Creutzfeldt-Jakob disease: current U.S. policy to further reduce the possible risk of transmission by transfusion

Biologicals : Journal of the International Association of Biological Standardization
D Menache, J P O'Malley

Abstract

Because the results of epidemiological and subhuman primate studies conducted over the last quarter of a century have failed to show a statistically significant risk of transmission of CJD by transfusion of blood components or plasma derivatives, the FDA's position is that only a theoretical low risk of CJD transmission cannot be excluded at this time. Consequently, FDA issued two memoranda on 8 August 1995 as updated interim policy documents recommending: (1) permanent deferral from donating blood or plasma for all persons who state at the time of donation, or for whom post donation information becomes available, that they have ever received pit-hGh, a dura mater transplant graft, or have a blood relative history of CJD, unless this increased risk for CJD is excluded on the basis of genetic analysis testing; (2) the quarantining of all undistributed in-date units of blood or blood components collected from either of these three groups of donors together with notification of all consignees of such in-date units so that distributed units also can be quarantined and recipient tracing and notification may be effected, and (3) the withdrawal from distribution and quarantining of in-date plasma derivative products derived from plasm...Continue Reading

Citations

Oct 16, 1999·British Journal of Haematology·M Turner
May 16, 2002·Haemophilia : the Official Journal of the World Federation of Hemophilia·B L EvattJ T Wilde
May 16, 2002·Haemophilia : the Official Journal of the World Federation of Hemophilia·A Farrugia
Jan 26, 1999·European Journal of Haematology·A C MoorA Brand

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