SO3 Inc. (TSX: TOS) (“TSO3” or the “Company”), an innovator in sterilization technology for medical devices in healthcare settings, joins with UCHealth, a nationally recognized, nonprofit network of 10 acute care hospitals and more than 150 clinics throughout Colorado, southern Wyoming and western Nebraska, in announcing the first patient procedure in Colorado performed with a duodenoscope sterilized using the STERIZONE® technology.
“Providing our patients with the highest level of safety is central to every decision we make,” said Darla Woodman, sterile processing nurse manager at UCHealth’s Medical Center of the Rockies and Poudre Valley Hospital. “It is critical that our guidelines for reprocessing duodenoscopes ensure that each device is sterilized for every patient and every procedure.”
Duodenoscopes are flexible endoscopes used during Endoscopic Retrograde Cholangiopancreatography (ERCP), which is a procedure that enables a physician to examine and take images of a patient’s gallbladder, common bile duct, pancreas and liver.
“Reducing infection rates isn’t dependent on technology alone, but through a team approach,” added Brenda Lynch, gastrointestinal lab nurse manager at UCHealth’s Greeley Surgery Center, Medical Center of the Rockies, and Poudre Valley Hospital. “Proper hand washing, wearing proper personal protective equipment and following hospital protocols all help lower the spread of bacteria and other infections. This sterilization system supplements our infection prevention tools that allow us to deliver a greater level of quality patient care.”
In May 2018, U.S. regulators cleared TSO3‘s most recent 510(k) submission for the terminal sterilization of multi-channeled flexible endoscopes using the Company’s STERIZONE® VP4 Sterilizer. The clearance for the STERIZONE® VP4 Sterilizer allows a hospital system like UCHealth to terminally sterilize gastrointestinal endoscopes that have dimensions within the cleared intended use.
“The recent and highly publicized infection outbreaks in the United States associated with the use of flexible endoscopes have highlighted the need for innovative approaches to reprocessing these complex devices,” said R.M. (Ric) Rumble, TSO3‘s president and CEO. “We are pleased to be a part of the solution to this serious health problem, which can be eliminated only through the collaborative efforts of healthcare providers like UCHealth, in combination with medical device manufacturers, reprocessing device manufacturers, regulatory agencies, and professional societies.”
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. By 2025, the CDC predicts more people will be diagnosed with an antibiotic-resistant infection than cancer. One type of antibiotic-resistant infection that was traced to contaminated endoscopes was caused by Carbapenem–resistant Enterobacteriace (CRE), a bacteria the CDC has designated as a “superbug.” This superbug has a high mortality rate in infected patients. In 2015, the CDC reports 287 cases of CRE across the state of Colorado.
Carla Warner of North Carolina knows the devastating power of a “superbug.” “Something I can’t even pronounce destroyed my husband,” said Warner, the widow of Bill Warner who contracted CRE following an ERCP procedure in North Carolina. Since that time, she has been a strong advocate for sterile devices. “The threat of antibiotic-resistant infections is absolutely not just hype, it is a very real issue affecting everyone. I’m hopeful we’ll get to the point where everything that is used on a patient is safe.” Click here to hear more of Warner’s story.
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).