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TSO3 Inc., an innovator in sterilization technology for medical devices in healthcare settings, has received clearance from Health Canada, the Canadian equivalent of the FDA in the United States, to sell the STERIZONE® VP4 Sterilizer with extended claims in the Canadian marketplace. With these claims, the TSO3 STERIZONE® VP4 Sterilizer becomes the only low-temperature sterilization system available in the market today that is capable of sterilizing complex medical instruments such as colonoscopes and other multi-channel flexible scopes.
One reason medical scopes are difficult to clean is because they have many internal channels that can harbor bacteria. Since their parts can be sensitive to the elevated temperatures that are typically involved in sterilization, the only alternative has been disinfection.
However, disinfection is significantly less effective than sterilization because it does not necessarily kill all harmful microorganisms, especially resistant bacterial spores. Low temperature sterilization with the STERIZONE® VP4 Sterilizer offers a more effective solution, since it involves a proprietary physical and chemical process that thoroughly destroys all types of microbiological organisms. Further, the STERIZONE® VP4 can sterilize up to eight channels in a single device, an industry first for any medical device sterilization process.
"This important clearance represents the introduction of an entirely new level of patient care and safety," says TSO3 president and CEO, R.M. Rumble. "Canadians can now be treated with fully sterilized instruments rather than those which were simply disinfected, with this being critically important given how these devices are used."
The expanded claims received for the STERIZONE® VP4 Sterilizer correspond to increasing scrutiny by regulatory authorities over medical device reprocessing, particularly for colonoscopes and other complex medical devices used during minimally invasive surgery procedures. Much of this concern stems from patient-to-patient transfer of multidrug-resistant bacteria, which are not inactivated by high-level disinfection, but are inactivated with the STERIZONE® VP4. Published reports confirm the significant risk of device-related transfer of antibiotic resistant microbes, which can lead to patient injury or death.
"The allowance of these claims helps support our pursuit of similar claims in other international markets, including the United States," adds Rumble. "In these markets, which are substantially greater than Canada, we believe our STERIZONE® VP4 Sterilizer maintains these unrivaled capabilities and the equal promise of revolutionizing the medical industry's standard of care."
The STERIZONE® VP4 Sterilizer developed by TSO3 is a dual sterilant, low-temperature sterilization system that utilizes vaporized hydrogen peroxide (H2O2) and ozone. Its single cycle can sterilize a large number and wide range of compatible devices, thereby allowing for a cost effective and error-free sterilization process. TSO3's unique Dynamic Sterilant Delivery SystemTM automatically adjusts the quantity of injected sterilant based on the load composition, weight and temperature. With its large 75 lb. load capacity and a short cycle time, the STERIZONE® VP4 Sterilizer can enhance throughput and lower sterilization cost. The STERIZONE® VP4 Sterilizer was cleared for commercialization in the United States in December 2014.
Source: TSO3 Inc.