Allograft Possibilities

Processing

A tissue processing facility should be accredited by the American Association of Tissue Banks (AATB) that uses Clinical Laboratories Improvement Act (CLIA) certified testing and environmental laboratories.  The facility also must be in full compliance with the FDA current Good Tissue Practices (cGTP). Upon arrival at the facility, donor tissue should be entered into a reliable inventory system and subjected to a robust process for reducing bioburden. This process should be carried out in certified clean rooms. The process by which the tissue’s bioburden is measured and diminished should include:

• Elimination or reduction of blood, debris and lipids

• Use of validated bactericidal washes and/or treatments

• Surface swab tests, solution extraction or destructive tests of companion tissue 

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.