title: [Evaluation of measures aimed to reduce serious adverse transfusion reactions (hemovigilance data from 1997 to 2008)].
abstract: On the basis of reports of serious transfusion reactions, measures aimed to improve the safety standard of the manufacturing process of blood components were evaluated from 1997-2008. Measures of the Paul-Ehrlich-Institut (PEI) as well as recommendations of the Advisory Committee "Blood" were considered. Reporting frequencies before and after the implementation of measures were compared. After the implementation of NAT pool testing, a reduction of virus transmission was seen for red blood cell concentrates (RBC) from 1.0/10(6) to 0.5/10(6) units and for platelet concentrates (PC) from 3.0/10(6) to 0.0/10(6) units. After the implementation of a pre-donation sampling, however, no reduction of bacterial infections associated with PC administration (>9.0/10(6)) was identified. To reduce the frequency of TRALI associated with FFP administration (11.2/10(6) units), the use of plasma from male donors or female donors without a history of pregnancy was established in September 2009. Without specific measures of risk reduction, the reporting frequency of severe allergic transfusion reaction increased for all blood components during the investigation period (from 0.8/10(6) to 6.2/10(6) RBC units). The benefit of measures to improve safety standards should be evaluated repeatedly by collecting precise hemovigilance data.
authors.affiliation: Referat S2 Pharmakovigilanz II, Paul-Ehrlich-Institut, Paul-Ehrlich-Str. 51-59, 63225, Langen, Deutschland. funma@pei.de
authors.forename: M B
authors.initials: MB
authors.lastname: Funk
authors.forename: S
authors.initials: S
authors.lastname: Günay
authors.forename: A
authors.initials: A
authors.lastname: Lohmann
authors.forename: O
authors.initials: O
authors.lastname: Henseler
authors.forename: B
authors.initials: B
authors.lastname: Keller-Stanislawski
mesh_terms: D001803:Blood Transfusion / Q000592:standards* / Q000706:statistics & numerical data*; D003140:Communicable Disease Control / Q000706:statistics & numerical data*; D003141:Communicable Diseases / Q000453:epidemiology*; D005260:Female; D005858:Germany / Q000453:epidemiology; D019983:Guideline Adherence / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D019221:Mandatory Reporting; D017410:Practice Guidelines as Topic; D011247:Pregnancy