TS03 Inc Trust Units TSTIF

NYT Ed Bd May 4: FDA Lack of Regulation of Medical Devices

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https://www.nytimes.com/2019/05/04/opinion/sunday/medical-devices.html?action=click&module=Opinion&pgtype=Homepage

FDA held an urgent meeting in May of 2015 to assess the scope of the duodenoscope contamination and patient injury/death problem. They acknowledged a serious problem (resulting in numerous deaths including with superbugs) exists with endoscope contamination, especially with the Olympus q180V for which Olympus has put aside a paltry initial $85 M for costs of litigation, etc. against them. And, in the past couple of years FDA demanded scope manufacturers do post-market surveillance to determine the extent of the problem. None of the scope manufacturers complied with this demand until the FDA threatened them again last year. And, now that this post-market surveillance of the contamination issue has been done it has been made clear that at least 3%+ of these endoscopes remain contaminated despite end users supposedly adhering to the new FDA recommendations that came out of the May 2015 FDA meeting, including thorough cleaning of endoscopes and supplemental decontamination with HLD x 2 or HLD + ETO. And, now, industry and scope manufacturers (despite at the same time settling with plaintiffs out of court for wrongful death and injury related to their scopes in order to deflect liability) is still blaming the contamination issue on inadequate adherence to their recommendations for cleaning and reprocessing. 

The medical industry self-regulating organization AAMI's latest draft (which should go public this summer) allows sterilizer manufacturers to do their own IFU's for endoscopes (because of the FDA's apparent opinion that they recognize it is not in the self-interest of the major scope manufacturer who makes a partially competing AER or HLD reprocessor to cooperate with a sterilzer manufacturer like TSO3 to do that IFU for their endoscope) and their upcoming standards recognize that sterilization is required to eliminate contamination for a raft of endoscopes including cystoscopes, duodenoscopes, gastroscopes, bronchoscopes (and possibly colonoscopes) used in critical (and possibly non-critical) procedures because older AER/HLD reprocessing is simply inadequate to eliminate contamination as found in post-market studies.

Will the FDA /CDC Health Care Infections Control Practices Advisory Committee at their meeting upcoming May 16 - 17 finally force the industry to new higher standards of patient care by recommending mandating terminal sterilzation of these complex endoscopes (and thereby force industry players to work with TSO3 (as Fuji is doing) and others to improve the adhesives and lubricants used in scopes to improve compatibility)? TSO3 offers terminal sterilzation that should be a significant part of the solution to the endoscope contamination issue that is effective and far more efficient in terms of time and cost than any other. Could TSO3 ramp up production later this year and early next to meet the demand of hundreds+ of VP4's that comes from the push to sterilization from this HICPAC meeting and the new AAMI endoscope reprocessing standards coming this Fall? You can bet they plan to try!

Again, as noted at the end of the NYT Editorial Board's piece the FDA's mission, supposedly, is to "PROTECT PATIENTS". Will they do this at  the HICPAC meeting in a couple of weeks, or will they continue to roll over and only pay lip service to the demand that the highest quality of care be provided to patients through terminal sterilization of endoscopes? 

I look forward to TSO3 managements' comments on these issues on Tuesday.