Recommended practices for surgical tissue banking

AORN Journal,  Feb, 2006  

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Originally published September 1984, AORN Journal. Revised April 1991.

Published as proposed recommended practices, February 1994.

Revised November 1998; published March 1999, AORN Journal. Reformatted July 2000.

Revised November 2003; published February 2004, AORN Journal.

RESOURCES

Bren, L. "Keeping human tissue transplants safe," FDA Consumer Magazine 39 (May/June 2005) 30-36.

Verble, M; Worth, J. "Cultural sensitivity in the donation discussion," Progress in Transplantation 13 (March 2003) 33-37.

Verble, M; Worth, J. "Fears and concerns expressed by families in the donation discussion," Progress in Transplantation 10 (March 2000) 48-55.

GLOSSARY

ALLOGRAFTS: Grafts taken from a living or nonliving donor for transplantation to a different individual.

AMERICAN ASSOCIATION OF TISSUE BANKS (AATB): A nonprofit organization that defines the standards for tissue banking.

AUTOGRAFTS: Tissue derived from an individual for implantation exclusively on or in the same individual.

DONOR SCREENING: Review of the donor's relevant medical records and physical assessment for evidence of past or present risk factors for relevant infectious agents or disease.

DONOR TESTING: Laboratory tests on blood specimens collected from a potential donor.

PRION DISEASES: A classification of infectious diseases, including Creutzfeldt-Jakob Disease (CJD), caused by a unique proteinaceous agent.

TISSUE BANK: A facility that participates in procuring, processing, preserving, and/or storing human cells and tissue for transplantation.

XENOTRANSPLANT: Cells or tissue from a nonhuman animal source that are transplanted, implanted, or infused into a human.

XENOTRANSPLANTATION: Any procedure that involves the transplantation, implantation, or infusion into a human recipient of either (a) live cells, tissues, or organs from a nonhuman animal source (eg, bovine heart valves); or (b) human body fluids, cells, tissues, or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs.

NOTES

(1.) US Food and Drug Administration, Proposed Approach to Regulation of Cellular and Tissue-Based Products (Rockville, Md: US Food and Drug Administration, Feb 28, 1997) 1-37.

(2.) US Food and Drug Administration, "Current good tissue practice for manufacturers of human cellular and tissue-based products; inspection and enforcement; proposed rule," Federal Register 66 (January 8, 2001) 1507-1559. Also available at http://www.fda.gov/OHRMS/ DOCKETS/98fr/010801 c.pdf (accessed 13 Sept 2005).

(3.) US Food and Drug Administration, "Suitability determination for donors of human cellular and tissue-based products; proposed rule," Federal Register 64 (Sept 30, 1999) 52696-52718. Also available at http://www.fda.gov/OHRMS/DOCKETS/98fr/093099a.pdf (accessed 13 Sept 2005).

(4.) US Food and Drug Administration, "Human cells, tissues, and cellular and tissue-based products; establishment registration and listing; final rule," Federal Register 66 (Jan 19, 2001) 5447-5469. Also available at http://www.fda.gov/OHRMS/DOCKETS/98fr/011901a.pdf (accessed 13 Sept 2005).