CE ONLINE
The Role of Cleaning
and Sterilization in
Infection Control:
A Focus on Powered Surgical Instruments
A Continuing Education Activity
Sponsored By
Grant Funds Provided By
Welcome to
The Role of Cleaning and Sterilization
in Infection Control:
A Focus on Powered Surgical Instruments
(An Online Continuing Education Activity)
CONTINUING EDUCATION INSTRUCTIONS
This educational activity is being offered online and may be completed at any time.
Steps for Successful Course Completion
To earn continuing education credit, the participant must complete the following steps:
1. Read the overview and objectives to ensure consistency with your own
learning needs and objectives. At the end of the activity, you will be
assessed on the attainment of each objective.
2. Review the content of the activity, paying particular attention to those areas
that reflect the objectives.
3. Complete the Test Questions. Missed questions will offer the opportunity to reread the question and answer choices. You may also revisit relevant content.
4. For additional information on an issue or topic, consult the references.
5. To receive credit for this activity complete the evaluation and registration form.
6. A certificate of completion will be available for you to print at the conclusion.
Pfiedler Enterprises will maintain a record of your continuing education
credits and provide verification, if necessary, for 7 years. Requests for
certificates must be submitted in writing by the learner.
If you have any questions, please call: 720-748-6144.
CONTACT INFORMATION:
© 2013
All rights reserved
Pfiedler Enterprises, 2101 S. Blackhawk Street, Suite 220, Aurora, Colorado 80014
www.pfiedlerenterprises.com Phone: 720-748-6144 Fax: 720-748-6196
OVERVIEW
The sterile processing of instruments, devices, and items is a significant part of infection
control in health care practice. This activity will explore the importance of infection control
and its impact on patient outcomes. The proper steps and key clinical considerations
for instrument cleaning and decontamination will be reviewed. The differences between
sterilization and high-level disinfection will be discussed. Different methods of sterilization
will be defined and the significance of sterilization monitoring as it impacts patient
outcomes. Special processing considerations for Creutzfeldt-Jacob disease, loaner
equipment, and single-use items will also be addressed.
OBJECTIVES
After completing this continuing education activity, the participant should be able to:
1. Explain the importance of infection prevention in patient care.
2. Define the Spaulding Classification.
3. Identify the steps involved with surgical instrument decontamination and cleaning.
4. Describe the difference between sterilization and high-level disinfection.
5. Distinguish the various methods of sterilization.
6. Explain the importance of sterilization monitoring.
7. Identify special considerations for sterile processing.
INTENDED AUDIENCE
This continuing education activity is intended for perioperative nurses, sterile processing
personnel, and other health care professionals who are interested in learning more about
sterile processing and the impact on patient outcomes.
CREDIT/CREDIT INFORMATION
State Board Approval for Nurses
Pfiedler Enterprises is a provider approved by the California Board of Registered Nursing,
Provider Number CEP14944, for 2.0 contact hour(s).
Obtaining full credit for this offering depends upon completion, regardless of circumstances,
from beginning to end. Licensees must provide their license numbers for record keeping
purposes.
The certificate of course completion issued at the conclusion of this course must be
retained in the participant’s records for at least four (4) years as proof of attendance.
IACET Credit for Allied Health Professionals
Pfiedler Enterprises has been accredited as an Authorized Provider by the International
Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite
500, McLean, VA 22102; (703) 506-3275.
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CEU STATEMENT
As an IACET Authorized Provider, Pfiedler Enterprises offers CEUs for its programs that
qualify under ANSI/ IACET Standard. Pfiedler Enterprises is authorized by IACET to offer
0.2 CEU(s) (2.0 contact hours) for this program.
IAHCSMM
The International Association of Healthcare Central Service Materiel Management has
approved this educational offering for 2.0 contact hours to participants who successfully
complete this program.
CBSPD
The Certification Board for Sterile Processing and Distribution (CBSPD) has approved
this program for 2.0 contact hours.
RELEASE AND EXPIRATION DATE
This continuing education activity was planned and provided in accordance with
accreditation criteria. This material was originally produced in October 2013 and can
no longer be used after October 2015 without being updated; therefore, this continuing
education activity expires in October 2015.
