RE:RE:RE:RE:RE:RE:LiabilityYou are right regarding the absolute minimum times for ETO, but this means if you are done with a scope at 9 AM on Day 1, you won't see it back until at least 1 PM the following Day 2, iff all goes perfectly and iff your facility has an ETO sterilizer, which most NA hospitals do not have. The great majority of hospitals and virtually all GI suites must send their scopes out for ETO, so you can add 1-4 hours of travel time each way, or longer, to your turnover cycle, making the scope available closer to 48 hours for use on the morning of Day 3 (unless it is used later in the evening on Day 2, though nearly all scope procedures are elective and done during the day). ETO compatibility with scopes is no better than the VP4 and in many cases worse.
I am not aware that FDA has recommended only ETO for contaminated scopes. As I noted, they merely recommended users do their best to mitigate contamination (through available options at the time which were 'grandfathered' unverified ETO, HLD x 2, or ETO + HLD - and independent studies confirm NONE of these options are in fact effective). Because FDA has not issued an updated statement on this issue certainly in no way precludes using a VP4 to sterilize a contaminated scope for which there is unique FDA approval as the only approved effective terminal sterilization process proven to work.
Again, as FDA has already recognized the VP4 as the ONLY low temperature sterilization process that can sterilize duodenoscopes and colonoscopes, and as the VP4 can sterilize any other scope (bronchoscope, ureteroscope, gastroscope) and more that the competition claims to sterilize, using the VP4 to sterilize any contaminated scope does not go against any FDA or AAMI recommendation, as these recommend sterilization where available. And, given new data and FDA's new evolving approach to allowing in use clinical postmarket data, I am certain any hospital facing a Joint Commission routine review would be fine to show the JC TSO3's data, both published in peer reviewed journals and as submitted to and approved by the FDA to validate use of a VP4 for contaminated scopes, especially duodenoscopes . We can only continue to look forward to more validation of the VP4 in use as more data, particularly as collected up to October by Vancouver General, is collected and made public.
TSO3's biological indicators do take until the next day and It is my understanding they recommend use of one of these daily to confirm sterility end of day to confirm the packaged sterile scope can be used the following morning, but they actually use a partner's rapid BI (not 3M's and that TSO3 supplies by agreement) for use with individual cycles so that cycles can occur on up to an hourly schedule.