Tissue bank

A tissue bank is an organization that recovers, processes, stores, and distributes human cells and tissues for transplantation, reconstruction, and related clinical use. [1][2] Tissue banks handle a wide range of non-organ grafts, including bone and other musculoskeletal tissue, skin, heart valves, blood vessels, corneas, tendons and ligaments, and birth (placental) tissue such as amniotic membrane. [1][3] In the United States, the products handled by tissue banks are regulated by the Food and Drug Administration (FDA) as human cells, tissues, and cellular and tissue-based products (HCT/Ps), and many tissue establishments additionally pursue voluntary accreditation through the American Association of Tissue Banks (AATB; now operating as the Association for Advancing Tissue and Biologics). [1][2][4]

Tissue banking is distinct from solid-organ procurement. Solid-organ donation (of hearts, lungs, livers, kidneys, pancreata, and intestines for transplant) is coordinated by federally designated organ procurement organizations (OPOs) within a national allocation system, and donated organs must be transplanted within hours of recovery. By contrast, recovered human tissue can usually be processed, sterilized, preserved, and stored for months or years before distribution, and a single tissue donor can yield grafts that benefit many recipients. [1][5] See Organ donation for the solid-organ side of donation and transplantation.

Types of tissue handled

Human tissue recovered and distributed by tissue banks falls into several broad categories. [1][3] Common allograft tissue types and representative clinical uses are summarized below.

| Tissue type | Examples | Representative uses | |---|---|---| | Musculoskeletal / bone | Cortical and cancellous bone, demineralized bone matrix, cartilage | Spinal fusion, joint reconstruction, fracture and bone-defect repair [3][6] | | Tendons and ligaments | Achilles tendon, patellar tendon, hamstring grafts | Ligament reconstruction (e.g., ACL repair) [3][6] | | Skin | Dermal allografts | Burn coverage, wound care, reconstructive surgery [3][7] | | Cardiovascular | Heart valves, blood vessels (vascular grafts) | Cardiac valve replacement, vascular reconstruction [3] | | Cornea / ocular | Corneal tissue | Corneal transplantation; recovered through eye banks [3][8] | | Birth / placental | Amniotic membrane, placental tissue | Wound care, ocular surface reconstruction, surgical applications [9] |

Birth tissue such as amniotic membrane is recovered from donated placentas obtained after planned cesarean deliveries, following donor screening, infectious-disease testing, and informed consent, and is processed by methods such as cryopreservation or dehydration. [9] Corneal and other ocular tissue is typically handled by specialized eye banks; see Eye banking and the EBAA. Bone and other musculoskeletal grafts are covered in more depth in Bone and musculoskeletal allografts, skin grafts in Skin allograft, and placental tissue in Amniotic membrane.

The recovery, processing, and distribution pipeline

Tissue banking proceeds through a sequence of steps: donor screening and authorization, tissue recovery, processing, packaging and (where applicable) terminal sterilization, storage, and distribution. [10][11]

• Recovery. Tissue is recovered from deceased donors (and, for some tissues such as amniotic membrane, from living donors). The term "recovery" has largely replaced the older term "harvest." Recovery is performed under controlled conditions and, depending on tissue type and donor setting, may occur in an operating room or autopsy-type facility. [10]
• Processing. Recovered tissue is processed using validated aseptic techniques that include mechanically agitating tissue to remove blood, lipids, and cells; cleaning with detergents, antibiotics, antifungals, or chemical disinfectants; and cutting or shaping in a clean room. Aseptic processing alone is not equivalent to a sterile process. [10]
• Sterilization. Many grafts undergo terminal sterilization, most commonly a validated low dose of gamma or electron-beam irradiation administered by an accredited third party; ethylene oxide and certain heat or chemical treatments are also used. Terminal sterilization is intended to reduce viable microorganisms to a defined sterility assurance level. [10][11]
• Storage and distribution. Because processed tissue can be preserved (frozen, freeze-dried, or otherwise stabilized), it can be stored and inventoried before being distributed to hospitals and surgeons, unlike time-critical solid organs. [1][10]

