Processing and Sterility
Donor tissue is recovered using the safest recovery techniques and sterile equipment to minimize any bioburden contamination. Ventris Medical® tissues are procured via the most stringent screening and recovery protocols in a highly controlled regulatory and quality assured processing environment, thus countering the risks of disease transmission at every step.
HCT/P Tracking
There have been no reported adverse reactions associated with any Ventris Medical® product.
Processing and Sterility
Per 21 CFR 1271.290, documentation about the tissue disposition to enable tracking from the donor to the consignee or final disposition must be maintained. Joint Commission standard QC.5.310.7 requires that “the organization that receives tissue provides a system that fully complies with the completion and return of tissue usage information cards requested by source facilities.” To comply with these requirements, a Tissue Tracking/Transplant Record (TTR) and pre-printed labels are provided with every allograft. Record the patient information, the transplant facility name and address, the allograft tissue information (using stickers) and comments regarding tissue use on the TTR. Return the completed TTR to Ventris Medical and retain a copy in the patient medical record. Even if the tissue has been discarded for any reason, a completed TTR with the allograft identification information and reason for discard shall be returned to Ventris Medical.
Amniotic Tissue
Communicable disease testing has been performed by a laboratory that is registered with the FDA to perform donor testing and certified to perform such testing on human specimens in accordance with Clinical Laboratory Improvement Amendments (CLIA) and 42 CFR Part 493, or that has equivalent requirements as determined by the Centers for Medicare and Medicaid Services. Names and addresses of testing laboratories, interpretation of all required infectious disease tests, and a listing of the documents reviewed as part of the relevant medical records are kept on file at the processing tissue bank and are available upon request.
Donor blood samples taken prior to or at the time of recovery were tested by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) and were found negative using FDA licensed tests for, at minimum; Hepatitis B Surface Antigen, Hepatitis B Core Antibody, Hepatitis C Antibody, Human Immunodeficiency Virus Types 1/2 and O Antibody, Hepatitis C Virus, Human Immunodeficiency Virus, Hepatitis B Virus and Syphilis.
Ventris provides high quality biologics with excellent fusion outcomes. The company provides great customer service and is actively involved with improving clinical outcomes with dedication to continued research and development.
American Board of Neurological Surgery
American Board of Spinal Surgery
I use Contour BA and Allocell AF for my fusion patients and have seen great results. Russell and his staff at Ventris are incredible partners to have in the operating room!
Orthopedic Surgeon
McLaren Macomb Hospital
