Re: What criteria decides sterilization of a medical device ?
Do you mean a decision as to whether a device should be terminally sterile? or whether it just needs to be sterilisable by the end user? or do you mean the sterilisation process to use?
A device needs to be sterilised if it's use in a non sterile form could cause infection in the patient. Therefore all implantables and invasive devices need to be sterile. Additionally devices which contact open wounds need to be sterile. I believe there is some debate with endoscopes as to whether they need to be sterile or just decontaminated - I seem to remember a discussion about that on this forum - there was some FDA guidance or something.
With regards to terminally sterilising a device there are no specific requirements to do this as far as I am aware other than market demands. Obviously with reusable devices there is not much point in providing them terminally sterilised. Implants are another matter, there is an increasing trend for single use devices, especially implants, to be provided in a sterile form.
With regards to the type of sterilisation - EtO, gamma, e-beam, steam etc, this is entirely dependant on the device and the effect each process would have on them