GREY:TSTIF - Post by User
Comment by
binjo222on Jun 10, 2017 11:03am
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Post# 26348655
RE:Recall date Hoya
RE:Recall date HoyaStocksFTB, I agree with you that the recalls and lawsuits associated with flexible scopes are major problems. In 2015 the FDA had a conference on how high level disinfection was still allowing contaminated scopes to transmit infections.
The joint submission with the oem (whoever it is) will be an important step. It will establish that a flexible scope can be sterilized in an efficent, economic way. That will give the oem an important selling point. It reduces a hospital's liability if a VP4 is used. (Oh, and it would also be good for patients.) I would expect other oems would want to be able to make a similar claim and would be approaching TSO3 for a tag-team to FDA.
I certainly hope there is some information about the joint submission on the next CC.