Biomedical tissue is biological tissue

Tissue (biology)

Tissue is a cellular organizational level intermediate between cells and a complete organism. A tissue is an ensemble of cells, not necessarily identical, but from the same origin, that together carry out a specific function. These are called tissues because of their identical functioning...

 used for organ transplant

Organ transplant

Organ transplantation is the moving of an organ from one body to another or from a donor site on the patient's own body, for the purpose of replacing the recipient's damaged or absent organ. The emerging field of regenerative medicine is allowing scientists and engineers to create organs to be...

ation and medical research, particularly cancer research.

Such tissues and organs may be referred to as: implant tissue, allograft, xenograft, skin graft tissue, human transplant tissue, implant bone. Tissue is stored in tissue establishments or tissue banks under cryogenic conditions. Fluids such as blood, blood products and urine are stored in fluid banks under similar conditions.

Regulation

The collection, storage, analysis and transplantation of human tissue involves significant ethical and safety issues, and is heavily regulated. Each country sets its own framework for ensuring the safety of human tissue products.

The regulation of human transplantation in the United Kingdom

United Kingdom

The United Kingdom of Great Britain and Northern IrelandIn the United Kingdom and Dependencies, other languages have been officially recognised as legitimate autochthonous languages under the European Charter for Regional or Minority Languages...

 is set out in the Human Tissue Act 2004

Human Tissue Act 2004

The Human Tissue Act 2004 is an Act of the Parliament of the United Kingdom which consolidated previous legislation and created the Human Tissue Authority to "regulate the removal, storage, use and disposal of human bodies, organs and tissue."...

 and managed by the Human Tissue Authority

Human Tissue Authority

The Human Tissue Authority is a non-departmental public body in the United Kingdom that regulates the removal, storage, use and disposal of human bodies, organs and tissue for a number of scheduled purposes such as research, transplantation, and education and training.It was created by the Human...

.

Tissue banks in the US

United States

The United States of America is a federal constitutional republic comprising fifty states and a federal district...

 are monitored by the Food and Drug Administration

Food and Drug Administration

The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

 (FDA). The Code of Federal Regulations

Code of Federal Regulations

The Code of Federal Regulations is the codification of the general and permanent rules and regulations published in the Federal Register by the executive departments and agencies of the Federal Government of the United States.The CFR is published by the Office of the Federal Register, an agency...

sets out the following topics:

• Donor Screening and Testing: the determination of donor suitability for human tissue intended for transplantation.
• Procedures and Records: the written procedures and records that must be kept
• Inspection of Tissue Establishments: the importation of tissues from abroad and the retention, recall, and destruction of human tissue.

Notable regulation cases

• Biomedical Tissue Services, Inc. is at the heart of an investigation by the Food and Drug Administration. http://www.fda.gov/bbs/topics/NEWS/2005/NEW01249.html