The Sterizone VP4 Sterilizer is a low-temperature (41°C or 105.8°F) sterilization system, which uses the dual-sterilants of vaporized hydrogen peroxide (H2O2) and ozone (O3) for achieving terminal sterilization of heat and moisture sensitive medical devices.
Its single pre-programmed cycle has the capacity to sterilize a range of compatible devices, resulting in error-free sterilization process.
The device features Dynamic Sterilant Delivery System, which automatically adjusts the quantity of injected sterilant depending on the load composition, weight and temperature.
TSO3 carrired out testing to evaluate the sterilizer’s performance using both double-channel and multi-channel flexible endoscopes including a ureteroscope and video colonoscope.
The sterilizer demonstrated the effect of the sterilization process’ chemistry against the gross materials present in the test devices.
The company said even though the testing could not confirm material compatibility of all devices that are within the general specifications for each of the load types, customers should contact the device manufacturer for compatibility of particular devices with the Sterizone process.
The expanded claims now cleared for the device correspond to increasing investigation by regulatory authorities over medical device reprocessing, especially for colonoscopes and other complex medical devices used during minimally invasive surgical procedures.
Sterizone VP4 enables to carry out a physical and chemical process, which destroys all types of microbiological organisms with a sterility assurance level of 10-6.
It is claimed to be the first FDA approved single cycle and low-temperature sterilizer that will process a 75-pound load of general instruments, single channel flexible endoscopes, and rigid and semi-rigid channeled devices.
Sterizone VP4 is also a first low-temperature sterilizer with a load-sensitive dynamic sterilant delivery system..
TSO3 president and CEO Ric Rumble said: "Our extended IFU claims have been cleared by the FDA demonstrating the truly superior capabilities of our Sterizone sterilization System.
"These extended claims further expand our technology leadership – offering enhanced patient protection in applications where terminal sterilization was not previously possible.
Image: The FDA campus is located at 10903 New Hampshire Ave, Silver Spring, Maryland. Photo: courtesy of The U.S. Food and Drug Administration.
