MASAC Recommendation #37
MASAC RESOLUTION CONCERNING PARVOVIRUS TRANSMISSION BY CLOTTING FACTOR CONCENTRATES
Approved by the Medical and Scientific Advisory Council (MASAC), July 9, 1994. Approved by the NHF Executive Committee, August 2, 1994
1) In view of the documented risk of transmission of parvovirus B19 to individuals with hemophilia who receive plasma-derived clotting factor concentrates regardless of virucidal steps employed during manufacture, and
2) In view of the known and currently unknown potential sequelae associated with parvovirus B19 infection in individuals immuno-compromised by HIV, pregnant women and individuals with anemia, and
3) In view that parvovirus B19 is representative of other potential pathogens that can be transmitted in plasma derived products and that may be resistant to currently unavailable virucidal measures, and
4) In view that certain persons with hemophilia are at risk of extraordinary exposure to parvovirus B19, (i.e. use of plasma-derived clotting factor concentrates for prophylaxis or induction of immune tolerance).
MASAC strongly recommends that:
1) It be incumbent upon the Food and Drug Administration (FDA) and manufacturers of clotting factor concentrates to develop methods to eliminate Parvovirus B19 infection from all clotting factor products both licensed and those awaiting FDA approval.
2) Furthermore, the FDA, National Heart Lung and Blood Institute (NHLBI) and the Centers for Disease Control and Prevention (CDC) should commit funding to support longitudinal surveillance and clinical evaluation of HIV-positive and negative individuals with hemophilia, previously exposed to parvovirus B19, in order to determine the long-term effects of this infection upon health status.
3) Finally, all licensed blood products which potentially contain live parvovirus and other viruses, should display this information in the product inserts.