White Paper on Structural Integrity and Safety of Irradiated JRF Ortho Tendon Allografts

The use of allografts in reconstruction and revision surgeries has become more commonplace where additional structural support is needed2,6. They are a beneficial tool because unlike autografts they are not associated with donor-site morbidity and also allow for shorter operative time and decreased surgical site pain.

Tissue distributed by JRF Ortho is minimally processed utilizing aseptic techniques and then cleansed using a proprietary method that does not use hydrogen peroxide to eliminate microorganisms and reduce graft contamination. The FDA accepts a sterility assurance level (SAL) of 10-3 as safe for implantable medical devices, including soft-tissue allografts utilized in ACL reconstructions. At this level, there is a one-in-1,000 chance that a microorganism could survive on the tissue. JRF Ortho achieves a SAL of 10-6 (one-in-1,000,000) while undergoing temperature controlled, ultra low-dose (.95-1.4 Mrad) irradiation that has minimal impact on the biomechanical integrity of the tissue. The Kaiser Permanente study reinforces positive clinical results for the processing methods of JRF Ortho tissue. 

JRF Ortho has no confirmed incidence of disease transmission and continues to deliver safe, high quality allografts. Surgeons should be mindful of the processing methods specific to each tissue vendor in order to make the best choice about allografts to use in surgeries to achieve the best outcome possible.

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