GREY:TSTIF - Post by User
Comment by
echo2on Jun 08, 2016 11:19am
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Post# 24946276
RE:RE:FDA stance after approval
RE:RE:FDA stance after approvalNews flow continues....
https://www.wsj.com/articles/bill-would-require-doctors-to-report-medical-device-hazards-1465395253
While this refers specifically to JnJ's morcellator and lack of reporting, it shows the direction of industry oversight (even from Republican bill sponsors) and would equally apply to inadequate communications regarding scope contamination problems such as with the Olympus Q180V duodenoscope and dysfunctional reprocessors over recent years.
While further FDA approval and endorsement of extended claims for the VP4 will create a defacto monopoly for TSO3 as the provider of the superior low temperature sterilization solution in the US, one can only presume the FDA cares less about granting TSO3 a defacto monopoly as the provider of improved standard of care technology and more about improving the provision of the highest quality of health care for US patients.
And, my guesstimate of TSO3 having to expand more rapidly than anticipated to produce 2000 units per year as early as 2018 may not be as unrealistic as many might think.