RE:RE:RE:WHY ALL THE BASHING? Please, Bernard, get your facts straight.
The AJIC study was done to mimic the standards of the FDA submission showing TSO3’s VP4 to be the only FDA validated and approved low temperature sterilizer for these complex scopes, including ERCP scopes, gastroscopes, and colonoscopes. This study was done on 2 ERCP scopes 3 x for the half cycle method and on 3 scopes x 3 for the simulated use using biofilm. You should be aware that ETO has never been so approved, but rather has been grandfathered for supplemental use only in addition to HLD as per the FDA’s 2015 recommendations. Studies have also shown ETO can be inadequate to reliably terminally sterilize these scopes, though if available, it can be part of the solution. If an ETO manufacturer could sterilize the complex scopes that the VP4 can sterilize, why don’t they submit data proving this to the FDA as TSO3 has done? (Please don't prolong this exchange by answering, the question is rhetorical.)
“Overkill (half-cycle) test method
The tested duodenoscope model was first evaluated in the hydrogen peroxide–ozone sterilizer with an overkill method performed in triplicate using 2 separate duodenoscopes. The overkill method (or half-cycle method) consists of inoculating the medical devices with more than 1.0×106 colony-forming units (CFU) of the most resistant organism identified for this sterilization process and by showing no growth after the half-cycle point of the sterilization cycle (cycle performed included 1 phase of sterilant exposure instead of 2 phases in a complete cycle). This results in a sterility assurance level of 10−6,54 meaning that there is a 1 in 1,000,000 chance of an organism surviving the sterilization process. Although sterilizing with a half-cycle would never be performed in clinical use, this overkill approach recommended by the FDA results in a significant margin of safety, which is not required when validating endoscope processing using HLD.”
“Simulated-use test method
The sterilization of the duodenoscope model was also evaluated in the hydrogen peroxide–ozone sterilizer with a simulated-use method performed in triplicate. Three separate duodenoscopes were used in this testing. When performing a simulated-use validation, the most resistant microorganism to the sterilization process is mixed with organic and inorganic soils and inoculated on devices. These simulated soils, including organic and inorganic compounds, mimic clinical use. The inoculated medical devices are not washed (thus simulating a worst-case scenario) and exposed to a complete cycle of the sterilization process.57 The intended use of the tested sterilizer stipulates that medical devices must be cleaned as per the manufacturer's instructions for use before sterilization. Nevertheless, the cleaning step is omitted in a simulated-use method to perform the test under worst-case conditions.”
As noted by one of the Olympus reps at one of the AAMI meetings last year, this OEM does not want to be involved in doing an IFU for any new low temperature sterilization system, though they do not officially oppose a sterilizer manufacturer (like TSO3) doing their own IFU using their new sterilization technology. The reason for a company like Olympus not endorsing or working with TSO3’s product, I believe, is two fold. 1) Olympus makes a competing though proven to be inadequate reprocessor (a HLD washer or AER) which is profitable for them and it is not in their financial interest to validate a competitor’s technology. 2) They continue to legally blame the end users for employing inadequate adherence to their recommended reprocessing techniques as per their old IFU’s using HLD/AER systems for the deaths and injuries to patients that have occurred, despite now setting these wrongful death and injury claims in numerous out of court settlements. To admit that there is an available practical solution to sterilize their scopes on an efficient and cost effective basis would mean they should include TSO3’s VP4 as an option to legally mitigate a risk which they legally deny exists, on recommendation of their lawyers. Again, to recommend the VP4 as a solution to mitigate risk of using their ERCP scopes would be to endorse a competitor’s product and is not in some OEM’s corporate financial interests.
The fact that a competitor’s older H2O2 sterilizer technology has had problems in no way means that the newer and improved VP4 might have similar issues. Such problems with the VP4 have not been reported to my knowledge. Technology and expertise evolves and is perfected, and the VP4 is the result.