TSO3 announced that it 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.
Image: TSO3 has expanded duodenoscope sterilization testing. Photo: courtesy of David Castillo Dominici / FreeDigitalPhotos.net.
“Since 2016, we have been actively pursuing US regulatory clearance of our patented STERIZONEVP4 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 US 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. TSO3 is dedicated to helping our customers continually innovate and improve patient care with best-in-class technology applications directed at 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, 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.
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 long, multi-channel flexible endoscopes (with a maximum of four channels) of up to 3.5 meters in length, such as certain 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).
Source: Company Press Release