The use of aseptic technique, including sterilized instrumentation, is a requirement for all survival surgeries1. If a surgical pack becomes contaminated, it clearly needs to be resterilized; however, there is no regulation governing the frequency required for re-sterilization of packs that are unopened and uncontaminated. In the case of Great Eastern University, the Department of Animal Resources had developed an internal policy requiring re-sterilization every six months, and this was approved by IACUC. It is not clear, though, whether this policy applied only to the Department of Animal Resources, or was meant to be a university-wide policy to which all researchers must adhere. If the latter, then the Reinhold lab may be held to that standard as an IACUC may set requirements that fall outside of, or are more stringent than, applicable guidelines and regulations.
Dr. Reinhold does make a case for his lab’s policy of keeping packs indefinitely if they are unopened and uncontaminated. He notes the lack of surgical infections in his lab’s surgical animals, and refers to a CDC report “Guideline for disinfection and sterilization in healthcare facilities (2008)”2 to support his stance. One study within these Guidelines states: “Another [study] evaluated the effectiveness of event-related outdating by microbiologically testing sterilized items. During the 2-year study period, all of the items tested were sterile. Thus, contamination of a sterile item is event-related and the probability of contamination increases with increased handling.” This document then goes on to include recommendations on proper handling and storage of medical and surgical devices following sterilization in order to prevent contamination. Some considerations noted in the guidelines include storage far enough from the floor, ceiling and outside walls to allow for air circulation, easing of cleaning and compliance with fire codes; and storing in locations where the packs will not become wet and contaminated. In this scenario from Great Eastern University, the method of storage was not delineated, but should also be taken into consideration when considering the sterility of the packs.
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