Blood Use in Normothermic Machine Perfusion: Regulatory Gaps, Patient Safety Risks, and the Urgent Need for Standardized Practice

Proposed Session Description: Normothermic Machine Perfusion (NMP) technologies have rapidly expanded across solid organ transplantation, requiring routine use of red blood cells (RBCs) during organ procurement and transport. Despite widespread adoption, there is no clear regulatory, accreditation, or evidence-based framework governing how blood products used for NMP should be ordered, issued, documented, billed, tracked, or regulated.

This interprofessional education session will present results from a national survey of transfusion services examining current practices for RBC support of NMP devices. Survey findings reveal marked variability and systemic gaps across institutions, including inconsistent EMR and LIS documentation, unclear regulatory classification (transfusion vs perfusion), absence of standardized component selection criteria, inconsistent lookback and recall processes, billing ambiguity, and reported wastage and compliance concerns.

Using real-world scenarios and case-based discussion, this session will examine how these gaps create patient safety risks, regulatory vulnerability, and operational inefficiencies for transfusion services, transplant programs, and hospitals. Faculty from transfusion medicine and laboratory leadership will guide participants through critical decision points encountered by multidisciplinary teams and highlight areas where current practice diverges from established transfusion safety principles.

The session will conclude with a call to action for AABB members and stakeholders to engage in collaborative efforts toward standardization, guidance development, and evidence generation to support safe, compliant, and sustainable transfusion practices for emerging organ perfusion technologies.