QUEBEC CITY and MYRTLE BEACH, SC—Yesterday TSO3 Inc., an innovator in sterilization technology for medical devices in healthcare settings, announced that an independent laboratory has completed studies demonstrating the efficacy of the STERIZONE VP4 Sterilizer for inactivation of prions.
Prions are abnormal, pathogenic agents believed to cause transmissible spongiform encephalopathies (TSEs), such as Variant Creutzfeldt-Jakob Disease. TSEs are rapidly progressive, uniformly fatal neurodegenerative diseases that can infect humans and animals. Prions generated great public concern after an outbreak of bovine spongiform encephalopathy occurred in many European countries and scientific evidence indicated its transmission to humans. Prions are unique in demonstrating a high level of resistance to conventional device reprocessing methods and have been linked to patient-to-patient transmission via contaminated medical devices.
The STERIZONE VP4 Sterilizer is a low-temperature sterilization system which 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 reportedly 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 cleared by the FDA 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).
“This study reinforces the broader clinical applications of our sterilization technology,” stated R.M. (Ric) Rumble TSO3’s President and CEO. “Results obtained by the independent laboratory confirmed the efficacy and performance of the STERIZONE VP4 Sterilizer for prion inactivation. This data enables the Company to pursue approval from regulators in Europe to be listed as a device that inactivates these challenging infectious agents.”