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RE:Study Confirms 71% Scopes Contaminated: Need Sterilization!!

[dant2]

Thanks for your post Echo. I'm wondering if anyone participated in the AAMI WG83 meetings two weeks ago, and if so were there any recommendations / changes as a result?

Two weeks ago today - more or less right at the tail end of the AAMI meetings - the FDA hosted a training webinar specifically for duodenoscope screening. As we know from recent warning letters to duo manufacturers - they want screening done so they can establish appropriate benchmarks.

Anyway around 873 sites called in to the webinar and many with multiple attendee's all of which were responsible for duodenoscope reprocessing. So one could say it was well attended. 

While this screening if implemented properly, will improve patient safety it has a awful lot of holes and its quite costly to implement. Number one being the screening process itself.

Carefully following the FDA guidlines requires  two qualified people for each screening procedure, and if one person is in training they recommend a qualified person to over see the procedure because it is quite easy to make simple mistakes and either miss cultures or contaminate them.

An even bigger issue arose during the Q & A, and that was how often should we screen duo's for contamination. Here the FDA would not provide a recommendation and said its up to each health care institution to determine what is appropriate for their specific needs. A suggestion came from one of the participants who cited Australia's policy which was to remove duo's for screening  once per week and have them screened. If they were found to be contaminated it was recommended they be scheduled for sterilization.

The screening process itself negatively impacts duo scope availability because once cultured the scope must be taken out of circulation for minimum 48 hours (if found to be clean) and longer if needing sterilization. Basically the cultures are tested at 24 hrs, 48  hrs and 72 hrs.  Since it may take time for this contamination to grow it is most prudent to wait out the 72 hrs before concluding whether the scope can immediately go back into circulation or be scheduled for sterilization.

So its pretty easy to see that screening once per week can easily expose patients to risk if the scope  happens to become contaminated early in its weekly cycle.

This webinar is a followup to recommendations provided by the FDA I believe in August 2015 where the originally recommended sterilization via ETO for the Duo's.

Hopefully they will update their recommendations and specify the VP4 as the preferred sterilization method after the 510K comes in. And unfortunately we can see from the in field screening frequency that patients will still be exposed to risks until such time as sterilization becomes the standard practice after each procedure.

The webinar is posted on the FDA's website if anyone is interested.