Allograft Safety

Patient safety is our highest priority.

While the options for surgical musculoskeletal repair continue to expand, a growing number of surgeons worldwide choose bone and soft tissue allografts as a safe, effective and convenient surgical option. Allografts bearing the SteriGraft® label fulfill the discriminating surgeon’s desire to extend extraordinary patient care. Our superior level of allograft processing begins with rigorous Donor Screening and meticulous Donor Recovery Procedures, Certified Laboratory Testing, validated Tissue Cleansing, Sterile Packaging, and a meticulous Quality Assurance & Documentation system that ranks second to none.

These combine to form the proprietary, GraftShield® allograft processing system, designed to set an entirely new standard in allograft sterilization. This system offers scientifically validated tissue sterilization (validated to SAL 10‑6 in accordance with ISO 11137-2 Method 1) which virtually eliminates the risk of bacterial disease transmission.

To learn more about the various certifications of Bone Bank Allografts and Texas Human Biologics, please click here.

Donor Screening & Processing

A meticulous donor screening system has been developed to assure that only uniform, high quality tissues will be recovered and processed.

  • Donor Screening and Review – An extensive donor screening process is conducted to review medical / social history. Only those donors that meet our standards and screening requirements are qualified to be accepted for donation. This rigorous screening process is performed in an effort to eliminate potential donors with risk factors, which may contribute to the transmission of infectious disease.
  • Donor Recovery and Processing – Our donor recovery partners and their staff are held to high standards. Specific policies and procedures are followed to ensure that donor tissue is recovered appropriately and under aseptic conditions.

Laboratory Testing

In accordance with FDA regulations, donor tissues are tested by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and carefully analyzed using the latest technology in order to confirm that the donor is free from the following infectious diseases:

  • Required – Human Immunodeficiency Virus Type I Ab, HIV I Antibody, HIV I Nucleic Acid Test, Human Immunodeficiency Virus Type II Ab, HIV II Antibody, , Hepatitis B Virus, HBc Antibody (total), HBs Antigen, Hepatitis C Virus, HCV Antibody, HCV Nucleic Acid Test, Syphilis ( Rapid Plasma Reagin Test, FTA Confirmation, West Niles Virus (living donors only)
  • Other testing that may be performed – Human T-Lymphotrophic Virus Type I, HTLV I Antibody, Human T-Lymphotrophic Virus Type II, HTLV II Antibody CMV (Cytomegalovirus) and (IgM and IgG antibody to CMV)

Tissue Processing

The Graftshield® process makes improvements at multiple steps in the tissue processing system. Our processing partner, Texas Human Biologics utilizes a state of the art processing facility which makes the following steps possible.

  • Tissue Cleansing – To prepare for processing, tissues are sanitized using GraftCleanse™. This proprietary blend of cleansing compounds significantly reduces bio-burden and allows for an aesthetic, white appearance.
  • Sterilization – GraftShield® utilizes a low dose radiation sterilization method that is validated in accordance with ISO 11137-2 Method 1. Terminal sterilization is achieved with allografts in their final packaging.
  • Custom Processing Machines – Custom equipment enables individual equipment sterilization between cases, thus eliminating the risk of cross contamination – a significant advance in the safety of processing human tissue allografts.
  • Allograft Performance – Each allograft is evaluated at the time of processing, packaging, labeling, and prior to release to ensure that high quality tissue is being made available for transplantation.
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Sterile Packaging

SteriGraft® Allograft Tissues from Bone Bank Allografts are sterilized in their final packaging to ensure the highest patient safety. Our packaging processes ensure allografts arrive in the surgery in the best possible condition to facilitate a successful transplantation.

Quality Assurance

To comply with the standards set out by the U.S. Food and Drug Administration’s (FDA), Good Tissue Practices, Bone Bank Allografts, its processing partner (THB), and the various donor processing organizations we work with are all subjected to an extensive quality process.

The proprietary GraftShield® process was designed to set a new standard in allograft processing, sterility, and patient safety. Thank you for looking into this process. If you have further questions, please feel free to contact us at 1-800-397-0088 or at sales@bonebank.com.