Preparation of bank bone using defatting, freeze-drying and sterilisation with ethylene oxide gas. Part 1. Experimental evaluation of its efficacy and safety.

We devised a method of sterilising bone allografts which consists of defatting in chloroform and methanol, freeze-drying and sterilisation with ethylene oxide gas. The purpose of defatting and freeze-drying was to facilitate subsequent sterilisation by eliminating the barrier to diffusion of the gas into bone, to lower residual levels of ethylene oxide and its toxic by-products, to eliminate alloantigens and to make storage possible at room temperature. The efficacy and safety of the method were evaluated by testing the sterilisation of infected bone from 6 patients with active chronic osteomyelitis, the penetration of ethylene oxide into human femoral heads treated by this or by freeze-drying or freeze-thawing, and the desorption of ethylene oxide and its toxic by-products from pieces of bone treated by these methods. All the samples of infected bone tested negative for bacteria after treatment. The gas penetrated into the central area of the femoral heads in a few hours. Residual levels of ethylene oxide and its toxic by-products were much lower in the treated bone than in freeze-dried or freeze-thawed bone, and decreased quickly in flowing air. Prior defatting and freeze-drying facilitated penetration of ethylene oxide into bone during sterilisation and the desorption of ethylene oxide and its toxic by-products after sterilisation. Preparation under clean, but not sterile, conditions and storage at room temperature make bone banking more practical and efficient.