Nationwide Implementation of Pathogen Inactivation for All Platelet Concentrates in Switzerland

Abstract

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.

Microbiological Screening of Platelet Concentrates in Europe

“…Since 2008, the reduced PC storage time led to a reduction in reported transfusion incidents by approximately 50% in comparison to the period before introduction of this measure, thus, resulting in a total of 5.3 cases per 10 6 platelet units. Interestingly, however, the analysis of hemovigilance data from 2005 to 2010 in Switzerland documented that the frequency of transfusion-transmitted bacterial infections was almost equally distributed among PC stored for 5 or 4 days [28]. Thus, prevention of 50% of TTID might represent the maximum benefit to be expected from PC storage time reduction to 4 days.…”

“…A similar situation is found in Switzerland, where the Intercept system was generally introduced in 2011. Recently, Jutzi et al [28] assessed the implementation of PR by comparing the number of reported adverse reactions related to both traditional and PR-treated PC. Before PR implementation, 2–4 septic reactions per year or 125 adverse reactions per million platelets units were reported.…”

Microbial safety of cellular therapeutics—lessons from over ten years’ experience in microbial safety of platelet concentrates

“…Collectively, these have proven very effective in reducing the rates of bacterial contamination and associated septic transfusions reactions by 50 to 75% . Nonetheless, the residual contamination risk is approximately 1 in 10 000 transfused PCs with nonfatal reactions occurring in 1 in 100 000 and fatal reactions in 1 in 500 000 transfused PCs, respectively, further action is needed .…”

Hemovigilance

“…In 2014 several papers considered the influence of blood product characteristics or modifications on product safety and transfusion efficacy [2][3][4][5][6]. The current issue deals with the nationwide implementation of pathogen inactivation (PI) for all platelet concentrates (PC) in Switzerland, as presented by Markus Jutzi and colleagues [7]. One of their major aims was to eliminate bacterial infections due to PC transfusion.…”

“…One of their major aims was to eliminate bacterial infections due to PC transfusion. Jutzi et al [7] reported that PI was successful to reduce the PC bacterial infection rate in Switzerland since 2011 to zero. The focus of this issue, however, is the interaction between the Rhesus blood group system and the recipients of red blood cell (RBC) components and/or PC [8][9][10][11].…”