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Reusables vs. single-use: The next round in the World Series of Risk Assessments?

As summer starts its (hopefully) gradual fade into the record books and the marathon of the baseball season starts its kick to the finish line, it seems that we are (yet again) faced with some guidance from the federales that I think will be best served by having a risk assessment in your back pocket.

Over the past few years (truly, more than a few, but we can focus on the most recent past), there has been a lot of scrutiny regarding the management of endoscopes, including how much of a role clinical engineering might play in managing the scopes as devices, how to ensure effective processing of the scopes once they have been used, etc. And just the other day, I encountered an article discussing the FDA’s recommendation to begin transitioning to scopes with disposable parts, nominally to ensure the efficacy of the post-use processing process (don’t you just love a processing process!). You can find the meat and potatoes of the FDA’s recommendation here. I’d encourage you to read this very carefully as there is mention of process elements, such as the use of adenosine triphosphate (ATP) test strips to assess scope cleaning—a use that is not currently sanctioned by FDA—to the point that the FDA is asking facilities not to rely on the ATP test strips to assess scope cleaning. There’s some other stuff that is worth consideration, so (again), please check it out.

The recommendation does indicate (and, to a certain extent, provides for) a period of transition to the disposable scopes, but now that the proverbial horse is out of the barn, I think it is only a matter of time before our friends in the various accreditation organizations start digging into the transition process as a function of patient safety (I don’t think there’s any among us that would dispute this as a patient safety concern), particularly as to how we are keeping folks safe during the transition period. And how do we typically provide evidence of the process for mitigating risks? Why, it’s our old(er) friend the risk assessment process. I think it is crystal clear that this serves as yet another example of the collaborative process between infection control, clinical engineering, perioperative services—and I encourage you to make good use of the risk assessment process. Even more so, if you are scheduled for an accreditation survey any time in the next 12-18 months (until the use of single-use scope technology is more pervasive), I would get this on your to-do schedule as soon as possible. As with so many things, you may have lots of data to support that your existing procedures, etc., are not putting anyone at risk, but (as these things tend to devolve) we’ve already seen how a really (and I mean really, really) small incidence rate (that of risk de ligature) drive a veritable cornucopia of significantly painful survey findings. And there’s every reason to include this in the list of contenders for the next heavy duty survey focus area.