Medical device sterilization aims to produce infection-free devices. Based on the materials used in the device, the sterilization methodology differs from case to case.
Ethylene Oxide (EtO) sterilization is the most used sterilization technique for major medical devices that have contact with the patient (direct or indirect). Various health issues are often associated with EtO sterilization, especially a heightened risk of white blood cell cancers, including non-Hodgkin lymphoma, myeloma, and lymphocytic leukemia.
As a result, alternatives to EtO sterilization that do not affect human health are preferrable. Also, in line with existing regulations, the proposed medical device sterilization should be validated based on ISO requirements.
The current paper is on medical device sterilization testing validation and alternates to EtO sterilization.