How to handle open, unused, instrument kits; addressing excessive environmental heat and humidity

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Q

In accordance with the surgeon’s preference lists prior to the start of a case, the operating room staff often open up multiple sets of instruments and packages of sterile extras such as hemostats. Quite often many of these items are not used and remain on the back table. The nurse manager of the OR, whom I report to, has told me that the unused instruments do not need to be handled in the same manner as the used contaminated instruments. He claims that the unused sets, which never left the back table, just need to be rewrapped and sterilized and that any loose, unused instruments can be manually rinsed or go through a rapid cycle in the washer. This seems to make sense to me as it saves a lot of unnecessary work. Recently I attended a hot topics roundtable workshop where this practice was discussed and opinions were mixed. A good number of people disagreed with how we handle the unused items. Do you think it is necessary to run unused clean instruments through the entire reprocessing cycle as you would for soiled items?

A Any sterile instruments or sets which are opened and unused should be cleaned and reprocessed in the same manner as those that are soiled and used. Airborne microorganisms may contaminate even instruments that remain on a back table, in a sterile field. During surgery the scrub nurse or other members of the surgical team may unknowingly touch and contaminate the unused “clean” instruments. During case breakdown and transport back to sterile processing the unused instruments may be inappropriately handled, come in contact with soiled instruments or utensils and/or get contaminated in other ways. It is important to remember that all soils are not visible. AORN guidelines for the cleaning and care of surgical instruments and powered equipment endorse the need to completely clean all opened instruments used and unused post-surgery. I would suggest that you reconsider your practice of opening up every item on the surgeon’s preference list prior to confirming its need. This might require an assessment of used and unused instruments and sets and updating preference lists accordingly.

Q It has been a very hot and humid summer this year which has made it very challenging to maintain our environmental conditions for temperature and humidity in the sterile storage area. Our HVAC system has had problems and we have had periods of time when our temperature and humidity levels have significantly exceeded AAMI standards. Also, I noticed that some of our packaging materials (e.g., peel pouches) listed higher-than-acceptable levels than those listed in the AAMI documents. We were in quite a mess and had to move many items to other locations. As a safeguard we broke down and reprocessed most of our OR sets. My question is just how long will items remain sterile when the temperature or humidity levels exceed those that are recommended? Is there a grace period of specific hours or days?

A Your situation is not unique. Many sterile processing departments have faced the same challenges and dilemmas in maintaining temperatures and humidity within the parameters of the various guidelines and standards that exist. I might note that not all the professional guidelines and standards are in concert with one another, which in and of itself creates a dilemma. One should always consult with the product manufacturer regarding storage conditions and sterility maintenance and comply with those IFUs.

I have reviewed many documents and articles and I have consulted with a number of peel pouch manufacturers on the subject and nowhere could I find a definitive, black-and-white answer as to just how long a peel pouch could maintain sterility when exposed to excessive temperature or humidity. There are just far too many variables amongst products and overall environmental conditions. There was agreement that the excess humidity is of greater concern than temperature. The prime concern in high humidity conditions is liquid borne contamination and that the longer you keep a sterile package in such conditions the higher the risk for potential contamination and microbial migration.

Currently the only source of detection we have is visual signs of moisture which is not always observed or reliable. Risks need to be assessed on a case by case basis. Some manufacturers suggest that if there is difficulty in the maintenance of recommended conditions the use of protective covers or containment devices could be used to protect the sterilized items from excessive moisture. I could see this as an effective means of protection from external moisture but I am not sure it would prevent the formation of condensate within the containment device or protective covers when exposed to excessive humid conditions. The issue of temperature and humidity parameters for sterile storage has thus become a hot topic in Sterile Processing and the issue is now on the agenda of various professional entities such as AAMI. I anticipate that in the future we will see standardization of the parameters for temperature and humidity in professional guidelines and standards.