Vitality Bone is terminally sterilized using validated gamma irradiation. Recovery and screening are performed according to FDA guidelines.
Vitality Bone is thoroughly tested for:
- Antibody to Human Immunode ciency Virus 1 & 2 (anti-HIV 1 & 2)
- Hepatitis B Surface Antigen (HbsAg)
- Hepatitis B Core IgC/IgM Antibody (HbcAb)
- Antibody to Hepatitis C (anti-HCV)
- Rapid Plasma Reagin or Serologic Test for Syphilis (STS by RPR)
- Human Immuno Deficiency Virus DNA using Polymerase Chain Reaction (HIV PCR DNA)
All tissue is processed in certified ISO Class 1000 and Class 100 clean rooms. Pre-processing and post-processing quality assurance and quality control reviews are performed on all donated tissues. Each donor is approved by the tissue bank’s Medical Director to ensure compliance with donor acceptance criteria prior to release.
Dr. Hamid Shafie
Director of postdoctoral implant training at Washington Hospital Center
Department of Oral and Maxillofacial Surgery
