Biomedical tissue
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Biomedical Tissue is used for transplantation. There is a large demand for these human tissue products and the supply can not keep up with this demand. Each country sets its own framework for ensuring the safety of human tissue products. In the US this is monitored by the Food and Drug Administration (FDA).
Such tissues and organs may be referred to as: implant tissue, allograft, xenograft, skin graft tissue, human transplant tissue, implant bone.
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[edit] Regulation in the United Kingdom
The regulation of human transplatation in the United Kingdom was set out in the Human Tissue Act 2004 and managed by the Human Tissue Authority.[1]
In the United Kingdom the Human Organ Transplants Act 1989 ("the HOT Act") forbids payment for organs and places considerable restrictions on transplants between living persons. Transplants between unrelated living persons may be performed with the prior approval of the Unrelated Live Transplant Regulatory Authority (ULTRA).
The transplantation of tissue and organs between different species, and in particular the transplantation of animal tissue into humans is regulated by the UK Xenotransplantation Interim Regulatory Authority (UKXIRA).
[edit] Regulation in the United States
The Code of Federal Regulations sets out the following topics:[2]
- Donor Screening and Testing - The Determination of donor suitability for human tissue intended for transplantation.
- Procedures and Records - The written proceedures and records that must be kept
- Inspection of Tissue Establishments - Including issues of the import of tissues from abroad as well as the retention, recall, and destruction of human tissue.
[edit] Notable regulation cases
Biomedical Tissue Services, Inc. is at the heart of an investigation by the Food and Drug Administration.FDA
[edit] External links
- (UK) Unrelated Live Transplant Regulatory Authority (ULTRA) website
- UK Xenotransplantation Interim Regulatory Authority]] (UKXIRA) website
[edit] Footnotes
- ^ Human Tissue Authority. Remit.
- ^ Food and Drug Administration (2003). Part 1270: 'Human Tissue Intended for Transplantation'. Title 21--Food and Drugs. Code of Federal Regulations.
