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The EUODD from a Practical Perspective

The EUODD from a Practical Perspective. Keith Rigg Consultant Transplant Surgeon Nottingham. Background. Development of Organ Donation Directive has been in gestation since 2006

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The EUODD from a Practical Perspective

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  1. The EUODD from a Practical Perspective Keith Rigg Consultant Transplant Surgeon Nottingham

  2. Background • Development of Organ Donation Directive has been in gestation since 2006 • Three key challenges of organ donation and transplantation identified in EU consultation – quality & safety, increasing donor numbers and organ trafficking • Organ Donation Directive deals predominantly with Quality & Safety • Need for common quality and safety standards

  3. The EUODD for Dummies Scope Key implications Procurement organisations and transplant centres will need to be licensed Need to ensure framework for quality and safety including Traceability SAE/R reporting & management Healthcare professionals involved are trained and competent Designation of Competent authority • Donation • Testing • Characterisation • Procurement • Preservation • Transport • Transplantation of organs intended for transplantation (but not including the transplant operation or after)

  4. Aren’t we already doing much of this? • In the UK we are generally doing what the EUODD requires, but we need to be able to demonstrate that we are. • In some areas we are • In other areas we should be, but are not • In other areas we are not

  5. What are the concerns of the transplant community? • Extra work • Extra bureaucracy • Extra money • Little perceived benefit • Do we need it? • Will it benefit patients and improve quality and safety? • Take away momentum from delivery of ODTF recommendations

  6. Challenge The EUODD will be implemented on 27 August 2012 In that time we need to draw together the requirements of the transplant community with the requirements of the HTA as the Competent Authority

  7. What do we need to do? • The Directive will be transposed into UK law, so we can’t fight it! • Understand what the Directive covers • Be prepared for August 2012 • Accept there will be more paperwork, but work to minimize the impact • Need to work with HTA and NHSBT to ensure implementation plans are workable

  8. Issues for discussion • Licensing of procurement and transplant centres • What is the role for a Designated Individual? • Traceability for 30 years of material in contact with donor organ

  9. The way forward • Transplant community needs to be engaged • Discussion • Consultation • Proportionate with minimum bureaucracy • Consequences of not meeting directive

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