1. 25 May 2019
Emerging issues: The new Council of Europe Guide for the Quality and Safety of Organs for Transplantation
7th International Congress Infection & Transplantation, Varese
Carl-Ludwig Fischer-Fröhlich
Stuttgart, Germany

2. Personal Disclosure
Together with Beatriz Dominguez-Gil (ONT) I am only co-chairing the working group elaborating the contents, Marta Lopez-Fraga (EDQM) chairs the whole project.
The project is on behalf of all European institutions caring for organ donation and transplantation
Thank you to all experts and users for their voluntary commitment to this guide.

3. Aim of the Guide Quick reference for daily use at bedside
Technical guidance to ensure the safety and quality of human organs used for transplantation with an update about the most recent advances in the field.
All European health care professionals - identifying possible organ donors, coordinators managing the process of donation, - responsible for clinical use of human organs, - quality managers and responsible Health Authorities should have open access access to this information (
In line with EU legislation while respecting national laws and regulations.

4. Contens of the Guide Chapter 1: Introduction
Chapter 2: Identification and referral of possible deceased organ donors
Chapter 3: Determination of death by neurologic criteria
Chapter 4: Consent / authorization for post mortem organ donation
Chapter 5: Management of the potential donor after brain death
Chapter 6: General donor characterization, assessment and selection criteria
Chapter 7: Specific organ characterization, assessment and selection criteria
Chapter 8: Risk of transmission of infectious diseases
Chapter 9: Risk of transmission of neoplastic diseases
Chapter 10: Risk related to the use of donors with other conditions and diseases
Chapter 11: Organ procurement, preservation and transportation
Chapter 12: Donation after circulatory death
Chapter 13: Living donation
Chapter 14: Donation of vascularized composite allografts
Chapter 15: Bio-vigilance and surveillance
Chapter 16: Achieving and measuring quality in organ donation and transplantation
Chapter 17: Measuring outcomes in transplantation

5. Project Plan 7th edition:
Start November 2016
Finalized document January 2018
Public consultation March 2018
Final adoption by CD-P-TO May 2018
Publication Nov (plan 8th ed.)
open access PDF print version
Challenge for working groups to provide evidence-based recommendations:
often only expert knowledge, no proper research despite exhaustive literature review
provide pragmatic solution fitting daily routine
harmonize between North-, East-, South-, West- and Middle-Europe
adherence to EU directives and rules of national health care systems
Balance risk benefit assessment of particular donor-recipient-pairs
Member of working groups in cooperation with other partners :
professionals working at the bedside (e.g. coordinators , procurement surgeons, transplant physicians, other professions) with a clinical background and active implication in the different steps of the process from donation to transplantation as well as scientific expertise.

6. New pills ?
Guidance of best practice (=should), standards according to EU Directives (=must)
WHO Critical pathway: -> crucial is identification and referral of possible donors
Determination of death by neurologic criteria: -> adhere to national rules
Donor management: -> based on published standards of intensive care medicine
Donor and organ characterization: -> standardize, unify & simplify the process, -> specific selection criteria: limited evidence, no objective contra-indications
Risk of Transmission of infectious diseases: -> HCV -> DAA -> anti-HCV + NAT - vs. anti-HCV + NAT + donor: how to proceed -> MDR bacteria vs. effective treatment for hours

7. New pills ?
Risk of transmission of neoplastic diseases: -> change from very limited data to growing experience, still be careful -> primary brain tumor: risk depends on WHO-Grade
“rare” diseases: -> -> algorithm on how to proceed
DCD, Living donation, Vascularized composite allografts: -> current best practice
Bio-vigilance: -> proper rapid alert communication system (serious & non-serious)
Quality management: -> e.g. monitoring of organ donation per hospital, -> outcome in transplantation after risk-benefit assessment (donor-recipient pair)

8. New pills (examples of conclusions boxes)

9. New pills (HBV: initial donor screening algrithm)

10. New pills (HBV)

11. New pills (HCV: initial donor screening algrithm)

12. New pills (HCV)

13. Thank you
You can download your individual free copy after registration at
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