Scope Cleaning is Important but Grossly InadequateAnother paper in a long list has just been published 'in press' on the AJIC website.
The study, which examined each of 45 endoscopes once only (mostly gastroscopes and some duodenoscopes) at two high volume institutions for a total of ?87 exams, 30 in storage following presumed previous HLD at some time in the past, 28 immediately following diligent and well performed manual cleaning, and 29 immediately post HLD processing, found positive cultures at 48 hours and gram -'ve quick testing on conrols and in channels in 66-100% of well cleaned, 3-7% immediatel post HLD treatment, and 7-63% of stored scopes. ATP testing (though and used by some to verify proper cleaning and disinfection) as well as protein testing in these two spots on the scopes was grossly unreliable and not correlated to cultures, with ATP testing very unreliable at one institution (0-3% for all groups and only one positive was post HLD) and otherwize 70%, 40% (post HLD) and 30% ATP positive and 10-63% protein +'ve, again with poor correlation to other tests.
Bottom line, while a amall but vocal minority at AAMI tried to argue (in their own interests as they don't want to reduce their income and throughput nor to spend to purchase a new VP4 sterilizer) that the contamination issues, particularly for gastroscopes, have been 'solved' or 'mitigated' due to adherence to better cleaning protocols, studies like this one seriously call into question the integrity and validity of such claims. Gastroscopes remain contaminated (66-100% at least) post cleaning. And, we also know that cultures of scopes are notoriously unreliable due to false negatives (i.e., the bacteria are there but the tester and the culture just failed to detect them adequately). (We all know cleaning is essential for duodenoscopes, too, but no ethical scientist will argue in the patients' interests these endoscopes are not contaminated even post HLD processing on top of cleaning and therefor must be terminally sterilized, and no one at AMMI suggested duodenscopes need not be terminally sterilized).
Add gastroscopes the list of endoscopes that should be terminally sterilized with a recommendation for this, in addition to duodenoscopes, bronchoscopes, ureterorscopes, cystoscopes...?colonoscopes?) soon to be written by conscientious and reliable experts at the AAMI table. Implementation date 2019?
How many gastroscopies are being done in N. America annually?
These numbers and the cycles needed to process them are staggering, in addition to all of the other endoscopes needing terminal sterilization, and we will soon see a mushrooming of demand for terminal sterilzation that will fundamentally change the delivery of this aspect of health care, and will place TSO3 as the unrivalled 'go to' leader in low temperature sterilization. And, some wonder why TSO3 needs to plan building the new assembly facility in Myrtle Beach?
Again, I just hope we aren't bought out for $5 before this market wakes up and gives its head a shake.
Assessment of test methods for evaluating effectiveness of cleaning flexible endoscopes
https://www.ajicjournal.org/article/S0196-6553(17)31259-2/fulltext