The U.S. Food and Drug Administration (FDA) recently released draft guidance aimed at reducing the risk of transfusion-transmitted malaria (TTM). This proposal has sparked significant debate within the blood banking community, as evidenced by the joint response from major organizations including the Association for the Advancement of Blood and Biotherapies (AABB), America’s Blood Centers (ABC), and the American Red Cross (ARC).
These stakeholders, while acknowledging malaria as a relevant transfusion-transmitted infection, raise critical concerns about the proposed changes. At the heart of their argument is the question of necessity: with current deferral policies already achieving a TTM risk of less than 1 per 10 million transfusions, is new testing truly warranted? The organizations contend that the proposed testing requirements would introduce substantial financial and operational burdens without a proportionate increase in safety.
The draft guidance suggests a shift from the current questionnaire-based deferral system to a selective testing approach. This change would necessitate complex modifications to blood establishment computer systems, extensive staff retraining, and potential logistical challenges in sample management and test ordering. Moreover, with only one FDA-approved malaria screening test currently available, the organizations also raise concerns about supply chain vulnerabilities.
Unintended consequences of the new approach are also highlighted, including the potential increased risk of other transfusion-transmitted diseases by testing rather than deferring recent travelers to endemic areas. The organizations argue for maintaining the option of the current questioning and deferral approach, conducting further real-world studies on test sensitivity, and extending the implementation period to at least 12 months if changes are mandated.