ISBT Global Blood Safety Working Party 2024-2025

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Chairperson and committee

Chairperson: Jay Epstein (USA)

Vice Chair: Silvano Wendel (Brazil)

Secretary: Thierry Burnouf (Taiwan)

Treasurer: Martin Smid (Netherlands)

Members at large:

Claude Tayou Tagny (Cameroon)

Nelson Tsuno (Japan)

Salwa Hindawi (Saudi Arabia)

Jean-Claude Faber (Luxembourg)

Susan Stramer (USA)


Membership

The Working Party currently has 68 members representing 31 different countries.

Presently 68 members from 31 countries with 4 new members and one loss (death of Dr. Dana Devine) during the year. Subgroups (No. of participants, chairpersons): “Voluntary versus Replacement Donation” (29, Nelson Tsuno); “Needs versus Demand” (30, Jean Stanley); “Safe Plasma Proteins” (22, Jean-Claude Faber and Thierry Burnouf); “Harmonization of Regulations and Standards” (17, Susan Stramer).


Meetings and Teleconferences

Plenary meeting of the WP: June 23, 2024 at the ISBT Congress in Barcelona

  • Invited Presentations:

- Blood Supply in the Dutch Caribbean, Prof. Ashley Duits

- Plasma fractionation infrastructure in Armenia, Dr. Mikayel Ginovyan

  • Subgroup reports

- General discussion

Meetings of the Organizing Committee

  • May 22, 2024:

- Preparation for the Business Meeting in Barcelona

- Opportunities for Cooperation with other WPs

  • November 1, 2024:

- Reflections on the Business Meeting in Barcelona

- Subgroup reports and plans

  • January 16, 2025:

- Preparation for the Business Meeting in Milan

- Recruitment of new ICSPP members after exiting by WFH and IPOPI in June 2024.

- Planning for OC elections


Activities during the period

Voluntary versus Replacement Blood Donation

  • Literature review on donation topics

- Review of donation incentives included a SWOT analysis.

- Review of motivators and deterrents is ongoing.

  • Interviews with countries close to 100% voluntary non-remunerated donation (VNRD) and surveys in those relying on family/replacement donations (FRD).

- Initial work involved interviews in countries with near-complete VNRD. A stakeholder questionnaire, based on member input, received responses from countries like Brazil, Finland, Georgia, Ghana, Indonesia, Japan, Oman, Saudi Arabia, Thailand, Turkey, and Malaysia.

- Data were analyzed using the PESTELE framework. Preliminary findings were presented at the ISBT Congress in Barcelona and a manuscript is in preparation.

  • Creation of regional groups to address local issues.

- Groups are being formed for Africa, Latin America, the Middle East, and Asia

- Discussions are ongoing on tools to help countries move from FRD to VNRD. One proposal includes a university student education program.

  • Assistance to WHO for review of upcoming WHO blood donation guidelines

Safe Plasma Proteins

ISBT Planning Group for ICSPP Steering Committee (SC) held regular planning and quarterly SC meetings.

  • Outreach to World Apheresis Association to join ICSPP
  • Progress in Ethiopia:
  • Adopted National Blood and Plasma Policy as a development framework.
  • WHO-supported training events.
  • May 2024 hybrid GMP training for blood establishments.
  • November 2024 webinar on “Strengthening Blood Systems through Regulation.”
  • February 2025 GMP "train-the-trainer" workshop addressing ICSPP audit findings at six key establishments.
  • New initiative with ISBT WP on Cellular Therapies: apheresis for cell products, plasma exchange, and plasma for fractionation.
  • Cooperation with AFRICARhE to explore local sourcing of anti-RhD plasma from previously pregnant women for preparing small-scale anti-D immunoglobulin.
  • Progress in Senegal:
  • Agreement with FIODS to mobilize donors, with potential support from African Society of General Medicine.

Other subgroup activities:

  • Revived project with Armauer Hansen Research Institute (AHRI), Addis Ababa, for local IgG production.
  • Ongoing VIPS support on facility design.
  • Planned Egypt training by Magdy El-Ekaiby.
  • Collaboration with WHO on cross-border plasma transfer guidance for PDMPs.
  • Advocated continued cryoprecipitate listing on WHO EMLs ; Supported WHO Survey on cryoprecipitate availability and use ; Submitted advocacy letter to EML Secretariat ; Reviewed 2025 EML Applications from WFH.

Need versus Demand

  • Literature review on best practices for assessing blood need/demand/supply gaps
  • Launched a project to measure gaps:
  • Pilot surveys in Ethiopia and Indonesia on maternal hemorrhage

- Phase 1: Retrospective data from national blood service, 2 blood establishments, and 4 hospitals per establishment (2 private, 2 public)

- Phase 2: Prospective data from same sites to validate phase 1

  • Reporting forms developed with local input; launch pending staff briefings

Harmonization of Regulations and Standards

  • Developed two manuscripts from a global survey (Oct 2023–Mar 2024) on TTID laws, regulations, standards, and practices. Respondents: 74 countries/regions (65 countries + Hong Kong and 8 regions). Data analyzed by World Bank Income level. Key findings:
  • 96% of respondents had regulatory authority over collection/processing; 94% nationally.
  • All reported screening for HIV, HBV, HCV; most for syphilis. Confirmatory testing common. NAT less frequent in lower-income countries.
  • Lower-income countries used fewer advanced methods: component separation, pathogen/leukocyte reduction, routine platelet bacterial testing.
  • All countries/regions provided donor education and deferred donors after reactive results.
  • Manuscript on laws, regulations and standards for blood/component collection and processing accepted by Vox Sanguinis
  • Manuscript on TTID testing and donor vigilance submitted to Vox Sanguinis

Working Party Publications

  • Farrugia A, Perry R, Rossi F, von Bonsdorff L, Bowie G, Faber J-C, et al. Generating pathways to domestically sourced plasma-derived medicinal products: Report from a workshop by the International Plasma and Fractionation Association and the Working Party on Global Blood Safety of the International Society of Blood Transfusion. Vox Sang 119(9):1012-1020,2024.
  • Burnouf T, Epstein J, Faber J-C, and Smid WM. Response to comments from the International Patient Organization for Primary Immunodeficiencies on “Stepwise options for preparing therapeutic plasma proteins from domestic plasma in low- and middle-income countries.” Vox Sang 119(9):1023-1024,2024.
  • Epstein JS, Maryuningsih Y, Faber J-C, Smid WM, and Burnouf T. Inclusion of cryoprecipitate, pathogen-reduced, in the WHO model lists of essential medicines for adults and children;a call for action. Blood Transfusion Medicine 22:481-483, 2024 doi:10.2450/BloodTransfus.687

Jay Epstein

ISBT Global Blood Safety Working Party Chairperson

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