STERIS Applied Sterilization Technologies, IDA Business and Technology Park, Tullamore, Ireland.
Bioscience Research Institute, Athlone Institute of Technology, Athlone, Ireland.
J Appl Microbiol. 2019 Nov;127(5):1403-1420. doi: 10.1111/jam.14412. Epub 2019 Sep 1.
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.
医疗器械是医疗保健提供的一个重要且不断发展的方面，其复杂性不断增加，以满足既定和新出现的患者需求。终端灭菌在提供安全医疗器械方面发挥着至关重要的作用。虽然医疗器械的终端灭菌技术包括多种辐射选择，但环氧乙烷仍然是主要的非热气态选择，为所有制造的医疗器械消毒 c. 50%。目前，用于临床灭菌应用的是汽化过氧化氢（国际标准化组织缩写为 VH2O2），其性能特点似乎符合要求，是医疗器械终端处理的一种可行的低温替代工艺。然而，VH2O2 存在操作限制，为工业规模采用带来了技术挑战。这篇及时的综述提供了 VH2O2 气体灭菌的简明概述，并探讨了其在医疗器械终端灭菌中的适用性。它还描述了一些未被充分认识的因素，例如非线性微生物失活动力学曲线的出现，这可能需要开发一种新的标准方法来验证 VH2O2 对医疗器械的终端灭菌效果。
