Risks of Using Sterilization by Gamma Radiation: The Other Side of the Coin

The standard sterilization method for most medical devices over the past 40 years involves gamma irradiation. During sterilization, gamma rays efficiently eliminate microorganisms from the medical devices and tissue allografts, but also significantly change molecular structure of irradiated products, particularly fragile biologics such as cytokines, chemokines and growth factors. Accordingly, gamma radiation significantly alters biomechanical properties of bone, tendon, tracheal, skin, amnion tissue grafts and micronized amniotic membrane injectable products. Similarly, when polymer medical devices are sterilized by gamma radiation, their physico-chemical characteristics undergo modification significantly affecting their clinical use.