Updated Recommendations for Reducing the Risk of CJD and vCJD by Blood and Blood Components

Recommendation

7/8 May 2024

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Regulatory Requirements and Practical Implementation

We had already reported in the past on assessments and recommendations by the authorities to reduce the risk of transmission of Creutzfeldt-Jakob Disease (CJD and vCJD). Now, the FDA has revised these recommendations and published a new draft guideline entitled "Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components".

The purpose of the guideline is to provide updated recommendations to blood establishments collecting blood and/or blood components to reduce the possible risk of transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by blood and blood components. This concerns the collection of whole blood and blood components intended for transfusion or for use in further processing, including source plasma. The following recommendation on donor screening has been revised or deleted:

• Geographical risk of possible exposure to bovine spongiform encephalopathy, including time spent on United States (US) military bases in Europe;
• receipt of blood transfusion in certain vCJD risk countries;
• risk factors for iatrogenic CJD (i.e. a history of taking human cadaveric growth hormone (hGH) derived from the pituitary gland);
• having blood relatives with CJD;
• existing history of injection of bovine insulin.

The new guideline replaces the previous document entitled "Amendment to 'Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products". After finalisation, the recommendation "Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products, Guidance for Industry" will also be replaced.

Further details can be found directly in the draft guideline "Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components".