ACL Reconstruction with Allograft – Sterilization Process

ACL Reconstruction with Allograft – Sterilization Process

Matthew A. Handling, M.D.

Allograft (cadaver) tissue has gained widespread acceptance by Orthopaedic Surgeons to reconstruct injured anterior cruciate ligament (ACL) tears. The American Association of Tissue Banks (AATB) has reported significant increases in the demand for allograft tissue. There is federal government oversight of tissue banks. Tissue banks have developed improved donor screening, donor testing techniques, and sterilization processes to ensure allograft safety. The First State Surgery Center and Glasgow Surgery Center use allograft tissue from JRF Ortho, LifeNet Health, and Maxxeus (as of 2025).

Maxxeususes three different methods to process tissue. All methods are AATB and FDA approved. 

1. Terminal Irradiation: Tissue processed via a proprietary method and then terminally gamma irradiated utilizing Cobalt 60 (sterile 10 -6)
2. Aseptic Processing: These grafts are non-irradiated and verified aseptic (10 -3) via USP<71> sterility standard. These grafts are subject to the strictest donor screening, are then manufactured in an ISO Class 5 environment, and are finally subject to a membrane filtration process with culture results determining the safety of the graft after 14 days quarantine (soft tissue grafts only).
3. E-Beam: Tissue follows same pathway as Terminal Irradiation with only difference being that terminal sterilization is achieved utilizing Electron Beam technology.

JRF Ortho uses patented processes, AlloSource and Community Tissue Services, which use tissue-friendly reagents that penetrate deep to remove blood and lipids. All grafts are irradiated at low doses at ultra-low temperatures to sterilize the tendon. Irradiating at ultra-low, dry ice temperatures have shown to remove all microorganisms but do not affect the structure and strength of the tendon. These processes go past the FDA recommendations to ensure high quality tissue. (sterile 10 -6)

LifeNet Health uses numerous sterilant and sterilant combinations to eradicate microorganisms on allograft tissue. These include chemical sterilants, gas plasma, ethylene oxide, gamma radiation, and E-beam radiation, as well as sterilization systems, such as LifeNet Health’s Allowash XG technology. Allowash XG is a comprehensive 6 step process that includes an intensive decontamination, disinfection, and scrubbing regimen validated to kill and remove viruses and bacteria. Processing reagent residuals are removed to ensure tissue biocompatibility. This is followed by a low dose gamma irradiation step. (sterile 10 -6)

The use of allograft tissue for ACL reconstruction is only used for certain patients. Other ACL graft choices consist of autograft tissue, such as bone patella tendon bone, quadriceps tendon, and hamstring tendons. The choice of which graft is best suited for each individual patient will be decided by the surgeon and patient after a thorough discussion.

Matt Handling, MD