America’s Blood Centers (ABC), the Association for the Advancement of Blood and Biotherapies (AABB), and the American Red Cross (ARC) submitted this joint comment letter to the FDA, offering critical feedback on recent guidance for human cells, tissues, and cellular and tissue-based products (HCT/Ps).
The blood community is requesting a clear direction on prioritizing the myriad of potential sepsis-causing pathogens for screening, emphasizing the need for focused testing efforts. It is also seeking clarification on the most effective pathogen testing methodologies to ensure accurate and timely donor eligibility determinations. A key point of discussion is the need for precise, evidence-based criteria to evaluate HCT/P donors for systemic infection, given the complex nature of sepsis symptoms and their potential overlap with non-infectious conditions. The letter highlights inconsistencies in terminology between different sections of the guidance, which could lead to misinterpretations in donor eligibility assessments. Additionally, the letter calls for clarification on physical assessment protocols for donors of cellular starting materials, particularly in collection facilities.
This collaborative effort aims to enhance the safety and efficacy of HCT/Ps, ultimately benefiting both the medical community and patients. For those involved in transfusion medicine, biotherapies, and related areas, this letter provides invaluable insights into current challenges in HCT/P safety and expert recommendations for improvement.