Safety + Quality

Adhering to stringent safety and quality standards.

We take extraordinary measures to ensure the recovery and processing of all tissue meets the guidelines set forth by the U.S. Food and Drug Administration (FDA) for the recovery and processing of all donated human tissue for allografts.

Medical surveillance of the grafts from donated tissues helps prevent contamination and also provides minimal manipulation so that the tissue’s biomechanical or osteoinductive properties remain as close to an autograft as possible.

Recovery

  • Recovery microbiologic cultures are taken from each tissue.
  • Follows Association of Operating Room Nurses aseptic technique standards.
  • Aseptic recovery and processing to assure biological and biomechanical integrity of the allograft tissue.
  • All reports are reviewed by the Medical Director(s) for pre-processing approval on the donor.

Processing

  • To maintain biological integrity, we process all tissue by using aseptic techniques in Class 100 cleanrooms or better.
  • Follows Association of Operating Room Nurses aseptic technique standards.
  • Selected tissues are terminally sterilized by gamma irradiation.
  • All tissues undergo multiple separate quality assurance checks prior to release.
  • 100% sampling at final stage of preparation.
  • All tissue is tracked from recovery through testing, processing, packaging and distribution.
  • Vivex records management system: Permits tracing of a tissue from the donor to the recipient and from the recipient to the donor. Permits identification of a tissue at any phase of the operation. Indicates the dates and staff involved in each significant step of the operation from the time of retrieval through final disposition of the tissue as well as the tissue identification number(s). Allows for laboratory and quality control specimens related to a donor or tissue to be traceable to the donor.

Laboratory screening
The following tests are performed using approved methods by a certified laboratory:

Human Immunodeficiency Virus (HIV)

  • HIV/I/II Antibodies
  • HIV-NAT Molecular Amplification Test for HIV-I/II proviral DNA

Hepatitis B (HBV) and Hepatitis C Virus (HCV)

  • HBV Surface Antigen
  • HBV Core Antibody (total)
  • HCV Antibody
  • HCV-NAT Molecular Amplification Test for HCV

Human T Cell Lymphotrophic Virus I/II

  • HTLV-I/II Antibody

Syphilis

  • Syphilis-Rapid Plasma Reagin Screen RPR