Thanks for the input.
“Also, the only proven sterilant that has stopped "Real-Life" outbreaks has been EtO. This is not mice engineered to get the results your hoping for in a incubator. This is in the "Real-World" where people have died. This is why I'm investing in this company. But, as an investor I have a right to point out actual facts. EtO has been the leading choice what the hospital industry turns to when an outbreak occurs and it's dropped the infections dead in it's scopes..."
If ETO is all a hospital has had to mitigate risk of cross-contamination with a duodenoscope, for example, it should be used and there is little doubt that employing ETO when available has played a positive role especially for cases of confirmed endoscope contamination. But, the VP4 must be recognized as a new, efficient, effective and compelling option and solution.
VGH, Hotel Dieu, Altru, Lehigh Valley and other early adopter users have confirmed that they chose the VP4 because it is superior to ETO (and competing H2O2 systems) in terms of cost, (including no need for HVAC installation and venting), accessibility, efficacy, and operating economics with excellent reliability and service from TSO3.
The VP4 replaces the use of both HLD + ETO in reprocessing scopes.
And, in a recently published study, only 12% of surveyed US facilities actually reprocessed duodenoscopes with ETO with 63% using HLD x 2. (Gastrointestinal Endoscopy, August 2018, Vol.88(2), pp.316-322.e2) Respondents in this survey identified the following “Barriers to ethylene oxide sterilization
For institutions that did not use EtO (n = 219), long reprocessing time (41.4% of respondents) was cited most frequently as a barrier to implementing EtO sterilization, followed by concerns for scope damage (37.4%), lack of institutional support or interest (32.5%), cost (32.0%), concerns regarding toxicity (25.6%), and lack of regional availability (24.6%).”
Clearly, there is an enormous market opportunity and need here that demands to be addressed by TSO3, with 88% of users reporting they are not terminally sterilizing duodenoscopes at all in the US!! H2O2 low temperature sterilization for endoscopes, and especially the cutting-edge VP4 with extended duodenoscope and colonoscope FDA claims, is a proven efficient alternative and replaces use of ETO and HLD “in Real Life”, though ETO will no doubt continue to have some niche complementary applications, IMHO, and it certainly remains a valuable technology. There is no need to get personal or to claim that my statements are not factual. Let end users decide what is best. Low temperature sterilization is a growing field and all boats will be lifted with the tide, especially the boats that are the best in class.
Just FYI, here are references to a couple of studies one of which reveals the inadequacy of ETO to prevent patient contamination issues with endoscopes.
This study did not find MDRO's in duodenoscopes, but did find that HLD x 2 and HLD + ETO was NOT effective in reducing contamination of scopes with other bacteria over HLD x 1, with a persisting 22.5% contamination rate, most likely due to biofilm on the scopes, which ETO is recognized to have trouble sterilizing. (On the other hand, see the recent publication by Malloy-Simard et al https://www.ajicjournal.org/article/S0196-6553(18)30915-5/fulltext that confirmed the VP4 achieves sterility of duodenoscopes under laboratory biofilm worst-case scenario and sterility of patient-soiled duodenoscopes under clinical in-use conditions. The FDA has endorsed only the VP4 to terminally sterilize duodenoscopes and colonoscopes. And, again, I look forward to publication of more clinical post-market studies validating the VP4!)
https://www.ncbi.nlm.nih.gov/pubmed/28711629 :
"BACKGROUND AND AIMS:
Duodenoscopes have been implicated in the transmission of multidrug-resistant organisms (MDRO). We compared the frequency of duodenoscope contamination with MDRO or any other bacteria after disinfection or sterilization by 3 different methods.
METHODS:
We performed a single-center prospective randomized study in which duodenoscopes were randomly reprocessed by standard high-level disinfection (sHLD), double high-level disinfection (dHLD), or standard high-level disinfection followed by ethylene oxide gas sterilization (HLD/ETO). Samples were collected from the elevator mechanism and working channel of each duodenoscope and cultured before use. The primary outcome was the proportion of duodenoscopes with an elevator mechanism or working channel culture showing 1 or more MDRO; secondary outcomes included the frequency of duodenoscope contamination with more than 0 and 10 or more colony-forming units (CFU) of aerobic bacterial growth on either sampling location.
