Lobator SD-2 Bonebank System

The Lobator SD-2 Bonebank System was designed in 1992 due to the growing problems with graft material including: viral and bacterial transmissions, quality concerns over gamma irradiated bone, costs of purchasing bone from tissue banks, non-standardization of tissue bank processing procedures among other concerns. Since 1992, there are 500 units in use and over 125,000 bone processed worldwide. The Lobator SD-2 is a thermal processing method that allows a hospital to retrieve the femoral head from a surgical living donor during a total hip arthroplasty. This bone, after pre-testing of the donor and donor approval, is then placed in the Lobator SD-2 for processing. The Lobator SD-2 is a thermal process that takes 94 minutes. During the process, the femoral head achieves a temperature of at least 82.5 degrees Celsius for 15 minutes. This temperature was determined for two reasons: 1. 82.5 degrees Celsius for at least 15 minutes is validated and approved to kill HIV-1, HIV-2, HIV-1/0, Hepatitis B, Hepatitis C, HTLV, Syphilis, CPV, CMV, BVDV and human vegetative pathogenic bacteria. 2. This temperature, while achieving viral and bacterial inactivation, still maintains the integrity of the bone, only decreasing the bone mechanics between 10-15 %. The Lobator SD-2 Bonebank System is validated and approved for use in a variety of countries as a safe viral inactivation method for surgical living donor bone. The EATB (European Association of Tissue Banks) and the AATB (American Association of Tissue Banks) have stated that certain facilities using the Lobator may proceed with the normal pretesting, donor selection criteria, and process the bone in the Lobator. This would eliminate the recommended 180 day quarantine period because the Lobator process kills what would normally be tested for at 180 days. Provided by Telos LP in Canada, Mexico, and South America.