TS03 Inc Trust Units TSTIF

RE:RE:RE:$$$$

[echo2]

The FDA document avoids the critical vs. semi-critical issue (leaving this to be solved at a later date, presumably) and instead states speciifcally that the new law/regulation applies to "Bronchoscopes, flexiible or rigid", 'ENT scopes and accessories" rigid and flexible, including esophagoscopes, "Gastroenterology and Urology Endoscopes that have elevator channels (not including accessories) [e.g., duodenoscopes used for endoscopic retrograde cholangiopancreatography (ERCP)]" as well as "Other Flexible Gastroenterology and Urology Endoscopes 1" such as gastroscopes, ureteroscopes, cystoscopes, etc. and "1: For endoscopes that fall under these product codes, 510(k) submissions must include reprocessing validation data for those endoscopes which are flexible." Thus, all bronchoscopes and ENT scopes are subject to the regulation, and the important factor for other scopes appears to be whether there is an elevator mechanism (as needed for performing a biopsy) or if the scope is flexible (not rigid only as for some sigmoidoscopes and coloscopes that have limited uses). 

It is also particularly interesting to note in the FDA document, that reprocessing instructions and data (for cleaning, disinfection, and sterilization) are required for "Automated Reprocessors for Reusable Devices" intended for and including "Accessories, cleaning, for endoscopes", "High level disinfection reprocessing instrument for ultrasonic transducers, mist" and "liquid", AND "washer, cleaner, automated, endoscope". I am not a legal expert, but it would appear that the FDA is asking that any new HLD washer or reprocessor prove as part of any new 510K for any new washer that they can be sterilized. Of course, with all the data having been published and no doubt far more that has not been made public showing the inability of these HLD washers to actually adequately decontaminate scopes, and data that even new scopes put through a clean but used washer frequently in fact come out contaminated, it is evident that these HLD washers cannot sterilize themselves. Does this mean that they will de facto no longer be given premarket 510k approval by the FDA unless they can solve their persistent contamination issues?