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STERILIZATION
POLICY & PROCEDURE
PURPOSE: The purpose of this policy is to provide current infection control guidelines regarding
cleaning, disinfecting, and sterilization of patient care equipment, instruments, and the patient care
environment
POLICY
All reusable instruments, equipment, and used surfaces will be decontaminated, disinfected,
or sterilized prior to use on a patient. The infection control guidelines for cleaning,
disinfecting and sterilization of patient care equipment, instruments and patient care
environment listed in Table 1 must be followed. A quality control program is important to
assure appropriate disinfection and sterilization.
Manufacturers’ directions and facility policies and procedures for reprocessing reusable
instruments and equipment, including directions for use of the reprocessing equipment (i.e.,
sterilizer, tunnel washers, etc.) should be available to staff at all times.
Personnel
o Personnel wear clean scrub attire
o Wear a fluid resistant cover gown (tied in back) and heavy-duty gloves during the
decontamination process
o Completely cover all head and facial hair with a surgical-type hair covering
o Wear mask and goggles or a face shield to protect against splashes or sprays
o Staff will follow the hand hygiene policy
o Personnel must have proper training on processing instruments with competency
testing on orientation to their jobs. Documentation of training should be maintained
in the employees personnel file. Continuing education (including training for all new
instrumentation, devices, and equipment) is conducted at regular intervals.
o All sterilization and reprocessing policies and procedures are readily available for
staff
DEFINITIONS
Cleaning: The removal of all soil from surfaces. This can be accomplished by using water with
detergents. Thorough cleaning is necessary before proceeding to high-level disinfection and
sterilization. This includes pre-cleaning, manual/ultrasonic, washer/sterilizers, decontaminators,
or point of use cleaning/disinfection processes.
Disinfection: A process that kills or destroys many or all disease-producing microorganisms on the
inanimate object. It usually does not kill spores
High Level Disinfection: A process that destroys all vegetative microorganisms, tubercle bacilli,
fungi, nonlipid and small viruses and medium-sized viruses with the exception of high numbers of
bacterial spores through a chemical process
Sterilization: The complete elimination/destruction of all forms of microbial life by physical or
chemical procedures
STERILIZATION
1. Select the appropriate method of sterilization according to the instrument or equipment’s
manufacturer’s instructions. Refer to Table 2 for additional information. The sterilization
process, including critical parameters (time, pressure, temperature) and chemical
indicators should be identified and followed accordingly.
2. Steam is the preferred method for sterilization of critical instruments not damaged by heat
3. Alternative sterilization methods may be used (ethylene oxide, hydrogen peroxide, gas
plasma) for heat or moisture-sensitive equipment
4. Special processing may be indicated for use with brain, dura mater, spinal cord and eye
(high-risk tissues) from high-risk patients (those known or suspected of having CJD)
I. Sterilization Packaging
1. Assure adequate drying time of instruments and equipment prior to packaging for
sterilization
2. If lubrication is necessary, use a non-toxic, water-soluble lubricant
3. Review and follow the manufacturer’s instructions for type of wrap or container that may
be used, shelf life, and storage recommendations; wrap all packages separately
4. When double wrapping, all wrapped items must be double-wrapped by using one of the
following:
a. Double-thickness woven or non-woven wrappers
b. Two non-woven wrappers-may be sealed
7. A wrap within a wrap of some items is recommended for ease in dispensing onto a sterile
field; if using double pouches, a smaller pouch should be used inside a larger pouch. Double
pouching should only be performed if validated by the manufacturer for that purpose.
9. Articles which have surfaces in close contact must be separated for steam penetration
10. Linen packs are prepared with articles arranged and folded according to the department
standards
11. Peel packs should not be placed inside of wrapped packages or containerized sets
12. Count sheets or instrument inventory lists should not be placed inside wrapped sets or rigid
containers
13. Total weight of instrument trays must not exceed 25 pounds or the weight specified by the
manufacturer of the sterilizer or container system, whichever is less
II. Monitoring
1. Mechanical (physical), chemical, and biological monitors must be used to assure that the
sterilization process has been effective. In the event of a failed biological monitor, follow the
“Management of Positive Biological Indicator in a Steam Sterilizer” policy.
a. Physical monitors include time, temperature, and pressure gauges, displays,
recorders, and digital printouts. At the end of each cycle, the operator should
examine the printout to verify that:
i. The printer is functioning properly
ii. The cycle identification number has been recorded
iii. All cycle parameters have been meet
b. Chemical monitors (internal and external) should be used with every load
c. Internal chemical indicators should be placed on all levels within the instrument
sets; they should be placed in the geometric center of wrapped packages and in two
opposite corners of rigid containers
d. For a dynamic-air-removal sterilizer, use a Class 2 indicator every day prior to the
first load but after a warm up cycle
e. Class 5 indicators (integrators) should be used for each immediate-use steam
sterilization load
f. Use a biological indicator as follows:
i. Steam sterilization: at least weekly, preferably daily, and for every load
containing an implant. Quarantine implantable items, whenever possible,
until the biologic indicator is positive.
ii. Ethylene oxide and ozone sterilization: for every load
DISCLAIMER: All data and information provided by the Oregon Patient Safety Commission is for informational
purposes only. The Oregon Patient Safety Commission makes no representations that the patient safety
recommendations will protect you from litigation or regulatory action if the recommendations are
followed. The Oregon Patient Safety Commission is not liable for any errors, omissions, losses, injuries, or
damages arising from the use of these recommendations.