DISCLAIMER
Accredited status as a provider refers only to continuing nursing education activities and
does not imply endorsement of any products.
SUPPORT
Grant funds for the development of this activity were provided by Stryker.
AUTHORS/PLANNING COMMITTEE/REVIEWER
Rose Moss, MN, RN, CNOR
Nurse Consultant/Author
Moss Enterprises
Elizabeth, CO
Julia A. Kneedler, RN, MS, EdD
Program Manager/Reviewer
Pfiedler Enterprises
Aurora, CO
Judith I. Pfister, RN, BSN, MBA
Program Manager/Planner
Pfiedler Enterprises
Aurora, CO
Kathryn Major, BSN, RN
Program Manager/Planner
Pfiedler Enterprises
Aurora, CO
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DISCLOSURE OF RELATIONSHIPS WITH COMMERCIAL ENTITIES FOR
THOSE IN A POSITION TO CONTROL CONTENT FOR THIS ACTIVITY
Pfiedler Enterprises has a policy in place for identifying and resolving conflicts of interest
for individuals who control content for an educational activity. Information listed below is
provided to the learner, so that a determination can be made if identified external interests
or influences pose a potential bias of content, recommendations or conclusions. The intent
is full disclosure of those in a position to control content, with a goal of objectivity, balance
and scientific rigor in the activity.
Disclosure includes relevant financial relationships with commercial interests related to
the subject matter that may be presented in this educational activity. “Relevant financial
relationships” are those in any amount, occurring within the past 12 months that create a
conflict of interest. A “commercial interest” is any entity producing, marketing, reselling,
or distributing health care goods or services consumed by, or used on, patients.
Activity Planning Committee/Authors/Reviewers:
Rose Moss, MN, RN, CNOR
No conflict of interest
Julia A. Kneedler, RN, MS, EdD
Co-owner of company that receives grant funds from commercial entities
Judith I. Pfister, RN, BSN, MBA
Co-owner of company that receives grant funds from commercial entities
Kathryn Major, BSN, RN
No conflict of interest
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PRIVACY AND CONFIDENTIALITY POLICY
Pfiedler Enterprises is committed to protecting your privacy and following industry best
practices and regulations regarding continuing education. The information we collect
is never shared for commercial purposes with any other organization. Our privacy and
confidentiality policy is covered at our website, www.pfiedlerenterprises.com, and is
effective on March 27, 2008.
To directly access more information on our Privacy and Confidentiality Policy, type the
following URL address into your browser: http://www.pfiedlerenterprises.com/privacy-policy
In addition to this privacy statement, this Website is compliant with the guidelines for
internet-based continuing education programs.
The privacy policy of this website is strictly enforced.
CONTACT INFORMATION
If site users have any questions or suggestions regarding our privacy policy, please
contact us at:
Phone: 720-748-6144
Email:
registrar@pfiedlerenterprises.com
Postal Address: 2101 S. Blackhawk Street, Suite 220
Aurora, Colorado 80014
Website URL:
http://www.pfiedlerenterprises.com
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INTRODUCTION
Registered nurses and other health care workers are continually challenged in today’s
rapidly changing health care environment, with newly recognized pathogens and
other well-known microorganisms that have become increasingly resistant to current
therapeutic modalities. Infection control and health care epidemiology are concerned
with preventing the spread of infections within the health care setting. Epidemiology is
the study of a disease’s population, prevalence, distribution, and determining factors.
Epidemiology examines epidemic (excess) and endemic (always present) diseases.
Epidemiology is based on the observation that most diseases do not occur randomly,
but are related to environmental and personal characteristics that vary by time, place,
and subgroups of the population. Hippocrates is generally said to be the “father of
epidemiology”. He is the first person known to have examined the relationship between
the occurrence of disease and environmental influences.
Infection control concerns itself with both prevention (hand hygiene/hand washing,
cleaning/disinfection/sterilization, vaccination and surveillance) and with the investigation
and management of demonstrated or suspected spread of infection within a particular
health care setting. The common title within health care facilities, “Infection Prevention
and Control”, has been adopted for this reason. Infection control practices should focus
on prevention. It is important that health care practitioners understand the importance
of cleaning, disinfection, and sterilization as these apply to everyday infection control
practices, health care personnel, patients, and positive patient outcomes.
