TS03 Inc Trust Units TSTIF

RE:RE:RE:AAMI standard week

[echo2]

TSO3 was formally represented chiefly by Jean-Luc Lemyre, Director of Science Development, at the important AAMI meetings last week, it appears, in addition to others. Getinge also had numerous representatives at the tables. The most important table was Working Group 84 which "is hard at work on a revision of ANSI/AAMI ST91, Flexible and semi-rigid endoscope processing in health care facilities, with a new draft anticipated by March 2018", (according to the AAMI PR from last week). Regarding WD-1 ST91 WG84 had received 322 comments to go through, (an enormous number), so the agenda over two days was packed and the attendance was huge.

The important notes/quotes that I take away from the minutes (publically available today) are as follows: (Bold emphasis is mine)

Referring to the September meeting where a move toward sterilzation was endorsed, "Mary Ann gave a summary of the endoscope stakeholders meeting presentations and discussions. The AAMI news article may have given the impression that a decision was made during that meeting to move all endoscopes to sterilization immediately, and that's not correct. It was clarified that the consensus of the group was that endoscope processing needs to move that way. However, it is up to WG84 to decide how or if to implement those recommendations."

"Janet Prust provided the clarification that classification of a device as a critical device depends on how it is used. This working group has been called upon to have the courage to step up and put out strong guidelines. AAMI has gathered a consensus group, which makes it ideal for developing the "one" standard.

"Group was reminded that this document is an American National Standard, and that there is no specified charge to look at what's being done internationally."

"A suggestion was raised for the working group to form a task group to write a new classification system and perhaps add it as an annex to ST91. Nancy suggested contacting the CDC to get involved in that. Janet commented that HICPAC seems to be focused on other things right now, and the previous HICPAC task group was comprised of a lot of this working group's members. It was noted that this group would be writing a clarification of what we mean by Spaulding and how that affects how these devices are processed.

There is a recognized need to bring everyone together to work on this, and many of the stakeholders were at the September 11th meeting. A suggestion was raised for this group to work on recommendations as a first step, and call another stakeholder's group meeting. One possible approach is group to take a position of clarifying how to classify in the scopes and then how to process them accordingly. Seth reminded the group that originally endoscopes were to be sterilized and people have lost sight of that. "

"The consensus of WG 84 members present was to write a clarification of the Spaulding classification, and to make a recommendation to sterilize endoscopes that enter sterile tissues and are compatible with sterilization."

"The group circled back to discussion of high-level disinfection versus sterilization of endoscopes. There was overwhelming agreement in the room that processing of endoscopes needs to move towards sterilization. The question is how to move the guidance that way."

"There will need to be an interm meeting prior to the next sterilization standards week, perhaps in early December at AAMI Standards Week in Redondo, California or in January perhaps at or near AAMI. AAMI will look into options and get back to the group." 

In other words, the group, with input coming from at least the CDC and a repeat meeting of WG84, recognizes that any use of a scope that breaches mucous membranes for biopsy, treatment, or surgery, for example, must be sterile, as any procedure in sterile tissues under the skin, snipping through the mucous membranes of the bowel with a colonoscope, through the epithelium of the bile duct as with a duodenoscope, penetrating in the surface of the bladder, prostate, or ureters with a cystoscope, or the bronchial epithelium with a bronchoscope, for example, are categorically defined as being sterile procedures.

And, this means reclassifying any scope used for these sterile procedures to the Critical category under Spaulding which must therefor be sterilized, not just HLD processed.

You can absolutely bet that others at the table, including Steris, JNJ, Cantel - makers of Medivators washer- , will do their very best to drag out the process as the have no sterilization solutions, as TSO3 does with the VP4!

But, at least we can see a timeline developing with another December meeting of stakeholders including FDA and preparation of a draft anticipated for the March 2018 meeting! This is enormous progress by a large group with diverse vested interests. A draft for the March 2018 meeting would definitely exceed my expectations of last year, without a doubt; but, then, I was as surprised as everyone else when the FDA introduced their new rule for sterilization of new scopes applying in the future for a premarket approval or 510k after this past August!

In the meantime, TSO3 should have submitted their data on duodenoscopes to the FDA and the ball will be in the FDA's hands to have approval of this game changing technology complete prior to presentation of the draft document to the group and the public at the next Sterilization Standards Week in March 2018!

The 'Critical' importance (pun intended) of this process cannot be underestimated in terms of its implications for TSO3! 3M with their old toxic and completely inefficient 24 hour cycle ETO technology is no competition for the VP4. Getinge may have been slow getting out of the gate in terms of getting sales and installs done over the past year, but this does nothing to detract from the incredible blue sky potential of this company! This is all tremendously positive!

https://standards.aami.org/higherlogic/ws/public/download/13080/STN202.pdf