Transfusion‐transmitted malaria in Europe and North America: Epidemiology, residual risk and implications for blood safety policies

Abstract Background and Objectives Transfusion‐transmitted malaria (TTM) is a rare but potentially severe transfusion complication. Increasing global mobility from malaria‐endemic regions challenges donor selection policies in non‐endemic settings, as asymptomatic parasitaemia may persist for years in previously exposed semi‐immune individuals. This review aims to contextualise the residual risk of TTM and critically appraise current and past preventive strategies considering available evidence, with particular attention to policy implications. Materials and Methods A literature review of all confirmed cases of TTM reported in Europe and North America between 2005 and 2024 was performed to retrospectively assess the effectiveness and limitations of past and current preventive strategies, with particular reference to the recommendations of the European Directorate for the Quality of Medicines & HealthCare (EDQM) Blood Guide and the U.S. Food and Drug Administration (FDA). Results Eighteen confirmed TTM cases were identified: 11 by Plasmodium falciparum with three fatalities, six by Plasmodium malariae and one by Plasmodium ovale . Sixteen cases were linked to donors born in or long‐term residents of malaria‐endemic regions, predominantly sub‐Saharan Africa; two involved short‐term European travellers. Since 2012, no P. falciparum TTM cases have been reported in Europe following the correct implementation of EDQM guidelines. Conclusion The residual risk of TTM in Europe and North America appears to be extremely low. However, long‐term asymptomatic carriers—particularly of P. falciparum —remain a potential threat. Approaches based on deferral and immunological testing appeared to be effective and sustainable; nevertheless, high‐sensitivity nucleic acid testing may represent a valuable alternative, particularly where blood availability is critical.