TSO3 Obtains New Clearance for the STERIZONE® VP4 Sterilizer

QUEBEC CITY and MYRTLE BEACH, SC, May 9, 2018

The new clearance for the STERIZONE^® VP4 Sterilizer will allow a hospital to terminally sterilize gastrointestinal endoscopes that have dimensions within the cleared intended use. The technical characteristics of the devices that could fall within this cleared intended use statement include certain colonoscopes, duodenoscopes and gastroscopes which have 4 or less channels and up to 3.5 meters in length with internal diameters of 1.2 mm or greater.

"In 2009, TSO₃ set itself on a path to bring about lasting and meaningful change to healthcare sterilization practices. The recent and highly publicized outbreaks associated with use of flexible endoscopes have highlighted the need for innovative approaches to reprocessing of these complex devices. Today, TSO₃ is proud to announce that this clearance enables a significant step forward in achieving this change and our goal to provide a sterile instrument for every procedure. This advancement required significant effort and innovation both in technology and reprocessing practices.  I am proud of the TSO₃ team who made this possible.  This clearance allows TSO₃ to partner with healthcare systems to facilitate the terminal sterilization of these devices," stated R.M. (Ric) Rumble, TSO₃'s President and CEO.

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, duodenoscopes 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).