Creutzfeldt-Jakob disease: Current US policy to further reduce the possible risk of transmission by transfusion

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 plasma pools containing a unit from either of these three groups of donors at known high risk for CJD, or donors subsequently diagnosed as having CJD. Consignees of these products are to be notified in order that they, in turn, may inform physicians or other qualified personnel responsible for the care of product recipients to provide counseling as deemed medically appropriate. The 'family history of CJD' criterion was further clarified to mean a 'history of CJD in 2 or more family members' during the BPAC meeting of 14 December 1995. In a workshop meeting on 29 January 1996 the FDA urged that additional laboratory animal data be generated by plasma derivative manufacturers in order to ascertain if the sterilization steps used in their production of plasma derivatives further reduce the risk of transmission of CJD. (C) 1996 The International Association of Biological Standardization