Independent report

SaBTO: Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) annual report 2024 to 2025

Published 14 July 2026

Introduction

This report covers the: 

• 57th meeting of the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) on 5 March 2025
• 58th meeting of SaBTO on 4 June 2025
• 59th meeting of SaBTO on 11 September 2025
• 60th meeting of SaBTO on 3 December 2025
• broader activities of working groups and contributions to the committee

Topics considered in December 2024 to December 2025

Consent for Blood Transfusion Working Group

Following the Infected Blood Inquiry, the Consent Working Group was formed to review previous guidance published by SaBTO in 2020. The updated consent guidelines were published in November 2025. The report was also published in the British Journal of Haematology. Guidance now includes advice for the transfusion of neonates and children.

Pathogen Reduction Technologies Working Group

The Pathogen Reduction Technologies (PRT) Working Group met 3 times and made progress on its review in line with its agreed terms of reference. The group’s remit includes:

• reviewing SaBTO’s existing recommendations on PRT (originally agreed in 2014 and reviewed in 2022)
• assessing technological developments
• identifying emerging patient safety risks to determine whether further policy review is required

Membership is being finalised, with a haematologist representative yet to be appointed. SaBTO’s new health economist has now joined the group.

The group has focused on engagement with commercial PRT providers, gathering up to date information on technological advancements since 2014. Following these discussions, the group will present an update to SaBTO outlining whether further review work is necessary at this time, including any potential policy implications, costs, benefits and associated risks.

EU SoHO Regulation

The Substances of Human Origin (SoHO) Regulation Review Programme launched in 2024 to consider recent changes that the EU has made through its SoHO Regulation ((EU) 2024/1938) as well as stakeholder proposals for legislation in this area. It is reviewing:

• patient safety
• the internal United Kingdom and UK-EU supply of SoHO
• innovation within the sector
• health inequalities

To support public health and the movement of SoHO, the review’s main principle is to maintain compatible high levels of minimum safety and quality standards for:

• blood
• blood components
• tissues and cells
• human breast milk
• intestinal microbiota
• blood preparations that are not used for transfusion

The SoHO Regulation Review Working Group carried out a gap analysis of the EU SoHO Regulation and current UK legislation in 2025. As part of phase 2 of the review, the Department of Health and Social Care (DHSC) launched a call for evidence on 25 March 2026. It will give stakeholders the opportunity to share views and highlight important issues and opportunities. Once the review has concluded a decision will be made about potential changes to legislation.

Health Economics Working Group

Members considered the need for a further paper to clarify principles of cost‑effectiveness, including:

• the rationale behind threshold selection
• the importance of recognising opportunity cost within the health system

The committee noted that although the current National Institute for Health and Care Excellence (NICE) cost‑effectiveness threshold is £20,000 to £30,000 per quality adjusted life year (QALY) (with planned changes to £25,000 to £35,000 for new medicines), some health economists argue that even these values may underestimate the true opportunity cost to the NHS.

Members discussed the application of incremental analysis in the context of strongyloides testing and recognised the need to take a broader view of outcomes when assessing cost‑effectiveness. They acknowledged that such approaches involve complex methodologies and require significant analytical time and resource.

Looking ahead, the committee agreed that tailored health economic models would be developed for individual issues as needed. For example, assessing the cost‑effectiveness of strongyloides testing would be comparatively straightforward, whereas modelling for interventions such as anti‑hepatitis B core (HBc) antigen testing would require a more extensive analytical framework.

Occult Hepatitis B Infection Review Group

The Occult Hepatitis B Infection (OBI) Review Group reported on the impact of anti-HBc antigen testing introduced in 2022. Findings included:

• more donors with OBI were identified than previously anticipated, with 25 OBI cases detected that would have been missed through pooled nucleic acid testing (NAT)
• the assay showed some false reactivity resulting in some donors being excluded despite lacking other hepatitis B virus (HBV) markers
• around 5,000 donors were deferred and this disproportionately affected donors of Black and Asian heritage
• no transfusion‑transmitted HBV infections have been identified since testing began, and lookback investigations confirmed no missed transmissions

A new economic appraisal, as recommended in the 2023 report, has not yet been completed but is in progress.

Members unanimously supported continuing anti‑HBc testing. The committee also discussed possible approaches to reinstating certain deferred donors, particularly those disproportionately affected. Potential options include applying individual donor-nucleic acid testing (ID‑NAT) testing at each donation for selected donor categories, informed by Scottish data showing intermittent NAT positivity in similar cases. The group agreed that the OBI review group had fulfilled its remit and should now stand down.

Creutzfeldt-Jakob disease (CJD) review

The Creutzfeldt-Jakob disease (CJD) Review Group has completed its report on potential changes to donor selection criteria on the risk of transmission of CJD to recipients of blood, tissues and organs after incorporating feedback from both SaBTO and its own members. A report has been approved by SaBTO.

Amyloid Beta Pathologies Working Group

The Amyloid Beta (AB) Pathologies Working Group, chaired by Professor Jean Manson, has a remit to evaluate the potential transmission risks of AB pathologies from donation of blood, tissues and organs. It will:

• explore surveillance options
• assess blood-based tests for AB pathologies, monitoring international initiatives, and encouraging research funding
• consider the financial and logistical implications of introducing such tests

The group’s membership is expected to evolve as additional expertise is brought in to support these goals.

Donor Organ Risk Assessment (DORA)

The Donor Organ Risk Assessment (DORA) Working Group:

• updated the terms of reference reaffirming that responsibility for explaining risk-benefit decisions to patients lies with clinicians rather than DORA
• agreed to provide guidance on the safety of vascular composite allografts
• agreed to set up a working group to explore organ donor characterisation to provide guidance on which screening tests should be available at the time of transplantation
• is developing a report on donor to recipient transmission events amid concerns of significant under reporting, potentially due to low recognition of transmission risks and varying thresholds for confirming events. DORA will collaborate with Serious Hazards of Transfusion (SHOT) to improve reporting guidance
• is updating guidance on donors with cancer, especially brain tumours
• is reviewing the microbiological safety of solid organ perfusion technologies

Human Herpesvirus 8 Working Group

The Human Herpesvirus 8 (HHV‑8) Working Group presented its report at the June 2025 SaBTO meeting. There was consensus on the need to move towards pre‑donation HHV‑8 testing to better identify high‑risk organ donors, though interim risk‑reduction measures are required. Interim recommendations include:

• continued universal antibody screening
• the introduction of sensitive HHV‑8 DNA testing for all deceased donors, alongside development of validated pre‑donation pathways
• screening for living donors by validated serology (or NAT where appropriate)
• additional NAT testing for seropositive individuals, with results centrally recorded and monitored

SaBTO:

• supported the recommendations as interim measures
• agreed further work is needed on implementation
• requested an update from the working group within 12 months

Membership

Full list of members, December 2024 to December 2025

Members during the period December 2024 to December 2025 were:

• Professor James Neuberger (chair)
• Dr Su Brailsford
• Dr Gail Miflin
• Professor Jean Manson
• Professor Mike Murphy
• Professor Peter Simmonds
• Mr Roger Graham
• Professor Will Irving
• Professor Yacoub Khalaf
• Professor Marc Turner
• Ms Charlotte Silver (to May 2025)
• Professor Richard Fordham (to September 2025)
• Dr Ines Ushiro-Lumb
• Dr George Greenhall
• Mr Aman Dhesi
• Dr Sharon Zahra
• Professor Mark Vickers
• Dr Adnan Sharif
• Ms Ella Poppitt
• Professor Neil Hawkins (from October 2025)