Advances in Vaporized Hydrogen Peroxide Reusable Medical Device Sterilization Cycle Development: Technology Review and Patent Trends.

Abstract

Vaporized hydrogen peroxide (VHP) terminal sterilization is one of the most promising techniques for sterilizing temperature-sensitive medical instruments like endoscopes. This technique requires only electricity and sterilant containers to perform the sterilization process in less than 1 h without any substantial safety concerns for patients, personnel, and the environment. This review studies recent advances and future trends in VHP sterilization cycle development using U.S. patent applications and 510(k) premarket notifications. In this regard, the patents focused on increasing VHP concentration or handling residual moisture are discussed in depth. The expired patents are analyzed to introduce existing unencumbered technologies, and active patents are presented to show the most current novelties and technology trends. In addition, 510(k) premarket notifications are explored to evaluate implemented technologies in US market-leading commercial products.