A clinical guide for low temperature sterilisation

Healthcare facilities are increasingly using vaporised hydrogen peroxide (VHP) as part of their decontamination strategies. Dr. Georgia Alevizopoulou provides an insight into the optimisation of VHP low temperature sterilisation processes to ensure safe and effective reprocessing of medical devices.

Over the past few years, our familiarity with vaporised hydrogen peroxide low temperature sterilisation (VH2O2) has increased significantly and we have seen growing adoption of the associated technology, equipment, and consumables within many sterile service departments, across the globe. Healthcare facilities choose VH2O2 technology typically as a method of choice for sterilisation of heat and moisture sensitive medical devices.

In some situations, facilities may additionally use VH2O2 cycles for more applications, when, for example, they wish to accelerate the availability and the throughput of devices that would normally undergo a steam process, or to process semi-critical devices, because they can then be stored as sterile devices in readiness for patient use – helping to promote the highest level of patient care. Figure 1 shows a representation of devices typically processed in VH2O2 sterilisers.

While our understanding of the technology and its applications continues to expand and hospitals embark on the low temperature sterilisation route, emphasis is being placed on the practical aspects of the decontamination process and the various steps required to prepare medical devices properly, in order to ensure consistent and successful VH2O2 sterilisation outcomes. The focus of this article is to review the various practices in preparing medical devices and show how users can more confidently use VH2O2 sterilisation systems

device inventory in use in the facility. The evaluation will typically occur at the time of agreement to purchase, acquisition of the steriliser, when new medical devices are purchased, or when medical devices are loaned to the facility. The user should always confirm each and every model of device that is to be sterilised; this record should be an intrinsic part of the department’s quality management system (QMS). Device models may have different compatibilities, so it cannot be assumed that two models of the same type of device are compatible simply because one of the models is.

Figure 1 – VH2O2 is designed to reprocess a variety of devices

– safely, efficiently and effectively. The task need not be challenging, but there is more to device reprocessing than simply pushing a button. As with any decontamination process, it requires a practical knowledge of the particular sterilisation modality and the sterilising agent employed, discipline and adherence to instructions for use (IFU); this will be coupled with following best practice, dictated both by the facility’s own practices and procedures, as well as the applicable consensus-developed standards, such as those developed by CEN and ISO.

Determine suitability

Before beginning to process anything, it is essential to determine the suitability of the VH2O2 steriliser chosen for the

Residual cleaning chemistries may interfere with the VH2O2 sterilisation process when not completely removed due to improper rinsing – an integral step to the cleaning process.


Manufacturers continuously make changes to improve instruments and older models in the series may not be compatible. What is more, just as models can vary, repair materials can vary. A compatible device may no longer be compatible if the materials used in the repair, such as adhesives, are not compatible with the decontamination process. It is recommended to review device repair

history prior to commissioning the service and confirm with the repair company that compatible materials were used; again, this would normally be recorded as part of the QMS. In the quest of suitability, the most recent instructions for use (IFU) provided from the device manufacturer ought always to be consulted. In addition, certain manufacturers of VH2O2 sterilisers have undertaken significant research and rigorous device compatibility testing and invested in developing online product lists for easy access to the database. Some of these tools are free to use and can be additional resources when searching for up- to-date reprocessing information for reusable medical devices.

Decontamination aspects If we consider the decontamination cycle of a reusable medical device, VH2O2 sterilisers fit in one of the last steps – sterilisation.


*Courtesy of Intuitive Surgical, Inc.

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