FOCUS ON FUNDAMENTALS - Vaporized Hydrogen Peroxide Sterilization: Guidance & ConsiderationsFOCUS ON FUNDAMENTALS - Vaporized Hydrogen Peroxide Sterilization: Guidance & Considerations

This three-day course, presented in three 60-minute sessions August 20, 21, and 22, will guide you through the challenges and requirements surrounding sterilization using vaporized hydrogen peroxide (VH2O2). The publication of ISO 22441:2022 and the US FDA’s recognition and 2024 reclassification of VH2O2 Established Category A process — now support wider use of this increasingly popular modality for single-use and other medical device applications.

DAY 1 - VH2O2, Sterilization Considerations

VH2O2 has been a common sterilization option for reusable devices for many years. Interest has increased for single-use device. The publication of ISO 22441:2022 and its recognition by the US FDA — coupled with the FDA’s 2024 reclassification of VH2O2 sterilization as an Established Category A process in 2024 — support this modality of sterilization. Each sterilization modality has its limitations, and there is not one modality that works for all the medical products. This session will provide essential knowledge for further considerations.

DAY 2 - Considerations for Biocompatibility

Biocompatibility assessments involve extensive evaluation, and changing the sterilization modality, such as to VH202, can trigger considerable, new resource-intensive testing. The session will highlight collaborative efforts between the FDA and industry to develop a tool to streamline evaluations. At present, however there are still ways to streamline the impact of switching to VH2O2. We will discuss what should be considered when looking at the impact VH2O2 has on the materials to investigate the overall impact to the biocompatibility profile of a medical device.

Day 3 - Toxicological Considerations of VH202 Sterilization Residuals

VH202 sterilization may leave hydrogen peroxide residuals on the device materials after the sterilization process whose toxicological risk must be evaluated (in addition to evaluating the device’s biocompatibility). ISO 22441 simply states that these limits shall be based on a health-based risk assessment per ISO 10993-17, which outlines expectations for the toxicological risk assessment of medical device constituents. This session will break down the required information for setting limits in hydrogen peroxide residual exposures, including consideration of the specific device’s intended use for the proper evaluation of devices for all intended patient populations and appropriate selection of test articles for evaluating multiple devices in a product family.