TS03 Inc Trust Units TSTIF

RE:RE:NEWS?

[echo2]

Not sure who this secret analyst might be, but the points need a reply and rebuttal to specifics...

It could be that, moving forward, the current disinfection procedures will
be questioned, but not rescinded, per se. There is no 'could be' in the FDA document. The regulatory law is clear: for all new 510K applications cleaning, disinfection, AND STERILIZATION data must be submitted and demonstrated or NO 510K approval will be granted. 

Rather, sterilization will be favored whenever feasible. No mention is made anywhere in this new law about 'whenever feasible': the law is clear, sterilization data must be submitted. But that has been
the standard for years: high-level disinfect those types of critical and
semi-critical devices that cannot be sterilized. The de facto point here is that for the scopes and other instruments mentioned clearly in the FDA document sterilization is a requirement, thus putting these devices in the 'critical' category (from the semi-critical). One would anticipate a regulatory move to amend the Spaulding Classification to reflect this law in time, but this will be difficult near term due to the sheer numbers of scopes covered by this law, the lack of numbers of installed VP4's, and given that, for now, the law is not retroactive and older instruments are grandfathered. Moving from sterilization
to disinfection, (your 'expert' meant to say 'moving from disinfection to sterilization', not a small error... :) ) while an option, will be costly for hospitals (who would
then be expected to purchase the new sterilization technoliges) NOTE: any hospital already has and uses for less complex scopes at least one low temperature H2O2 older technology and/or outdated ETO unit, and these generally have a 10 year life span, with anticipated replacements occurring as I write estimated to be in the range of 2000-3000 units worldwide per year.... It is just that no longer will any hospital or GI Unit replace or purchase new any inferior H2O2 unit. And, hospitals and GI Units will be purchasing NEW state of the art VP4 units to meet new standards as well as patient and health care provider (and their lawyers') expectations of the highest standard of care available, and it can
be reasonably argued that the true focus should instead be re-directed onto
emphasizing the proper validation of the reusable device's design to ensure
its reprocessing instructions are effective. But, please recognize that manufacturers, such as Olympus with their upcoming rumoured Q190V duodenoscope, will continue to manufacture complex scopes that are necessary to do complex procedures and that scope complexity, while an issue, is a solvable problem and no longer a limitation, in light of the ability of the VP4 to sterilize these complex scopes now and as they come to market.

Reusable semi-critical devices for which high-level disinfection fails will
typically (if not always) feature a device design flaw, and while
sterilization might "account" for or "overcome" this design flaw, it would
not correct or fix the flaw. (my bold) Your 'expert' is missing the point that these devices are no longer being recognized as 'semi-critical' but as 'critical' going forward!! Design flaws can be fixed, if needed, but these scopes can be sterilized by the VP4 in any case even as they are now in the market. The biggest market for TSO3's technology is in the existing installed base of scopes that, while they might be theoretically grandfathered, are not going to be replaced soon; their users (and thier patients and their lawyers) need a means of treating these instruments with terminal sterilization and solving their existing and potential problems now, and in the future.

The point made here applies to the VP4.  I won't go through the many indications we are getting through the litterature, Here's only one recent example from the the AJIC where one find in the highlights

• • 

  Endoscopes accumulated contamination, visible damage, and debris over time.

• • 

  Examination of internal components detected damage or fluid inside every endoscope. (my bold)

• • 

  Routine cleaning verification tests identified endoscopes requiring re-reprocessing.

• • 

  Microbial culture incubation >48 hours fostered growth and pathogen identification.

•

in https://www.ajicjournal.org/article/S0196-6553(16)30970-1/fulltext
Your 'expert' is simply in error, here. This paper demonstrated contamination of scopes persistently despite the use according to standard protocols of AER's only. There was NO sterilization process studied in this paper. Studies of sterilization of scopes with the VP4 are in the data collection process, I believe, and the VP4 has been validated in Canada and EU to sterilize the scopes in this study with no evidence of persistent contamination ever found. This fact will be publicized once further studies of in-use testing and protocols are published from data from strategic partners of TSO3. While it is well established that AER's, (washers), themselves appear to spread contamination from one scope to another, it is simply false to put sterilizers in the same boat as AER's!!

These suggest that the disinfection-sterilization procedures themselves might contribute in the wearing-down of the scopes and from there to the difficulty in cleaning them. Of course, putting a scope through an AER washer disinfection process or through the VP4 low temperature H2O2 plus Ozone sterilizer will result in breakdown of some lubricants, for example, used internally, but it is expected that any scope should be sent back for servicing after, perhaps, 30-60-90 cycles to replenish lubricants or seals that might deteriorate, for example, depending on the instrument. TSO3 management has discussed this in cc's in the past and has made it clear that TSO3 is working, on its own and in collaboration with some scope manufacturers, to produce more robust durable lubricants, for example, that will allow scopes to stay in use longer without servicing. This technological progress is being led by TSO3 in order to assist manufacturers in solving their contamination problems, and it is just another feather in the cap of TSO3 management making the VP4 the recognized standard for low temperature sterilization.

I, for one, look forward to hearing more positive developments (and patents) from TSO3 in this regard. This is a positive for TSO3, certainly not a negative!


In case someone doubts that it is the case with the use of the VP4, check the compatibility matrix of the VP4 on the Tso3 web site.  There is nothing in the american version as the VP4 has not been cleared yet for the duodenoscopes (this will be submitted in July for Pentax and for Olympus scopes in use, or has this 'expert' missed this news? :) ) but in the canadian section, one will find this notice associated with both the Pentax and Olympus duodenoscopes

LIMITATIONS ON REPROCESSING:
Processing of this device in the STERIZONE® VP4 Sterilizer may eventually affect the frequency of maintenance of this instrument

I strongly suspect your 'expert' is a consultant to a competitor of TSO3, and that they are not interested in seeing TSO3's technology take command of the low temperature field, as we have every reason to anticipate it will, and is.