The International Federation of Perioperative Nurses - 1006 Sterilization and Disinfection

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IFPN Guideline for
Developing Standards
Sterilization and Disinfection

2006 Sponsored with an Educational Grant by Vernon Carus 1008
Original: 02; Reviewed: 06 1
Purpose:
To provide guidelines to achieve sterilization and disinfection of supplies and
equipment. Positive patient outcomes of surgical interventions depend on the maintenance of
an aseptic environment. Supplies and equipment should be free of contamination at the time
of use. Sterilization and disinfection are methods to achieve this. Sterilization provides the
greatest assurance that an object does not have viable microbes. Disinfection reduces the
risk of microbial contamination but does not have the same level of assurance as sterilization.
A. Sterilization
Recommendations:
1. All items to be sterilized should be thoroughly cleaned to reduce the bioburden.
Rationale: Sterilization is affected by the number, type, and resistance of
organisms on the item(s) to be sterilized. This is referred to as the bioburden.
Any residual soil, oils, or other materials present may interfere with penetration
of the sterilant.
2. Items to be sterilized should be prepared in a clean, controlled environment.
Rationale: Temperature, humidity, lighting, personnel attire, room design, and
cleaning procedures are some of the factors to be considered to assure proper
presterilization processing.
3. Care must be taken to arrange items to be sterilized in a manner that will
expose all surfaces to the sterilant. All jointed instruments should be open and
unlocked. Instruments should be disassembled when possible. Instruments
should not be held together with rubber bands. Any needed lubricant should
be nontoxic and water soluble.
Rationale: Reliable sterilization depends on good quality contact between the
sterilant and all surfaces.
4. Instrument sets should be placed in perforated trays or instrument container
systems.
The total weight of the metal mass should not exceed the recommendations
made by the manufacturer of the sterilizer or the container system
manufacturer.
Rationale: Conditions necessary for sterilization are difficult to achieve in
excessively heavy instrument pans/packs. Heavy pans/packs may require
longer time to attain sterilization temperature and drying time may be extended
due to condensation and pooling of moisture.
2006 Sponsored with an Educational Grant by Vernon Carus 1008
Original: 02; Reviewed: 06 2
5. When instruments are nested inside the pack, they should be separated by
absorbent towels or other moisture absorbing material.
Rationale: Placing absorbent towels or other moisture absorbing materials
between nested instruments enhances passage of steam to all surfaces during
the sterilization cycle and facilitates drying by preventing pooling of the
condensate.
6. All packs should be arranged on sterilization carriers/racks in a manner that
does not interfere with air removal and infusion of the sterilant.
Rationale: Proper placement of packs in the steam sterilizer facilitates
displacement of air and contact of steam with all surfaces of the containers and
their contents. It also facilitates drying time. In combined loads of fabrics and
hard surface packs, place hard surface packs on the lowest shelves/racks to
prevent any dripping that may occur from hard surface packs.
7. A chemical indicator should be clearly visible on the outside of packs to be
sterilized.
Rationale: Chemical indicators show that items have been exposed to physical
conditions during a sterilization cycle to render the items sterile. Chemical
indicators do not replace quality assurance measures such as time, pressure,
and temperature monitoring; biological monitoring; proper packaging; proper
sterilizer maintenance; and, proper storage and handling.
8. Chemical indicators may be placed in packages or in open trays to be
sterilized.
Rationale: Whenever chemical indicators are used, they should be placed in
the position of the pack or tray which is the most difficult for the sterilant to
reach.
9. Chemical indicator results should be tracked and interpreted according to the
manufacturers written instructions.
Rationale: Each practice setting should formulate its own polices regarding the
use of chemical indicators. Factors to be considered should include a
cost/benefit analysis, performance limitations, and personnel knowledge of
sterilization.
10. The sterilizing process should be monitored at regular intervals with reliable
biological
Indicators. Commercially manufactured biological indicators prepared in
accordance with minimum performance criteria should be stored and used
according to the indicator manufacturers written instructions. Measurements
should be performed with a biological indicator that employs spores of
established resistance in a known population.
Rationale: The biological monitoring process is the best method presently
available to help confirm the effectiveness of the sterilizing process.
2006 Sponsored with an Educational Grant by Vernon Carus 1008
Original: 02; Reviewed: 06 3
11. Saturated steam under pressure should be used to sterilize heat and moisture
stable items. Sterilizers should be used according to manufacturers written
instructions. The time/temperature settings recommended by the device
manufacturer should be followed.
Rationale: The time and temperature required to achieve sterilization by steam
varies with the type of sterilizer, cycle design, bioburden, packaging, and the
size and type of items being sterilized.
