A process is provided for sterilizing brachytherapy devices with Ethylene
Oxide gas and releasing the devices on a parametric release basis.
Devices that can be sterilized with this process include interstitial
radiation seed strand implants and the needles used for implantation. In
order to be sterilized effectively by EtO gas, the devices are
constructed such that surfaces not readily infused with EtO gas are made
to be gas permeable, and will not retain the gas after the sterilization
process. Performance qualification of the sterilization process is
performed through physical and microbiological studies, and set of
established physical process parameters. Maintaining the physical process
parameters in subsequent sterilization cycles will consistently yield the
desired sterility assurance level without having to test the devices for
sterility.