. Additionally, ISBT 128 ensures high standards in handling and processing medical products, preserving their integrity and efficacy.

To learn more about ISBT 128, ICCBBA, which is the international non-profit organization that manages, develops and licenses ISBT 128, offers a wealth of resources, including technical documents, guidelines and educational materials on its ICCBBA website. Its Cellular Therapy Coding and Labeling Advisory Group (CTCLAG), established in 2004, advises ICCBBA of the needs of cellular therapy organizations for coding and labeling. Membership comprises representatives from major cellular therapy professional organizations including AABB, APBMT, ASTCT, ASFA, EBMT, FACT, ISBT, ISCT, JACIE, NMDP and WMDA and other technical experts.

Additionally, the AABB Standards provide comprehensive guidelines that align with ISBT 128, ensuring high standards in transfusion medicine and biotherapies. Embrace the power of ISBT 128 labeling to safeguard patient health and drive innovation in health care.