Impacts to Process Validation when changing sterilisation method?

Hi Folks…proposal here to allow parametric release of devices post completion of sterilisation cycle. In the event of issues with the sterilisation cycle a proposal by team is to qualify the option of a second sterilisation cycle. Current process runs on ETO x 1 cycle. In the event of issues the products will be processed to a 2 x ETO.

Orignal process validations were completed post 1 x ETO…what is standard practice out there if a second cycle is made available (this is a non-API device)? Is process validation reexecuted? Bear in mind that a repeat of design testing will be completed…

Would appreciated your thoughts!