ALLOGRAFTS

Registration & Licensure

Genesis Biologics is registered with the U.S. Food and Drug Administration (FDA) and maintains all federal, state, and local regulatory requirements. [View Documents]

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Donor Screening

Donor screening and recovery partners meet or exceed all industry standards set forth by the American Association of Tissue Banks.

Following donation consent, an extensive evaluation process includes:

• A detailed potential donor screening and evaluation process to review medical history as well as any lifestyle or behavioral issues that may disqualify donation. Individuals identified with risk factors for or clinical evidence of relevant communicable diseases and disease agents (RCDADS) such as AIDS, viral hepatitis, sepsis, etc., are ruled out as potential donors or are later disqualified if the subsequent investigation reveals high-risk markers.

• An on-site review of the potential donor’s relevant medical records to evaluate other rule-out conditions.

• A physical assessment of each donor candidate just prior to tissue recovery to confirm donor identity, to evaluate the accuracy of medical and social history collected, and to look for signs/symptoms of other disqualifying conditions or risk factors.

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Tissue Recovery

All recoveries are performed or supervised by technicians who have received certification by the American Association of Tissue Banks (AATB).Environmental control is crucial during the recovery process in order to prevent contamination/cross-contamination of tissue. Environments that are outside of a hospital operating room or specially designated tissue recovery room must be evaluated and meet strict environmental requirements prior to tissue recovery. Recovery of tissue begins after proper documentation is started for the purpose of evaluating and tracking each donor. Documentation is continued throughout the entire recovery process to ensure all pertinent information is recorded as set forth by the FDA and AATB. Prior to the recovery of tissue, the identity of the donor is verified, blood specimens are collected for infectious disease testing/archive, and a physical assessment of the donor is performed for signs of high-risk behavior/symptoms of a communicable disease, trauma, etc. In addition, photographs may also be taken for quality assurance purposes and shared with the medical examiner. Only after these steps are taken can the recovery of tissue take place.

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Allograft Processing

Our source facilities process all tissue utilizing aseptic technique. Tissue from only one donor is processed in a room at a time; pooling of tissue from multiple donors is strictly prohibited. Our source facilities use proprietary techniques involving a series of mechanical and reagent cleaning and disinfection steps to reduce any potential bioburden. These cleansing processes involve a combination of biological detergents that work in conjunction with traditional treatments such as alcohol and hydrogen peroxide to enhance the solubilization and removal of bone marrow, blood, and lipids (elements that may possibly act as a reservoir for disease transmission). In addition, antibiotics are also used in the processing of allografts. The tissue to be demineralized is further processed using hydrochloric acid and sodium phosphate buffer.

Tissue is processed when all test results are negative. Aseptically processed (non-irradiated) tissue is not released for transplantation unless the final culture result supports no bacterial growth. On occasion, if sterilization is required, tissue is terminally sterilized using a (low dose) Gamma irradiation at 15kGy to 25.8kGy.

 

Quality Assurance

Our source facilities have strict donor screening criteria, recovery, and processing methods, and they request autopsies on all donors whenever possible. These safeguards are designed to prevent the introduction, transmission, or spread of communicable diseases from allografts. To further limit risks, each facility has a comprehensive Quality Assurance Program that oversees every step, from family consent to tissue distribution.

 

Traceability

Genesis Biologics uses the source facilities’ unique identification number for identifying tissue in order to maintain traceability at any phase of the operation. Records indicate the dates and staff involved in each step of the operation, from the time of shipping (source facility)  to the final disposition of the tissues, as well as the tissue identification number(s). Laboratory and QC specimens related to a donor or tissue are maintained at the source facility and traceable to the donor via the unique identification number provided by the source facility.