Canada-based medical device company TSO3 has secured US Food and Drug Administration (FDA) clearance for expanded indications for use (IFU's) of its STERIZONE VP4 Steriliser.
The steriliser is a low-temperature system that uses the dual-sterilants of vaporised hydrogen peroxide (H2O2) and ozone (O3) to completely sterilise heat and moisture sensitive medical devices.
TSO3 president and CEO R M Rumble said: "Our extended IFU claims have been cleared by the FDA demonstrating the truly superior capabilities of our STERIZONE Sterilisation System.
"These extended claims further expand our technology leadership offering enhanced patient protection in applications where terminal sterilisation was not previously possible."
The device involves a single pre-programmed cycle which can sterilise a wide range of compatible devices through a cost-effective, error-free sterilisation process.
It features the Dynamic Sterilant Delivery System which automatically adjusts the quantity of injected sterilant based on the load composition, weight and temperature.
This capability also eliminates the need of guesswork and risk of human error, as there is no need to sort instruments and choose the appropriate cycles as with other machines.
The STERIZONE VP4 Steriliser can process a varied load consisting of general instruments, single and multi-channel flexible endoscopes, and single or double channel rigid endoscopes in the same cycle with load weights of up to 75lb.
This ability to run mixed loads minimises labour costs by reducing the amount of instrument sorting required, while increasing the device productivity.
A test was performed to exhibit the performance of the STERIZONE VP4 Steriliser using both double-channel and multi-channel flexible endoscopes including a ureteroscope and video colonoscope.
It demonstrated the efficacy of the chemistry of the sterilisation process in cleaning the gross materials present in the test devices.
Low temperature terminal sterilisation facilitated by the STERIZONE VP4 Steriliser offers an effective solution as it leverages on a patented physical and chemical process that destroys all types of microbiological organisms with a sterility assurance level of 10-6 (SAL-6).