We get our tissue from third party vendors and local donations
Our Licensed Physician Designee has determined if the donor of the tissue in this product is eligible to donate tissue for transplantation based on the following criteria:
- The results of the donor screening indicated that the donor was free from risk factors for and clinical evidence of infection due to relevant communicable disease agents and diseases
- The results of donor testing for the following relevant communicable disease agents are negative or non-reactive:
- Hepatitis B
- Hepatitis C
- Human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2)
- Human T-lymphotropic virus type 1 and type 2 (HTLV-1 and HTLV-2)
- West Nile virus
- Zika virus (ZIKV)
- Tissues are collected after full term live births by c-section and conducted only by licensed professionals.
A donor’s medical history and behavior risk assessment are obtained prior to donation. Discussions with physicians and/or the donor mother are conducted to identify circumstances that may lead to exclusion of the donor or donated tissue. The blood sample test results, donor medical history, behavior risk assessment, physical assessment and other records have been evaluated by the Licensed Physician Designee. Communicable disease testing and sterility testing have been performed on this tissue by a laboratory registered with the FDA to perform donor testing and certified to perform testing on human tissue in accordance with Clinical Laboratory Improvements Amendments of 1988 and 42 CFR part 493 or has met requirements determined by the Centers for Medicare and Medicaid Services.