RE:RE:RE:RE:News Coverage of FDA Statements April 12The FDA does not pretend TSO3's solution does not exist, but FDA does not endorse particular companies as solutions and they won't mention names in a PR. But, they remain firm, as they did at the AAMI table, that the move is toward mandating sterilzation of flexible endoscopes for critical (and semi-critical) use and they supported recognition of IFU's of sterilizer manufacturers as equivalent to an OEM IFU's. FDA recognizes that the contamination of scopes, particularly duodenoscopes, remains far more prevalent than they are willing to accept in the pubic interest and they, with CDC, will thererfor hold a meeting to discuss options, which should certainly include the VP4, in mid-May. I am sure that TSO3 management and/or scientific officers will be in attendance and are already in close communication with FDA and others in identifying the role the VP4 will play, and is already playing for early adopters, as part of the solution to this complex question.
TSO3 is collaborating to a degree with Fuji on an IFU and with an OEM they can't name on a brand new family of endoscopes. They are also working with 3rd party servicing to improve adhesives and lubricants used in these scopes in order to improve future compatibility, which the FDA acknowledges as has TSO3, is an issue for low temperature sterilizers. Can better adhesives, for example, allow TSO3 double the 30 - 60 cycle number before a scope should be serviced, or, is this as important as end users used to think it was given the damage that is occurring to scopes through routine use (and misuse) that means they need servicing anyway at 30 - 60 uses?
Even if a hospital or GI suite doesn't terminally sterilize every one of their flexible endoscopes following every single use, (as they do at my hospital), sterilizing them in a VP4 at the end of each day or on a weekly schedule (depending on scope use) and then placing them sterile on the shelf available for next use would certainly substantially mitigate and help solve the scope contamination issue. And, it would mean that hospitals (particularly in the huge US market) doing endoscope procedures (critical and semi-critical) should have a VP4 available for use in their facilities. And, this = sales! And, as has been noted, the VP4 is not only useful for scopes, but for a host of other medical items that can't be steam sterililzed including batteries and robotics.
While the 'grandfathered' use of ETO will also play some role, the closing of the large Sterigenics facility due to EPA concerns about environmental contamination and increased cancer rates for people living near the facility definitely highlights some of the ongoing problems with relying on toxic and expensive ETO going forward.
Management and sales people from TSO3 are presently at the SGNA Society of Gastroenterology Nurses and Associates in Portland. I wish them well! They need to continue to work hard to raise awareness among end users of how TSO3 can help solve this contamination problem! All of this news from the FDA is only positive wind for TSO3, as will be the final drafts of the AAMI regulations for reprocessing flexible endoscopes. The big meeting, IMHO, for TSO3 is the upcoming IAHCSMM at the end of April. https://s6.goeshow.com/iahcsmm/annual/2019/conference_program_sessions.cfm