The Human Tissue Authority (HTA) has been selected as the body that will set standards for the quality and safety of transplant organs across the EU.The HTA has also been named as the organisation for England, Wales, Scotland and Northern Ireland, for the EU Organ Directive and will take the lead on developing a regulatory framework and implementation into legislation by August 2012.
It is the first time a formal regulatory framework has been developed for the donation and transplant of organs. The aim is to standardise the systems and processes used by member states. It will also assist in a more effective exchange of organs between member states on the small number of occasions where this is necessary. The ultimate goal is to ensure common high quality and safe standards for the donation, procurement, transportation, traceability and follow up of donated organs for transplant across the EU.
The intent is to:
• Create an overall framework that will ensure the all organisations involved in organ donation and transplantation comply with the directive.
• Develop a system to license procurement and transplantation.
• Confirm arrangements for reporting serious adverse events and reactions.
• Issue guidance to healthcare providers involved in all stages of the transplant chain.
• Supervise organ exchange between member states.
The EU Organ Donation Directive will improve the quality and safety of organs to be transplanted into patients across Europe. EU member states must be compliant with the EU Directive 2010/53 EU by August 2012
The number of organ donations and transplantations has grown steadily across the EU and thousands of lives are saved every year through this medical procedure. Organ transplantation is now the most cost-effective treatment for end-stage renal failure. Currently, there are wide variations in quality and safety requirements between member states. A directive is needed to ensure a high level of health protection throughout the EU by establishing common standards of quality and safety of human organs intended for transplantation and for those exchanged between EU countries each year.
The HTA aims to maintain confidence by ensuring that human tissue is used safely and ethically, and with proper consent. The HTA regulates organisations that remove, store and use tissue for research, medical treatment, post-mortem examination, teaching and display in public. It also gives approval for organ and bone marrow donations from living people.
The EU Organ Donor Directive (ODD) is a European requirement that aims to bring all EU countries up to the same high quality and safety standards. With better organs available in the EU, more citizens may benefit from the availability of suitable organs transferred from across Europe. The ODD will affect governance and clinical practice in organ donation and transplantation.
A full copy of the EU Directive can be found here.
It is the first time a formal regulatory framework has been developed for the donation and transplant of organs. The aim is to standardise the systems and processes used by member states. It will also assist in a more effective exchange of organs between member states on the small number of occasions where this is necessary. The ultimate goal is to ensure common high quality and safe standards for the donation, procurement, transportation, traceability and follow up of donated organs for transplant across the EU.
The intent is to:
• Create an overall framework that will ensure the all organisations involved in organ donation and transplantation comply with the directive.
• Develop a system to license procurement and transplantation.
• Confirm arrangements for reporting serious adverse events and reactions.
• Issue guidance to healthcare providers involved in all stages of the transplant chain.
• Supervise organ exchange between member states.
The EU Organ Donation Directive will improve the quality and safety of organs to be transplanted into patients across Europe. EU member states must be compliant with the EU Directive 2010/53 EU by August 2012
The number of organ donations and transplantations has grown steadily across the EU and thousands of lives are saved every year through this medical procedure. Organ transplantation is now the most cost-effective treatment for end-stage renal failure. Currently, there are wide variations in quality and safety requirements between member states. A directive is needed to ensure a high level of health protection throughout the EU by establishing common standards of quality and safety of human organs intended for transplantation and for those exchanged between EU countries each year.
The HTA aims to maintain confidence by ensuring that human tissue is used safely and ethically, and with proper consent. The HTA regulates organisations that remove, store and use tissue for research, medical treatment, post-mortem examination, teaching and display in public. It also gives approval for organ and bone marrow donations from living people.
The EU Organ Donor Directive (ODD) is a European requirement that aims to bring all EU countries up to the same high quality and safety standards. With better organs available in the EU, more citizens may benefit from the availability of suitable organs transferred from across Europe. The ODD will affect governance and clinical practice in organ donation and transplantation.
A full copy of the EU Directive can be found here.
Medical tourism news06 May 2011
Related linkFull copy of the EU Directive
Related linkThe Human Tissue Authority (HTA)
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