Donor eligibility and screening

Under FDA regulations, a donor-eligibility determination, based on donor screening and donor testing for relevant communicable disease agents and diseases, is required for donors of cells or tissue used in most HCT/Ps. [12] The establishment responsible for the determination must evaluate the donor's eligibility based on screening (review of medical and behavioral/social history and physical assessment for risk factors) and on laboratory testing. [12]

Donor testing must use appropriate FDA-licensed, approved, or cleared donor-screening tests, used according to the manufacturer's instructions, to adequately reduce the risk of transmission of relevant communicable disease agents or diseases. [12] In general, the donor specimen for testing must be collected at the time of recovery, or up to seven days before or after recovery, with longer windows specified for certain donor types. [12] FDA has issued guidance addressing screening and testing for agents and conditions including HIV, hepatitis B virus, hepatitis C virus, Mycobacterium tuberculosis, and sepsis. [13]

Regulation in the United States

In the United States, human tissue intended for transplantation is regulated by the FDA under Title 21 of the Code of Federal Regulations, Part 1271 (21 CFR Part 1271), as part of the framework for HCT/Ps. [14] The stated purpose of Part 1271 is to create an electronic registration and listing system for establishments that manufacture HCT/Ps and to establish donor-eligibility, current good tissue practice (CGTP), and other procedures to prevent the introduction, transmission, and spread of communicable diseases. [14]

The framework has three central components: [11][14]

• Registration and listing. Establishments that manufacture HCT/Ps must register with the FDA and list their products in the agency's electronic system.
• Donor eligibility. Donor screening and testing requirements (described above) govern who may be a donor.
• Current Good Tissue Practice (CGTP). CGTP requirements govern methods used in, and the facilities and controls used for, the recovery, processing, storage, labeling, packaging, and distribution of HCT/Ps to prevent contamination and the transmission of communicable disease.

Many tissues distributed by tissue banks are regulated solely under Section 361 of the Public Health Service Act ("361 HCT/Ps") and do not require premarket approval, provided they meet defined criteria; products that do not meet those criteria are regulated as drugs, devices, or biological products requiring additional FDA authorization. [11][14] A fuller treatment of the legal framework, including the distinction between 361 and 351 products and CGTP details, appears in FDA regulation of human tissue (HCT/Ps).

Standards and accreditation: the role of the AATB

The American Association of Tissue Banks (AATB), a nonprofit organization founded in 1976, develops voluntary standards, inspects facilities, and accredits tissue establishments in North America. [2][4] Its Standards for Tissue Banking, first published in 1984, are described by the association as the most comprehensive private tissue-banking standards published in the United States and have served as a model for federal and state regulation as well as international directives; a 15th edition was released in 2024 and became effective in January 2025. [2] AATB has operated a voluntary accreditation program since 1986; accreditation indicates that an establishment adheres to AATB standards and policies and is subject to audits and on-site inspections. [2][4] Accreditation by AATB is voluntary and separate from the mandatory FDA registration that all U.S. tissue establishments must complete. [2][14]

Allograft sterilization and tissue-banking safety practices, including aseptic processing versus terminal sterilization, are areas in which AATB standards and FDA CGTP requirements both apply. [10][11]

Allograft versus autograft

Tissue used in grafting may be an allograft or an autograft. An autograft is tissue taken from one site on a patient's body and transplanted to another site on the same patient (for example, a skin graft after removal of a skin cancer, or a tendon harvested from the patient for ligament reconstruction). An allograft is tissue taken from one person (a donor) and transplanted into a genetically non-identical recipient of the same species. [15][16] The principal difference is the source of the tissue: autograft tissue comes from the recipient's own body, while allograft tissue comes from a separate donor and is the kind of tissue that tissue banks recover and distribute. [15][16] Commonly grafted tissues include bone, tendons and ligaments, skin, heart valves, blood vessels, and corneas. [15]

Scale of tissue transplantation

Tissue transplantation in the United States is large in volume. As of figures cited by the AATB, AATB-accredited tissue banks recover tissue from more than 70,000 donors and distribute in excess of 3.3 million allografts for more than 2.5 million tissue transplants performed annually in the United States, with the majority of distributed human tissue coming from AATB-accredited banks. [17] Earlier published estimates put U.S. distribution at roughly 1.5 million allografts in 2007, reflecting growth in tissue use over time. [18] These volume figures are point-in-time and should be re-confirmed against current AATB and FDA primary sources. (Figures as of 2026-06-24.)

