The Generative Brain

Arbeitskreis Blut statement S 27 on variant CJD: exclusion criteria for blood and plasma donation (Germany, 6 December 2024)

S 27 is a statement of the Arbeitskreis Blut, the national expert advisory committee on blood that sits at the Robert Koch Institute, on donor exclusion criteria for blood and plasma donation linked to variant CJD. It was adopted on 6 December 2024, posted by the RKI on 3 February 2025 and printed in Bundesgesundheitsblatt 2025;68(5):562-566. According to search excerpts of the statement and of the Paul-Ehrlich-Institut (PEI) decision that followed, it reassesses the German rule, in place since 2001 and 2005, that excluded people who had spent more than 6 months in the UK between 1980 and 1996 or had surgery or a transfusion in the UK since 1980, and finds lifting that exclusion acceptable for donors of blood components and for plasma donors. The PEI then revoked its 2005 order on UK surgery and transfusion and the related warning in product information, and German blood services report that UK stays or births no longer exclude donors on their own. This makes Germany one of the countries that followed the EU reflection paper revision 3, which the statement cites. The statement text itself could not be read as text in this order, so the details below are marked by read depth. Information only, not medical, legal or regulatory advice.

Key facts

  • S 27 is titled as a statement on variant CJD exclusion criteria for blood and plasma donation; it was adopted at a meeting of the Arbeitskreis Blut on 6 December 2024. Springer and Europe PMC give the 96th meeting, the RKI page the 95th.
  • The RKI page gives a publication date of 3 February 2025; the journal version appeared online on 13 May 2025 in Bundesgesundheitsblatt 68(5):562-566 (DOI 10.1007/s00103-025-04025-5), listed by Europe PMC as a news item without abstract and behind a subscription.
  • The rule under review: since October 2001 Germany excluded donors with 6 months or more in the UK between 1980 and 1996, and from 1 May 2005 a PEI order barred starting material for whole blood, cellular components and plasma for transfusion from donors who had any operation or transfusion in the UK or Northern Ireland after 1 January 1980.
  • The 2005 order rested on two UK transfusion-associated vCJD cases, the lack of a blood screening test, leucodepletion judged useful but not reliable, and the risk from surgical instruments; cord blood was exempted.
  • Reasons for change reported in search excerpts of S 27: the last two UK vCJD cases occurred in 2013 and 2016, no UK transfusion transmission has been seen since 1999, and model calculations led the USA, Australia, Canada and Ireland to lift similar exclusions. (search excerpt only)
  • Outcome reported in search excerpts of the PEI revocation: lifting the exclusion after UK stay, surgery or transfusion is judged acceptable for donors of blood and blood components for transfusion, and also for plasma donation because manufacture of plasma derivatives adds prion-reducing purification steps. (search excerpt only)
  • The PEI published the revocation of its 4 April 2005 order (UK surgery or transfusion exclusion plus the product information warning) on 28 May 2025; the file is dated 16 May 2025.
  • The statement's reference list cites EMA CHMP reflection paper revision 3 (2024), the ECDC 2021 risk assessment and 2023 guidance on UK-stay donors, FDA 2022 guidance, the Australian TGA 2022 change, the UK SaBTO 2019 report, the PPTA prion removal data collection (Cai 2013), Thomas 2023 on UK plasma for fractionation, UK appendix and tonsil prevalence studies, and the 2005 Arbeitskreis Blut vCJD statement.
  • A regional German Red Cross blood service reported in December 2025 that UK births or stays between 1980 and 1996 no longer automatically exclude donors nationwide, with other exclusion reasons still applying, and its staff said the rule has applied there since 1 August 2025.
  • The federal blood donation information site still lists a general exclusion for anyone at risk of transmitting a transmissible spongiform encephalopathy such as CJD, without naming UK stays.
  • The RKI list of current Arbeitskreis Blut statements still includes the 2005 variant CJD statement and an undated statement on vCJD risk from plasma derivatives alongside S 27; a separate Votum 46 (2018) covers the procedure when vCJD arises in connection with blood, plasma and blood products.

Timeline

  1. 2001Germany excludes donors with 6 months or more in the UK between 1980 and 1996.
  2. 2005PEI orders exclusion of donors with surgery or transfusion in the UK after 1 January 1980, in force 1 May 2005 and published 7 May 2005.
  3. 2005Arbeitskreis Blut statement on variant CJD published (Bundesgesundheitsblatt 9/2005).
  4. 2018Arbeitskreis Blut Votum 46 on handling vCJD in blood, plasma and blood products published.
  5. 2024Arbeitskreis Blut adopts S 27.
  6. 2025RKI posts S 27.
  7. 2025S 27 published online in Bundesgesundheitsblatt (print issue May 2025).
  8. 2025PEI publishes revocation of its 2005 UK surgery and transfusion order.
  9. 2025A German Red Cross blood service applies the new rule (staff statement).
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