TS03 Inc Trust Units TSTIF

RE:RE:RE:Pentax recall of Duo-scopes

[dant2]

Certainly this is an improvement to the Pentax scope and should provide some level of improved patient safety. Looks like the FDA is willing to grandfather these changes to help out medical device suppliers, and it seems the their new product sterilization mandate from last August 7th may end up extending PLC's for existing devices.

However in the grand scheme of things this change and approval does little to stem an ongoing and never ending stream of medical devices that harbor bacterial contamination post reprocessing.

No matter which supplier search you enter into MAUDE, all continue to return contaminated scopes of every kind presenting ongoing risks to patients through bacterial contamination.

HAI's have long been cited as a major factor contributing to escalating health care costs and patient risk. But how long it will take for the regulatory bodies to connect the dots and eliminate what may be one of the major contributors to such infections?

The example below - and I don't have the patience to read all this crxp but - the facility cited does over 3000 ERCP's p.a. and they are instituting double reprocessing to help combat the problem, and also they have ordered another 40 Olympus duoscopes to insure availability. see - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=7231101&pc=FDS

In the mean time TOS continues to languish as it struggles to overcome existing entrenched but inadequate reprocessing methodologies. Add the uncertainty surrounding Getinge and our distribution model, and it now seems a favorable H1 510K outcome on the duoscope is quite important.

Will we see expanded early adopter activity through Q1/2.  Will we see follow on signs of a shift to earily majority in H2/18 - without regulatory mandates? What are the most significant of these signs and when might they take place. I'm betting it will happen but just when is anybody's guess?
GL