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 650 units in use and over 170,000 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:
- 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.
- 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.