Organs - How We Monitor Safety
The implementation of legislation ensures high standards of quality and safety, nationally and across EU Member States.
Role of the organ procurement organisation or transplantation centre
- Comply with the requirements laid down in relevant Legislation.
- Apply to the HPRA for an Organ Procurement Organisation/Transplant Centre Authorisation as per Regulation 6 of S.I. 325 of 2012.
- Undergo inspections by the HPRA in order to obtain authorisation and regular inspections thereafter.
- Notify the HPRA of any substantial changes it intends to make in the prescribed activities it undertakes.
- Notify the HPRA and HSE of, and provide the HPRA and HSE with a report analysing the cause and ensuing outcome of any serious adverse events and reactions which may influence the quality and safety of organs. (See below)
Role of the HPRA with organ procurement organisation or transplantation centre
The HPRA and HSE have been designated as the national Competent Authorities for the purposes of this legislation.
As a result the HPRA is obliged to:
- Authorise all activities relating to the donation, testing, characterisation, procurement, preservation, transport, or transplantation of organs intended for transplantation to the human body.
- Organise inspections and appropriate control measures to ensure that the requirements of the legislation are complied with.
The HSE via The Office for Organ Donation and Transplant Ireland (ODTI) is responsible for the development of best practice guidance and the maintenance of donor and recipient registers.
Organs - Reporting of Serious Adverse Reactions and Events (SAR/Es)
In accordance with the legislation, development of a system to facilitate reporting, evaluation and the management measures applied to SAR/E is underway, in collaboration with the HSE/ ODTI.
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).
The HPRA and HSE/ODTI have developed a guidance document for procurement organisations / transplantation centres and/or other relevant organisations on the procedure to follow for reporting suspected SAR/Es, including advice on completion of SAR/E report forms, information on reportable reactions and events and examples of SAR/Es.
SAR/E reports should be submitted using the Serious Adverse Reaction / Event Report Form for Human Organs Intended for Transplantation and the Guide to SAR/E Reporting for Human Organs Intended for Transplantation.
SAR/Es should be submitted to the HPRA and ODTI/HSE as per details provided in the guidance document.
Further Information The Department of Health website
provides further information about the respective roles of the HPRA and the HSE. The European Commission website
provides information on the organ directives and future implementing directives.
Contact the HPRA - Please email firstname.lastname@example.org