25 May 2019 Emerging issues: The new Council of Europe Guide for the Quality and Safety of Organs for Transplantation 7th International Congress Infection.

Slides:

Advertisements

Similar presentations

1 EU Policy in the field of Organ Donation and Transplantation Media Seminar - EU Health Journalist Prize Brussels, 29 October 2009 Anna Pavlou European.

Advertisements

Midlands Collaborative, November 2012 Timely Identification and Referral of Potential Organ Donors Paul Murphy National Clinical Lead for Organ Donation.

Emergency contraception: a guideline for service provision in Europe June

Quality dimensions in health policy state of the art & visions of the future Marek Haber Deputy Minister of Health.

Organ Donation Past, Present and Future Donor Identification and Referral Louise Davey, Team Manager Dr Alex Manara, RCLOD South West 26 th June

Introduction to PPDs Regulatory requirements and rationale.

Donation Process: Preparing for the Gift Breakout Session A Presenters: Jennifer Do, RN, Unit Director, Surgical Transplant ICU, Ronald Reagan UCLA Medical.

Is Nucleic Acid Testing for Organ Donors the ‘Right’ Choice? Reference: Humara A, Morrisb M, Blumbergc R, et al. Nucleic acid testing (NAT) of organ donors:

ACCORD Mark Roberts ACCORD Business Lead. Achieving Comprehensive Coordination in ORgan Donation EU funded Joint Action Joint Action led and coordinated.

Research & Innovation International Rare Disease Consortium: Data Sharing Policy 3 rd International Traumatic Brain Injury Research Meeting Catherine BERENS.

The Role of Coordinators Throughout the European Union Carl-Ludwig Fischer-Fröhlich, Stuttgart, Germany Thank you to the support of support of all coordinators.

Taskforce Implementation – Progress and Results Chris Rudge FRCS National Clinical Director for Transplantation Renal CDs Meeting 12 March 2010.

Revision of the Medical Device Directives The case of ‘Borderline’ Products used in a self-care context 48th AESGP Annual Meeting Nice, 6-8 June 2012 Laurent.

Organ donation Peter Bishop Clinical lead for organ donation.

Regional variation of organ donors in Swedish ICUs may indicate missed opportunities for donation Thomas Nolin*, Sten Walther*, Caroline Mårdh*, Göran.

Handicap-International Challenges of the Sustainability of physical rehabilitation sector Nepal, January 2013.

ACCORD Mark Roberts ACCORD Business Lead. Achieving Comprehensive Coordination in ORgan Donation EU funded Joint Action Joint Action led and coordinated.

Quality of Healthcare in Europe Royal College of Physicians London Council Chamber 19 January 2009 Robert Madelin Director General for Health and Consumers.

Organ Donation Past, Present and Future Donor Identification and Referral Rachel Stoddard-Murden Dr Alex Manara 9 th July SOUTH WEST.

Organ Donation Past, Present and Future Donor Identification and Referral Jeremy Brown Huw Twamley 4 th June LONDON.

Revision Process for the PHS Guideline for Reducing HIV, HBV and HCV Transmission through Solid Organ Transplantation Matthew J. Kuehnert, M.D. Office.

The impact on practice, costs and outcomes of New Roles for health professionals in Europe (MUNROS) Antoinette de Bont/ associate professor/ Erasmus University.

Prime Responsibility for Radiation Safety

Origin and Process of Utah Guidelines Anna Fondario, MPH Utah Department of Health Violence and Injury Prevention Program.

Australian Health Ethics Committee Professor Colin Thomson address to International Dialogue on Ethics European Commission Bureau of European Policy Advisers.

European Donation & Transplant Coordination Organisation The Donation & Procurement Section of ESOT and

Organ Donation Past, Present and Future Donor Identification and Referral Becky Clarke Dr Malcolm Watters 11 th June SOUTH CENTRAL.

Proposal to Align OPTN Policies with the 2013 PHS Guideline for Reducing Transmission of HIV, HBV, and HCV Through Solid Organ Transplantation Ad Hoc Disease.

Organ Donation Past, Present and Future Donor Identification and Referral Michelle Tyler – Team Manager Dr Malcolm Watters 10 th June EASTERN.

