All tissue recovered meets stringent specifications during donor screening and laboratory testing to reduce the risk of transmitting infectious disease.
EpiFix allografts are procured and processed in the United States according to standards and/or regulations established by the American Association of Tissue Banks (AATB) and the United States Food & Drug Administration (FDA).
All tissues are recovered under full informed consent of the donors (mothers of the newborn children). The donors have consented to the transfer of the allografts to third parties. A thorough medical and social history of the donor is also obtained. The listed communicable disease testing is performed by a laboratory registered with FDA to perform donor testing and certified to perform such testing on human specimens in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493, or that has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services (CMS).
The donor is screened for:
- HIV-1&2 Plus 0 Antibody
- Hepatitis B Surface Antigen
- HIV Type 1 (Nucleic Acid Test (NAT))
- Hepatitis C Antibody
- HTLV-1&2 Antibody
- Hepatitis C Virus (Nucleic Acid Test (NAT))
- Syphilis (Serologic Test)
- Hepatitis B Virus (Nucleic Acid Test (NAT))
- Hepatitis B Core Antibody
- West Nile Virus (Nucleic Acid Test (NAT))*
*WNV NAT screening conducted on donors based on exposure risk per FDA Guidance for Industry.
Only tissue from donors with acceptable test results, according to the standards of MiMedx Tissue Services, LLC, as well as the standards and/or regulations of all state and federal regulatory bodies, are released.