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TS03 Inc Trust Units TSTIF



GREY:TSTIF - Post by User

Post by echo2on Jan 08, 2019 4:11pm
311 Views
Post# 29202418

AAMI Update from Today...

AAMI Update from Today...

Some people might be interested in the progress being made today by the working group on scope sterilization at AAMI. Today, they were working through some of the latter aspects of the draft of the new AAMI Standards for Endoscope Reprocessing relating to storage, drying, etc.. 

 

Things that I have gleaned, are, IMHO, very TSO3 and VP4 friendly!!!

 

To begin, the committee discussed edits to their previous public draft 2 last year and are now amending draft 3. But, they don’t appear to have made substantial changes to these most important draft 2 recommendation wordings during their Fall 2018 meetings that were private, though this wording has not been yet confirmed. 

 

These sentences from draft 2 are of particular interest and importance to TSO3:

“With the infection risk that endoscopes present to the patient, terminal sterilization is the preferred method of microbial inactivation and the only option in sterile environments. Sterilization continues to be recommended for endoscopes. Those that enter sterile body cavities or tissues should be terminally sterilized. Terminal sterilization is recommended for endoscopes that are intended for critical procedures (e.g., bronchoscopes, cystoscopes, ureteroscopes, choledochoscopes, laparoscopes, hysteroscopes, nephroscopes, mediastinoscopes, thoracoscopes, duodenoscopes). Terminal sterilization is required for all endoscope accessories that penetrate mucosa, such as biopsy forceps, sphincterotomes, etc. Most flexible endoscopes require low temperature s t e r i l i z a t i o n . Compatibility with low temperature processes varies with endoscope make and model and can include ethylene oxide (EO), hydrogen peroxide (HP) with or without plasma phase, and hydrogen peroxide ozone (HP-ozone) sterilization systems, based on validated efficacy and compatibility testing by the endoscope and/or sterilizer manufacturer and recommendation in the written IFU or official documentation. Steam sterilization is often not compatible with flexible and semi-rigid endoscopes, but should be used when the endoscope manufacturer’s written IFU provides steam reprocessing information showing compatibility with steam processes.”

 

In other words, terminal sterilization for ERCP scopes and many others including those listed above will be recommended in the next draft (no timeline for implementation mentioned to my knowledge). And, this recommendation does not state ‘where available’ as it previously did. 

 

So end users will be acquiring the technology to meet these new standards.

 

And, the VP4 is the best in class and the only LTS system that can with FDA approval terminally sterilize duodenoscopes (and some other complex gastroscopes and colonoscopes, for example).

 

There was no question of support for sterilization on the new standards, so much so that even some members questioned the discussion of solutions to storage of non-sterile scopes. This is because if a scope is terminally sterilized storing it in a cabinet is irrelevant: the scope will be sterile wrapped and ready for use in an hour, a day or a month. The storage cupboard becomes obsolete. However, facilities will now each have to have a sterile storage area instead for terminally sterilized scopes. The goal posts are being moved. In TSO3’s favour!

 

2) IFU or validation of sterilization documentation from TSO3 for particular scopes will be accepted by industry and thus the Joint Commission or other certifying bodies, and end users will not have to wait for cooperation of OEM’s to slowly redo their IFU’s for terminal sterilization

 

3) The committee voted to support mandatory drying of 10 minutes for all scopes following each use before the next patient.

 

What this means is that drying following cleaning or reprocessing for 10 minutes is now to be a standard going forward, so no one will now complain that they have to dry before a scope goes into a VP4 to be sterilized. (H2O2 processed scopes must be dried before being sterilized to avoid the possibility of H2O2 reacting with the water.) For the VP4, a scope is cleaned and then dried and then sterilized. Done. No HLD delay.

 

4) One interesting discussion involved JNJ tried to get the committee to reference liquid chemical sterilization (with peracitic acid) as having some equivalence to SAL spore kill sterilization standards that all terminal sterilizers must meet, and the committee soundly denied JNJ’s revision to the document to allow this because no liquid chemical sterilization process is recognized by FDA as having valid measurable SAL score or data. This indicates A) as I have believed and stated here indeed JNJ/ASP is about to release an HLD system using peracetic acid just like the Steris 1e and Cantel’s new offering, (or, why else would they want this change to the document as they don’t presently make a liquid chemical ‘sterilizer’). and B) I think JNJ/ASP rep wanted to muddy the waters about the designation of these peracetic acid systems as being ‘sterilizers’, as part of their promotion of their new product, BUT the committee definitely will keep the designation of a terminal sterilizer such as the VP4 or ETO as being very different and superior from a liquid HLD (or ‘liquid sterilizer’) process that does not meet the FDA’s basic definitions of sterilization.
 

The group is close to proposing a ‘committee draft’ that will be presented to the public for input and comments. So, we will likely see a WD-4 for the next AAMI meeting in March for 2 days, or for even another extra day meeting in late February or early March. But, they are hoping to have the document public for 45 days of public input in some months (possibly in October or earlier) with a committee draft for a vote in the Fall and published publicly for end users, etc. by end of 2019.

 

 

 

Hope you find this information and MHO’s useful.

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