Regulation and Standards
- The tissue processing in the United States is governed by mandatory requirements enforced by federal and state regulatory authorities. The authorization of the gift of tissues is governed by the Uniform Anatomical Gift Act.
- Tissue banks in the United States are governed by the National Organ Transplant Act (NOTA), which dictates that tissues cannot be bought or sold. The law does allow for reimbursement of costs associated with the recovery, processing and storing of tissue and for the development of tissue processing technologies. These activities can include research, screening and testing, sterilization processes and precision-tooled shaping of allografts for transplantation.
- Regardless of their status, all tissue banks must meet the same regulatory requirements and have the same goal of assisting in the process of making tissue safely available for transplants. Human tissue processed and distributed for transplantation by AATB-accredited tissue banks is subject to Food and Drug Administration (FDA) regulation and AATB's Standards.
- Tissue transplantation has an impressive safety record. Transmission of infectious diseases through allografts is prevented through careful donor screening, including extremely sensitive laboratory testing, and tissue processing.
- Human tissue products are inherently biocompatible, meaning they can be incorporated into a human body more easily and with fewer complications than many analogous synthetic products or those of animal origin (xenografts).
- Every medical procedure, including the use of tissue for transplant, comes with risks and benefits. The AATB encourages any patient considering a tissue transplant to discuss the risks and benefits of the procedure with their physician.
- Both FDA regulation and AATB's Standards require tracking tissue from the moment of recovery through all handling and distribution to the consignee, which is the entity that accepts the final delivery of the allografts.
- FDA regulation does not require the consignee to track the tissue to final disposition, including use in a patient. This makes it critical for healthcare facilities to have systems to read bar codes containing unique identifiers, tracking allografts to the patient.
- AATB's Standards require that members have a protocol in place to provide methods for the consignee to provide follow-up data collection (e.g., tissue trace card to complete and return) on the recipient. However, although critical, completion by end users is voluntary.
- AATB does not regulate tissue internationally. It is regulated by the FDA.