HEALTH CARE ASSOCIATED INFECTIONS (HAIs)
In October 2008, five leading health care organizations came together to publish
practical, science-based strategies to help prevent the six most important health care
associated infections (HAIs). The Compendium of Strategies to Prevent Health Care
Associated Infections in Acute Care Hospitals was produced by1:
• The Society for Healthcare Epidemiology of America (SHEA);
• The Infectious Disease Society of America (IDSA);
• The American Hospital Association (AHA);
• The Association for Professionals in Infection Control and Epidemiology (APIC);
and
• The Joint Commission.
The document states that preventing HAIs is one of the nation’s highest goals for
priority public health and patient safety. The Centers for Disease Control and Prevention
(CDC) estimate that two million Americans contract an infection while receiving medical
treatment. Over 90,000 Americans will die as a result of complications from an infection
each year. Hospital infections cost Americans between $4.5 billion and $6.5 billion
annually in extra health care costs. Surgical Site Infection (SSI) occurs in 2-5% of
patients undergoing inpatient surgery in the United States with an estimated 500,000
occurring annually. Overall, SSIs are associated with about $7 billion to $10 billion in
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annual health care expenditures in the United States. Health care professionals must
have the expertise and knowledge to provide patients a safe environment in regard to
the cleaning, disinfection, and processing of equipment and instrumentation within their
practice setting to prevent adverse patient outcomes.
SPAULDING CLASSIFICATION
Potentially pathogenic (disease producing) microorganisms are everywhere in our daily
lives. Health care practitioners must be aware that pathogenic microorganisms are
prevalent in health care facilities due to the large number of patients with transmittable
diseases and any patient is a potential host in acquiring a disease or infection. To
accomplish successful transmission from an environmental source, all of these
requirements for the “chain of infection” must be present. The absence of any one
element will prevent transmission. The pathogenic microorganism must overcome
environmental stresses to retain viability, virulence, and the capability to initiate infection
in the host. The transmission of infection involves a chain of events that includes:
• Presence of a pathogenic agent,
• Reservoir,
• Portal of exit,
• Transmission,
• Portal of entry, and
• Host susceptibility.
Prevention of disease transmission occurs when there is a break in the chain of
transmission. How equipment and instruments are cleaned, disinfected, and sterilized
can provide a break in this chain by eliminating the presence of pathogenic organisms.
The Spaulding Classification system was proposed in 1972 by Dr. Earle Spaulding and
classifies equipment and instruments for disinfection and sterilization based on the risk of
infection for the patient.14,15 This classification system has withstood the passage of time
and continues to be used today to determine the correct method for preparing equipment
and instruments for patient use. Items to be sterilized or disinfected have been classified
as critical, semi-critical, and non-critical, based on the risk of infection for the patient.
According to the Spaulding system, the requirements for sterilization or disinfection are
based on the nature of the device or instrument and the manner in which it is to be used.
These categories are:
Critical
Critical items are instruments or devices that are introduced directly into the bloodstream
or other normally sterile areas of the body. These items require sterilization. Critical items
include surgical instruments, certain types of catheters, needles, and implants.
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Semi-critical
Semi-critical items are instruments or devices that come in contact with intact mucous
membranes but do not ordinarily penetrate the blood barrier. These items may be either
sterilized or high-level disinfected. Semi-critical items include noninvasive flexible and
rigid fiber optic endoscopes, endotracheal tubes, and anesthesia breathing circuits.
Non-critical
Non-critical items are instruments or devices that do not ordinarily touch the patient
or touch only intact skin. These items can be cleaned and then disinfected with an
intermediate level disinfectant, sanitized with a low level disinfectant, or cleaned with
soap and water. Non-critical items include blood pressure cuffs, bedpans, linens,
furniture, floors, and other medical accessories.
