TSO3 Inc., an innovator in sterilization technology for medical devices in healthcare settings, announced that the company has initiated sterilization testing intended to support repeated sterile reprocessing in the TSO3 STERIZONE VP4 Sterilizer of the Fujifilm ED-530XT duodenoscope supplied by FUJIFILM Medical Systems U.S.A., Inc.
“Since 2016, we have been actively pursuing US regulatory clearance of our patented STERIZONE VP4 Sterilizers to address growing concerns with existing reprocessing protocols used by medical facilities and specifically in gastrointestinal departments. Change is now coming,” stated R.M. (Ric) Rumble, President and CEO of TSO3.
“As the only sterilization technology having received U.S. regulatory clearance for the terminal sterilization of long, complex, multi-channel flexible endoscopes that fall within certain dimensions, such as gastroscopes, colonoscopes and duodenoscopes, we are ideally positioned to collaborate with OEMs to improve processes related to infection prevention.”
Although the Fujifilm duodenoscope dimensions fall within TSO3’s US Food and Drug Administration (FDA) cleared label claim for sterilization of long, flexible gastro-intestinal endoscopes (see claims at tso3.com), the additional data TSO3 will generate as a result of the testing is intended to further support customer needs for device documentation. There can be no assurance as to the results of this testing or that any additional regulatory submissions will be made other than claims already cleared for the sterilizer and the reprocessing of the endoscope.
Results from this testing are anticipated by the end of the first half of 2019.
