Further FDA and Other Links, and TSO3's Bright Future...To add to lematou’s posts, for those interested in a reasonable summary of Olympus’s scope problems, check out this recent link to QMed with a timeline of their problems:
https://www.qmed.com/news/how-olympus-scope-problems-got-so-unbelievably-bad I thought I would also suggest a couple of links to the FDA's websites that relate to scopes, particularly duodenoscopes, and reprocessors.
This first gives a summary (updated March 15, 2016) by the FDA regarding scopes and the contamination problems:
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ReprocessingofReusableMedicalDevices/ucm454630.htm
This second link (updated February 23, 2016) describes some of the FDA's positions regarding the reprocessors used to do high level disinfection of scopes.
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ReprocessingofReusableMedicalDevices/ucm483896.htm
Note that the FDA removed ETO as a valid sterilization procedure for the Pentax duodenoscopes. The FDA is still considering the application by Fuji for 510(k) approval of their main scope, (as it was previously modified without FDA approval).
Also note that while the FDA has recently validated the guidelines or instructions for Olympus, Pentax, and Fuji duodenoscopes, Olympus's reprocessor is not one of the only two reprocessor systems that has "completed the updated high level disinfection or liquid chemical sterilization validation testing with duodenoscopes". In other words, while the new cleaning and reprocessing instructions are validated with more complex and lengthy protocols, the FDA has not yet determined whether the other three major unapproved reprocessors can actually achieve the high level of disinfection that the FDA deems necessary. Will they ever achieve this?
Of course, I expect that with the new cleaning instructions and protocols the VP4’s efficacy to sterilize will only be improved. The two approved reprocessor systems use liquid peracetic acid to disinfect a duodenoscope and, then, it is my understanding is the scope is rinsed in decontaminated but not sterile water before it must be immediately used, (i.e., the scope is not terminally sterilized, though almost, and it cannot be left in temporary storage before it is used on a patient without being reprocessed.) To be clear, these peracetic acid reprocessors are good and might provide targeted limited solutions for some health care providers, but these systems are not capable of the terminal sterilization that TSO3’s H2O2 + Ozone (Sterizone) technology achieves for a much broader range of scopes with an effective, much larger capacity, more efficient, and more cost effective system.
Of course, duodenoscopes are not the only source of FDA concern. Many will have seen and recall their statement from September regarding bronchoscopes, for example.
https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm462949.htm And, note that, I believe, TSO3 has validated claims in Canada, and probably in Europe, to terminally sterilize the relevant bronchoscopes and solve these problem, too.
With the previous expressed intents of the FDA and health care leaders to move toward treating the use of scopes, including duodenoscopes, brochoscopes, and colonoscopes, as critical and not just semi-critical according to the Spaulding Classification (thus requiring terminal sterilization), one can only hope for the benefit of patients and the public that it will not be long, (?H1 2016 ?3rd quarter 2016) before the FDA adds a new category for TSO3's VP4 to this list referred to above and other lists (achieving not just ‘adequate’ high level disinfection, but definitive terminal sterilization of these scopes)! I might be reading between the lines, but it is great to see in their recent press release that TSO3 is establishing their protocol for a routine trusted extended claims approval process with the FDA for each group of scopes, or even each particular scope design, one at a time. As I have stated, patience is needed: progress is being made!
I am looking forward to Mr. Rumble’s conference call this Wednesday, where he will no doubt shed further light upon the incredibly exciting progress TSO3 is making in establishing the VP4 as the new standard of care in the low temperature industry.
WKH
P.S.,
The shorts are toast. :)