From the hands of the recovery technician to the hands of the surgeon, good tissue providers take meticulous care with each allograft.
According to the FDA cGTP, donor pooling and batching is prohibited. Each donor should be processed individually in a separate processing session. Acceptable providers should have established quality assurance procedures in place, which are “…designed to prevent, detect, and correct deficiencies that may lead to circumstances that increase the risk of introduction, transmission, or spread of communicable diseases.” Superior facilities are capable of producing a broad line of standard allografts as well as alternate and customized grafts. Critical attributes, especially accuracy of graft dimensions, can be a deciding factor in successful outcomes.
Once processed, the allografts should be sealed in sterile pouches and clearly labeled with a unique donor and tissue ID, product ID code, allograft description, size, expiration date and storage instructions.