DECONTAMINATION AND CLEANING OF SURGICAL
INSTRUMENTATION
Surgical instrumentation can be used and processed numerous times during the course
of a busy day. Ensuring that all instruments are properly decontaminated, cleaned,
and prepared for use is critical for any surgical department in promoting safe patient
care. Processing starts with the initial use in the operating room (OR) during a case,
then involves disassembly, decontamination and cleaning, re-assembly, packaging, and
high-level disinfection or sterilization. Many standards and recommended practices have
been developed and approved by various professional organizations to assist facilities in
proper decontamination of surgical instruments for terminal disinfection or sterilization.
The efficacy of a terminal sterilization or disinfection process depends upon lowering
or limiting the amount of bioburden on the item to be processed; therefore, items to be
processed should be precleaned to reduce the bioburden to the lowest possible level.2 In
this regard, when an instrument is suspected of harboring soil or debris that can prevent
proper sterilization, decontamination needs to take place. As such, decontamination is
the first step in the process of preparing an instrument for reuse. Recommendations for
proper cleaning and care of surgical instruments are outlined below.3
• Instruments should be kept free of gross soil during surgical procedures.
Blood and bodily fluids can cause pitting of instruments and, if left to dry, are
often difficult to remove. If blood and bodily fluids are not removed, they can
prevent adequate sterilization, which could be an avenue for transmission of
other potentially infectious materials. During a procedure, the scrub assistant
should constantly assess used instruments and wipe gross debris from them to
promote proper functionality and reduce the presence or build-up of bioburden. In
addition, instruments with lumens should be irrigated with sterile water as needed
throughout the procedure.
• To prevent the formation of biofilm cleaning and decontamination should occur
as soon as possible after instruments and equipment are used. As noted above,
cleaning and decontamination must be thoroughly accomplished or disinfection
and sterilization may not be effective. Furthermore, all instruments opened for
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an operative or invasive procedure should be considered contaminated and
therefore, should be decontaminated, whether or not they have been used. Even
though an instrument may not have been used during the surgical case, it may
have been inadvertently touched by a scrubbed person’s soiled glove, or have
come into contact with instruments that have been used.
• Contaminated instruments must be contained during transport and should be
transported in a timely manner to a location designed for decontamination. Proper
containment of contaminated instruments reduces the potential for injury to
personnel or their exposure to infectious organisms; it also prevents damage to
the instruments during transport.
• Instruments should be decontaminated in an area that is physically separated
(ie, with a door) from locations where clean activities are performed to minimize
the risk of cross-contamination. For example, cross-contamination can result
when soiled items are placed in close proximity to clean items or placed on
surfaces upon which clean items are later placed. In addition, aerosols created
during cleaning can also cause cross-contamination. Instruments should not be
decontaminated in scrub or hand sinks, as these are used for clean activities, eg,
hand washing, surgical hand antisepsis.
• The automated washer is the safest method for cleaning and provides an
effective cleaning process. It is commonly used in hospitals or very large dental
clinics. Contaminated instruments are placed in cassettes or baskets. Then
they are run through the unit’s cycle of cleaning, rinsing, and disinfection at
temperatures high enough to provide at least a high-level of disinfection. This
results in a “no touch” system in which the potential for injury during instrument
processing is greatly reduced.
• The automated cleaning process generally entails the following steps:
◦◦ Gross removal of soil.
◦◦ Arrangement of devices in washer basket to prevent contact between the
devices and assist in water drainage.
◦◦ Washer disinfector cycle:
▪▪ Pre-rinse for 2 minutes with cold tap water.
▪▪ Enzyme wash 2 minutes with hot tap water (60°C set point).
▪▪ Rinse for 2 minutes with hot tap water (60°C set point).
▪▪ Dry for 15 minutes at 115°C.
◦◦ Visual inspection of devices.
◦◦ If any visible debris is observed on the products during inspection, the
cleaning must be repeated.
• The type of water available for cleaning should be consistent with the
manufacturer’s written instructions and intended use of the equipment and
cleaning agent. Water quality is affected by several factors including conductivity;
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the presence of dissolved mineral solids, chlorides, and other impurities; and
its acidity or alkalinity. Water quality also fluctuates over time. The optimum
combination of chemicals used in a washer decontaminator is based on the
hardness of the available water. Potable water should be used for either manual
or automated decontamination methods unless contraindicated by instrument
manufacturers’ instructions; softened or deionized water should be used for the
final rinse.
