GREY:TSTIF - Post by User
Comment by
dant2on Sep 24, 2017 7:13pm
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Post# 26735791
RE:A Follow-up to the AAMI Report
RE:A Follow-up to the AAMI ReportGood article Lematou. Thank you. Looks like this was originally penned in 2015 and updated about four weeks ago - just after the FDA mandated sterilization as part of submission requirements. The paper is obviously biased but 3M clearly sees the trend away from HLD and L/CS and wants to be part of the 'sterilization' solution.
In the article they suggest ETO as a viable solution for endoscopes in general and specifically for duodenoscopes. I'm wondering if they are or will seek expanded 510K ETO claims and if so exactly what scopes that might entail?
Do you have means to see whether there are other such claims currently before the FDA?
Either way it will take the industry some time to adjust but even if multiple solutions do emerge I like TOS' position - with the caveat that meaningful uptake is probably still a few quarters away.
With the AAMI follow up meeting just three weeks away, the duo claims pending and TOS' Q3 results in the offing ... its going to be an interesting fall :-)