Introduction
All EU member states are obliged to fulfil the requirements of Directive 2012/25/EU on reporting and handling of Serious Adverse Events (SAE) and Serious Adverse Reactions (SAR) in the field of organ donation and transplantation.
Eurotransplant (ET) offers a SAE/R handling service to all its member states.
Definition of a SAE/R
SAE
A Serious Adverse Event (SAE) is defined as any undesired and unexpected occurrence associated with any stage of the chain from donation to transplantation that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalization or morbidity.
Events could be:
- Malignancies found in the donor after transplantation
- Match relevant virology changes after matching
- HLA changes
- Blood group changes
Potential damage could be:
- Organ loss
- Organ rejection
- Prolonged hospital stay
SAR
A serious adverse reaction (SAR) is defined as an unintended response, including a communicable disease, in the living donor or in the recipient that might be associated with any stage of the chain from donation to transplantation that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalization or morbidity.
Reactions could be:
- Malignancies
- Infectious diseases
- Allergies
Contact list
A list of National Competent Authorities (NCA's) per EU country can be found on the following website in which you can find contact information on organ and donor characterization, traceability of organs and on reporting SAE/R.
Services of ET
The handeling procedure for SAE/R has been developed by ET with the help and guidance of the ET Organ Procurement Committee (OPC) which is as follows:
- ET sends a SAE/SAR form to the reporting organization
- ET collects all necessary information to prepare a report
- ET informs the NCA, delegated body and involved transplant- and donor centers
Directive 2012/25/EU
In Directive 2012/25/EU which is issued by the European Commission, information procedures for the exchange of human organs intended for transplantation between member states have been defined.
