The ISBT Working Party for Global Blood Safety (GBS) aims to foster and support global improvements in blood safety and availability through research, collaboration, and capacity-building initiatives.
Chairperson and committee
Chairperson: Jay Epstein (USA)
Vice Chair: Silvano Wendel (Brazil)
Secretary: Nelson H Tsuno (Japan)
Treasurer: Martin Smid (Netherlands)
Members at large:
Steve Fonkou (Cameroon)
Susan Stramer (United States)
Divot Singh Lamba (India)
Salwa Hindawi (Saudi Arabia)
Mikayel Ginovyan (Armenia)
Chair Subgroups:
Safe Plasma Proteins (15)
- Chair: Thierry Burnouf (Taiwan)
- Co-chair: Steve Fonkou (Cameroon)
Host of the International Coalition for Safe Plasma Proteins (ICSPP)
- ISBT lead representative and Chair: Jay Epstein (United States)
- ISBT alternate representative: Thierry Burnouf (Taiwan)
Voluntary vs. Replacement Donation (23)
- Chair: Nelson H Tsuno (Japan)
Harmonization of Regulations and Standards (7)
- Chair: Susan Stramer (USA)
- Technical Lead: Galen Conti (USA)
Need vs. Demand (25)
- Chair: Jean Stanley (USA)
Membership
The Working Party has 64 current members from 26 countries with a wide range of expertise in transfusion medicine, blood safety, and public health collectively representing all global regions. Seven new members joined during the reporting period while 10 members were lost (one death, 9 either withdrew or failed to renew ISBT membership). Membership spans high-, middle- and low-income settings, enabling a global perspective on challenges to blood safety and availability including access to plasma-derived medicinal products. Efforts are ongoing to further expand participation, particularly from underrepresented regions, and to establish collaborative projects with other Working Parties.
Meetings
GBS Business Meeting at the ISBT Congress, Milan (June 2025) - hybrid
- Keynote presentation by Ashenafi Tazebew Amare, Director General of the Ethiopian Blood and Tissue Bank Service.
- Subgroup updates:
- Findings of an international survey on TTID related laws, regulations, standards and practices
- Interviews in eleven countries with close to 100% VNRD, and PESTELE analysis
- WHO/ICSPP webinar and workshop trainings on blood regulation and GMP
- Launch of a survey project in Indonesia to estimate gaps in blood need vs. supply
Organizing Committee
- Virtual meetings were held on 28 April, 8 July, 30 September and 10 December 2025
- Topics included preparation of the 2024 Annual Report, organization of elections, preparation for the GBS business meeting in Milan, revision of the GBS TORs, review of the ISBT revised Code of Ethics, advocacy for continued WHO support of blood systems, and overview of subgroup activities and plans
Subgroup Meetings:
- Each subgroup met virtually at least monthly
- The ICSPP Steering Committee met on 24 March, 25 June, 22 September and 9 December
- Key topics discussed in the subgroup meetings included:
- A regional survey on plasma management in Eastern Europe
- An initiative in Ethiopia on use of domestic plasma to provide access to anti-D immune globulin through contract fractionation
- Transition from replacement to voluntary non-remunerated blood donation (VNRD) and use of the PESTELE framework in data analysis
- Development of follow-on surveys to better understand blood safety practices and regulatory frameworks relevant to TTIDs
- A survey in two regions of Indonesia on availability of blood and peripartum blood use
These meetings resulted in strengthened collaborations, alignment of subgroup activities, and development of future research and policy initiatives.
