Qubec City, Canada/Myrtle Beach, SC, USA, November 15, 2018 – TSO3 Inc. (“TSO3” or the “Company”) (TSX: TOS), an innovator in sterilization technology for medical devices in healthcare settings, announces today that the results of the Company’s clinical in-use and simulated use testing of the terminal sterilization of duodenoscopes have been published in the American Journal of Infection Control. The paper describes innovative testing methods developed and deployed by the Company in support of its STERIZONE® VP4 Sterilizer, which has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA), for terminal sterilization of multi-channeled, flexible endoscopes that fall within the specified indications for use, including duodenoscopes.
The paper is titled “Elevating the standard of endoscope processing: terminal sterilization of duodenoscopes using a hydrogen peroxide-ozone sterilizer.” The paper is available on line in advance of the print publication: https://doi.org/10.1016/j.ajic.2018.09.009
“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,” stated Brad Catalone, TSO3’s Chief Scientific Officer and one of the authors of the paper. “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.”
Duodenoscopes are flexible endoscopes used in a procedure called an Endoscopic Retrograde Cholangiopancreatography or ERCP, which enables a physician to perform diagnostic and therapeutic procedures involving a patient’s gallbladder, common bile duct, pancreas and liver. Approximately 500,000 ERCP procedures are performed each year in the United States. Antibiotic-resistant infections that resulted in life-threatening infections and deaths have recently been linked to the improper reprocessing of duodenoscopes. Carla Warner of North Carolina knows the devastating impact that Carbapenem-resistant Enterobacteriaceae (CRE), an antibiotic resistant infection, had on her husband, who contracted the infection following an ERCP procedure and died. Click here to hear more of Warner’s story. As recently as June 2018, infections believed to be transmitted via a duodenoscope were reported to the FDA through FDA’s Manufacturer and User Facility Device Experience (MAUDE) Database. Failure to consistently and effectively reprocess flexible endoscopes is listed second on the Top 10 Health Technology Hazards for 2018 published by the ECRI Institute, and has been in the top 10 list for several years.
“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,” stated R.M (Ric) Rumble TSO3’s President and CEO.