TSO3 Inc. an innovator in sterilization technology for medical devices in healthcare settings, has received 510(k) clearance from US regulators for a significant improvement to its Sterizone VP4 sterilizer. The cleared change can improve the customer installation process and reduce start-up costs by significantly reducing the oxygen supply requirements for the system.
“We are excited to incorporate this new feature to our Sterizone VP4 sterilizer”, said TSO3 president and CEO R.M. (Ric) Rumble. “The improvement now makes the installation of our device more cost-effective, further solidifying its position as the least expensive, on a cost per item sterilized basis, low temperature sterilizer available today relative to legacy hydrogen peroxide-based sterilizers.”
All of the company’s new Sterizone VP4 sterilizers, along with any upgraded units in existing inventories, can now incorporate this new feature and several other additional customer improvements intended to improve the user experience.
The Sterizone VP4 sterilizer is a low-temperature sterilization system that utilizes the dual-sterilants of vaporized hydrogen peroxide (H2O2) and ozone (O3) to achieve terminal sterilization of heat and moisture sensitive medical devices. Its single pre-programmed cycle can sterilize a large number and wide range of compatible devices, creating a cost-effective sterilization process with error free cycle selection. The device's unique Dynamic Sterilant Delivery System™ automatically adjusts the quantity of injected sterilant based on the load composition, weight and temperature. This capability 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.
The Sterizone VP4 sterilizer is the only terminal sterilization method that is FDA cleared to sterilize multi-channeled flexible endoscopes (with a maximum of four channels) of up to 3.5 meters in length, such as video colonoscopes and gastroscopes - an industry first for any medical device sterilization process.
The Sterizone VP4 sterilizer is also the only cleared low temperature sterilizer that can process a mixed load consisting of general instruments, single channel flexible endoscopes, and single or double channel rigid endoscopes in the same cycle with load weights of up to 75 lb. The ability to run mixed loads significantly reduces labor costs by minimizing the amount of instrument sorting required, while maximizing the device turns (more productivity from increased throughput capacity).