Infection Prevention

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Is Anything That Goes Below the Waist Non-Sterile?


Q I was taught that anything below the waist in the OR is non-sterile. Shouldn't the doctor in this photo keep his hands up as he dons his sterile gown?

A You are right: Anything that goes below waist-level is considered non-sterile according to the age-old standard of practices for OR procedures. Many rules are part of the standards for good reasons, but few have scientific evidence to support them - and this is a prime example.

I have consistently recommended that common sense replace some of these practices, particularly when the practice interferes with improving technique or process and/or puts the patient at risk. For example, can you place a non-sterile instrument set in the sterile field without contaminating the entire sterile field? If it quickly, safely and logically gets instruments where they are needed, yes you can. After all, the "bugs" do not crawl or fly from the non-sterile tray to the rest of the sterile field.

If the sterile nurse brushes against the back of the surgeon and she consequently has to change, causing a delay in a time-sensitive procedure, that is wrong because it puts the patient at risk. And besides, the back of the gown is no more non-sterile than the front.

Do you really believe that the surgical drape is sterile down to 6 inches or 8 inches - or any other arbitrary dividing line - and non-sterile below that line? And do you really believe that the surgeon pictured is now non-sterile simply because his hands went below the waist? If a 7-foot surgeon were operating, all the scrub nurses would have to hold their hands above their shoulders to stay "sterile."

This example is not intended to disrespect a well-intentioned and rigidly practiced and taught standard in the OR; rules must be followed so that OR personnel do net get too casual about the risks of infecting patients. The problem is that the rules that determine what is sterile, when defined by arbitrary measurements, don't always pass scientific or even common-sense scrutiny.

The technique illustrated in the picture to the left is perfectly safe as long as the doctor doesn't touch anything. Unfortunately, it violates one of these sacred rules. In a real situation, would you break down the case and have everyone re-garb? I hope not.

I should add that nothing in the picture is sterile in the absolute sense of the word. As soon as sterile gowns are removed from their protective package, they are subject to contamination from the environment. Remember that there is no such thing as a "sterile environment" unless it is under filtered laminar flow conditions.

Q What type of tray is best for use in a steam gravity sterilizer?

A I recommend mesh-bottom trays when you are using gravity sterilization simply because they do not provide places where air can be trapped. Remember, air is forced out of the sterilizer's chamber by the downward-displacement action of the steam (the "gravity"). Trays with holes are also acceptable, as long as you follow the manufacturer's guidelines for time at temperature.

Q Where in our hand-hygiene regimen should we incorporate alcohol-based rubs?

A Studies indicate that a two-stage surgical scrub comprised of using an antiseptic detergent followed by an application of an alcohol-based rub is effective.

Always apply the alcohol-based rub according to manufacturer's instructions (usually, this means rubbing hands together until they are dry). Studies show that formulations containing 60 percent to 95 percent alcohol alone - or 50 percent to 95 percent alcohol when combined with limited amounts of a quarternary ammonium compound, hexachlorophene or chlorhexidine gluconate - lower bacterial counts on the skin almost immediately. Although alcohols are not considered to have persistent antimicrobial activity, bacteria appear to reproduce slowly on the hands after a surgical scrub with alcohol, and bacterial counts on hands after wearing gloves for one to three hours seldom exceed pre-scrub values. The next most active agents (in decreasing order) are chlorhexidine gluconate, iodophors, triclosan and plain soap.

So, for example, you could use an initial one- to two-minute surgical scrub with 45 chlorhexidine gluconate or povidone-iodine followed by an application of an alcohol-based product. It's as effective as a five-minute scrub with an antiseptic detergent and will maintain its effectiveness for a longer period of time. Less time and more effective - hard to beat.

A Primer on Parametric Release

QWhat is parametric release?

AWhen products are sterilized in their final containers and are released without having been exposed to a sterility test, they've been parametrically released. Validating the manufacturing process is essential for parametric release (PR), because assurance that the product being released is of the quality intended is based on information collected during the manufacturing process. Many facilities test with chemical and biological indicators (which are often a waste of money the way they're used), then over-sterilize to compensate.

QHow do I implement parametric release?

AWork with your sterilizer manufacturer to set up the testing process at your facility, which involves testing each variable of the sterilization process for each load in the sterilizer. Here are four steps to implementing PR.

  • Pre-process. Upon installation, run the sterilizer to demonstrate that all automatic cycles run as specified. Document that the sterilizer does this, and that it has been properly installed.
  • Installation qualification (IQ). Confirm that the equipment meets specifications regarding air removal, temperature distribution and instrument accuracy. Evaluate the steam supply system for steam saturation, quality and purity by testing in an empty sterilizer chamber. Document every step and record results (more than 90 percent of sterilizer problems arise from poor steam quality). You now have your initial parameters.
  • Operational qualification (OQ). Confirm that the sterilizer sterilizes products you routinely put in it. Measure again the same parameters you measured during IQ, plus conditions within the products/packs. Profile and record temperatures of individual packs throughout the exposure period and from point to point within the load. Small loads are more difficult to sterilize than full loads, so be sure to include typical small loads as part of the OQ. The manufacturer should furnish you with the temperature probes. Insert these probes at the point where it is most difficult for steam to reach each pack.
  • Performance qualification (PQ). This step includes the people, items and practices that will routinely be used. Monitor at many points (not each pack) in the chamber and in the toughest-to-sterilize items in the load. Data should demonstrate that temperature measurements in packs and chamber points are known and within specified tolerances for each load profile. When three consecutive cycles are replicated, the steam sterilization process will be validated for PR.

- Dan Mayworm

Q What hand-hygiene practices are effective against spore-forming bacteria? Are alcohol-based gels, foams and rubs good for this purpose?

A Some healthcare facilities have reported increases in diarrhea caused by Clostridium difficile that seem to coincide with the implementation of alcohol-based handwashes into hand-hygiene routines. Though not positively identified as a cause of this increase, the use of rubs may contribute to a false sense of security regarding the elimination of spore-forming bacteria.

So it is important to note that none of the hand-hygiene agents (including alcohols, chlorhexidine, hexachlorophene, iodophors, PCMX or triclosan) are reliably sporicidal against Clostridium spp. or Bacillus spp.

Washing hands with water and non-antimicrobial or antimicrobial soap may help to physically remove spores from the surface of contaminated hands. An alcohol-based rub should be used as a follow-up to that. In addition, healthcare workers should be, at the very least, encouraged to wear gloves when caring for patients with C. difficile-associated diarrhea.

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