How we monitor the safety of human organs for transplantation

Please note

We have changed our email address to btosafety@hpra.ie. Please use this address for vigilance queries related to blood, tissues and cells, and organs.

Our old email addresses tissueandcellsafety@hpra.ie and organsafety@hpra.ie are no longer in use. We advise that you remove them from your contact list.

Organs vigilance

Through the Office for Organ Donation and Transplant Ireland (ODTI), the HPRA and HSE have been designated as the National Competent Authorities for the purposes of implementing EU and national legislation relating to human organs intended for transplantation.

Together with the ODTI, we have established a system for the notification of suspected Serious Adverse Reactions (SARs) and Serious Adverse Events (SAEs) associated with human organs intended for transplantation.

The reporting of SAR/Es is important to highlight any unexpected complication, particularly if recipients may be at risk. It provides a mechanism for monitoring the quality and safety of organs during the entire chain from donation to transplantation through report investigation and implementation of Corrective and Preventative Actions (CAPA).

How to Report

You can submit SAR/E reports using the  Serious adverse reaction event report form for human organs intended for transplantation. A copy of this form can be downloaded from our page below.

We have worked with the HSE/ODTI to develop a guidance document for procurement organisations / transplantation centres and/or other relevant organisations. The guidance document outlines:

• The procedure to follow for reporting suspected SAR/Es,
• Advice on completion of SAR/E report forms,
• Information on reportable reactions, and
• Events and examples of SAR/Es.

A copy of this Guide can be found below.

SAR/Es should be submitted to the HPRA and ODTI/HSE as per details provided in the guidance document.