VIVEX is expanding our Amnion & Wound Care Distribution Network. Interested in becoming a distribution partner? Click here to learn more.
We take extraordinary measures to ensure the recovery and processing of all tissue meets the guidelines set forth by the US Food and Drug Administration (FDA) for all donated human tissue for allografts. VIVEX Biologics’ proprietary Integrity ProcessingTM methodology helps prevent contamination and provides minimal manipulation so the grafts from donated tissue’s biomechanical or natural properties remain as close to an autograft as possible.
Tissue Recovery & Processing
  • Microbiologic cultures are taken from each tissue
  • All donor records are reviewed by our Medical Directors to determine donor eligibility for transplantation.
  • To maintain biological integrity, we process all tissue by using aseptic techniques in Class 100 environments
  • Selected tissues are terminally sterilized by electron beam radiation
  • All tissues undergo multiple, separate quality assurance checks prior to release to ensure utmost quality and safety
  • Traceability is maintained for all tissues from recovery through testing, processing, packaging, and distribution
Records Management
Our records management system allows for the tracing of a tissue from the donor to the recipient, and from the recipient to the donor, to help identify a tissue at any phase of the process. Through the use of a robust tissue identification system, we can track the dates and the staff involved in each significant step of the operation, from the time of tissue retrieval through final disposition of the tissue.
Integrity Processing™
VIVEX’s Integrity Processing™ is our innovative process methodology focused on protecting tissue from harmful cleaning agents, maintaining the natural state of tissue, and thus preserving the inherent characteristics of tissue and bone allografts to support patients’ regenerative potential.
Laboratory screening
The following tests are performed using approved methods by a CLIA certified laboratory:
Human Immunodeficiency Virus (HIV)
  • HIV-1/2 Plus O Antibodies (HIV-1/2 Plus O Ab)
  • Nucleic Acid Test for HIV-1 RNA (HIV-1 NAT)
Hepatitis B (HBV)
  • HBV Surface Antigen (HBsAg)
  • HBV Core Antibody (IgG & IgM) (HBcAb)
  • Nucleic Acid Test for HBV DNA (if performed) (HBV NAT)
Hepatitis C Virus (HCV)
  • HCV Antibody (HCVAb)
  • Nucleic Acid Test for HCV RNA (HCV NAT)
Syphilis*
  • Rapid Plasma Reagin (RPR) Screen
  • T. Pallidum Ig

*A donor whose blood specimen is unsuitable for the non-treponemal screening assay, such as the RPR test, or with a reactive result from the non-treponemal screening assay, is cleared for transplantation use only when the result from the treponemal-specific (confirmatory) assay is nonreactive.

Screening tests for exposure to other viruses or parasites such as those listed below may have been completed:

CYTOMEGALOVIRUS**
  • CMV Ab (IgG & IgM)
EPSTEIN BARR VIRUS
  • EBV Ab (IgG & IgM)
HUMAN T CELL LYMPHOTROPIC VIRUS I/II**
  • HTLV-I/II (Antibody HTLV-I/II-Ab)
TOXOPLASMA GONDII
  • Toxoplasma Ab (IgG &IgM)
TRYPANOSOMA CRUZI
  • T. cruzi Ab (IgG & IgM)
WEST NILE VIRUS (WNV)
  • Nucleic Acid Test for WNV RNA (WNV NAT)
ZIKA VIRUS
  • Zika Ab (IgM)
  • Nucleic Acid Test for Zika RNA (Zika NAT)

**A donor with a reactive result for the CMV or HTLV-I/II Antibody test is suitable for use only when the result from a confirmatory assay is nonreactive.

American Association of Tissue Banks (AATB)
The American Association of Tissue Banks is the organization that sets standards, inspects facilities, and accredits tissue banks in North America. AATB trains and certifies tissue banking specialists. In crafting new federal regulations for tissue banking, the FDA has relied heavily on the expertise of the AATB.
Quality Policy Statement

VIVEX Biologics is committed to consistently providing products and solutions that are of the highest quality and safety to our recipients and customers. We are dedicated to serving our donors and donor families and honoring their gift. Our quality system is built on a foundation of continuous improvement to exceed regulations and standards. Our culture promotes competency, development, transparency, and collaboration to accomplish our core purpose: Your Gift, Their Life.

VIVEX Policy Guidelines

We adhere to strict policies and procedures in all activities. Our policies and procedures are designed, written, and revised to stay abreast of new developments and improved methods of donor examination and allograft development. All staff are trained in new procedures that affect their job responsibilities.

Quality assurance and quality control are central to all operations. Quality audits are regularly performed, and feedback is provided to staff, with the goal of providing the highest quality and safest tissue for transplantation.