Introduction Organ Transplantation Program Update Advisory Committee on Organ Transplantation November 17, 2015 Melissa Greenwald, MD Acting Director Division.

Proposal to Align OPTN Policies with the 2013 PHS Guideline for Reducing Transmission of HIV, HBV, and HCV Through Solid Organ Transplantation Ad Hoc Disease.

The EU Directive on "Services in the internal market", COM(2004) 2 final/3 Agnese Knabe Project coordinator European Public Health Alliance Civic Alliance.

Bulgarian National Hepatitis Plan and Compassionate Use Regulations Dr. Stanimir Hasardzhiev Executive Director, ELPA Chairperson, Hepasist REPUBLIC OF.

National Information Day Greece 23 July 2015 Funding priorities under the work plan 2015.

Quality Metrics of Performance of Research Ethics Committees Cristina E. Torres, PhD FERCAP Coordinator.

1 The EU’s efforts to provide high quality and safe Organ transplantation Anna Pavlou European Commission Health and Consumers Directorate General Public.

1 Infectious Disease Verification to Enhance Patient Safety Operations and Safety Committee.

Responsibility of Professionals in Implementing

Shubhangi Arora1; Eden Haverfield2; Gabriele Richard2; Susanne B

The MESOT region Population = 600 m GNI: $2,387 - $79,426

Bosnia and Herzegovina Current status and ways to improve transplantation Halima Resic ERA-EDTA Congress, Istanbul, May 2013.

Uncontrolled organ donation after circulatory death protocols in out-of-hospital cardiac arrests. A potential solution to organ shortage? Alexandre Garioud1*,

Axel Rahmel – Frankfurt/Main, Germany

A capacity building programme for patient representatives

White Paper: Ethical Considerations of Imminent Death Donation

3rd International HIV/Viral Hepatitis Co-Infection Meeting HIV/Viral Hepatitis: Improving Diagnosis, Antiviral Therapy and Access Sunday, 17 July.

Annex III to BS/SC/PDF/A(2003)1

EudraVigilance.

Cascade of care for persons newly diagnosed

Expanding the Donation Opportunity:

Organ Procurement Organization Committee Fall 2014

EU Reference Centres for Animal Welfare

Achieving World-Class Cancer Outcomes A Strategy for England

Organ Procurement Organization Committee Report

Achieving World-Class Cancer Outcomes A Strategy for England

Modify HOPE Act Variance to Include Other Organs

3rd ACSH WORKSHOP ON NATIONAL OSH STRATEGIES: Lessons learned – Revised versions of nat. OSH Strategies Luxembourg, September 2016 Panel 3 – latest.

3rd ACSH WORKSHOP ON NATIONAL OSH STRATEGIES: Lessons learned – Revised versions of nat. OSH Strategies Luxembourg, September 2016 Panel 3 – latest.

The evaluation process

PRESENTATION OF MONTENEGRO

Diagnosis of disease M2/D2

IMPROVING PUBLIC INFORMATION

Midlands Organ Donation Services Team

Towards International Harmonized Nomenclature for Medical Devices

UNION EUROPÉENNE DES MÉDECINS SPÉCIALISTES voice of European medical specialists 60

White Paper: Split Versus Whole Liver Transplantation

Vascularized Composite Allograft (VCA) Transplantation Committee

EU Food Safety Requirements: - Hygiene of Foodstuffs -

Outline Background: development of the Commission’s position

EU legislation on noise emission in the environment by equipment for use outdoors: latest developments September 2018 European.

Presentation transcript:

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

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.

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 (https://register.edqm.eu/freepub) In line with EU legislation while respecting national laws and regulations.

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

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. 2018 (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.

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 24-48 hours

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: -> www.Orpha.net, -> 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)

New pills (examples of conclusions boxes)

New pills (HBV: initial donor screening algrithm)

New pills (HBV)

New pills (HCV: initial donor screening algrithm)

New pills (HCV)

Thank you You can download your individual free copy after registration at https://register.edqm.eu/freepub Please do not share the pdf (otherwise outdated copies will circulate in the web)