Cleaning the SPD; sterilizing bone tissue; retaining count sheets; incomplete IFUs

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Q I work in a small rural hospital and like others we are dealing with tough financial woes. We have cut back on personnel and other expenses. We have now been required to take care of routine housekeeping in our department. Once a week a housekeeping company comes in to do the heavy cleaning of the floors. I am not sure exactly what level and type of disinfectant I should be using to clean the surfaces in the sterile prep area. What would be appropriate?

A The CDC and HICPAC stress that the responsibility for the routine cleaning and disinfection of environmental surfaces should be assigned to appropriately trained personnel. Environmental cleaning procedures need to be monitored to ensure they are consistent and performed correctly. EPA registered disinfectants or combined detergent/disinfectants with label claims for use in healthcare should be selected and utilized as directed. Disinfectant agents should not be used as cleaning agents unless the label indicates the product is suitable for such use. It is imperative that healthcare workers follow the manufacturers IFUs for use in cleaning and disinfection including the precise dilutions, contact times, and disposal.

Cleaning may be all that is needed for environmental surfaces such as walls and floors, which do not normally come in direct contact with patients during the delivery of healthcare. When the need for disinfection may be indicated, a low-level disinfection would be appropriate for such surfaces.

Q I am the OR nurse liaison for clinical support services in a small community hospital. Recently we had an emergency procedure involving a young patient with a severe head injury. I was advised that the surgeon would be removing a wedge of skull tissue that would have to be saved to be implanted back into the patient at a later date. We planned to place the skull tissue in a sterile container and refrigerate it until it was needed. Unfortunately, the patient did not survive surgery. In a later discussion the issue of sterilizing the bone tissue prior to implanting it back into the patient came up. I was not aware if bone tissue could be sterilized. If needed, would it be acceptable to steam sterilize the tissue?

A Generally bone tissue should not be subjected to the steam sterilization process unless there is a specific clinical indication that warrants it should be done. The steam sterilization process could severely damage the bone composition and structure, as it denatures proteins. This would increase the potential of the resorption of the implanted bone. In other words the body’s own cells could eat away and dissolve implanted sterile bone. Rejection may also be heightened as the changed and unfamiliar autologous sterile bone would be now be a foreign body. It should also be noted that subjecting the bone to the steam sterilization process would also be considered a form of manufacturing requiring your facility to register with the FDA as a tissue bank.

References:

1. Guideline for autologous tissue management. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc.

2. Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/ Ps). Silver Spring, MD: US Food and Drug Administration; 2012.

Q Do AAMI and AORN require that completed count sheets be kept in the patient’s records? Currently we do not keep copies of completed count sheets. The OR staff places a note in the patient’s OR record indicating counts were completed and the outcome of counts. The count sheets are returned to sterile processing for quality control monitoring of tray assembly. How long must completed count sheets be retained?

A Currently AAMI documents do not address count sheets and to my knowledge AORN does not have a recommendation to include count sheets in the patient’s record or to retain the count sheet for any specific amount of time. AORN does provide recommendations for conducting instrument counts. The actual count sheet is a tool to help facilitate the instrument count, it’s not a medical record.  If your hospital decides to develop a policy for the retention of count sheets you may want to consult with your risk management professional and ensure that any policy is in compliance with any regulatory and accreditation requirements.

Q In preparation for accreditation I was reviewing various IFUs and noticed that the IFU for our sterilization containers did not clearly address sterilization processes and relative drying times. The representative told me that their IFUs were in compliance but I still believe they are vague. What is the responsibility of the manufacturer? Shouldn’t the process address drying time?

A Section 10 of AAMI ST79 does address the responsibilities of the manufacturer and the suitability of the container system for specific sterilization cycles .

“The manufacturer of a rigid sterilization container system should demonstrate by scientific evidence that the system is suitable for the specific sterilization methods and cycles for which it is designed and recommended. The manufacturer should provide the user with complete written IFU and in-service education, as well as documentation of the methodology and results of performance testing of the container system. This documentation should cover the following aspects of performance: sterilization (10.10.2.2), drying (if applicable) (10.10.2.3), and sterility maintenance (10.10.2.4).”

Reference:

1. AAMI ST79 Nov, ’13 revision