12. Ethylene Oxide (EO) may be used to process heat and moisture sensitive
items. EO sterilizers and aerators should be used and vented according to the
manufacturers written instructions. Items to be EO sterilized should be
disassembled, cleaned, rinsed and wiped or air dried until no visible water
droplets remain.
Rationale: Heavily soiled items inhibit gas permeation. Excessive moisture
inhibits sterilization and produces toxic byproducts that are not removed during
aeration.
13. Items should be positioned in the EO sterilizer to allow free circulation and
penetration of the sterilant.
Rationale: EO sterilization depends upon a correct balance of essential
parameters which include concentration of sterilant, relative humidity,
temperature, and exposure time. The sterilizer operating manual should
explain the required relationship between these parameters for proper
operation.
14, All EO sterilized items should be aerated according to the device and aerator
manufacturers written instructions.
Rationale: Aeration of EO sterilized items is essential to reduce the residue of
EO
which can be harmful to staff and/or patients. Length of aeration depends on
many variables:
a. Composition, form, density, and weight of items to be sterilized
b. Type of EO sterilization system used
c. Temperature and number of filtered air changes per hour of
aeration chamber
d. Intended use of item (used externally or implanted)
15. The sterilizer manufacturers recommendations for door opening and transfer of
items should be followed.
Rationale: The carts or baskets used to transfer items from the EO sterilizer to
the aerator should be pulled rather than pushed. Pushing causes air to flow
over the contents of the cart and the potential for inhalation of EO by the
operator is increased.
2006 Sponsored with an Educational Grant by Vernon Carus 1008
Original: 02; Reviewed: 06 4
16. Personnel should avoid direct contact with items during the transfer from EO
sterilizer to aerator. The EO sterilized items should remain on the cart or in the
basket during transportation. Inhalation of EO should be avoided or minimized.
Rationale: Excessive exposure to EO presents a health hazard to workers.
17. EO sterilizers and aerators should be vented to the outside atmosphere via an
appropriate vent line.
Rationale: EO sterilizer and aerator design and venting guidelines are
extensive. Consult governmental regulations and the Sterilizer and aerator
manufacturers recommendations for requirements for use.
18. Every package should be labeled with a load control number that indicates the
sterilizer used, the cycle or load number, and the date of sterilization. Load
control numbers should be used for quality control to facilitate the identification
and retrieval of supplies, inventory control and stock rotation.
Rationale: Quality control records to insure sterility must be documented and
records maintained by the facility.
19. Sterilized articles should be carefully handled, and only as necessary. They
should be stored in a well-ventilated, limited access area with controlled
temperature and humidity. All wrapped sterilized items should remain
untouched on the sterilizer rack or carriage until adequately cooled.
Rationale: Placement of warm wrapped sterilized items on a cold surface can
induce condensate formation resulting in contamination of items.
20. The contents of any sterilized package should be considered contaminated if
the integrity of the packaging is visibly damaged. All wrapped sterilized
packages should be handled and stored in a manner which minimizes stress
and pressure. The storage area should provide protection against dust,
insects, vermin, and temperature and humidity extremes.
Rationale: Cautious minimal handling of sterile packages reduces the
possibility of microbial contamination.
21. Performance records should be maintained for all sterilizers. Mechanical
control monitors such as time-temperature recordings, and temperature and
pressure gauges should be monitored by the sterilizer operator at the
beginning and end of each sterilizer cycle to verify function. Sterilizer records
should include sterilizer identification number, date, cycle number, contents of
each load, duration and temperature of exposure phase, identification of
operator, results of biological tests and dates performed, time-temperature
recording charts from sterilizers, and any other test results.
Rationale: Sterilizer performance records may be used for documentation for
product recall and for quality assurance.
2006 Sponsored with an Educational Grant by Vernon Carus 1008
Original: 02; Reviewed: 06 5
22. Preventive maintenance should be performed according to the manufacturers
recommendations and individual facility policy. Sterilizers should be inspected
and cleaned daily or at an interval recommended by the manufacturer.
Rationale: Daily cleaning includes washing and rinsing all surfaces of the
sterilizer to prevent accumulation of grease residue from materials being
sterilized. The strainers located in the opening of the chamber discharge line
should be removed and cleaned daily to insure that pores are free from lint and
sediment.
23. The chamber discharge system should be cleaned at least weekly according to
the manufacturers instructions.
Rationale: Periodic cleaning of the discharge system will prevent build up of
grease residues and cogging substances that may retard air and condensate
discharge from the chamber.
