TSO3, an innovator in sterilization technology for medical devices in healthcare settings, has received FDA 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a universal design of its STERIZONE® VP4 sterilizer.
The STERIZONE® VP4 Sterilizer was originally cleared for commercialization in the U.S. in December 2014. The new clearance enables the company to streamline assembly and shipping around a single sterilizer platform that meets global regulations for electromechanical design.
"Obtaining this clearance is significant in two ways," said R.M. (Ric) Rumble, TSO3’s president and CEO.
"First, since the new design addresses all applicable country and regional requirements for electrical scheme and hazardous substance restrictions, we can now harmonize production around a single design. This will allow us to reduce inventory costs and complexity, while improving production rates and efficiency."
"Secondly, given the updated device maintains the same performance standards, including with sterilization of multi-channel flexible endoscopes, the STERIZONE® VP4 Sterilizer will now have the same claims language in both Europe and Canada," said Rumble.
"This will provide clarity to our customers, while facilitating sales and marketing in both regions. In sum, this clearance paves the way for us to sell a single product with consistent design and claims language around the globe."
In December 2015, TSO3 announced that it had completed studies in order to support expanded use of the STERIZONE® VP4 Sterilizer in the U.S. and had filed for such claims with the U.S. FDA.
FDA clearance of the additional claims would represent an entirely new level of patient protection against ineffective device reprocessing resulting from the use of less robust disinfecting systems, particularly for multi-channel endoscopic devices such as colonoscopes. The expanded claims sought in the U.S. represent similar claims for the STERIZONE® VP4 Sterilizer available in Canada and Europe.
In November of 2015, TSO3 signed Getinge Infection Control AB, a global leader in infection control solutions, as the exclusive distributor for the STERIZONE® VP4 Sterilizer. Getinge has submitted purchase orders for the full amount of its minimum purchase commitment for 2016, with the first shipments rolled out in January.
The company believes it is in a position to assemble and deliver in excess of 100 sterilizers in 2016.
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. In December 2014, the STERIZONE® VP4 Sterilizer was cleared for commercialization in the U.S.