TSO3 Files for an extended claim for duodenoscopes
July 23, 2017
MYRTLE BEACH, SC – TSO3 Inc. (TSX: TOS), an innovator in sterilization technology for medical devices in healthcare settings, announced that the Company has filed a 510(k) submission with US regulators for its STERIZONE® VP4 Sterilizer for the terminal sterilization of duodenoscopes used in endoscopic retrograde cholangio-pancreatography (ERCP) procedures. If awarded such claim, TSO3’s STERIZONE® VP4 Sterilizer would become the first and only validated sterilizer technology in the US with a cleared label claim for the terminal sterilization of duodenoscopes.
TSO3’s filing is supported by laboratory data that validates that the STERIZONE® VP4 Sterilizer, with its dual sterilants of hydrogen peroxide and ozone, can terminally sterilize multi-channel flexible endoscopes with a distal end elevator mechanism (duodenovideoscopes). If achieved, the claim will match existing claims already made by the Company in Canada and Europe.
“This submission is another step towards improving upon the existing standard of care in healthcare sterile reprocessing. Duodenoscopes have historically been defined as “semi-critical” devices, and are not required to have a validated terminal sterilization claim at this time. Our approach has been to demonstrate that these devices can in fact be terminally sterilized and offer healthcare facilities the ability to use our more robust process to process devices known or suspected to be contaminated with multidrug resistant organisms (MDRO)”, stated R.M. (Ric) Rumble, TSO3’s President and CEO. “New US regulatory requirements recently published require manufacturers to provide validated sterilization methods with future submissions for new semi-critical devices such as duodenoscopes, bronchoscopes, gastroscopes, colonoscopes and other endoscopes. TSO3’s unique existing endoscope sterilization claims, along with a potential expanded duodenoscope claim, position the STERIZONE® VP4 Sterilizer to be an integral part of a healthcare institution’s infection control strategy.”
About the STERIZONE® VP4 Sterilizer
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). More information about the STERIZONE® VP4 Sterilizer is available through TSO3’s website, under the Products section at http://www.tso3.com/en/products/sterizone-vp4/.
About TSO3
Founded in 1998, TSO3’s activities encompass the sale, production, maintenance, research, development and licensing of sterilization processes, related consumable supplies and accessories for heat-sensitive medical devices. The Company designs products for sterile processing areas in the hospital environment that offer an advantageous replacement solution to other low temperature sterilization processes currently used in hospitals. TSO3 also offers services related to the maintenance of sterilization equipment and compatibility testing of medical devices with such processes.
