Regulatory

The risk of communicable disease transmission through tissue transplantation is mitigated with careful donor screening and testing, and subsequent processing techniques that are designed to control contamination or cross-contamination. 

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. 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.

The scope of FDA regulatory authority and AATB’s Standards and accreditation requirements end at final disposition. Regulations require systems that track tissue from the donor to the consignee or final disposition, and from the consignee or final disposition to the donor. However, they do not extend beyond this point to require tracking to the recipient. 

This makes it critical for end users, such as hospitals, dental offices, and surgical clinics, to implement robust and dependable processes to track tissue once it’s under their control, ensuring traceability through transplantation to the recipient, or other final disposition, such as discard. For facilities accredited by The Joint Commission, such tracking is required; they must be able to trace tissue to the recipient or other final disposition. It is strongly encouraged that all end users, not solely those accredited by The Joint Commission, also have such systems in place to identify the disposition of all human tissues received. 

Additionally, AATB's Standards require accredited establishments to have protocols enabling consignees to provide follow-up data collection (e.g., tissue tracing cards). However, since the scope of AATB’s Standards does not extend to non-accredited end users, their completion of such data remains voluntary, though still vital for maintaining traceability across the continuum of care.

US Health & Human Services (HHS)

US FooD & Drug Administration (FDA)

Center for Biologics Evaluation & Research (CBER)

Centers for Disease Control & Prevention (CDC)

Center for Devices & Radiological Health (CDRH)

European Commission

World Health Organization (WHO)

Health Canada