Terminal sterilization of medical devices using vaporized hydrogen peroxide: a review of current methods and emerging opportunities.

Abstract

Medical devices are an important and growing aspect of healthcare provision and are increasing in complexity to meet established and emerging patient needs. Terminal sterilization plays a vital role in the provision of safe medical devices. While terminal sterilization technologies for medical devices include multiple radiation options, ethylene oxide remains the predominant nonthermal gaseous option, sterilizing c. 50% of all manufactured devices. Vaporized hydrogen peroxide (abbreviated VH2O2 by the International Organization for Standardization) is currently deployed for clinical sterilization applications, where its performance characteristics appear aligned to requirements, constituting a viable alternative low-temperature process for terminal processing of medical devices. However, VH2O2 has operational limitations that create technical challenges for industrial-scale adoption. This timely review provides a succinct overview of VH2O2 in gaseous sterilization and addresses its applicability for terminal sterilization of medical devices. It also describes underappreciated factors such as the occurrence of nonlinear microbial inactivation kinetic plots that may dictate a need to develop a new standard approach to validate VH2O2 for terminal sterilization of medical devices.