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Dichotomy: If It’s Not One Thing, It Must Be the Other

“When you come to a fork in the road, take it.”—Yogi Berra

“I know what you’re thinking: ‘Did he fire six shots or only five?’ Well, to tell you the truth, in all this excitement, I’ve kinda lost track myself…you’ve got to ask yourself one question: ‘Do I feel lucky?’ Well, do you, punk?”—Dirty Harry

di·chot·o·my /dīˈkädəmē/ n.      a division or contrast between two things that are or are represented as being opposed or entirely different.1

So, it’s one or the other. Never both. And one choice is going to be a lot better than the other.

I am an avid reader of the AAMI Members Discussion Group digest, the LinkedIn Sterile Processing Department Professionals group, and the Facebook Sterile Processing Professionals group. I read these postings because I want to learn new things (new to me) and to (hopefully) make useful suggestions when I can. One thing I see in common in these groups is people looking for answers to help them make a decision; to choose the best solution to an issue where the two choices could very well be called a dichotomy.

Here are a few examples from real-life observations, where the difference between the two alternatives is enormous and telling.

Is it or is it not sterile?
That’s a thorny question. The only sure way to know is to take everything in the load and culture it for 21 days in growth media at 37°C (98.6°F). Not useful for department throughput. So, we use indicators, we check the cycle tapes, we run test packs, we run leak tests, and for prevacuum steam, we run a Bowie-Dick test (DART, for those of you who only speak Steris). Here are some examples of questions that have arisen:

  • The tape/container lock spot changed color but the internal indicators failed. Is it sterile?
  • The cycle failed but the indicators passed. Is it sterile?
  • The BI passed but the integrator failed. Is it sterile?

The answer is three resounding “absolutely nots.”

All conditions and monitors must show process success. If the process monitors (indicators) weren’t needed, they wouldn’t be used unless your department has too much money in the budget.

The dichotomy here is whether the item can be shown to be sterile or did the process monitoring show a failure in one way or another?

Is it clean?
This is another thorny question. Cleaning is a complex process for even simple instruments that starts at point of use and requires attention to the needs of each instrument’s design features. And I don’t want to hear any five-second rule nonsense. If you can’t get the item off the floor in five nanoseconds (that’s five billionths of a second, 0.000000005 seconds), it goes back through the passthrough.

  • The load went through the washer. Inside the container. With the lid on. And the filters weren’t removed. Is it clean?
  • I’m running these cleaning indicators. All the red comes off, but there’s this crinkly yellow stuff left. Is the washer cleaning properly?
  • I have a bunch of take-apart rongeurs. I ran them through the full manual precleaning process, the ultrasonic, and the washer-disinfector without dismantling them. Are they clean?

Again, no.

It doesn’t take a complex instrument to cause a healthcare-acquired infection (HAI). It takes one that hasn’t been cleaned properly. Residual soil, even if it is only not removed from the knurling of a handheld instrument (for example) will shield pathogens from sterilization and, of course, the soil flakes off into the patient causing an HAI. Which can be a mild infection or deadly, as we learned from the carbapenum-resistant Enterobacteriaceae (CRE) events associated with duodenoscopes.

How do you choose the right part of the dichotomy? You pay attention to detail. You make sure that the process of returning an instrument to use for the next patient is done.

  1. Starting at the point of use with precleaning and treating with a moisture-retaining product (foam, spray, humidification pack, etc.).
  2. Continuing through decontam,
    1. where you MUST soak at the right temperature for the right amount of time in the right detergent;
    2. (please) sonicate unless the IFUs say not to;
    3. run the device through the washer-disinfector (unless the instrument IFUs say not to) that you have tested and the indicators are so clean that you could and would eat off of them.
  3. On the clean side,
    1. the instruments are inspected for residual soil with a magnifier for the outside and a borescope for the inside (if there is an inside) and there isn’t any;
    2. sterilize in a sterilizer that has been shown to be working properly before you run the cycle, and all indicators and monitors show that the cycle was run correctly; and
    3. you store the item in a way that there is no compromise of the sterile barrier.

It’s a complex process that takes a systematic approach to ensure success, which is defined as patient safety. There should be only one dichotomy; should I or should I not allow this instrument to be used on the patient? Shortcuts lead to “no,” proper procedure leads to “yes.”

References

  1. “Dichotomy.” Google. Wed. 26 Feb. 2020.

Dr. Jonathan Wilder has worked with all thermal and chemical sterilization methods, as well as cleaning and disinfection methodologies, bringing his background in physical chemistry and surface physics to bear upon difficult problems in the field. He has been an active participant in U.S. and international standards development since 1998 through AAMI. As of January 2018, he is the cochair of the U.S. standards-making committee for hospital steam sterilizers.

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