Recommended practices for sterilization in the perioperative practice setting

AORN Journal,  March, 2006  

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The following recommended practices ere developed by the AORN Recommended Practices Committee and have been approved by the AORN Board of Directors. They were presented as proposed recommended practices for comments by members and others. They are effective Jan 1, 2006.

These recommended practices are intended as achievable recommendations representing what is believed to be an optimal level of practice. Policies and procedures will reflect variations in practice settings or clinical situations that determine the degree to which the recommended practices can be implemented.

AORN recognizes the numerous types of settings in which perioperative nurses practice. These recommended practices are intended as guidelines adaptable to various practice environments. These practice settings include traditional ORs, ambulatory surgery units, physicians' offices, cardiac catheterization suites, endoscopy suites, radiology departments, and all other areas where operative and other invasive or minimally invasive procedures may be performed.

PURPOSE. These recommended practices provide guidance for sterilizing items (eg, instruments, supplies, equipment, medical devices) to be used in the surgical environment. The creation and maintenance of an aseptic environment has a direct influence on patient outcomes. A major responsibility of the perioperative registered nurse is to minimize patient risk for surgical wound infection. The expected outcome of primary importance to this recommended practice is outcome O10, "The patient is free from signs and symptoms of infection." (1) One of the measures for preventing surgical wound infections is to provide surgical items that are free of contamination at the time of use. This can be accomplished by subjecting them to a sterilization process. Steam, ethylene oxide (EO), low temperature gas plasma, peracetic acid, ozone, and dry heat are sterilization methods that are used in the health care environment. Sterilization of each item to be processed must be validated by the product manufacturer. Directions for sterilizing items should be reviewed in consultation with the manufacturers of the sterilizer and the item to be sterilized. Each sterilization method and some instrumentation has limitations; these limitations should be identified before purchase and use of any sterilizer. Sterilization provides the highest level of assurance that surgical items are free of viable microbes.

RECOMMENDED PRACTICE I

Items to be sterilized should be cleaned and decontaminated in a controlled environment and in accordance with the device manufacturer's written instructions.

1. Factors to be controlled in the environment include room temperature, humidity, and ventilation. To aid in environmental control, there should be a physical separation between the decontamination and sterilization areas. Health care personnel should use standard precautions when performing decontamination activities. Appropriate personal protective attire must be worn, and cleaning procedures should minimize the possibility of spreading contamination. (2-4)

2. Items should be cleaned and dried thoroughly in accordance with AORN's "Recommended practices for cleaning and caring for surgical instruments and powered equipment," (5) "Recommended practices for cleaning and processing endoscopes and endoscope accessories," (6) and the "Multi-society guideline for reprocessing flexible gastrointestinal endoscopes." (7) The reliability of sterilization is affected negatively by the number, type, and inherent resistance of microorganisms, including biofilms, on the items to be sterilized. Soils, oils, and other materials may shield items from contact with the sterilant or combine with and inactivate the sterilant. (2,3,8)

RECOMMENDED PRACTICE II

Items to be sterilized should be packaged according to guidelines established in AORN's "Recommended practices for selection and use of packaging systems." (9)

1. Items should be prepared and packaged so sterility can be achieved and maintained to the point of use. The Association for the Advancement of Medical Instrumentation (AAMI) provides guidance for the density of wrapped packages. Manufacturers of packaging systems should be consulted for package preparation, configuration, and sterilization recommendations and the ability of the packaging to allow for presentation of the package contents to the sterile field in an aseptic manner. (3,9,10)

2. Instruments should be held in an open and unlocked position. Preparation and assembly procedures should consider the type of surgical instruments in the set and total set weight, configuration, and density. Paper/ plastic peel pouches should not be placed in a container or wrapped set. Container or instrument manufacturers do not validate this configuration. Additional packaging materials inside a set can interfere with sterilization efficacy and drying. (3)

3. Instrument sets and container systems should be of a weight specified by the manufacturers of the surgical instruments, sterilizers, and container systems. If instrument sterilization/container systems are used, the manufacturer's written instructions for maximum weight, set preparation, sterilizer loading procedures, exposure times, and drying cycles should be followed. Sets weighing more than approximately 20 lbs are known to be difficult to dry without lengthy drying times. The manufacturer of the instrument sterilization/container system being used should provide written data to support its recommendations. (11) The National Institute for Occupational Safety and Health (NIOSH) has published a lifting equation for calculating a recommended weight for specified, two-handed lifting tasks. This document and the accompanying Applications Manual for the Revised NIOSH Lifting Equation should be consulted. (12-14)