Safety & Quality Assurance
Tissue Recovery & Aseptic Processing
During the Tissue recovery and processing steps, every pre-caution is taken to ensure that the patient will receive safe, high quality bio-implants. Before being released, extensive donor screening and laboratory testing is performed using CLIA Certified laboratories. All Stability implants are delivered sterile to the operating room. All donor tissue recovery and processing criteria meet both FDA 21 CFR 1271 regulations and AATB Standards requirements for each HCT/P product type. Stability products are manufactured under strict controls and terminally sterilized with a validated sterilization process to ensure all products meet a SAL of 10-6.
Donor Selection & Screening
All donors must meet strict acceptance criteria as well as undergo and pass vigorous evaluation by the Medical Director. The donor’s next of- kin is interviewed and all relevant medical records are reviewed and evaluated. Each donor undergoes a rigorous screening and serological testing process to ensure patient safety.
All donor screening and eligibility criteria meet both FDA 21 CFR 1271 regulations and AATB Standards requirements for each HCT/P product type.