Dealing with the uncertain risk of variant C reutzfeldt‐ J akob disease transmission by coagulation replacement products

Summary The identification of variant Creutzfeldt‐Jakob disease (v CJD ) in the UK in 1996 led to significant concerns about the possibility of secondary transmission, however the prevalence of subclinical v CJD and risks of v CJD transmission by plasma are not known. In the UK , public health precautions have been implemented in all recipients of coagulation factor concentrates manufactured from UK plasma pools between 1980 and 2001. The recent demonstration of abnormal prion protein in a spleen sample at autopsy of a UK haemophilic patient who received coagulation factor concentrates to which a donor incubating v CJD had contributed most likely represents the first case of v CJD transmission by coagulation factor concentrates. We review the uncertainties that surround risk of v CJD transmission by coagulation factor concentrates, the challenges in dealing with undefined risks, the rationale behind current policies and the implementation of v CJD surveillance and risk management measures in bleeding disorder patients in the UK .