Organ transplantation is a growing field and saves thousands of lives each year. It is the only treatment for end-stage organ failure, and the most cost-effective treatment for renal failure.
In 2011, 30,000 organs were transplanted in the European Union (EU), many of which were shipped across borders. The European Union Organ Donation Directive 2010/53/EU (EUODD) was introduced in 2012 to bring all EU countries up to the same high quality and safety standards when transplanting organs. The EUODD means that UK citizens will benefit from the availability of better quality organs from across Europe.
It has now been 20 months since the Human Tissue Authority (HTA) was appointed as the UK’s Competent Authority under the EUODD, and we began licensing this sector. In this short time we have seen some significant changes to the regulatory landscape.
Following consultation with professionals, we developed the UK’s first formal framework for the donation and transplant of organs. Under this framework we have licensed and audited all of the UK’s 37 establishments involved in various aspects of organ donation and transplantation.
We audit establishments against specific criteria and gather evidence through a combination of inspection, review, and interviews with staff involved in each aspect of the ‘organ pathway’.
These audits are carried out by a core team of expert HTA inspectors who meet regularly to review, discuss and compare findings. The review shows that we have found good compliance across the sector.
ODT sector review and presentation
In March 2014 the HTA produced a document detailing lessons learned from regulating the ODT sector (PDF) and held a workshop event for people working in the sector. PDFs of the slides from the ODT workshop presentations are below.