TS03 Inc Trust Units TSTIF

FDA Decides to Advise Public Re: "Emerging Signals"...

[echo2]

0. https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm479248.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery
   
   Following the US Senate committee's relatively harsh admonishment earler this year of the FDA for dragging it's bureaucratic feet for a year or two before issuing a public advisory about the obvious potential dangers of duodenoscope contamination and the resulting unacceptable patient harm that ensued, (and continues), the FDA appears to have responded, and suggests that going forward it will do better to notify the public earlier about medical device safety risks.
   
   However, while "The decision to provide public information about an emerging signal is intended to give health care providers, patients, and consumers access to the most current information about a device that may help inform their patient management decision making.", and on the recommendation of their lawyers, the issuance of such an advisory about an emerging signal "does not mean that FDA has definitively concluded that there is a causal relationship between the medical device and the emerging signal; nor does a public notification about the emerging signal mean that FDA is advising health care providers, patients, or consumers to limit their use of the device. Furthermore, such a notification does not necessarily imply that specific actions are expected on the part of the manufacturer(s) at that time. However, CDRH generally does not intend to issue a public notification unless 1) credible scientific evidence supports a new causal relationship, but the Agency needs additional time to reach a more definitive conclusion, for example by conducting additional analyses or 2) FDA has concluded a causal relationship exists, but the Agency needs additional time to develop recommendations, for example if the Agency believes advice should be sought from one of its advisory panels. FDA’s communications should be clear about what the Agency knows and does not know, as well as whether or not the Agency recommends specific actions and why. " .... etc. .... etc.
   
   To a cynic, it would be almost amusing to read about the travails of Olympus as their executives all "take the 5th" in a court of law about not advising practitioners, hospitals, or any others involved with the use of their duodenoscopes about potentially lethal HAI's from contaminated scopes, were it not for the dozens of patients who actually died, and the hundreds who were exposed and possibly made ill, and continue to be. (How many more studies on the inadequacy of high level disinfection need to be published and considered, before the FDA and others will move forward by recommending sterilization and improving patient care??)
   
   You would think these bureaucrats at the FDA would be phoning TSO3 weekly, if not daily, to ask if they have their data ready for their consideration so that a definitive solution to the scope contamination problem could be duly recognized and its implementation recommended across the nation, and nations, instead of making TSO3 jump through more and more bureaucratic hoops and spending precious time (as they did for their original 510k and extended claims endorsements) making sure all of the i's are properly dotted and the t's crossed precisely according to an indelible FDA submission protocol.
   
   The VP4 works: just get this done, IMHO. :)