• Surgical instruments, medical devices, and equipment manufacturers’ validated
instructions should be followed regarding the types of cleaning agents (eg,
enzyme preparations, detergents) to be used for decontamination. Following
the manufacturers’ instructions reduces the possibility of selecting and using
cleaning agents that could potentially be harmful to instruments (eg, abrasives
can damage the protective surfaces of instruments, contribute to corrosion, or
impede sterilization). Moreover, the use of inappropriate cleaning agents can
result in damage to the instruments and equipment, and possibly limit or void their
warranties.
• All surgical instruments, medical devices, and equipment manufacturers’
validated instructions should be followed regarding the types of cleaning
methods (eg, manual, automated) to be used for decontamination. The use of
inappropriate cleaning methods could also result in damage and can potentially
limit the warranty of the surgical instruments or equipment.
• Surgical instruments should be inspected for cleanliness and proper working
order after decontamination, prior to assembly of trays, in order to identify those
instruments that require additional cleaning or repair before use. Instruments
should be inspected for:
◦◦ Cleanliness;
◦◦ Alignment;
◦◦ Corrosion, pitting, burrs, nicks, and cracks;
◦◦ Sharpness of cutting edges;
◦◦ Loose set pins;
◦◦ Wear and chipping of inserts and plated surfaces;
◦◦ Missing parts;
◦◦ Any other defects;
◦◦ Removal of moisture; and
◦◦ Proper functioning.
Instruments can become damaged during use or decontamination. Sterilization may not
occur in the presence of soil or water. Instruments should be thoroughly dried to help
prevent rust formation during instrument storage. Furthermore, the presence of moisture
can impede various sterilization processes. For example, moisture on instrument
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surfaces alters the moisture content of steam and can pose a challenge for effective
heating of the instrument. Ethylene Oxide (ETO) combines with water and creates
ethylene glycol (ie, antifreeze), which is toxic and is not removed during aeration. Excess
moisture also inhibits the hydrogen peroxide plasma sterilization process and can result
in an aborted cycle.
The instrument manufacturers’ written instructions should be followed for selection and
appropriate use of lubricants, which reduce friction between working surfaces; however,
some instruments do not require lubrication. Cleaning, in particular ultrasonic cleaning,
removes lubricants from instruments. Instruments should be clean before the lubricant is
applied, since applying lubricants to soiled instruments can compound the problem of stiff
joints and inhibit smooth movement. Lubricants should be compatible with the method of
sterilization to be used.
• Cleaned surgical instruments should be organized for packaging in a manner
to allow the sterilant to contact all exposed surfaces. Proper organization and
adequate drying facilitate contact of the sterilant on all instrument surfaces.
Instruments should be placed in a container tray or basket that is large enough to
evenly distribute the metal mass in a single layer.
• Special precautions should be taken for reprocessing ophthalmic surgical
instruments, as Toxic Anterior Segment Syndrome (TASS) can result from
contaminants introduced into the eye during ophthalmic surgical procedures.
Instruments should be wiped clean with sterile water and a lint-free sponge during
the procedure, since viscoelastic solution can harden on instruments within
minutes. The instruments should be immersed in sterile water immediately at the
end of the procedure; keeping the organic material moist to prevent the formation
of biofilm. Single-use cannulas should be used whenever possible. If reusable
cannulas are used, the lumens should be flushed with sterile water immediately
at the end of the procedure. As with all instruments, the manufacturers’ written
instructions for cleaning each instrument should be reviewed and followed.
• Insulated electrosurgery instruments should be decontaminated after use
according to manufacturers’ validated, written instructions and inspected for
damage. Breaks in the insulation of electrosurgery instruments can occur during
use and handling; these insulation failures can cause current leakage and
result in subsequent burns. Inspection of the instruments provides a screening
mechanism to identify visible breaks in the insulation.
• Special precautions should be taken when cleaning robotic instruments. This
type of instrumentation has lumens with complex, difficult to clean internal and
external components that require special attention to adequately decontaminate
them. Gross soil should be removed from the external surfaces with a soft-bristled
brush. The ports of robotic instruments and equipment should be flushed:
◦◦ With a water line,
◦◦ In the sequence and for the duration identified by the manufacturers’ written
instructions,
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◦◦ While moving the robotic wrist through a full range of motion to expose all
surfaces to the cleaning solution, and
◦◦ Until the fluid exiting the ports is clear.
