RE:Sterilization Standards meetingThanks for the question.
There were some valuable and positive decisions made by the committee, but remember this is just a draft and this is just my take. Unfortunately, the group became bogged down in areas such as drying times, definitions, and a host of technical details related to cleaning and spaces for proper reprocessing, for example. I can only give my impressions, and I would hope that TSO3 can give theirs with more colour at the update next week though their comments might be limited as this is only a draft still. The group was unable to get through all of the revisions/edits that had been suggested for discussion, so they will meet again in very early July for a day to complete the final third of this draft and have it out by August and then have it ready for pubic input and final approval in the earlyfall with a publication date no later than the end of this year. The slow process of finalizaing these new standards might be partially intended to give end users the chance to see clearly what is coming later this year and to allow them to prepare themselves for this move to sterilization.
One of the most important take aways, IMHO and in my words, are that the group, with FDA's strong opinion and insistance, are that all flexible endscopes that enter sterile body cavities or tissues SHALL be sterilized (this was previously only a 'should', and this new stronger word mandates sterilization for these scopes used in critical procedures). Also, there was discussion and wording included thatpromoted and justified sterilization of not only critical but semi-critical scope use. The FDA, IMHO, clearly supports the move to sterilization for all flexible endoscopes. The implications for a significant increase in low temperature sterilizer demand once these standards are implemented are obvious, with TSO3's technology having the broadest claims avaibable.
Perhaps more practically significant and a game changer for TSO3, again IMHO, is that the FDA endorsed with the committee the ability of not just an OEM scope manufacturer to make an IFU for the end user, under the new standards an IFU for any scope or instrument can also be made by a sterilizer manufacturer. As I think I have already opined, I believe companies like Olympus have not cooperated with TSO3 on IFU's because it is not in their corporate financial interest, (they make a HLD system that, while functionally inadequate to eliminate contamination, completes with the VP4). This ability of TSO3 to do their own IFU, demonstrated by the recent announcement by TSO3 that they are cooperating on one with Fuji for their duodenoscope that should be done by end of H1, is extremely significant. I should expect that after Fuji has led the way, others will follow, and the technicians and scientists at TSO3 and and will be working hard and concentrating on teeing up a host of IFU's over the next nine months that they will have ready and be able to publicly publish (and not just distribute confidentially to early end users and adopters of their leading edge technology) once these new standards are implemented. This is huge for TSO3!
Adding to TSO3's superior economics and efficacy with their excellent sterilizer with their oxygen concentrator, having the ability to publish their own IFU's will remove perhaps the main obstacle that I see and allow TSO3 to effectively and radically accelerate their penetration of the low temperature sterilizer market as we had expected. These new standards have been 4 slow years coming, but all end users can now see the writing on the wall: sterilzation for flexible endoscopes will soon be the standard that end users will have to meet, with TSO3's help. Do I need to remind how huge this flexible endoscope market is?