TS03 Inc Trust Units TSTIF

RE:RE:As much as I want to understand the notice from FDA ...

[echo2]

I find the apparent confusion in the market regarding the significance of this new FDA law/regulation quite remarkable. Perhaps, if TSO3 (even jointly with Getinge) were to put out some sort of comment or clarification in coming days, the significance of this news might impress the market, and the reporters for LATimes and elsewhere, a bit more.

In light of this FDA news, any health care provider, G I Unit, or hospital will obviously chose the VP4 over any other low temperature sterilizer given all of its advantages and its virtual monopoly on meeting these NEW FDA standards, now and in the future.

Please note that when the new FDA law refers to requiring manufacturers going forward to validate and submit data on reprocessing their devices for 510K approval, they are referring by 'reprocessing' to cleaning, disinfecting via washer, and (now) sterilization, (not to the use of a washer reprocessor). 

The FDA has mandated a new standard of care going forward for the reprocessing of these devices, particularly the scopes that only TSO3's technology can sterilize, including offending duodenoscopes, colonscopes, utereroscopes, bronchoscopes.

Obviously, the FDA has heard from TSO3, has a positive relationship with them, having seen their past data and impeccibe submissions, and will be quite delighted to have their latest data on duodenoscopes officially submitted. The FDA doesn't care that they are stepping on the toes of our competition: the FDA mandate is patient and community health and safety. It is just surprising that they have made this move so quickly and with such force in the Federal Registry.

Again, "FDA believes that a majority of manufacturers for the reusable devices listed below are already conducting validation of their reprocessing instructions because FDA already has provided recommendations for reprocessing validation in relevant FDA documents. Sponsors of new 510(k) notifications for reusable devices identified in the tables below must also include validation data regarding cleaning, disinfection, and sterilization, in addition to all the other required elements of a 510(k) identified in 21 CFR 807.87, starting on August 8, 2017."

"III. List of Certain Reusable Medical Devices and Design Features

The 21st Century Cures Act (section 3059) requires the Agency to identify and publish a list of reusable device types that are required to include “instructions for use” and “validation data” regarding cleaning, disinfection, and sterilization in 510(k) notifications. Accordingly, FDA is publishing the list in table 1 that identifies those reusable medical devices that FDA has determined pose a greater likelihood of microbial transmission and represent a high risk of infection (subclinical or clinical) if they are not adequately reprocessed.

FDA believes arthroscopes, laparoscopic instruments, and electrosurgical instruments, and their respective accessories with specific design features, identified in table 2, may pose a challenge to adequate reprocessing. 510(k) notifications for such devices that incorporate any of the design features listed in table 2 must include validated reprocessing instructions and reprocessing validation data reports, and if such are determined to be inadequate, FDA will find the device not substantially equivalent."

Looking forward to the markets gaining a bit of an understanding regarding the significance of this FDA move! I continue to buy TOS! GLTA!