We’ve published an updated version of The Quality and Safety of Organs Intended for Transplantation: A documentary framework which details information on the mandatory regulatory requirements that hospitals licensed by the HTA in the Organ Donation and Transplantation sector must follow.
With the potential for the introduction of Assessment and Recovery Centre’s (ARCs) for organs, the framework has been updated with new directions. It is intended that ARCs will act as an intermediary centre where the function and suitability of organs will be assessed using a mechanical perfusion device, before being transported to a recipient centre for transplantation.
It is usual practice for HTA A and HTA B forms to be completed by the donor and recipient centres respectively to ensure traceability of organs. However, organ characterisation data may also be generated whilst an organ is on a machine perfusion device at an ARC.
Under the new directions, where an organ is sent to an establishment for assessment or recovery purposes and a mechanical perfusion device is used, the establishment under whose licence this activity takes place must record and store any organ characterisation and traceability data generated for a period of 30 years.
If you have any questions about the updates please get in touch enquiries@hta.gov.uk
Related information:
Legal Directions | Human Tissue Authority (hta.gov.uk)
Regulatory alerts | Human Tissue Authority (hta.gov.uk)