The Most Significant News FDA Has Ever Released re:TOS!!I have just come across an remarkable and beyond significant new regulation/law published by the FDA on June 9:
https://www.federalregister.gov/documents/2017/06/09/2017-12007/medical-devices-validated-instructions-for-use-and-validation-data-requirements-for-certain-reusable
"AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or Agency) has determined that it is necessary for manufacturers of certain reusable medical devices to include in their premarket notifications (510(k)s) instructions for use which have been validated and validation data regarding cleaning, disinfection, and sterilization, for which a substantial equivalence determination may be based. This notice includes a list of these reusable devices that will require validated instructions for use and validation data in their premarket notification. FDA is publishing this list in accordance with the requirements established by the 21st Century Cures Act. This action ensures that the premarket requirements for these device types are clear and predictable which facilitates more efficient review of these 510(k)s.
DATES:
These actions are effective on August 8, 2017."
Please refer to the link which show that this includes all of the relevant scopes in this industry, including duoenoscopes, colonoscopes, ureteroscopes, bronchoscopes....
"FDA expects specific required validation data regarding cleaning, disinfection, and sterilization to be included in 510(k) submissions for certain reusable medical device types as outlined..." "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."
AND INCLUDED IN THE RELEVANT TABLE IS REFERENCE THAT THIS LAW APPLIES TO : "Gastroenterology and Urology Endoscopes that have elevator channels (not including accessories) [e.g., duodenoscopes used for endoscopic retrograde cholangiopancreatography (ERCP)]" The upshot, here, is that, as of August 2017 the FDA WILL ONLY APPROVE A 510K FROM A SCOPE MANUFACTURER IF THEY CAN SHOW THAT THEIR NEW OR MODIFIED SCOPE CAN BE STERILIZED.
NOW, PLEASE BE AWARE THAT THERE IS ONLY ONE LOW TEMPERATURE STERILIZER IN THE MARKET THAT CAN STERILIZE THESE SCOPES, THE VP4 MADE ONLY BY TSO3!!! (the relatively obsolete and extremely inefficent one cycle per day ETO sterilzer excepted).
Couple this remarkable news the TSO3's paper waiting for publication in the Canadian Journal of Infection Control regarding TSO3's singular validation technique and process for a peer reviewed technology for all of these scopes including duodenoscopes that definitiely shows TSO3 is the only FDA reviewed (with 510K for bronchoscopes, ureteroscopes, colonoscopes and gastroscopes and with submission soon to be completed for duodenoscopes) and
PICK YOURSELF BACK UP OFF THE FLOOR!!! THIS IS THE SIGNIFICANT NEWS WE HAD HOPED MIGHT START TO COME FROM THE FDA IN 2018. IT IS HERE NOW. What this means is that all all manufacturers of new or modified scopes applying for 510Ks for their devices with FDA (Olympus is rumoured to be working on new 190 series update to the 180 series, for example!!) must be sterilizable and show data proving this as part of the 510K, AND TSO3'S VP4 IS THE ONLY PRACTICAL AND EFFICIENT STERILIZER IN THE MARKET THAT CAN VALIDATE THESE 510K'S. The FDA will not give the 'substantially equivalent' designation for approval for a scope as of August unless that scope can be shown as part of the submission to the FDA to be sterilized (BY ONLY THE VP4 MADE BY TSO3, FOR ALL INTENTS AND PURPOSES!!)
THIS, MY FRIENDS, IS NEWS!!!!!!
THIS IS THE BIG NEWS WE HAVE BEEN WAITING FOR!!!
SOME HAVE WONDERED HOW LONG IT WILL TAKE THE FDA TO TURN AROUND TSO3'S SUBMISSION IN JULY FOR THE OLYMPUS AND PENTAX SCOPES?? HOW ABOUT BY AUGUST 7, 2017!!??
ALL HOSPITALS, GI SUITES, OR HEALTH CARE PROVIDERS WILL BE OBLIGED TO RECOGNIZE THE NECESSITY OF HAVING A VP4 (OR 2 OR 6 OF THEM) IN THEIR FACILITY TO STERILIZE SCOPES FROM AUGUST ONWARD. (This makes changes to the Spaulding Classification for the relevant scopes a fait accomplie, a done deal!!!)
DO YOU UNDERSTAND THE SIGNIFICANCE OF THIS FDA LAW???
WOW.
PLEASE SPREAD THIS NEWS!!!!!