Nationwide Implementation of Pathogen Inactivation for All Platelet Concentrates in Switzerland.

Introduction: Bacterial contamination of platelet concentrates (PCs) has been identified as the most prevalent transfusion-associated infectious risk. To prevent PC-related septic transfusion reactions, the Intercept® pathogen inactivation procedure was introduced for all PCs in Switzerland in 2011.

Methods: Based on numbers of transfused units and mandatorily reported adverse events with high imputability, we compare the risks associated with transfusion of conventional PCs (cPCs) and pathogen-inactivated PCs (PI-PCs).

Results: From 2005 to 2011, a total of 158,502 cPCs have been issued in Switzerland, and 16 transfusion-transmitted bacterial infections (including 3 fatalities) were reported. This corresponds to a morbidity and mortality rate of ca. 1:9,900 and 1:52,800, respectively. From 2011 to 2016, a total of 205,574 PI-PCs have been issued, and no transfusion-transmitted bacterial infection was reported. Despite continuously increasing transfusion reaction rates per 1,000 RBC and plasma issued between 2008 and 2016, we observed reductions of 66% for life-threatening and fatal reactions and of 26% for all high-imputability transfusion reactions related to PI-PCs as compared to cPCs. No increased rates of bleeding or clinical observations of ineffectiveness of PI-PCs have been reported. After implementation of PI-PCs, the annual increase in platelet usage per 1,000 inhabitants decelerated.

Discussion: Swiss hemovigilance data confirm a favorable safety profile of the nationwide introduced Intercept pathogen inactivation procedure and its reliable prevention of septic transfusion reactions and fatalities due to bacterially contaminated PCs.