Donor Prion Disease Precautions

Principle:

Prion diseases, including variant Creutzfeld-Jakob disease (mad cow disease), can be efficiently transmitted by transfusion of blood components.  Since there is a variable, often long (measured in months to years) incubation time before the disease is manifest, it is important to note individuals at high-risk and exclude them from the donor pool.

This is the August 2020 revision of the previous CBER recommendation on this topic.

Policy:

The following categories of individuals are permanently prohibited from donation (whole blood, apheresis, or organ):

  1. Anyone who received human growth hormone derived from human pituitary glands
  2. Anyone who received dura mater grafts
  3. Anyone from families with a history of Creutzfeld-Jakob Disease or other prion diseases (including variant Creutzfeld-Jakob—Mad Cow Disease, Gerstmann-Straussler-Scheinker Syndrome, Fatal Familial Insomnia, Kuru)
  4. Anyone with a family history of dementia or any other chronic neurologic illnesses
  5. Anyone with first-degree relatives (parent, sibling, children) who have a prion disease
  6. Anyone who has used (injected) bovine insulin of UK origin since 1980
  7. Defer indefinitely a donor who has spent five years or more cumulatively in France or Ireland from 1980 to 2001.
  8. Anyone having resided in the United Kingdom or visited there for a total of at least three months between 1980-96
  9. Anyone who received a blood component transfusion in the United Kingdom, France, or Ireland since 1980.

Definitions:

  1. For the purposes of this policy, the United Kingdom UK is defined as any one of the following areas:  England, Northern Ireland, Scotland, Wales, Isle of Man, Gibraltar, Channel Islands, or the Falkland Islands.
  2. France refers only to mainland France and NOT to French overseas departments, e.g. Martinique, French Guiana, Guadeloupe, Mayotte, and Réunion

All donors (except autologous) must be asked questions to rule out any of the above possibilities.

References:

  1. Recommendations to Reduce the Possible Risk of Transmission of Creutzfeld-Jakob Disease and Variant Creutzfeld-Jakob Disease by Blood and Blood Components, Guidance for Industry, US Department for Health and Human Services. FDA, Center for Biologics Evaluation and Research CBER, August, 2020
  2. Association Bulletin #02-2, American Association of Blood Banks, Bethesda, Maryland, USA, 8/3/02
  3. FDA Guidance for Industry:  Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeld-Jakob and Variant Creutzfeld-Jakob Disease by Blood and Blood Products, FDA Guidance for Industry, 9/1/2002
  4. Belay E.D. and Schonberger L.B., The Public Health Impact of Prion Diseases, Annu. Rev. Public Health 2005. 26:191–212, Division of Viral and Rickettsial Diseases, Centers for Disease Control and Prevention, Atlanta Georgia,
  5. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
  6. Guidelines to the Preparation, Use, and Quality Assurance of Blood Components, European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS), Current Edition