24. In prevacuum sterilizer, a Bowie-Dick test should be carried out each day prior
to the first sterilization cycle. If the sterilizer is in use 24 hours a day, the test
should be run at the same time each day. The Bowie-Dick test pack should be
placed horizontally at the bottom front of the sterilizer near the door, in an
otherwise empty chamber for 3.5 minutes.
Rationale: The Bowie-Dick test evaluates the ability of prevacuum sterilizers to
reduce air residuals effectively from the chamber space. If air has not been
sufficiently removed, steam will drive air back into the load, air pockets will
develop, and sterilizing conditions will not occur.
B. Disinfection
Recommendations:
1. A high-level disinfectant should be used if an item is to be disinfected rather
than
sterilized. The manufacturers written instructions should be followed for use.
Rationale: Chemical disinfection differs from sterilization by its power to kill
spores.
2. Items to be disinfected should be thoroughly cleaned, rinsed and dried to avoid
interference with the disinfecting process of dilution of the disinfectant.
Rationale: Disinfection is divided into 3 levelshigh, medium, and low. A
high-level disinfectant can be sporicidal as well as bactericidal and virucidal if
contact time is sufficient. An intermediate-level disinfectant is not sporicidal but
will kill the more resistant bacterial and viruses. A low-level disinfectant is not
sporicidal and will kill only less resistant bacteria and viruses.
3. All surfaces, including lumens and channels, of items must be in contact with
the disinfectant solution for the recommended exposure time.
2006 Sponsored with an Educational Grant by Vernon Carus 1008
Original: 02; Reviewed: 06 6
Rationale: The time required to achieve high-level disinfection varies
depending on factors including the nature of the contaminating
microorganisms, length of exposure to the agent, bioburden, and temperature.
4. An expiration date, determined according to the manufacturers written
instructions, should be marked on the container of the disinfectant currently in
use.
Rationale: All disinfectants will cease to remain effective after repeated use
due to dilution, inactivation, and/or instability.
5. High-level disinfectant contact with skin, mucous membranes, and eyes should
be avoided. Solutions should be kept covered and used in a well ventilated
area.
Rationale: Some high-level disinfectant solutions have been reported to be
irritating to the skin and eyes.
C. Policies and Procedures
Recommendations:
1. Policies and procedures for sterilization and disinfection should be written,
readily available in the practice area, and reviewed annually. They should
establish authority, responsibility, and accountability for sterilization and
disinfection processes.
Procedures for sterilization and disinfection processes may include:
a. Preparation of items for processing
b. Processing of limited use items
c. Loading of sterilizers
d. Use of chemical and biological indicators
e. Type of processes and length of time for sterilization and
disinfection of individual items
f. Use of each type of sterilizer and disinfectant
g. Specific aeration requirements for each type of EO sterilized
material
h. Maintenance records of sterilizers and aerators
i. Safety precautions associated with use of sterilizers, aerators,
and disinfectants
j. Handling and storage of sterilized instruments and supplies
k. Designation of shelf life
l. Recall and/or disposal or reprocessing of outdates sterile
supplies
Rationale: Documentation aids in communication, provides a mechanism for
evaluation of nursing care, and serves as evidence of care in legal maters.
References
2006 Sponsored with an Educational Grant by Vernon Carus 1008
Original: 02; Reviewed: 06 7
AORN Standards and Recommended Practices (Denver: Association of Operating
Room Nurses, Inc. 2002.
Association for the Advancement of Medical Instrumentation, Good Hospital Practice:
Steam Sterilization and Sterility Assurance, ANSI/AAMI (Arlington, VA);
Association for the Advancement of Medical Instrumentation, 1994.
Bond, W. W.. Biological Indicators for a liquid chemical sterilizer: A solution to the
instrument reprocessing problem? Infection Control and Eipdemiology 14
(June 1993).
Crow. S. Steam sterilizers: An evolution in design. Infection Control and
Eipdemiology 14 (August 1993).
Fortunato-Phillips, N. Berry & Kohns Operating Room Technique, 10th ed. St. Louis:
Mosby, 2003.
Fuller, J. R. Surgical Technology: Principles and Practice. Philadelphia: W. B.
Saunders Co, 1986.
Gardner, J. F., Peel, M. H. Introduction to Sterilization and Disinfection. New York
City: Churchill Livingstone, 1996.
Kleier, D. J., Averbach, R. E. Glutaraldehyde nonbiologic monitor. Infection Control
and Hospital Epidemiology 11 no 8 (August 1990).
Reichert, M. and Young, J. Sterilization Technology for the Healthcare Facility.
Gaithersburg, Md: Aspen Publishers, Inc, 1993.
Rothrock, J. C., et al. Alexanders Care of the Patient in Surgery, 12th ed. St. Louis:
Mosby-Year Book, Inc., 2003.