TS03 Inc Trust Units TSTIF

RE:APIC Conference

[echo2]

Thank you for this link.

Rutala does note up front that he has consulted  for ASP (old outdated H2O2 techology) and others over the past year.

And, much of his assessment of the problem of scope contamination and HAI's is accurate. For example,  he  notes  
" - >130 plus endoscope-related outbreaks
-GI endoscope contamination rates of 20-40% after HLD
-Scope commonly have disruptive/irregular surfaces
->50,000 patient exposures involving HLD"

He states that "Sterilization Enormous Margin of Safety!
-100 quadrillion (1017 ) margin of safety

-Sterilization kills 1 trillion spores, washer/disinfector removes or inactivates 10-100 million; ~100 microbes on surgical instruments"

He notes the FDA has accepted sterilization for duodenoscopes, and that the numberous industry and regulaory bodies involved are all recommending the move from HLD to terminal sterilization.

And, he relates some of the problems of implementing terminal sterilization due to pushback from doctors: "GI physicians did not want to add the “secondary” to the definition...as they feel thatit will make many GI scope procedures as critical devices, mandating terminal sterilization which basically means that they have to ETO sterilize most of their GI scopes. They argued that this will disrupt the business and significantly increase the cost of care, and therefore many people won’t afford such procedures. Thus, increasing the bar from HLD to sterilization at this time without having practical fast and compatible sterilization technologies will create more harm than benefit to the patients."

He also notes that there is a new sterilization solution without identifying this technology (i.e., the VP4).

But, though he makes mention of this new technology, he makes no effort in his slides to clarify the utility and solution offered by TSO3's ozone + H2O2 technology. (He does not identify older outdated competing technology manufacturers, either, by name.)

He allows the argument to be made by doctors  that to demand terminal sterilzation today (as of March 2018??), that the only option for low temp sterilization is the time consuming (24hr +) and completely inefficient and proven (by Ofstead's most recent paper among others) microbiologically ineffective use of ETO.

Where has the dear Dr. been over the past few months?? Has Rutala not had time to update his sildes? Is he not  aware that TSO3 obtained FDA approval to sterilize the Olympus Q180V duodenoscope on May 9, 2018??

Is he not aware that the VP4 terminally sterilizes these problem duodenoscopes in a single cycle following normal, thorough, and recommended cleaning and inspection of the scope as per the FDA? A scope need no longer be out of service for days or hours, but for an hour!! And, HLD is not a part of this terminal sterilzation process, nor are the ineffective and outdated ETO or ASP or Steris solutions. Only TSO3's VP4 can terminally sterilize these scopes in the same time  (or less) than it would take to run two HLD's cycles (one standard and one supplimental as FDA reocmmended in 2015).

Should not Dr. Rutala be asking when the FDA will put out a non-biased statement identifying and recommending TSO3's VP4 as the definitive solution of effective and efficient terminal sterilization of duodenoscopes in an effort to update their outdated recommendations 2015, (as well as for gastroscopes, ureterosocpes, colonoscopes...) ???

The VP4 is not a supplement to HLD!! It is a complete replacement for this ineffective and outdated technology in so far as it is used to reprocess duodenoscopes!! 

Interestingly, he also notes that H2O2 is effective against HPV transmission, which is a huge and separate public health issues, but one that obviously TSO3's VP4 H2O2+ozone is effective at mitigating.

In terms of his discussion of new technology that  solves the duodenoscope contamination issue, his role as a consultant to the Fortive/ASP competition aside, I do hope the dear Dr. updates his slide and verbal presentation by tomorrow!

;)