RE:RE:FDA, CDC and ASM are providing recommendations for health...(And, please pardon this website for deleting my formatting and paragraphs in that previous post. I will try again... :) )
I have been asked to clarify my comments on some sort of equivalency between TSO3's VP4 technology and old ETO sterilization.
To be clear, while CDC (https://www.cdc.gov/hicpac/pdf/flexible-endoscope-reprocessing.pdf) in June of 2017 and FDA in previous recommendations for supplemental processes to reduce duodenoscope contamination from 2015 identified repeating HLD x 2, for example, and supplementing this with ETO or other "FDA-cleared low-temperature sterilization" methods, it should be noted that there is "insufficient evidence" as per the CDC to show the effectiveness of this supplemental processing, except for the case of TSO3's VP4 H202 + ozone technology.
I presume completely that TSO3 in no way is aiming to simply be regarded as substantially equivalent to supplemental ETO sterilization, as using the VP4 already can be regarded as a more valid supplemental process than any of the other processes on the CDC or the FDA lists as it is the only process with extensive data proving it works. Cost and efficiency savings of 40% to end users are just a huge bonus for those who adopt TSO3's technologies.
TSO3 has applied to the FDA for a clear 510k recognition and labelling, as it has done with colonoscopes, as a valid low temperature sterilization process for ERCP duodenoscopes! Period. Exclamation point. They are not looking for equivalency to ETO as a supplemental sterilization process to HLD, as they already have this status. Again, they have not submitted that their technology is only, though better than other unvalidated processes, a possible supplemental process to inadequate HLD! TSO3 has done the testing and validated the VP4 to terminally sterilize these duodenoscopes as per Rumble's RBC presentation and I am sure he is as dismayed as anyone, or more, at the FDA's delays in granting TSO3 this clear extended 510k claim!
My point is that the FDA should approach the solution for the duodenscope contamination in two separate steps.
1) They should immediately provide TSO3's VP4 with the labelling and extended claim that they can sterilize the ERCP duodenoscopes. The extensive data validating the VP4 for this use is on their desks and has been since November 2017 and before, with possible additional data in December and early January 2018.
2) If the agency is concerned about compatibility issues of sterilization or reprocessing of any scopes, (which they have never asked HLD or ETO manufacturers to provide) this is a second issue that needs input from and open discussion with the FDA, scope manufacturers in cooperation with TSO3, ETO and HLD manufacturers.
And, the agency's insistence that scope manufacturers assist in post-market surveillance of contamination issue is a separate issue from both of these. That TSO3's technology solves the contamination issue is a different issue from determining the extent of the contamination problem.
I hope these comments are clearer.
This share price is ludicrous. Period.
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