GREY:TSTIF - Post by User
Comment by
lematou22on Mar 21, 2016 1:24pm
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Post# 24684087
RE:TSO3 south of the border
RE:TSO3 south of the borderThrough it's multiple interventions, the FDA has oftentimes signaled it's disquiet with the current cleaning procedures if not with the design of the scopes. At he same time, it has also repeated it's reluctance to disrupt this whole specialty of the medical system. It is not ready to send the surgeons to their knives!
An example I found very close to the problem at hand is the case of the System1 sterilizer by Steris. For memory, in 2009-2010, it found the sterilizer to be ineffective. In short, it gave the hospitals that had those machines 18 months to get rid of them and find alternatives. Here's a shorth summary of that saga
https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm192685.htm#action
There is a huge difference of scale though. In the SS1 case, only the hospitals reliant on the machines had to make the switch. If it were to move all the hospitals that rely on disinfecting procedures to someting similar to what's being offerd by Tso3, it would create a crisis, medical but also with political ramifications.