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.
B-roll and interviews at Altru Health System:
About the STERIZONE® VP4 Sterilizer
The STERIZONE® VP4 Sterilizer is a low-temperature sterilization system that 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 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 the only terminal sterilization method that is FDA cleared to sterilize multi-channeled flexible endoscopes (with a maximum of four channels) of up to 3.5 meters in length, such as video colonoscopes, duodenoscopes 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).
More information about the STERIZONE® VP4 Sterilizer is available through TSO3‘s website, under the Products section at https://www.tso3.com/en/products/sterizone-vp4/.
About Altru® Health System
Altru® Health System is a community-owned, integrated system, based in North Dakota, with an acute care hospital, a specialty hospital, more than a dozen clinics and a large home care network across a 17-county service area in northwestern North Dakota and northeastern Minnesota. It employs nearly 200 physicians and 4,000 staff and has an annual net operating revenue of more than $549 million. As the first member of the Mayo Clinic Care Network, Altru®’s providers have access to clinically integrated tools extending Mayo Clinic’s knowledge and expertise to patients. For more information about Altru®, visit the website: altru.org.
Founded in 1998, TSO3‘s activities encompass the sale, production, maintenance, research, development and licensing of sterilization processes, related consumable supplies and accessories for heat-sensitive medical devices. The Company designs products for sterile processing areas in the hospital environment that offer an advantageous replacement solution to other low temperature sterilization processes currently used in hospitals. TSO3also offers services related to the maintenance of sterilization equipment and compatibility testing of medical devices with such processes.
For more information about TSO3, visit the Company’s website at www.tso3.com.The statements in this release and oral statements made by representatives of TSO3 relating to matters that are not historical facts are forward-looking statements that involve certain risks, uncertainties and hypotheses, including, but not limited to, the limited history of sales or distribution of the Company, the ability of the Company to obtain the required regulatory clearances to market its products, general business and economic conditions, the condition of the financial markets, the ability of TSO3 to obtain financing on favourable terms and other risks and uncertainties. Although TSO3 believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations will prove to have been correct. The complete versions of the cautionary note regarding forward-looking statements as well as a description of the relevant assumptions and risk factors likely to affect TSO3’s actual or projected results are included in the Management’s Discussion and Analysis for the year ended December 31, 2017, which is available on the Company’s website. The forward-looking statements contained in this press release are made as of the date hereof, and TSO3 does not assume any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise unless expressly required by applicable securities laws.