America’s Blood Centers (ABC), the Association for the Advancement of Blood and Biotherapies (AABB), and the American Red Cross (ARC) have submitted this joint response to the FDA’s draft guidance on reducing disease transmission risks associated with sepsis in human cells, tissues, and cellular/tissue-based products (HCT/Ps). While supporting the FDA’s mission to enhance HCT/P safety, these organizations raise critical concerns about the proposed recommendations. They request clarification on prioritizing pathogens for screening, defining “suspicion of sepsis,” and standardizing terminology around timeframes. The groups also advocate for tailored approaches when dealing with cellular starting materials from healthy donors, suggesting modifications to screening processes and physical examinations. This comprehensive feedback underscores the complex interplay between ensuring product safety and maintaining practical, effective donation procedures in the vital field of blood and biotherapies.
