Health Technology Assessment of the use of prion filters to reduce the risk of variant CJD transmission from transfusion of red cell concentrates in Ireland

Date of publication:

Variant Creutzfeldt-Jakob Disease (vCJD) is a rare and fatal degenerative disorder of the human nervous system that is caused by infectious prion particles. Between 1999 and 2006 four patients were diagnosed with vCJD in Ireland. Worldwide, 217 cases have been identified, of which 170 were in the UK.

The most common route of transmission appears to be oral, via consumption of BSE-infected meat. The disease may also be transmitted by blood transfusion as a result of receiving blood products from an infected donor. Infection via blood products has not been reported to date in Ireland, but there are three probable cases reported worldwide. Those infected may never go on to develop clinical disease, but rather remain as asymptomatic carriers. No screening test is available to detect if a person is infected with vCJD.

A number of measures have already been implemented by the Board of the Irish Blood Transfusion Board to reduce the risk of transmission of vCJD via blood products. Prion filtration of red cell concentrates is a newly available technique that has the potential to further reduce any remaining risk of transmission of vCJD via blood transfusion by decreasing levels of prion infection in the filtered units.

The Department of Health and Children has requested that the Health Information and Quality Authority undertake a Health Technology Assessment of prion filtration to reduce the risk of transmission of vCJD via transfusion. This is to inform a decision as to whether or not prion filtration of red cell concentrates should be adopted as a standard approach by the Irish Blood Transfusion Service.

Terms of reference of the evaluation:

(a) To describe the epidemiology of vCJD in Ireland.

(b) Examine the current risk of contracting vCJD from a blood transfusion in Ireland.

(c) Examine the current controls and practices in place to prevent the transmission of vCJD via transfusion.

(d) Examine the current evidence of efficacy and safety for prion removing filters.

(e) Examine the costs and cost effectiveness associated with the implementation of prion filtration of red cell concentrates in the Irish Blood Transfusion Service.

(f) Advise on other issues which may need to be considered prior to the introduction of such a policy.

(g) Advise on the appropriateness of using prion filters in subgroups of the transfused population only, and the potential costs associated with this.

The Authority has convened a multidisciplinary Expert Advisory Group to oversee the process of the Health Technology Assessment and to provide access to expert advice and information as required. The membership of the Expert Advisory Group is as follows:

  • Dr Mairin Ryan (Chairperson), Health Information and Quality Authority
  • Dr Patricia Harrington (Project Leader), Health Information and Quality Authority
  • Dr David Asher, Food and Drug Administration, Office of Blood Research and Review
  • Dr Colette Bonner, Department of Health and Children
  • Dr Francesca Brett, 1National CJD Surveillance Unit, 2Irish Institute of Clinical Neurologists
  • Mr Matthew Collins, Department of Health and Children
  • Dr Robert Cunney, Health Protection Surveillance Centre
  • Dr Catherine Flynn, Haematology Association of Ireland
  • Dr Tony Finch, Health Service Executive
  • Dr Jenny Kiernan, Infectious Diseases Society of Ireland
  • Mr Stephen McMahon, Irish Patients’ Association
  • Dr Deirdre Madden, University College Cork
  • Dr William Murphy, Irish Blood Transfusion Service
  • Mr Brian O’ Mahony, Irish Haemophilia Society
  • Dr Joan O’ Riordan, Irish Blood Transfusion Service
  • Professor Marc Turner, SaBTO (Advisory Committee on the Safety of Blood, Tissues and Organs) UK

The completed HTA will be submitted to the Minister for Health and Children by the end of 2010.

Further Information: 

Marty Whelan, Head of Communications and Stakeholder Engagement
01 814 7481 / 086 2447 623
mwhelan@hiqa.ie