UCHealth Performs First Patient Procedure in Colorado Using STERIZONE Technology

TSO₃ Inc., 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, US 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 US 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 Enterobacteriaceae (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.” – Medical Buyer Bureau