Historical safety incidents and the development of regulation

Concerns about the safety of allograft tissue, particularly the risk of transmitting infection, were a principal driver of tighter U.S. regulation in the early 2000s. After the 2001 death of a 23-year-old man from Clostridium sordellii sepsis following implantation of a contaminated musculoskeletal allograft, the Centers for Disease Control and Prevention investigated recovery, processing, and testing methods used by tissue banks; the broader cluster of Clostridium infections associated with musculoskeletal-tissue allografts focused attention on processing and sterilization practices. [19]

In 2005, the FDA implemented the three-part HCT/P framework described above (registration, donor eligibility, and CGTP), including a requirement that tissue establishments report certain serious post-transplant infections. [11][20] A subsequent analysis found that reported infections after human tissue transplantation rose from about 21 per year in 2001-2004 (before the CGTP rules) to roughly 97 per year from 2006 through mid-2010 (after the rules), a change attributed primarily to enhanced mandatory reporting rather than to a true increase in infections. [20]

A separate, widely reported episode further shaped public and regulatory attention to tissue banking. Biomedical Tissue Services (BTS), a New Jersey tissue-recovery firm, was shut down by the FDA in 2005 after its principal, Michael Mastromarino, and others were charged with illegally recovering tissue from cadavers awaiting cremation without consent and forging donor-eligibility and consent records, in some cases for donors who were medically ineligible. [21][22] The case drew international attention when it emerged that the remains of broadcaster Alistair Cooke had been among those whose tissue was taken without family authorization; Cooke had died at age 95 of cancer and would not have been an acceptable donor. [21] Some recipients of BTS-derived grafts reported serious harm, and the episode intensified calls within the industry and among outside experts for stronger controls on who may recover tissue. [21][22] These events are described here neutrally and are widely cited as context for the strengthening of FDA tissue rules and the prominence of voluntary AATB accreditation. [11][21]

Ethics and informed consent

Informed consent (or authorization) is the central ethical principle governing tissue donation. [23] When a deceased person's own donation wishes are not documented, family members or other authorized parties asked to decide about tissue donation should be given the information needed to make an informed decision. [23] The World Health Organization's Guiding Principles on Human Cell, Tissue and Organ Transplantation provide that cells, tissues, and organs may be removed from a deceased person for transplantation if any consent required by law has been obtained and there is no reason to believe the deceased objected. [24] The WHO principles also hold that donors and their families must not be paid, coerced, or exploited, and that breaches should be sanctioned by relevant professional and regulatory authorities. [24] The scope and content of disclosure made to families during the tissue-donation request, and the role of next of kin in authorizing or vetoing donation, remain subjects of ongoing ethical discussion. [23][24]

For-profit and nonprofit landscape

Tissue establishments in the United States include both nonprofit organizations (some operating alongside or within organ procurement organizations and eye banks) and for-profit companies that process and distribute tissue products. [1][11] Recovery, processing, and distribution functions may be performed by different entities, and processed allografts move through a supply chain that can include recovery organizations, processors, and distributors before reaching hospitals and surgeons. [10][11] Regardless of ownership structure, all U.S. establishments that manufacture HCT/Ps are subject to the same FDA registration, donor-eligibility, and CGTP requirements, and many also seek voluntary AATB accreditation. [2][14] This article describes the for-profit and nonprofit landscape neutrally and does not endorse any organization or business model.

