• Home
  • Safety | Snoasis Medical
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, its processor, MiMedx Group, 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 Purion® Processing and Regulatory standards.