The fluid expelled from the ports during flushing should be directed into a drain and
not allowed to run into the receptacle of clean solution. Ports should be primed with
clean enzymatic cleaner and the device cleaned in an ultrasonic cleaner according the
manufacturer’s written instructions. Ultrasonic cleaning facilitates removal of debris
that has adhered to any parts. After ultrasonic cleaning, the ports should be flushed
with deionized water under pressure in the sequence and duration identified by the
manufacturer’s written instructions to remove residual cleaning solution. Ports should
also be cleared with compressed air in the sequence and duration identified by the
manufacturer’s written instructions. The movable parts of robotic instrumentation should
be lubricated according to the manufacturer’s written instructions; lubrication facilitates
the functioning of the hinges and joints of robotic instruments which coordinate fine
dissection and manipulation of tissue. The outside of the instruments should be wiped
with alcohol or an instrument disinfectant, before preparation for steam sterilization to
render the instrument safe to handle.
• Special precautions should be taken to minimize the risk of transmission of prion
diseases (see Special Considerations below).
• Personnel handling contaminated instruments and equipment must wear
appropriate personal protective equipment (PPE) and should be vaccinated
against the hepatitis B virus. Personal protective equipment helps to protect the
employee from exposure to bloodborne pathogens and other potentially infectious
materials. The appropriate PPE for these types of exposures include, but are not
limited to, a fluid-resistant gown, heavy-duty gloves, a mask, and face protection.
In addition:
◦◦ Hands must be washed after removing PPE, as perforations can occur in
gloves, and hands can become contaminated while removing PPE.
◦◦ Reusable protective attire must be decontaminated and the integrity of the
attire confirmed between uses.
◦◦ Two pairs of gloves should be worn when cleaning instruments and
equipment, if there is a risk for perforation of the outer glove.
Exposures to bloodborne pathogens should be reported immediately through the
approved health care organization channels.
DECONTAMINATION AND REPROCESSING OF BATTERY POWERED
SURGICAL INSTRUMENTATION
Cleaning and Decontamination. Cleaning begins at the point of use; instruments should
be kept clean and free of gross soil throughout a surgical procedure.4 Blood and bodily
fluids can cause damage to instruments and powered equipment; they can also be
difficult to remove if left to dry. Instruments should be kept clean and wiped as needed
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with sterile sponges moistened with sterile water (not saline) during the procedure to
remove gross soil (ie, blood and body fluids) since these fluids, as well as saline, are
highly corrosive. Damage to instruments and equipment (ie, corrosion, rust, and pitting)
can occur when saline, blood, and debris are left to dry in or on surgical instruments. If
dried blood and debris are not removed from all surfaces during the decontamination
process, subsequent disinfection or sterilization may not be achieved, which could
potentially be an avenue for transmission of other potentially infectious materials.
Attachments, including blades, drill bits, chucks, burr guards, and wrenches, should
be removed from powered equipment in the OR by the scrub person at the end of the
procedure. These attachments are all metal and retain a great deal of blood and debris.
Organic debris left on powered equipment hinders the sterilization process and can
interfere with proper functioning. If debris is not removed during the procedure and
subsequent transport, biofilm will build within the complex lumens, movable parts, and
intricate internal components. In addition, sharp accessories should be segregated
from other instruments in order to minimize the risk of injury to personnel handling the
equipment during decontamination. Heavy instruments, such as drills and other powered
equipment, should be placed on the bottom of storage containers or in a separate tray.5
Many powered instruments cannot be submerged in an enzymatic solution, but can be
covered with a wet towel until the decontamination process can begin. Transportation
to the decontamination area should be immediate and should take place in a manner
to prevent exposure of patients and personnel to infectious organisms.6 Following
transportation, decontamination takes place. Decontamination should occur as soon as
possible after the equipment is used in order to prevent the formation of biofilm, as noted
above. The goal is to reduce the microorganisms on the instrument to render it safe for
handling.
