title: Evaluation of Risk Minimisation Measures for Blood Components - Based on Reporting Rates of Transfusion-Transmitted Reactions (1997-2013).
abstract: BACKGROUND
  To assess the impact of safety measures, we compared reporting rates of transfusion-related reactions before and after the implementation of six measures in 1999, 2004, 2006, 2008 and 2009.
  
  
  METHODS
  Reporting rates of transfusion-transmitted bacterial infection (TTBI), viral infection (TTVI) and immune-mediated transfusion-related acute lung injury (TRALI) were calculated on the basis of confirmed annual reports and distributed blood components.
  
  
  RESULTS
  The introduction of HCV NAT testing caused a significant reduction of HCV reporting rate from 1:0.6 to 1:83.16 million administered blood components (p < 0.0001), donor screening for antibodies to hepatitis B core antigen caused a reduction of HBV reporting rate from 1:2.90 to 1:10.70 million units (p = 0.0168). A significant reduction from 1:0.094 to 1:2.42 million fresh frozen plasma (FFP) units could also be achieved by risk minimisation TRALI measures (p < 0.0001). Implementation of pre-donation sampling did not result in a significant decrease in TTBI, whereas limitation of shelf life for platelet concentrate (PC) minimised the TTBI reporting rate from 1:0.088 to 1:0.19 million PC units (p = 0.041). For HIV NAT pool testing, no significant reduction in HIV transmission was found due to very low reporting rates (1:10 million versus 1:27 million blood components, p = 0.422).
  
  
  CONCLUSIONS
  On the basis of haemovigilance data, a significant benefit could be demonstrated for four of six implemented safety measures.
authors.affiliation: Division of Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institut, Langen, Germany.
authors.forename: Markus B
authors.initials: MB
authors.lastname: Funk
authors.affiliation: Division of Transfusion Medicine, Paul-Ehrlich-Institut, Langen, Germany.
authors.forename: Margarethe
authors.initials: M
authors.lastname: Heiden
authors.affiliation: Section of Biostatistics, Paul-Ehrlich-Institut, Langen, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Volkers
authors.affiliation: Division of Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institut, Langen, Germany.
authors.forename: Annette
authors.initials: A
authors.lastname: Lohmann
authors.affiliation: Division of Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institut, Langen, Germany.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Keller-Stanislawski
keywords: Blood components; Haemovigilance; Reporting rate; Risk minimisation measures; Transfusion reaction