Safety
Overview
PLACENTAL TISSUE SAFETY AND PROCUREMENT
All placental tissue is sourced in the United States with informed consent from pre-screened mothers who choose to donate their placenta following elective caesarian section deliveries. The tissue is procured, processed, and distributed according to standards and regulations established by the American Association of Tissue Banks (AATB) and the United States Food & Drug Administration (FDA). All tissue must meet stringent specifications during donor screening and laboratory testing to reduce the risk of transmitting infectious disease.
All donors are screened for:
HIV-1&2 PLUS 0 ANTIBODY HIV TYPE 1 (NAT) HTLV-1&2 ANTIBODY SYPHILIS (SEROLOGIC TEST) HEPATITIS B VIRUS (NAT) HEPATITIS B CORE ANTIBODY WEST NILE VIRUS (WNV (NAT))* HEPATITIS B SURFACE ANTIGEN HEPATITIS C VIRUS (NAT) HEPATITIS C ANTIBODY *WNV NUCLEIC ACID TEST (NAT) SCREENING CONDUCTED ON DONORS BASED ON EXPOSURE RISK PER FDA GUIDANCE FOR INDUSTRY All screening tests must produce negative results and are reviewed before release of the tissue. Only tissue from donors with acceptable test results, according to the standards of Snoasis Medical, as well as the standards and regulations of all state and federal regulatory bodies, are released. For more on our safety practices, learn about our proprietary Processing and Regulatory standards. |