The safety of fibrin sealants.
Fibrin sealants are prepared from fibrinogen, thrombin and sometimes also factor XIII that have been purified from human plasma. Bovine aprotinin is also included in some preparations. Each of these components has the potential to carry blood-borne pathogens, albeit at a very low frequency. In order to minimize the risk of viral transmission from commercial fibrin sealants, plasma donations undergo a series of procedures that contribute to avoiding, inactivating and eliminating potential contaminants. The procedures for selection and screening of plasma donors, and the testing of donated plasma, incorporates highly sensitive molecular techniques (e.g. PCR testing) and contributes significantly to reducing the theoretical possibility of viral transmission. The starting material for bovine aprotinin is also carefully selected, and the manufacturing process rigorously assessed, to minimize the putative risk of transmission of bovine spongiform encephalopathies. The manufacturing process for commercial fibrin sealants comprises a range of procedures, including heat treatment (e.g. pasteurization, dry or vapor heating), filtration, solvent/detergent treatment, precipitation, pH treatment and chromatography. Some steps are an inherent part of the purification process and others (e.g. pasteurization, nanofiltration) are deliberately introduced to inactivate/eliminate potential pathogens. Current manufacturing processes provide a very high degree of safety for fibrin sealants. In 20 years of worldwide use, there have been no known cases of hepatitis or HIV transmission associated with the use of commercial fibrin sealants.
Joch
Christine
C
Global Drug Surveillance, Aventis Behring GmbH, PO Box 1230, D-35002 Marburg, Germany. christine.joch@aventis.com
D001771:Blood Banks; D003257:Consumer Product Safety; D004345:Drug Industry; D015718:Fibrin Tissue Adhesive / Q000737:chemistry*; D006801:Humans; D011786:Quality Control; D014777:Virus Diseases / Q000517:prevention & control / Q000635:transmission
D015718:Fibrin Tissue Adhesive