RE:NEWS?Here's another take I got from a well known american consultant who doe not want to be named at this point as he he intends to write a more developed paper.
Thanks for your email.
Yes, I have read and studied the Federal Register document.
It could be that, moving forward, the current disinfection procedures will
be questioned, but not rescinded, per se.
Rather, sterilization will be favored whenever feasible. But that has been
the standard for years: high-level disinfect those types of critical and
semi-critical devices that cannot be sterilized. Moving from sterilization
to disinfection, while an option, will be costly for hospitals (who would
then be expected to purchase the new sterilization technoliges),
and it can
be reasonably argued that the true focus should instead be re-directed onto
emphasizing the proper validation of the reusable device's design to ensure
its reprocessing instructions are effective. Reusable semi-critical devices for which high-level disinfection fails will
typically (if not always) feature a device design flaw, and while
sterilization might "account" for or "overcome" this design flaw, it would
not correct or fix the flaw. (my bold) The point made here applies to the VP4. I won't go through the many indications we are getting through the litterature, Here's only one recent example from the the AJIC where one find in the highlights
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Endoscopes accumulated contamination, visible damage, and debris over time.
- •
Examination of internal components detected damage or fluid inside every endoscope. (my bold)
- •
Routine cleaning verification tests identified endoscopes requiring re-reprocessing.
- •
Microbial culture incubation >48 hours fostered growth and pathogen identification.
•
in https://www.ajicjournal.org/article/S0196-6553(16)30970-1/fulltext
These suggest that the disinfection-sterilization procedures themselves might contribute in the wearing-down of the scopes and from there to the difficulty in cleaning them.
In case someone doubts that it is the case with the use of the VP4, check the compatibility matrix of the VP4 on the Tso3 web site. There is nothing in the american version as the VP4 has not been cleared yet for the duodenoscopes but in the canadian section, one will find this notice associated with both the Pentax and Olympus duodenoscopes
LIMITATIONS ON REPROCESSING:
Processing of this device in the STERIZONE® VP4 Sterilizer may eventually affect the frequency of maintenance of this instrument No wonder Tso3 will soon file joint applications with the FDA. Eventhough it took a lot of time and it got many on this board to lose their marbles.
Could it be that RR and his team know better than (file in your handle name here....).