Recommendations to reduce the possible risk of transmission of Creutzfeldt-Jakob disease and variant Creutzfeldt-Jakob disease by blood and blood components
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services. issuing body. United States. Food and Drug Administration. issuing body. Center for Biologics Evaluaton and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Biologics Evaluation and Research, August 2020
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Blood Donors Blood Transfusion Creutzfeldt-Jakob Syndrome -- prevention & control Creutzfeldt-Jakob Syndrome -- transmission United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Genre(s):
- Technical Report
- Abstract:
- We, FDA, are issuing this guidance document to provide you, blood establishments that collect blood and blood components, with revised recommendations intended to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood components. The recommendations in this guidance apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing, including Source Plasma. We are revising or removing our prior recommendations to screen blood donors for: 1) geographic risk of possible exposure to bovine spongiform encephalopathy, including time spent on United States (U.S.) military bases in Europe; 2) receipt of a blood transfusion in certain vCJD risk countries; 3) risk factors for iatrogenic CJD (i.e., a history of taking cadaveric pituitary human growth hormone (hGH)); 4) having blood relatives with CJD; and 5) a history of injecting bovine insulin. These changes are summarized in the Appendix of this guidance. This guidance updates the guidance of the same title dated April 2020. The April 2020 guidance finalized the draft guidance of the same title, dated January 2020, and superseded the document entitled “Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob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” dated May 2010 and updated January 2016 (2016 guidance).
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (i, 17 pages)).
- NLM Unique ID:
- 9918227270606676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918227270606676