TSO3 Inc. has 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.
“This study reinforces the broader clinical applications of our sterilization technology,” stated TSO3 President and CEO R.M. “Ric” Rumble. “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.”
