While the Centers for Disease Control and Prevention (CDC) guidelines do allow for the extended storage of sterilized surgical packs, the guidelines also describe specific requirements with respect to the preparation, sterilization and storage of surgical packs. These requirements emphasize the importance of proper storage conditions when attempting to maintain the sterility of surgical packs over extended periods of time. “Event-related factors that contribute to the contamination of a product include bioburden (i.e., the amount of contamination in the environment), air movement, traffic, location, humidity, insects, vermin, flooding, storage area space, open/closed shelving, temperature, and the properties of the wrap material “(p. 75)1. The Guide states: “General principles of aseptic technique should be followed for all survival surgical procedures”, including “sterilization of instruments, supplies, and implanted materials” (p118)2. As it is probably not reasonable to expect that all preparation, sterilization and storage requirements will be adhered to in research laboratory spaces, a re-sterilization frequency of once every six months would be considered a reasonable request to help ensure that the sterility of surgical instruments is maintained in a laboratory setting.
If the re-sterilization policy provided to Dr. Reinhold originated within the Department of Animal Resources, and as a direct result was not broadly accepted as an IACUC policy, then it is reasonable that investigative staff may conclude that the policy does not apply to their laboratories. The Department of Animal Resources’ policy on surgical pack re-sterilization should be re-reviewed by the IACUC, and if the Committee approves, the policy should be renamed in a way that underscores that it is an institutional policy and is intended to cover all animal research at Great Eastern. To further evaluate whether Dr. Reinhold’s practices pose a threat to animal welfare the IACUC could request Dr. Reinhold’s lab provide supporting documentation that the lab’s surgical packs have been prepared, sterilized, and stored in a manner that has not resulted in contamination during storage. While Dr. Reinhold may still resist adhering to the institutional policy based on his knowledge of existing governmental guidelines, a collegial discussion with the IACUC and the veterinary staff can help to address the investigators concerns, and inviting Dr. Reinhold or Department of Surgery staff to help develop or refine the institutional policy in cooperation with the veterinary and IACUC staff could help with future compliance.
Although veterinarians are the subject matter experts with respect to the use of aseptic technique in a laboratory animal setting, the IACUC should make an effort to work closely with the veterinarians, researchers and other stakeholders when developing survival surgical guidelines and policies, and to ensure that the scope of any policy generated is clearly communicated.
Rutala, W.A., Weber, D.J. and the Healthcare Infection Control Practices Advisory Committee (HICPAC). Guideline for disinfection and sterilization in healthcare facilities (2008). https://www.cdc.gov/infectioncontrol/guidelines/disinfection/
Institute for Laboratory Animal Research. Guide for the Care and Use of Laboratory Animals. 8th edn, (National Academies Press, Washington, DC, 2011).
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Reaves, M., Prestia, K. & Rasmussen, S. Clarify and communicate policies. Lab Anim 47, 298 (2018). https://doi.org/10.1038/s41684-018-0178-5