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By Nancy Chobin, RN, AAS, ACSP, CSPM, CFER
Q: I am a certified tech and have been for 25-plus years. I have a question that I am hoping that someone can put an answer in writing for me. For whatever reason as of late, the people in my OR think it is ok to put sterile gloves on and take a tray off of my cart that was still hot. They have seen it in other facilities and so in their minds this must be okay. I was taught that you do not handle a tray or take it to use and open on your field when it just came out of the sterilizer. However, I don’t know what to say to them when they ask how this is any different than if we flash sterilize something and take it to our field hot? Any help with an answer they can understand would be appreciated. Is this something that is acceptable?
A: You have posed an excellent question. The recommendations from ANSI/AAMI (ST-79), our national standard are noted below. In current section 8.8.1, the Association for the Advancement of Medical Instrumentation (AAMI) states, “All items removed from the sterilizer after sterilization processing, including items packaged in rigid sterilization container systems, should remain on the sterilizer cart until adequately cooled. They should not be touched during the cooling process. Rigid sterilization container systems should remain on the sterilizer cart until container surfaces are cool to the touch and can be handled safely by the operator with bare hands. The cool-down period begins within the sterilizer chamber. The door may be opened slightly at the end of the cycle and the items left inside for a period of time in order to reduce the potential for condensation formation. The time allowed for cooling should take into account the type of sterilizer being used, the design of the device being sterilized, the temperature and humidity of the ambient environment, and the type of packaging used. A minimum cooling time of 30 minutes is recommended.”
However, the 30-minute minimum time could be much longer depending on the environmental conditions in your area, the packaging materials used, the weight and density of the set, the age and condition of your sterilizers, etc. AAMI goes on to state that, “Although a minimum cooling time of 30 minutes is recommended, adequate cooling could require two hours or more.”
According to AAMI, it is important not to touch packages, sets or trays before cooled because “packages contain a significant amount of moisture after being exposed to steam. That moisture migrates out of the package as a gas or water vapor during both the drying phase and the cooling phase. Packages should not be touched until they are cool because a hand can act as a point of condensation for the warm water vapor emanating from the package, thereby creating a moist area on the outside of the package. This moist area can act as a wick to draw bacteria from the hands into the package.”
AORN's Guideline for Sterilization (2015) also states, “After sterilization, items removed from the sterilizer should be left untouched until cool enough to handle without concern that retained moisture can serve as a wick for bacteria that is on the hands of personnel who handle the package. A period of 30 minutes to two hours may be needed. Note that neither of the aforementioned guidelines states that any other practice, including the use of sterile gloves is acceptable. When you follow your “own” guidelines” you are left on your own since there is nothing to back it up.
For the reasons stated above, many facilities today use infrared thermometer guns to determine the actual temperature of each package BEFORE it is touched. Prior to implementation of infrared thermometer guns, the only way we could tell if a package was cool enough was to touch it. This was not scientific furthermore if the pack was still hot or warm, it could lead to contamination of the pack.
With the use of the infrared thermometer, you know the exact temperature of each package so you only remove the specific packages when cool enough. The use of this method solves issues with handling packs before they are adequately cooled.
If you use the thermometer gun, the current recommended temperature for release is 72 to 80 degrees F. (ambient temperature). The de-vices should be calibrated at least yearly or as needed and used in accordance with the manufacturer’s instructions. The manufacturer’s instructions will also recommend that the gun be at a specific distance from the specific item to get an accurate temperature reading. It is important to comply with this information. You should include the process for the release of items after sterilization as part of your Sterilization Policy. In-service the SPD and OR staff members of this process.
In summary, sterile packs are most vulnerable to contamination immediately after sterilization, when the packaging is still hot. Sterilized items should remain on the sterilizer cart, untouched, until they are completely cooled. When we deviate from accepted standards of practice, we are liable for our actions. It is recommended to meet with the OR staff to discuss this matter, bringing the standards with you and collaborate to improve your process by implementing a more scientific method for release of items after sterilization.
Nancy Chobin, RN, AAS, ACSP, CSPM, CFER, is a sterile processing consultant and educator.
ANSI/AAMI: ST79:2010 & A1:2010 & A2:2011 & A3:2012 A4:2013Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities.
Basics of Sterile Processing 6th Edition. Sterile Processing University, LLC. Lebanon, NJ.