Regulatory and Quality Assurance
The Applied Biologics™ line of human allograft products are regulated by the FDA Center for Biologics Evaluation and Research (CBER) which regulates human cells, tissues, and cellular and tissue-based products (HCT/Ps). The products are minimally manipulated amniotic fluid and amniotic membrane allografts and intended for homologous use only. These products are regulated under 21 CFR Part 1270 and 21 CFR Part 1271 and Section 361 of the Public Health Services Act.
DONOR SCREENING AND TESTING
A healthy mother may be considered as a candidate for donation during a scheduled, elective Cesarean Section delivery. All donor are subject to strict regulatory and quality assurance compliance, medical and social history screening, informed consent, and medical records history review. Prior to processing, the donor’s medical and social history will be screened for conditions and disease processes that would prevent the donation of tissues. All policies and procedures for donor screening, serologic, and microbiologic testing comply with all current standards and regulations established by the United States Food and Drug Administration. The donor’s medical and social history will be screened for HIV, Hepatitis, and other relevant communicable disease agents in accordance with current United States Public Health Services Recommendations and FDA Regulations and Guidance Documents and may be considered a contraindication for tissue donation. Other contraindications for tissue donation include: presence of infectious disease, neurological degenerative disease, disease of unknown etiology, and exposure to toxic substances.
Communicable disease testing has been performed by a laboratory registered with the FDA to perform donor testing and certified to perform such testing on human specimens in accordance with Clinical Laboratory Improvement Amendments (CLIA) and 42 CFR Part 493, or that has equivalent requirements as determined by the Centers for Medicare and Medicaid Services. Names and addresses of testing laboratories, interpretation of all required infectious disease tests, and a listing of the documents reviewed as part of the relevant medical records are kept on file at the processing tissue bank and are available upon request.
Donor blood samples taken prior to or at the time of recovery were tested by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) and were found negative using FDA licensed tests for, at minimum:
- HBsAg: Hepatitis B Surface Antigen
- HBcAb: Hepatitis B Core Antibody
- HCVAb: Hepatitis C Antibody
- HIV 1/2/Ab: Human Immunodeficiency Virus Types 1/2 and O Antibody
- HCV NAT: Hepatitis C Virus
- HIV NAT: Human Immunodeficiency Virus
- HBV NAT: Hepatitis B Virus
- RPR/STS or Equivalent: Syphilis
PROCESSING AND STERILITY
Donor tissue is recovered using the safest recovery techniques and sterile equipment to minimize any bioburden contamination. Applied Biologics LLC tissues are procured via a network of qualified and trained recovery partners, one of the most stringent screening and recovery protocols, and a highly controlled regulatory and quality assurance processing environment, thus countering the risks of disease transmission at every step.
There have been no reported adverse reactions associated with any Applied Biologics™ product.
Per 21 CFR 1271.290, documentation about the tissue disposition to enable tracking from the donor to the consignee or final disposition must be maintained. Joint Commission standard QC.5.310.7 requires that “the organization that receives tissue provides a system that fully complies with the completion and return of tissue usage information cards requested by source facilities.” To comply with these requirements, a Tissue Tracking/Transplant Record (TTR) and pre-printed labels are provided with every allograft. Record the patient information, the transplant facility name and address, the allograft tissue information (using stickers) and comments regarding tissue use on the TTR. Return the completed TTR to the processing tissue bank and retain a copy in the patient medical record. Even if the tissue has been discarded for any reason, a completed TTR with the allograft identification information and reason for discard shall be returned to the processing tissue bank.