Rutala continued, “The way we can shift is to modify the Spaulding classification. I recommend that we consider for sterilization the critical items which directly or secondarily enter normal sterile tissue. So, it doesn’t have to directly touch, but secondarily touch sterile tissue would require sterilization. The way this could be done is the FDA, in collaboration with professional organizations and industry, could modify the Spaulding classification scheme. Of course, they would modify only the critical component of the Spaulding classification scheme, and it would say essentially that objects which directly or secondarily enter normal sterile tissue or the vascular system should be considered sterile. When manufacturers submit a new device for clearance that secondarily enters normally sterile tissue, the FDA should not accept high-level disinfection, but require sterilization. Eventually, to unify reprocessing and reduce infection risk, healthcare facilities would require sterilization of all gastrointestinal endoscopes.” He added, "“doing nothing is not an option.” He says that in order to protect the public health and prevent ERCP-related outbreaks, there is an urgent need to shift from HLD to sterilization. "
And, two years later, with 2018 rapidly approaching, where are we? It has been found repeatedly that HLD techniques are grossly inadequate to make scopes, in particular duodenoscopes, safe and remove bacterial contamination from them prior to use. It has also been found that gastroscopes are actually even more contaminated than colonoscopes and probably represent a greater risk to patients, similar to the risk of contaminated duodenoscopes with 50-60% of scopes tested being contaminated with bacteria following rigourous reprocessing with high level disinfection HLD!! At the time, Rutala advocated for outdated and inefficient (and not FDA approved) ETO sterilization for scopes because no other option was recognized in early 2015 to effectively sterilize these complex scopes.
But, now, the health care industry has an option: the VP4 and TSO3's Sterizone technology! As we await another submission by TSO3 and its scope manufacturer partner to the FDA to demonstrate that the VP4 can indeed sterilize this duodenoscope in the US, as is recognized in Canada and in Europe, don't forget that the FDA has already given approval to TSO3 for extended claims regarding complex mulitchannel gastroscopes and colonoscopes!! The significance of this doesn't get the recognition it deserves! No other low temperature sterilizer in the market can make these claims. Period.
And, last week, TSO3 announced that its scientists have authored another paper that will be published in the Fall validating a testing protocol developed by TSO3 that the FDA does recognize. This testing demonstrates a unique technique for contaminating and then sterilizing in the lab and in the hospital the complex narrow lumens of these scopes! No other low temperature sterilizer even attempts to equal TSO3's robust testing and validation of sterilization protocols simply because these competitors know very well that their technology cannot match the VP4's ability to sterilize these complex scopes and lumens. TSO3's technology and the VP4 are in a low temperature sterilization class of their own! Period. Exclamation point!
Infection Control Today just did a survey of sterile processing professionals that revealed that "55 percent of respondents believe that endoscopes should be sterilized in addition to high-level disinfection, while 22 percent disagreed and 23 percent were uncertain." This survery also found that only 3% actually do sterilize, using outdated ETO technology. If even half of all users were to adopt low temperature sterilization solution represented by the VP4 over the short term as the FDA phases in a revision to the Spaulding Classification standards, TSO3 would be installing over a thousand units a year! I realize that the medical industry is slow to adopt needed changes; but, maybe, the company will in the near future have an excellent use for the money they could raise so easily by doing a US NASDAQ listing: to build an new US facility capable of manufacturing a thousand units a year to meet mushrooming demand, especially TSO3's techology penetrates the rapidly growing gastrointestinal surgical centre field in addition to traditional hospitals.
So, will the FDA get off their collective butts, stop listening to the industry lobby by inferior competitors like Sterrad/JNJ, and begin this year to revise the Spaulding Classification system so that these complex gastroscopes, bronchoscopes, colonoscopes, and, very soon, duodenoscopes, become critical devices requiring sterilization, not just ineffectual high level disinfection?? Will new recommendations by the FDA be in place, as Rutala has suggested, by 2018, given that the industry now has a clear solution, the VP4 Sterizone sterilizer from TSO3? I realize that for the FDA to make this change will put TSO3 in a virtual monopoly position in the low temperature sterilizaton industry; but, that is only Steris and JNJ's problem: this is not a health care providers' or our patients' problem, it is a solution for them!
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