The Critical Role of Donor Eligibility Determination – Safeguarding Recipients
Welcome back! As the field of tissue donation and transplantation has revolutionized modern medicine, it impacts the quality of life for many recipients. From restoring vision to reconstructing damaged tissues after trauma, donated human tissue is a cornerstone of advanced healthcare. Today, we’re revisiting one of the rigorous processes required by the Food and Drug Administration (FDA) and the American Association of Tissue Banks (AATB) which are the essentials of donor eligibility determination, its critical importance, and the impact of regulatory oversight in ensuring safe and ethical tissue transplantation.
Donor eligibility is the systematic assessment of potential tissue donors to determine if their tissues can be safely and legally recovered for transplantation. This process involves evaluating the medical and social history of the donor, conducting laboratory testing, and performing physical examinations/assessments. The goal is to minimize the risk of disease transmission, ensure the quality of recovered tissues, and uphold public trust in the donation process.
The FDA released their guidance, “Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) [1] ” back in August 2007 to assist tissue establishments in making donor eligibility determination including donor screening and testing in compliance with 21 CFR Part 1271. On January 21, 2025, the FDA released the draft guidance, “Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), Draft Guidance for Industry” which is still in its comment stage, as the intent of the guidance was to separate out recommendations for reducing the risk of transmission for specific communicable disease agents and diseases for donors of HCT/Ps; specifically, human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), Mycobacterium tuberculosis (Mtb), sepsis, human transmissible spongiform encephalopathies, cytomegalovirus (CMV), Chlamydia trachomatis and Neisseria gonorrhoeae, human T-lymphotropic virus (HTLV), Treponema pallidum (syphilis), vaccinia virus, West Nile virus (WNV), and communicable disease risks associated with xenotransplantation [2].
The FDA’s donor eligibility requirements include, but are not limited to:
Donor Screening: A thorough review of medical and social history to identify risk factors for communicable diseases.
Donor Testing: Approved laboratory tests (those laboratories accredited under the Clinical Laboratory Improvement Amendments, CLIA, or equivalent as determined by the Centers for Medicare and Medicaid Services, CMS) for infectious diseases such as HIV, HBV, HCV, syphilis, and other pathogens.
Physical Examination/Assessment: Examination for signs of disease, trauma, or high-risk behavior.
Documentation and Record Keeping: Detailed records must be maintained to ensure traceability and allow for audits.
The AATB accreditation standards address:
Enhanced Donor Screening: In-depth medical and behavioral history interviews conducted by trained staff.
Serological and Microbiological Testing: Approved laboratory tests (CLIA or CMS equivalent), requirements for validated testing methods and laboratory accreditation.
Physical Examination/Assessment: Detailed protocols for assessing donor eligibility.
Quality Management: Mandates for continuous process improvement, error reporting, and corrective action.
Ethical Considerations: Informed consent, donor confidentiality, and respectful treatment of tissue donors.
Overview of the Donor Eligibility Determination Process:
Referral and Initial Assessment: When a potential donor is identified, medical and social history is collected from medical records, next-of-kin, and other sources.
Screening for Risk Factors: Trained staff assess for risk behaviors, infectious disease exposure, travel history, and other contraindications.
Physical Examination/Assessment: The donor undergoes a thorough examination to identify any signs of systemic illness, trauma, lesions, needle tracks, or other findings that could pose a risk.
Laboratory Testing: Blood samples are tested for infectious agents as required by FDA and recommended by the AATB.
Documentation and Review: All findings are reviewed by qualified medical personnel or a medical director who makes the final eligibility determination based on all available information.
Donor criteria are established by the Medical Director of the tissue establishment and is required per the FDA prior to the tissue being transplanted. This list is ongoing and changes as our industry continues to evolve. The paramount goal is to protect the safety and well-being of recipients. Tissue establishments are expected to maintain robust surveillance systems, report adverse events, and implement corrective actions as needed. Continuous improvement, education, and training of staff is essential to sustaining the standards of practice. Donor eligibility determination is critical in ensuring safe products are transplanted into patients. Through vigilance, collaboration, and adherence to the highest standards, we honor the altruism of donors and their families and ensure that the gift of donation continues to save and impact lives for generations to come!
Thanks for stopping by! Keep checking back as we talk about trends and regulatory changes that impacts our industry!
Have questions about donor eligibility determination or how to establish a donor eligibility process? Contact us here!
References
[2] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-determining-eligibility-donors-human-cells-tissues-and-cellular-and-tissue-based