ISBT Representation at External Meetings
- African Blood Regulators Technical Committee Meeting (Nairobi, Kenya, May 2025):
- Reconstitution of the committee
- Revision of Terms of Reference
- Leadership elections and discussion of ISBT support
WHO Drafting Groups
- Implementing cross-border transfer of domestic plasma to obtain plasma-derived medicinal products: policy guidance
- Action framework to advance universal access to safe, effective and quality-assured blood products 2026–2030
- Updated guidance on donor selection
One World One Blood – International Cooperation in Transfusion Medicine (15 October 2025, Bologna, Italy)
Activities during the period
Major Projects and Initiatives
- Safe Plasma Proteins (SPP):
- Implementation of projects in Africa, including diagnostic capacity development for inherited clotting disorders in Senegal and for primary immunodeficiency in Ethiopia
- AFRICARhE project exploring domestic production of anti-D immunoglobulin
- Survey in Eastern Europe assessing PDMP availability, with PESTELE-based analysis underway
- Voluntary vs. Replacement Donation:
- Global survey assessing progress toward 100% VNRD
- Analysis using the PESTELE framework to identify systemic barriers and enablers
- Development of a tabletop exercise to generate knowledge on transition pathways to VNRD, with planned pilot implementation
- Development of a “Marketplace” model for donor recruitment strategies in collaboration with the ISBT Donors & Donations Working Party
- Harmonization:
- Completion of a major international survey (131 responses from 65 countries) on transfusion-transmitted infection (TTI) safety
- Development of two follow-up surveys focusing on advanced safety technologies and donor/hemovigilance systems
- Need vs Demand:
- Ongoing research project to model gaps between blood need, demand, and supply under routine conditions, with a specific focus on obstetrical hemorrhage
- Initial pilot survey conducted in collaboration with the Indonesian Red Cross and selected hospitals in Bekasi and Boyolali regions
- Planned implementation of a 12-month prospective study using REDCap for monthly data collection
- Ongoing research project to model gaps between blood need, demand, and supply under routine conditions, with a specific focus on obstetrical hemorrhage
Scientific / Technical Progress
- Application of structured analytical frameworks (PESTELE) across multiple subgroup activities
- Identification of disparities in implementation of advanced safety measures (e.g., NAT, pathogen reduction) in low- and middle- income countries
- Advancement of methodological approaches to assess real-world transfusion needs, including prospective clinician-level data collection
- Expansion toward mixed-methods research, including planned semi-structured interviews and design of a tabletop exercise on pathways towards 100% VNRD
Collaboration and Partnerships
- Engaged in cooperative activities with WHO to develop policy and guidance
- Expanded membership of the International Coalition for Safe Plasma Proteins (ICSPP) to include AABB and World Apheresis Association
- Established a collaboration with the the AFRICARhE project of the Worldwide Initiative for Rh Disease Eradication (WIRhE) to provide access to anti-D immune globulin in Ethiopia through fractionation of anti-D positive domestic plasma consistent with the ongoing ICSPP project in that country
- Cooperated with the Indonesian Red Cross and hospital networks for need versus demand modeling
- Continued involvements with African regulatory networks and global policy initiatives
- Established a collaboration with the ISBT Donors and Donations Working Party (D&D-WP) on advancement of progress towards 100% VNRD
- Engaged with Prof. Na Li, Ph.D., at University of Calgary on modeling of blood need
Education and Outreach
- Presentations at the ISBT Congress in Milan 2025
- Presentations about stepwise access to safe plasma proteins initiative (AATM Mumbai 2025; AfSBT Windhoek 2026)
- Contribution to African Blood Regulator Technical Committee activities
- Ongoing knowledge exchange initiatives to support VNRD transition
Training / Workshops / Events
- Participation in international regulatory and technical workshops (e.g., Nairobi 2025)
Other Activities
Advocacy for inclusion of cryoprecipitates as essential blood products in WHO Model Lists of Essential Medicines
Working Party Publications
Challenges and Opportunities
Key challenges included limited participation from underrepresented regions in global surveys, as well as variability in regulatory implementation and enforcement across countries. Ethical review processes for multi-country survey-based research also introduced additional complexity, while resource constraints limited the implementation of advanced safety technologies in some settings. Operational barriers further affected need-demand studies, particularly through language differences, time zone challenges, and limited clinician engagement.
At the same time, several important opportunities were identified. These included the expansion of PESTELE-based analytical approaches, stronger partnerships with the WHO and regional organizations, and the development of innovative models such as donor recruitment “Marketplace” systems. There was also growing emphasis on implementation science and capacity-building, alongside advances in prospective data collection methodologies to better quantify clinical blood needs.
Summary
In 2025, the GBS achieved substantial progress in advancing global blood safety through coordinated efforts across its subgroups. Key achievements include large-scale international surveys, expansion of strategic partnerships, contributions to WHO policy development, and advancement of initiatives to improve access to safe blood and plasma products in Ethiopia and Senegal.
Work of the Need vs Demand subgroup further strengthens the Working Party’s ability to address fundamental gaps between clinical need and blood supply. The integration of structured analytical frameworks, particularly PESTELE, alongside innovative data collection approaches, enhances the capacity to generate actionable insights. New memberships in the ICSPP will enhance its effectiveness. These efforts collectively support evidence-based policy, improved clinical practice, and strengthened blood systems globally.
