Low-energy electron-beam treatment as alternative for on-site sterilization of highly functionalized medical products - A feasibility study

摘要

Over the last decades, the medical device industry has grown significantly. Complex and highly functionalized medical devices and implants are being developed to improve patient treatment and to enhance their health related quality of life. However, medical devices from this new generation often cannot be sterilized by standard methods such as autoclaving or sterilizing gases, as they are temperature sensitive, containing electronic components like sensors and microchips, or consist of polymers. Gamma irradiation for sterilization of such products is also problematic due to long processing times under highly reactive conditions resulting in material degradation or loss of functionality. Low-energy electron-beam treatment could enable irradiation sterilization of medical surfaces within seconds. This method is very fast in comparison to gamma irradiation because of its high dose rate and therefore degradation processes of polymers can be reduced or even prevented. Additionally, electron penetration depth can be precisely controlled to prevent damage of sensitive components like electronics and semiconductors.