In the United States, standards for cell and tissue processing have been developed by a variety of professional tissue banking organizations. Several organizations, including the American Association of Tissue Banks and the Eye Bank Association of America, have accreditation programs for member institutions. Some governmental agencies, such as the New York State Department of Health and the Food and Drug Administration, have adopted strict regulations, which may subject noncompliant tissue banks to certain enforcement actions. Professional tissue banking organizations have also issued guidelines that provide recommendations for implementing efficacious policies and procedures for the acquisition, processing, storage, and distribution of tissues.
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American Fertility Society.Guidelines for gamete donation.Fertil. Steril.59(Suppl. 1): 1S9S; 1993.
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Centers for Disease Control and Prevention.Guideline for preventing transmission of human immunodeficiency virus through transplantation of human tissue and organs.MMWR43(RR-8): 117: May; 1994.
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CiavarellaD.; LindenJ.V.The regulation of hematopoietic stem cell collection and storage. The New York State approach.J. Hematother.1: 201214; 1992.
10.
Eye Bank Association of America.Medical standards.Washington, DC: Eye Bank Association of America; June 1992.
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Food and Drug Administration.21 CFR 1270. Human tissue intended for transplantation.Federal Register58: 65,51465,521; December 1993.
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Food and Drug Administration.Application of current statutory authorities to human somatic cell therapy products and gene therapy products.Federal Register58: 53,24853,251; October 1993.
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Food and Drug Administration.Federal Standard 209D. Airborne particulate cleanliness classes in cleanrooms and clean zones. Rockville, MD: Food and Drug Administration; September 1992.
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Food and Drug Administration.Guidelines on sterile drug products produced by aseptic processing.Rockville, MD: Center for Drugs and Biologies and Office of Regulatory Affairs. Food and Drug Administration; June 1987.
15.
FriedlaenderG.E.Bone banking and clinical applications.Transplant Proc.XVII (Suppl. 4): 99104; 1985.
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Human Milk Banking Association of North America.Guidelines for the establishment and operation of a human milk bank.Raleigh, NC: HMBANA; October 1990.
17.
National Marrow Donor Program.Standards of the national marrow donor program, 5th ed. Revised September 1990.
18.
New York State Department of Health.Stem cell banks. Subpart 58-5 of title 10(health) of the official compilation of codes, rules and regulations of the State of New York.
19.
New York State Department of Health.Tissue banks and nontransplant anatomic banks. Part 52 of title 10(health) of the official compilation of codes, rules and regulations of the State of New York.
20.
ShermanJ.K.Synopsis of the use of frozen human semen since 1964: State of the art of human semen banking.Fertil. Steril.24: 397416; 1973.
21.
South-Eastern Organ Procurement Foundation.Guidelines and standards for excision, preparation, storage and distribution of human tissue allografts for transplantation.Richmond, VA: South-Eastern Organ Procurement Foundation; 1990.
22.
SpenceR.J.The banking and clinical use of human skin allograft in trauma patients: The banking of allograft skin in Maryland.Md. Med. J.35: 117119; 1986.
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