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My initial response was based on:

1. What we have always been taught

2. What information is published in CS text books

3. Sterilization guidelines, recommendations and documents such as those published by AAMI and other professional entities

4. First hand experience in the real world

As one might imagine this conflicting information has generated several calls and letters from a myriad of users, sterilization experts, and engineers expressing their concerns, opinions and offering further enlightenment on the subject.

Here’s the latest, all three of the major Sterilization manufacturers Steris, Getinge, and Belimed claim it is not necessary to crack the door after a cycle to allow for temperature stabilization. As a matter of physical science they state, heat vapors move outward from the hottest point which would minimize the likelihood of outside contaminants from entering a sterilized package while cooling. All agree that one should never leave items in a sterilizer to dry following the sterilization cycle. Any moisture visible or not following the sterilization cycle is unacceptable and is an indication of some malfunction or poor steam quality. Leaving items in the sterilizer to dry is merely masking a problem that should be corrected and dealt with. All newer sterilizers have self activating gaskets which actually advance outward producing a tight seal once the door is engaged. Older models relied on muscle power when cranking the door shut. Once the cycle is completed the action gaskets actually disengage and retract prior to opening the door which in essence (is like cracking the door) this does allow for some heat stabilization. One manufacturer and engineer I consulted said there would be no harm in cracking the door to allow for further stabilization of temperatures other then unnecessarily tying up the sterilizer which could affect productivity.

Does all this mean that we do not have to be concerned with the possibility of temperature changes contributing to the possible formation of condensate and the contamination of sterile packages? Absolutely not! Depending on the pack contents, packaging materials, metal mass and the like, hot items placed in or on extremely cooler surfaces, environments or adjacent to air conditioning vents could create condensate. In the ideal situation again, depending on packaging methods, contents and materials used, the strict adherence to technique, the enforcement of policies and procedures, proper sterilizer functioning, appropriate environmental controls and adequate secure space and equipment to segregate sterilized items while cooling it is probably fine to remove sterile items from a sterilizer immediately following the cycle. In the real world and in many CS departments this is not the case. The responsibility lies with each CS/SPD manager to assess their particular environment and situation and to then implement protocols that are most appropriate for their unique situation to ensure sterility maintenance. As the editors indicated in the July issue of HPN: Our industry sources tell us that because there are many factors to consider about each facility’s unique sterilization environment, and every sterilizer and situation may be different, it is advisable to contact your sterilizer manufacturer directly for their advice on handling the removal of items from the sterilizer and whether or not to leave the door cracked.

Your technical expertise of work area needs and standards can guide them in the development and design. You will want to make sure that proper traffic flow is addressed to prevent the need to go from soiled to clean areas. You will want to consider the need for restricted and or semi restricted areas that will affect traffic flow and dress code issues. You will also want to ensure that the work areas are conducive to proper technique and include physical barriers for the separation of clean, sterile and soiled work and holding areas. You will need to address various HVAC (heating ventilation and air conditioning) concerns and the flow of air. Since you will be renovating the decontamination area and breaking up that space to create new rooms, the air handling system will need to be modified to ensure the proper circulation and flow from clean to soiled areas. The decontamination area should maintain negative pressure and the new areas positive pressure.