RESULTS:
After 3 months of enrollment, the study was closed because of the futility; we did not observe sufficient events to evaluate the primary outcome. Among 541 duodenoscope culture events, 516 were included in the final analysis. No duodenoscope culture in any group was positive for MDRO. Bacterial growth of more than 0 CFU was noted in 16.1% duodenoscopes in the sHLD group, 16.0% in the dHLD group, and 22.5% in the HLD/ETO group (P = .21). Bacterial growth or 10 or more CFU was noted in 2.3% of duodenoscopes in the sHLD group, 4.1% in the dHLD group, and 4.2% in the HLD/ETO group (P = .36). MRDOs were cultured from 3.2% of pre-procedure rectal swabs and 2.5% of duodenal aspirates.
CONCLUSIONS:
In a comparison of duodenoscopes reprocessed by sHLD, dHLD, or HLD/ETO, we found no significant differences between groups for MDRO or bacteria contamination. Enhanced disinfection methods (dHLD or HLD/ETO) did not provide additional protection against contamination.”
To repeat and to quote from a recent survey of the scope contamination problem discussing the problems with the FDA’s 2015 supplemental mitigation recommendations for reprocessing duodenoscopes,
(New Developments in the Prevention of Gastrointestinal Scope-Related Infections. Jonathan D. Grein MD and Rekha K. Murthy MD, FRCPC
Infectious Disease Clinics of North America, 2018-12-01, Volume 32, Issue 4, Pages 899-913, Copyright © 2018 Elsevier Inc.):
“Ethylene oxide
Gas sterilization with ETO has been used for decades to sterilize medical equipment and supplies and is included in reprocessing instructions of many endoscopes. As with all methods of disinfection, ETO is less effective if manual cleaning is not performed well or in the presence of biofilm. Despite the appeal of gas sterilization, many health care facilities have eliminated the use of ETO because of its potential safety risks to employees, given its flammability and carcinogenic potential. At present, prolonged exposure to ETO is the only low-temperature sterilization technique available; however, it is costly, inefficient, associated with potential toxicity to personnel, cannot sterilize residual gross soil, warrants concern about endoscope durability, and is not widely available. Furthermore, ETO is not approved by the FDA for reprocessing endoscopes.”
“Repeat High-Level Disinfection
The FDA-recommended practice of performing 2 successive HLD cycles on endoscopes before use is based on a theoretic rationale that back-to-back HLD may reduce or eliminate microbial contaminants remaining from the first cycle. Although this practice has been used in some countries, there is little published evidence to support the practice and it can increase turnaround time. The greatest concern regarding this practice is its lack of efficacy, based on the observation that contaminated duodenoscopes have caused outbreaks at health care facilities throughout the United States and Europe despite having undergone sometimes dozens of cycles of HLD without eradicating the bacteria. This finding suggests that there may be internal bacterial contamination of the duodenoscopes on surfaces that are not adequately disinfected by HLD and therefore not addressed through multiple HLD cycles.”
From another study showing the inadequacy of HLD alone in reducing scope contamination
( https://www.ajicjournal.org/article/S0196-6553(18)30152-4/fulltext )
"In this study, 71% of endoscopes had microbial contamination—a proportion exceeding previous findings by our team and others in the field (8%-64%). Differences in microbial growth are likely due to the more stringent methods used to obtain and process samples in this study. We used the flush-brush-flush method, since flush-only methods are now considered inadequate. Multiple endoscope components were sampled because previous studies detected contamination on various endoscope surfaces. "
"Numerous studies have found that HLD is not effective at eliminating bioburden on flexible endoscopes, even when HLD is performed multiple times. Experts are calling for a shift to sterilization, and Olympus recently released new reprocessing instructions that recommend sterilization rather than HLD for endoscopes that come into contact with “sterile areas” of the body. "
https://www.ajicjournal.org/article/S0196-6553(16)30970-1/fulltext
Thanks for the discussion.
TOS is extremely undervalued. Period. We need to see sales. Period.