Hemovigilance monitoring of platelet septic reactions with effective bacterial protection systems
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Updated: Feb 24, 2026
Treatment of Platelet Products with Riboflavin and UV Light: Effectiveness Against High Titer Bacterial Contamination
Published on: August 24, 2015
Richard J Benjamin1, Thomas Braschler2, Tina Weingand3
1Cerus Corporation, Concord, California.
Background:
Delayed, large-volume bacterial culture and amotosalen/ultraviolet-A light pathogen reduction are effective at reducing the risk of bacterial proliferation in platelet concentrates (PCs). Hemovigilance programs continue to receive reports of suspected septic transfusion reactions, most with low imputability. Here, we compile national hemovigilance data to determine the relative efficacy of these interventions.
Study Design And Methods:
Annual reports from the United Kingdom, France, Switzerland, and Belgium were reviewed between 2005 and 2016 to assess the risk of bacterial contamination and septic reactions.
Results:
Approximately 1.65 million delayed, large-volume bacterial culture-screened PCs in the United Kingdom and 2.3 million amotosalen/ultraviolet-A-treated PCs worldwide were issued with no reported septic fatalities. One definite, one possible, and 12 undetermined/indeterminate septic reactions and eight contaminated "near misses" were reported with delayed, large-volume bacterial cultures between 2011 and 2016, for a lower false-negative culture rate than that in the previous 5 years (5.4 vs. 16.3 per million: odds ratio, 3.0; 95% confidence interval, 1.4-6.5). Together, the Belgian, Swiss, and French hemovigilance programs documented zero probable or definite/certain septic reactions with 609,290 amotosalen/ultraviolet-A-treated PCs (<1.6 per million). The rates were significantly lower than those reported with concurrently transfused, nonpathogen-reduced PCs in Belgium (<4.4 vs. 35.6 per million: odds ratio, 8.1; 95% confidence interval,1.1-353.3) and with historic septic reaction rates in Switzerland (<6.0 vs. 82.9 per million: odds ratio, 13.9; 95% confidence interval, 2.1-589.2), and the rates tended to be lower than those from concurrently transfused, nonpathogen-reduced PCs in France (<4.7 vs. 19.0 per million: odds ratio, 4.1; 95% confidence interval, 0.7-164.3).
Conclusion:
Pathogen reduction and bacterial culture both reduced the incidence of septic reactions, although under-reporting and strict imputability criteria resulted in an underestimation of risk.
Insights
Both bacterial culture and pathogen reduction significantly lower septic reactions in platelet concentrates. Hemovigilance data shows these methods are effective, though under-reporting may underestimate the true risk reduction.
Area of Science:
- Transfusion Medicine
- Infectious Disease Prevention
- Hematology
Background:
- Platelet concentrates (PCs) are susceptible to bacterial proliferation.
- Delayed, large-volume bacterial culture and amotosalen/ultraviolet-A light pathogen reduction are key safety interventions.
- Suspected septic transfusion reactions are reported to hemovigilance programs, necessitating efficacy assessment.
Purpose of the Study:
- To compare the relative efficacy of bacterial culture versus pathogen reduction in preventing septic reactions.
- To analyze national hemovigilance data for transfusion safety outcomes.
Main Methods:
- Review of annual hemovigilance reports from the UK, France, Switzerland, and Belgium (2005-2016).
- Assessment of bacterial contamination and septic reaction risks associated with different pathogen reduction strategies.
- Statistical analysis of reported septic reactions and near misses.
Main Results:
- Over 3.95 million PCs were analyzed, with zero reported septic fatalities for both methods.
- Delayed bacterial culture showed a decreased false-negative rate in later years.
- Amotosalen/ultraviolet-A treatment demonstrated significantly lower septic reaction rates compared to non-pathogen-reduced PCs in Belgium and Switzerland.
Conclusions:
- Both bacterial culture and pathogen reduction effectively decrease the incidence of septic transfusion reactions.
- Reported rates likely underestimate the true risk due to under-reporting and strict imputability criteria.
- These pathogen reduction strategies enhance the safety of platelet transfusions.
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