Duodenoscopes now sterilized with low-temperature sterilizer
Grand Forks/Myrtle Beach, United States and Quebec City, Canada – June 14, 2018 – TSO3 Inc. (TSX: TOS) (“TSO3” or the “Company”), an innovator in sterilization technology for medical devices in healthcare settings, joins with Altru® Health System in announcing the landmark U.S. terminal sterilization of long, flexible gastrointestinal endoscopes, like the duodenoscope, using TSO3’s paradigm-shifting STERIZONE® technology.
“Being the inaugural facility to offer terminal sterilization of endoscopes using the TSO3 technology, provides our patients with a level of safety above current best-practice standards in the industry,” says Stacie Avdem, Director of Surgical and Procedural Services at Altru® Health System.
“Altru® has achieved industry leading practices with centralization, cleaning verification, and borescope inspection in endoscope reprocessing. The ability to sterilize endoscopes, specifically duodenoscopes, is paramount to achieving our mission of delivering world-class care to the residents of our region. It shows our ongoing investment in and commitment to patient safety,” says Jenni Gibbs, Manager of Central Sterile Department at Altru® Health System.
In May, U.S. regulators approved TSO3’s most recent 510(k) submission for the terminal sterilization of multi-channeled flexible endoscopes using the Company’s STERIZONE® VP4 Sterilizer. The new clearance for the STERIZONE® VP4 Sterilizer allows a hospital like Altru® Health System to terminally sterilize gastrointestinal endoscopes that have dimensions within the cleared intended use.
“Our mission, to provide a sterile device for every patient, is what TSO3 works toward every day,” said R.M. (Ric) Rumble, TSO3’s President and CEO. “The recent and highly publicized infection outbreaks associated with the use of flexible endoscopes have highlighted the need for innovative approaches to reprocessing of these complex devices. We are pleased to celebrate this major milestone with Altru® and are working with customers in the U.S. and across the world that will soon be sterilizing their endoscopes using our advanced technology.”
According to the U.S. Centers for Disease Control (“CDC”), at least two million Americans are infected with antibiotic-resistant bacteria each year, and more than 23,000 of them die. Included in those statistics are patients who were infected in healthcare settings. One type of antibiotic-resistant infection that was traced to contaminated endoscopes was caused by Carbapenem–resistant Enterobacteriaceae(CRE), a bacteria the CDC has designated as a “superbug.” This superbug has a 50% mortality rate in infected patients.