AAMI News October 2018

The Challenges and Benefits of Moving toward Sterilization

For the September/October issue of AAMI’s journal, BI&T (Biomedical Instrumentation & Technology), AAMI Managing Editor Joe Sheffer held a roundtable discussion with three experts in sterile processing and disinfection:

  • Trabue Daley Bryans, president of BryKor LLC in Marietta, GA
  • Jenny Crnkovich, corporate assistant director and educator in the Department of Sterile Processing at NorthShore University HealthSystem in Evanston, IL., and an independent consultant
  • Betty McGinty, high-level disinfection safety/quality director at Northside Hospital in Atlanta, GA

This is an excerpt from the discussion. Look for the full article in BI&T.

Q AAMI WG84, the workgroup responsible for ANSI/AAMI ST91:2015, Flexible and semi-rigid endoscope processing in health care facilities, has been considering more stringent guidelines for processing endoscopes, moving away from high-level disinfection (HLD) and toward sterilization. What benefits could this change provide? What are some of the real-world challenges to implementation?

Betty McGintyBetty McGinty With my focus being on HLD, I have a huge vested interest in this. However, the benefit would be that sterilization would of course kill all of the microorganisms versus the survival of various levels of spores with HLD. The real-world challenges are related to the time and expense of sterilization, as well as the cost related to additional scopes and sterilizers with the correct capabilities. But even with all of those measures, the bottom line is that cleaning still may be inadequate. Of course, we all know we can’t sterilize or high-level disinfect an item has hasn’t already been cleaned appropriately. I’ve worked with scopes for most of my practice, and seeing all the challenges involved, I do think we’ll be moving toward either a disposable-type environment or to sterilization.

It’s also worth noting that patients often think that a sterilized endoscope is being used or that the scope has never been used on anyone else.

Jenny Crnkovich Betty, you make a really great point in addressing not only the increased number of scopes but also the cleaning challenges. To increase the quality of cleaning, the scope could be run through an automatic endoscope reprocessor after initial precleaning and cleaning versus solely relying on what sometimes is a completely manual process. That seems like a long and expensive process, but every year, if you can put in for capital and build up your capabilities and portfolio, it’s within reach. Basically, it’s a way to ensure that safety is increased, especially for difficult-to-clean scopes. Borescopes certainly help with visualizing lumens. In a future state, a recommendation that certain scopes are to be sterilized can be very beneficial.

Trabue Bryans They have some very, very small borescopes too, where you can really get down in the tiny lumens.

Betty McGinty I purchased one of those, and I use it in my quality assurance program. I look for moisture and damage in endoscopes following HLD. They are great diagnostic devices. Jenny Crnkovich WG84 may consider adding them as a requirement. Relying on the manual process is one thing, but when we have these tools, we should take it one step further for quality checks, like Betty is describing.

Trabue Bryans It definitely could be added, because manual visual inspection is already a step. Using borescopes for visual inspection could be an option for clinical places that can afford them. But also, for the reprocessing validation done at labs, you could add that as a requirement—actual observation as opposed to relying on subjective data.

Betty McGinty We already expect that for cleaning verification. Adenosine triphosphate (ATP) testing is expected to be done on every flexible scope at my organization before the devices make it out of the manual cleaning phase and into HLD. Scopes with high ATP are the ones that I target for visualization and additional testing.

Jenny Crnkovich This sheds light on potentially incorporating standards for the type of enzymatic solution effective enough to get the job done.

Betty McGinty There also are different schools of thought. Some say it should be a detergent without an enzymatic. Finding reliable information is difficult, and you can’t necessarily look to your IFUs [instructions for use] for help with enzymatic solutions. Some of them will simply say, “low foaming, low sudsing, easy to rinse, neutral pH”—information that isn’t sufficiently detailed.

Trabue Bryans Those terms could be quantitated and put in a requirement. It would be a matter of defining the terms, where “easy to rinse” means, for example, “The residuals rinse away with three rinses to a level of X.”