TSO3 develops innovative validation method linked to sterilisation of multichannel endoscopes
TOS3 an innovator in sterilisation technology for medical devices in healthcare settings, has come up with first and only gravity-based direct inoculation (intentional bacterial contamination) method which meets the requirements of US regulators for confirmation that the inoculum is deposited into the middle of each channel of complex multichannel endoscopes.
The method is the subject of a new paper co-authored by Dr. Sylvie Dufresne and Dr. Thomas Richards, and accepted for publication in the peer-reviewed Canadian Journal of Infection Control. Additionally, the paper describes the TSO3 Sterizone low temperature sterilisation system and its ability to sterilize such scopes.
According to the company, the unique inoculation method can be used for targeting the most challenging location within the long narrow flexible channels found in devices such as colonoscopes.
This new methodology was a necessary precursor to validating effective sterilisation of these scopes by the Sterizone VP4 Steriliser.
Until now, numerous methods have been published on how to inoculate and recover test organisms for use in sterilisation validation studies but typically these methods have been validated for only simple lumen devices.
The paper highlights how this new method satisfied the requirements of the US Food and Drug Administration (FDA) for targeted inoculation and recovery efficacy, and also demonstrates that the Sterizone VP4 Steriliser can achieve a sterility assurance level (SAL) of 10-6 using this enhanced method.
The paper additionally discusses how the inoculation method and the steriliser performance were validated using high and low level recovery methods as well as half-cycle, simulated-use, and “in-use” clinical testing.
Ric Rumble, TSO3’s President and CEO, said: “The significance of this work reaches into tens of millions of reprocessing cycles practiced annually and reinforces TSO3‘s expanding clinical and economic opportunity.”
The Sterizone VP4 Sterilizer is a low-temperature sterilisation system that uses the dual-sterilants vapourised hydrogen peroxide (H2O2) and ozone (O3) to achieve terminal sterilisation of heat and moisture sensitive medical devices. Its single pre-programmed cycle can sterilise a large range of compatible devices, creating a cost-effective sterilisation process with error free cycle selection.
The device's dynamic sterilant delivery system automatically adjusts the quantity of injected sterilant based on the load composition, weight and temperature. This removes the guesswork and potential for human error, as there is no need to sort instruments and choose the appropriate cycles as with other machines.