Question: I have heard a lot of controversy regarding the use of sterilized goods if there is moisture found inside the rigid container. Over a two week period the O.R. manager and I took several swab samples of various instrument sets which had minimal moisture on the bottom of the container following sterilization. The results of all these cultures were negative. Based on the results of our study we are considering a change in policy, which would allow the use of instruments sterilized in a sealed rigid container when minimal moisture is found on internal base of the container below the basket. What is your opinion on this practice?

Answer: I cannot support the use of any sterilized instruments, supplies or devices if any degree of moisture is found inside the sterilized package or rigid container. The only exception might be for goods processed via a flash cycle where there is no drying phase and moisture is expected. Sterility testing is a complex process requiring special skills, equipment and the like. Most hospital settings and labs are not adept or capable to do sterility testing of sterilized goods appropriately. While I respect your efforts, simply doing random swab samples of some of the set’s components and instruments is not adequate and although the cultures may have rendered negative results you cannot assume or have confidence that all the components or parts are indeed sterile. Moisture found inside of sterile sets is unacceptable and indicative of a processing problem. Do not fall prey to the myth that water found inside of a sterilized container is sterile. In most instances you cannot be 100% sure of the source of the moisture, when it entered the package, or its sterility. Furthermore moisture "sterile" or not is never a friend to a sterile field as it can soak through the sterile drapes and provide a conduit for microbial strike through. If you are finding moisture in your containers following sterilization it is indicative of a problem that must be addressed and corrected. Some common causes of moisture in sterilized packages include:

• Instruments wet when packaged

• Too much metal mass

• Inappropriate placement, assembly and positioning of contents

• Sterilizer malfunction

• Steam quality issues

• Packing materials and accessories

• Inadequate dry time

• Inappropriate use of containers

• Sterile integrity and quality of containers

• Defective or damaged container parts

• Environmental controls, temperature and humidity within sterile storage area

• Inappropriate handling of hot sterile goods

• Placement of hot items near air conditioning vents or on cold surfaces

Through a thorough assessment of all of these potential problem sources you should be able to determine the real cause or causes for your moisture problem and thus facilitate the necessary changes in products and processes to eliminate wetness in your sterilized packages and containers.1

Question: I am relatively new to the sterile processing discipline and would like to have a better understanding regarding monitoring the sterilization process. We basically have only one type of chemical indicator that we use exclusively for all our needs. I recently read something referencing classes and levels of indicators; frankly I am confused. What’s the difference in these classes and levels? Do we really need to have various indicators?

Answer: There are 5 classes of chemical indicators. As a sterile processing practitioner it is important for you to understand the different types and classes of indicators. Each type / class has a distinct response to the detection of sterilization conditions. ANSI the American National Standards Institute is the agency which specifies the performance requirements for process indicators. Process indicators, via chemical and or physical changes will demonstrate exposure to the sterilization process.

• Class 3—This is a single parameter indicator that only responds to one of the critical parameters required for a specific sterilization process. For example steam sterilization has three parameters: saturated steam, time, and temperature. The class 3 indicator may only respond to one of these parameters such as temperature or steam. The manufacturer of the indicator must specify the parameter and clearly indicate this on the product labeling.

AAMI recommendations state that internal indicator should be used in each package to be sterilized, including items to be flash sterilized. The internal indicator demonstrates that the inside of the wrapped item has been exposed to one or more conditions of sterilization (depending on the classification of the indicator). Remember that the external indicator differentiates between processed and unprocessed items. An external indicator alone cannot indicate if the internal part of the package has been exposed to the required sterilization parameters. HPN