TSO3 Inc., an innovator in sterilisation technology for medical devices in healthcare settings, has received clearance from US regulators for its most recent 510(k) submission for the terminal sterilisation of multi-channeled flexible endoscopes using the company’s Sterizone VP4 Steriliser.
The new clearance for the Sterizone VP4 Steriliser will allow a hospital to terminally sterilise 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 sterilisation practices. The recent and highly publicised 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 sterilisation of these devices,” stated R.M. (Ric) Rumble, TSO3’s president and CEO.
The Sterizone VP4 Steriliser is a low-temperature sterilisation system that utilises the dual-sterilants of vaporised hydrogen peroxide (H2O2) and ozone (O3) to achieve terminal sterilisation of heat and moisture sensitive medical devices. Its single pre-programmed cycle can sterilise a large number and wide range of compatible devices, creating a cost-effective sterilisation 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 Steriliser is the only terminal sterilisation method that is FDA cleared to sterilise 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 sterilisation process.
The Sterizone VP4 Steriliser is also the only cleared low temperature steriliser 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 minimising the amount of instrument sorting required, while maximising the device turns (more productivity from increased throughput capacity).