allogeneic bone safety

Patient safety is at the forefront of every procedure and material selection at Oral and Maxillofacial Surgery of Elkhart. Consistent with this philosophy, Dr. Burns carefully selected Life Net Health Biologics, Inc. to supply the allogeneic bone that is used for bone grating procedures. 

All donors of the allogeneic bone have been meticulously screened, and tissues have been carefully recovered, processed, stored, tested, and distributed in accordance with current U. S. Federal regulations as promulgated in 21 CFR1271, the current Standards for Tissue Banking set forth by the American Association of Tissue Banks (AATB) and international laws and regulations, as required.

Required Infectious Disease Testing:

  • TEST
    Types of Anesthesia
  • HBcAb: Hepatitis B Total Core Antibody
    negative / non-reactive
  • HBsAG: Hepatitis B Surface Antigen
    negative / non-reactive
  • HCV NAT: Hepatitis C Virsu Nucleic Acid Test
    negative / non-reactive
  • HBV NAT: Hepatitis B Virus Nucleic Acid Test (not required for donors prior to December 2016)
    negative / non-reactive
  • HIV-1 NAT: Human Immunodeficiency Virus Type 1 Nucleic Acid Test
    negative / non-reactive
  • HIV 1 / 2 AB: Human Immunodeficiency Virus Type 1 / 2 Antibody RPR/STS or Equivalent: Syphilis
    negative / non-reactive
  • HTLV 1 / 2 AB: Human T-Lymphotropic Virus Type 1 / 2 Antibody (not required for donors after March 2020)
    negative / non-reactive

The following video further explains the careful process by which the donated tissue is sterilized utilizing the Allowash XG Sterilization procedure.