REGENX: Ousia bioGRAF is supplied by REGENX. All tissue has been sourced by UMTB of 1951 NW 7th Avenue, Suite 200, Miami, FL 33136, operating in accordance with the Standards for Tissue Banking of the American Association of Tissue Banks (AATB) and Food and Drug Administration (FDA) regulations. The allografts have been processed and sterilized to the highest standards set forth by both American Association of Tissue Banks (AATB) and FDA, providing one of the purest particulates available today. The Ousia product line provides the ability to participate in the dental bone grafting arena, with high-quality, time-tested, bone regeneration products for both hard and soft tissue.
Ousia bioGRAF products are used in situations where a human allograft is appropriate, such as dental bone grafting procedures. bioGRAF particulates are, low-dose, gamma-irradiated particles of allogeneic human bone.
bioGRAF Allografts are declared safe for transplant. All tissue meets stringent donor screening and laboratory testing to reduce the risk of transmitting infectious disease.
The processing of bioGRAF consists of a strict, quality-controlled procedure that involves thorough cleaning and gentle preservation of the tissue.
The presence of infection at the transplantation site is a contraindication for use of musculoskeletal allografts. The presence of gross infection at the transplantation site is a contraindication for use of skin allografts. Contraindications customary to the use of bone grafts should be observed. In addition, bioGRAF should not be used in patients with:
• Osteomyelitis at the surgical site
• Metabolic diseases (diabetes, hyperparathyroidism, osteomalacia)
• Severe renal dysfunction
• Severe liver disease
• High-dose therapy with corticosteroids
• Vascular impairment at the implant site
• Discard grafts when mishandled, or when possible contamination of the graft has occurred.
• Return to the supplier, any package in which the sterile barrier has been compromised.
• Do not re-sterilize.
• Unused bone should be properly discarded.
• Single patient use only.
• Federal law (USA) restricts use to licensed clinicians
• Trace amounts of Polymyxin B Sulfate, or Bacitracin may be present and caution should be exercised if the recipient is allergic to these antibiotics.
Handling and Preparation
Graft preparation instructions are intended as guidelines as part of established surgical techniques. They are not intended to replace or change standard procedures or
Caution: All preparation should be performed using aseptic technique.
In order to obtain the bioGRAF Allograft, peel the outer tyvec lid back, twist off the plastic lid from the plastic vial and remove the bioGRAF onto a sterile field. Once the packaging has been opened, the tissue must either be transplanted or discarded. It is recommended that
bioGRAF be reconstituted prior to use by covering with sterile isotonic solution for approximately 15 minutes, (30 minutes maximum) using aseptic/sterile technique. Rehydration can also be achieved by mixing bioGRAF with the patient’s blood. Reconstituted grafts must be used for the surgical event for which they were reconstituted or otherwise DISCARDED.
Donor eligibility (screening and testing) is performed in accordance with AATB Standards and FDA regulations. Donor screening includes assessment of the medical and social history as well as physician assessment of the donor to assure that no conditions exist that may make the tissue unacceptable for transplantation. Donor has been
determined to be eligible by a UTMB Medical Director (1951 NW 7th Avenue, Suite 200, Miami, FL 33136).
Communicable disease testing was performed by a laboratory registered with the FDA to perform donor testing and certified to perform such testing on human specimens in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR Part 493. The testing was conducted using FDA licensed, approved, or cleared donor screening tests for cadaveric specimens where applicable. The records of this testing are maintained at UTMB. The following required testing was performed and found to be negative or non-reactive:
• Antibody to Human Immunodeficiency Virus 1 & 2 (HIV 1 & 2)
• Human Immunodeficiency Virus Type 1 (HIV-1 NAT)
• Antibody to Hepatitis C (HCV)
• Hepatitis C Virus (HCV NAT)
• Hepatitis B Core IgG/IgM Antibody (HBcAb)
• Hepatitis B Surface Antigen (HBsAg)
• Rapid Plasma Reagin or Serologic Test for Syphilis (RPR or STS)
Additional tests including, but not limited to, Human T-Cell Lymphotropic Virus Type I & II (HTLV I & II) may have been performed at the time of donor screening, and were found to be negative or non-reactive. A list of additional communicable disease test(s) performed will be provided upon written request to REGENX at the address provided.
Tissue is subjected to microbiological testing at recovery and in the course of processing, and must be free of specific aerobic/anaerobic microorganisms and fungal contaminants whose presence would preclude tissue from processing or transplantation.
Medical Director Assessment
Donor eligibility determination is made by a Medical Director who reviews and approves each donor for processing. Pertinent records may be made available upon written request to REGENX at the address provided.
Potential Complications / Adverse Reactions:
As with any surgical procedure, the possibility of infection exists. Although the bone processing is designed to eliminate antigenic properties of the graft, the possibility of such rejection is present in any allograft procedure. Re-operation could be necessary to correct adverse effects. bioGRAF products remain sterile as long
as the package is not opened and/or damaged. The graft must be used before the expiration date. Before clinical use, the surgeon should thoroughly understand all aspects of the surgical procedure and the limitations of the graft. Patients should be instructed in the limitations of the graft and should be taught to govern their activities
appropriately. Appropriate placement and retention are critical factors in the avoidance of potentially adverse effect on graft performance. Adverse reactions should be immediately reported to REGENX.
It is the responsibility of the hospital or clinician to maintain tissue for transplantation according to recommended storage conditions. Do not use if tissue has not been stored according to the recommended storage instructions.
• Store at ambient temperature
• Do not freeze