Allograft Tissue Safety and Technology

Allograft tissues are commonly used by orthopedic surgeons and are processed using a variety of technologies to increase safety and clinical use. For safety, although disease transmission is a tangible risk, this possibility has been dramatically minimized through modern tissue-processing methods. These include steps to prevent processing tissues with unacceptable bioburden through rigorous screening using donor medical and social histories along with microbial testing of recovered tissue and viral testing of donor serum. Potential bioburden is also controlled through aseptic recovery and processing methods and then reduced through disinfection steps that can include antibiotics, detergents, mechanical process, chemical solutions, and terminal sterilization. Processing steps may also include decellularization methods to lower immunogenic potential of some tissues. To enhance fusion potential of bone void fillers, demineralization steps may be used, and the resultant demineralized bone matrices may be combined with a carrier to improve handling. Bone void fillers and osteochondral allografts may also be specially processed to retain a living cellular component. To preserve relevant biological, biochemical, and physical properties of allografts for clinical use and ease of handling, a number of methods may be used which include: (1) refrigeration in media, (2) freeze-drying, (3) cryopreservation, (4) freezing, and (5) media storage at room temperature. As academic and industry research continue to drive advances, the future direction of allograft tissue likely includes injectables, coatings, cellular therapies, and combinations with other materials. The technology approaches outlined here will be further described along with future directions.