Transportation to the Decontamination Area. Contaminated instruments must be
contained during transport and should be transported in a timely manner to a location
designed for decontamination.7 Proper containment of instruments reduces the potential
for injury to personnel or their exposure to infectious organisms; it also prevents
damage to the instruments during transport. The Occupational Safety and Health
Administration’s (OSHA) bloodborne pathogen standard requires that during transport to
the decontamination area, contaminated instruments must be contained in a leak-proof
container to minimize the risk of exposing personnel or patients to bloodborne pathogens
and other potentially infectious organisms.8
Decontamination. During decontamination, powered surgical equipment and
accessories that are composed of more than one piece should be opened, disassembled,
and arranged in an orderly fashion. Disassembling and opening of instruments and
equipment followed by their proper arrangement minimizes the risk of instrument
displacement and improves the efficiency of reprocessing.
When manually cleaning, instruments should be washed in a manner that provides
proper decontamination. Although automated methods are preferred, some delicate
instruments (eg, microsurgery, eye), powered equipment, and other instruments that
cannot be submerged require manual cleaning. Manual cleaning should be accomplished
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by submerging the instrument in warm water with an appropriate detergent followed by
complete submersion of the instrument in rinse solution to minimize aerosolization of
contaminants. Aerosolization of contaminants, splashing of infectious material, and injury
from sharp objects are possible when manual cleaning is performed under a stream of
running tap water.
Powered surgical instruments should not be immersed or placed under running water,
in ultrasonic cleaners, washer disinfectors, or washer sterilizers unless indicated by the
manufacturer.9 The surface of the instrument should be wiped with a mild detergent,
using caution to prevent the solution from entering the internal mechanism. The
detergent is wiped off with a damp cloth and the mechanism is dried with a lint-free
towel. Air hoses should remain attached when cleaning pneumatic handpieces, keeping
the internal parts of the handpiece dry during cleaning; powered instruments can be
damaged if fluid is allowed to come into contact with internal mechanisms. The air hose
and electrical cord should be wiped with detergent, a damp cloth, and dry towel. The
accessories are disassembled for cleaning.
Hand clean powered instruments with a neutral or mild alkaline pH enzymatic solution
and ensure that all surfaces are thoroughly wetted. Use a stiff, non-metallic brush,
paying attention to crevices and hard-to-reach areas such as seams, joints, triggers,
and connectors. Use a bottle brush to clean cannula. Rinse the instrument to remove all
cleaning solution. Check with the manufacturer if running water is to be used. Repeat the
hand washing until all debris is removed and then dry thoroughly.
Inspection. Inspection of the instruments and equipment for cleanliness and proper
working order is the step following decontamination and cleaning. Inspecting instruments
and equipment for sterilization before assembly of trays provides an opportunity
to identify those instruments that require additional cleaning or repair before use.
The equipment should be inspected for corrosion, pitting, missing parts, and proper
seating of attachments; the instrument should be tested for proper working order prior
to sterilization. Air hoses should be inspected for damage or wear before and after
decontamination and before use.10 All traces of detergent or germicide and excess fluids
should be gone from the surface of the air hose. Batteries and power cords should be
inspected for damage, cracks, and wear. The surface of hoses and cords should be clear
of debris and traces of cleaning solutions.
Powered equipment should be lubricated with a product specifically recommended by
the manufacturer and applied according to manufacturers’ instructions.11 Lubrication
of powered equipment and attachments may be recommended because it decreases
friction between working parts, which is essential for optimal functioning of the
instrument and helps to prolong equipment life. Some powered instruments are sealed
and do not require lubrication, while others have a longer life span if the maintenance
recommendations are followed.12 Manufacturers may recommend an oil-based or nonoilbased lubricant for powered equipment. Water-soluble lubricants allow steam penetration
during sterilization; however, oil-based products cannot be penetrated and thus prevent
the sterilant from contacting the instrument’s surface.
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Upon inspection, any instrument or device found to be in disrepair should be tagged
or labeled and removed from service until it is repaired. Identification of defective
instruments facilitates segregation of these instruments from those to be used when
assembling sets and prevents defective instruments from being used on patients.