See also

• FDA regulation of human tissue (HCT/Ps)
• Bone and musculoskeletal allografts
• Skin allograft
• Eye banking and the EBAA
• Amniotic membrane
• Organ donation

References

• Pathology Outlines. "Transfusion medicine - Tissue banking." https://www.pathologyoutlines.com/topic/transfusionmedtissuebanking.html
• Association for Advancing Tissue and Biologics (AATB). "Standards for Tissue Banking." https://www.aatb.org/standards
• LifeLink Tissue Bank. "What is an Allograft." https://lifelinktissuebank.org/patients-recipients/
• Association for Advancing Tissue and Biologics (AATB). "Accreditation." https://www.aatb.org/accreditation
• Health Resources and Services Administration (HRSA) / OrganDonor.gov. "Organ Donation Statistics." https://www.organdonor.gov/learn/organ-donation-statistics
• American Academy of Orthopaedic Surgeons / "Allografts: Graft Sterilization and Tissue Banking Safety Issues." PMC. https://pmc.ncbi.nlm.nih.gov/articles/PMC7310937/
• "Current Safety, Sterilization and Tissue Banking Issues for Soft Tissue Allografts." PMC. https://pmc.ncbi.nlm.nih.gov/articles/PMC7131467/
• Eye Bank Association of America (EBAA). https://restoresight.org/
• IntechOpen. "Placental Cells and Tissues: The Transformative Rise in Advanced Wound Care." https://www.intechopen.com/chapters/53065
• "Understanding Tissue Sterilization, Part 1: Aseptic Processing vs. Terminal Sterilization." https://allografts.com/understanding-tissue-sterilization-part-1-aseptic-processing-vs-terminal-sterilization/
• FDA. "Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)." https://www.fda.gov/media/70689/download
• eCFR. "21 CFR Part 1271, Subpart C - Donor Eligibility." https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271/subpart-C
• FDA. "Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products." https://www.fda.gov/regulatory-information/search-fda-guidance-documents/eligibility-determination-donors-human-cells-tissues-and-cellular-and-tissue-based-products
• eCFR. "21 CFR Part 1271 - Human Cells, Tissues, and Cellular and Tissue-Based Products." https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271
• National Library of Medicine / MedlinePlus and Britannica. "Allograft." https://www.britannica.com/science/allograft
• Healthline (medically reviewed). "Allograft vs. Autograft Transplants." https://www.healthline.com/health/skin/allograft-vs-autograft
• Association for Advancing Tissue and Biologics (AATB). Federal advocacy materials (tissue distribution statistics). https://www.aatb.org/sites/default/files/2023/Federal%20Advocacy%20Letters/TPG%20Best%20Practices%20for%20Guidance%20Comment%20Letter%20FINAL.pdf
• Eastlund T., et al. "Reported infections after human tissue transplantation before and after new FDA regulations, United States, 2001 through June 2010." Cell and Tissue Banking. https://link.springer.com/article/10.1007/s10561-011-9253-5
• Kainer M. A., et al. "Clostridium Infections Associated with Musculoskeletal-Tissue Allografts." New England Journal of Medicine. https://www.nejm.org/doi/full/10.1056/NEJMoa023222
• "Reported infections after human tissue transplantation before and after new FDA regulations, United States, 2001 through June 2010." Cell and Tissue Banking. https://link.springer.com/article/10.1007/s10561-011-9253-5
• Wikipedia. "Biomedical Tissue Services." https://en.wikipedia.org/wiki/Biomedical_Tissue_Services
• "FDA shuts down human tissue company." PMC / NIH. https://pmc.ncbi.nlm.nih.gov/articles/PMC1388122/
• "Consenting to donation: an examination of current practices in informed consent for tissue donation in the US." PMC. https://pmc.ncbi.nlm.nih.gov/articles/PMC3568202/
• World Health Organization. "WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation" (WHA63.22, May 2010). https://www.edqm.eu/documents/52006/286852/WHO+guiding+principles+on+human+cell,+tissue+and+organ+transplantation,+as+endorsed+by+the+63rd+WHA,+May+2010,+Resolution+WHA63.22.pdf