TSO3 (TSE:TOS) yesterday touted the publication of results from a study exploring clinical in-use and simulated use testing of terminal sterilization of duodenoscopes with its Sterizone VP4 sterilizer.
Results from the study were published in the American Journal of Infection Control, the Quebec City-based company said.
Results from the study indicated that the Sterizone hydrogen peroxide-ozone sterilizer was efficient and effective in the terminal sterilization of duodenoscopes.
Researchers in the trial aimed to explore the efficacy of the Sterizone sterilizer in sterilizing duodenoscopes. Validation studies were performed in both laboratory simulated-use and clinical in-use conditions.
Investigators wrote that its overkill method study showed a reduction of 6-log of Geobacillus stearothermophilus spores at a half-cycle, providing a sterility assurance level of 10^-6. The sterilizer achieved a 6-log reduction of G. Stearothermophilus in the presence of both inorganic and organic soils in the simulated use study, and the clinical in-use study confirmed sterilization of patient-soiled duodenoscopes in actual-work conditions.
“In this study, we were able to conclusively demonstrate, in both simulated use testing as well as real-world clinical testing, the ability of the Sterizone VP4 Sterilizer to terminally sterilize the most challenging locations of these complex devices, including the elevator recess location in the distal end cap of the duodenoscope. The rigorous testing employed by TSO3 included validating the terminal sterilization effectiveness under worst case conditions, including devices that had been intentionally contaminated with the most resistant form of bacteria mixed in the absence and presence of an organic load without any prior cleaning,” paper author and chief scientific officer Brad Catalone said in a prepared statement.
TSO3 said that results from the study were originally used to support its FDA 510(k) clearance for the terminal sterilization of multi-channeled, flexible endoscopes.
“We are proud to share our continued innovations with the scientific and medical communities and are pleased to have additional peer confirmation of the science behind our transformational sterilization technology that is playing a role in solving a significant and urgent unmet medical need,” prez & CEO R.M Rumble said in a press release.
In August, TSO3 said that it dropped a distribution agreement with Getinge and that it inked a $20 million debt financing deal with a fund under advisement by Courage Capital Management to support commercialization of its Sterizone VP4 sterilizer.