RE:More news - Olympus in a world of trouble likelyAgain, it is great that you have posted this important information! Thanks! The link to Olympus's letter to all facilities possessing this scope is
https://medical.olympusamerica.com/sites/us/files/pdf/160118-Olympus-TJF-Q180V-Customer-Letter.pdf?utm_source=PR_Newswire&utm_medium=press_release&utm_campaign=TJFQ180V
At least Olympus appears to have been working with the FDA to mitigate the issues surrounding contamination of patients by obtaining a 510k for the TJF-Q180V scope with a new modified forceps elevator mechanism, recalling all these scopes for modification with this new modified forceps elevator mechanism, requesting yearly return of the scopes to Olympus for inspection and repairs if needed, and clarifying their high level disinfection processes.
Olympus's past problems due to apparently not being forthcoming with relevant information to the FDA, health care providers, and the public about the contamination problems and risks of use of their scope are medical-legal issues that will no doubt continue, however.
Importantly, we do not see any data or statement from the FDA that reprocessing is any more effective now than it was last year when experts noted that reprocessing was inadequate to completely eliminate contamination problems.
This news does not make the ability of the VP4 to terminally sterilize the Olympus scope any less important or relevant to ongoing patient care and safety. The news is, if anything, another positive for TSO3 because the modified scope will remain the number one scope used in ERCP's, (presently 85% of the market), and the VP4 is the only low temperature sterilzer with the claim (in Canada only so far) to be able to sterilize this scope. And, the reprocessing procedures remain complicated, and not as simple as using the user friendly VP4 to terminally sterilize the scope and eliminate the contamination risk using this revolutionary technology.
Note that the press releases do refer to the outdated use of ETO sterilzers; but, as has been noted repeatedly, there is no public data regarding implied claims of ETO sterilzers to actually sterilize the TJF-Q180V scopes, (i.e., does this process actually work for these scopes?), and these old sterilizers are incredibly inefficient (12 hr + cycle time), use very toxic materials, and are not widely available in most hospitals.
We can only look forward to the market's and the FDA's consideration of the VP4 as a far more efficient, cost effective, and practical solution to this ongoing scope contamination problem and await the FDA's specific (for the TJF-Q180V, for example) and general recommendations for the use of low temperature sterilization protocols going forward.
GLTA WKH