Web-net tool based and nationwide system for referring and monitoring serious adverse events and reactions in the area of organ transplantation

JarosÅ‚aw CzerwiÅ„ski^1,3, Piotr KaliciÅ„ski², Roman Danielewicz^1,3

¹Dep. of Surgical and Transplant Nursing, Medical University of Warsaw. Poltransplant, Warsaw, Poland, ²Dep. of Pediatric and Transplant Surgery, Children's Memorial Health Institute, Warsaw, Poland, ³Polish Transplant Coordinating Center, Poltransplant, Warsaw, Poland

Following Directive 2010/53/UE serious adverse events (SAEs) and reactions (SARs) alerting system  in the area of organ transplantation was implemented in Poland on technical basis of web-net platform connecting all transplant centers.

Substantial issue of this system, distinctly problematic and widely discussed among professionals and decision makers was the catalog of events and reactions must be referred.

Finally constructed catalog consists of:

1. Events related to organ recipients: transplantation from the donor with incomplete or incorrect characteristic, transplantation of organ after abnormal or too long preservation, absence of valid potential recipient’s plasma for cross-match, organ transplantation from a donor with a viral infection (unrelated to the rules of allocation), severe and uncontrolled bacterial, fungal or protozoan infection, transplantation form a donor with cancer, unintentional transplantation from a donor with non-identical or incompatible blood group ABO.
2. Reactions related to organ recipients: resignation from transplantation due to organ damage at the time of donation, storage and implantation, transmission from a donor viral infection (unrelated to the rules of allocation), organ lost due to the absence of proper recipient, transmission of cancer, never function of the graft, recipient’s death within 30 days after transplantation or during the initial hospitalization graft loss within 30 days of transplantation or during the initial hospitalization, HIV transmission  from the donor, severe bacterial, fungal, or protozoan infection
3. Events related to living organ donor: organ procurement from the donor with incomplete or incorrect characteristic
4. Reactions related to living organ donor: serious health consequences (illness, serious complications) in the donor associated with the donation

In the year of 2012 the total number of 51 SARs and 6 SAEs was documented in the system with regards of 1653 totally transplanted organs.