Packaging. Only validated containment devices should be used to organize or segregate
instruments within sets. Many devices used to organize or segregate instruments
within sets have not been validated as safe and effective by container or wrap/pouch
manufacturers. The presence of these devices inside of a packaged instrument set can
prohibit:
• Air removal,
• Sterilant contact with instruments in close proximity to the containment device,
• Sterilant evacuation, and
• Condensate drainage and drying.
◦◦ Rubber bands should not be used to keep several instruments together.
Sterilant cannot contact surfaces beneath rubber bands and instruments
may not be sterilized.
◦◦ Paper-plastic peel pouches should not be used to organize or segregate
instruments within sets unless their use is validated by the containment
device manufacturer.
◦◦ Small accessory baskets or boxes with lids or covers to contain instruments,
parts, or accessories should not be incorporated into sets unless their use is
validated by the containment device manufacturer.
◦◦ Nonabsorbent, nonwoven disposable wrap material (eg, polyolefin
spunbound) should not be used as a tray liner or to organize or segregate a
small group of instruments to be placed into the instrument set. This type of
material is not intended for use within an instrument set that is to be steamsterilized because it does not absorb moisture. Moisture can pool on this
material, causing a wet pack.
Secure, protective packaging is best for powered instruments. For example,
rigid sterilization containers offer ease of handling and maximum protection. The
manufacturer’s technical data for types of devices validated for use inside the container
(eg, power equipment, items with lumens) should be obtained and special instructions for
sterilization followed.13
STERILIZATION VERSUS DISINFECTION
Disinfection
Disinfection is generally a less lethal process than sterilization.16 Disinfection is the
process of killing some, but not necessarily all, microbial life on an item or surface
(eg, bacterial spores). Disinfection is a procedure that reduces the level of microbial
contamination, but there is a broad range of activity that extends from sterility to a
minimal reduction in the number of microbial contaminants. Chemical disinfection
16
and particularly high-level disinfection differs from chemical sterilization by its lack of
sporicidal ability. Chemical disinfectants vary in their level of effectiveness and are
influenced by:
• The nature and number of contaminating microorganisms, especially bacterial
spores.
• The amount of organic matter present, such as soil, blood, and feces.
• The type and condition of the instruments, devices, and materials to be
disinfected.
• The concentration, time of exposure, pH, and the required temperature of the
chemical disinfectant.
• Water hardness and the presence of surfactants.
Spaulding also classified chemical germicides by activity level.
High-Level Disinfection
High-level disinfection kills vegetative microorganisms and inactivates viruses, but
not necessarily a high number of bacterial spores. As high-level disinfectants, they
are generally used for short periods of time, but may be capable of sterilization when
the contact time is extended. The manufacturer’s instructions should be followed to
determine the appropriate outcome. These agents are also called chemical germicides
and in the United States are classified by the Food and Drug Administration (FDA) as
sterilant/disinfectants.
Intermediate-Level Disinfection
Intermediate-level disinfection kills vegetative microorganisms, including Mycobacterium
tuberculosis, most fungi, and inactivates most viruses. These chemical germicides
often correspond to the Environmental Protection Agency (EPA) approved “hospital
disinfectants” that are also “tuberculocidal”.
Low-Level Disinfection
Low-level disinfection kills most vegetative bacteria except M. tuberculosis, some fungi
and inactivates some viruses. The EPA approves these chemical germicides in the
United States as “hospital disinfectants” or “sanitizers”.
Sterilization
Sterilization is defined as the complete elimination or destruction of all forms of microbial
life. A sterilization process is one that kills all microorganisms, including a high number
of bacterial spores. Sterilization processes that are used in the health care environment
include steam, ethylene oxide (EO), low-temperature hydrogen peroxide gas plasma,
peracetic acid, ozone, and dry heat. The term “sterile” is measured as the probability
of sterility for any instrument, device, or other item; this probability is known as Sterility
Assurance Level (SAL). The likelihood that an instrument, device, or item is free of
microorganisms is expressed in terms of the probability of a microorganism surviving
the sterilization process. SALs can be used to describe the microbial population that
17
was destroyed by the sterilization process. Each log reduction 10-1 represents a 90%
reduction in microbial population. So if a 6 log reduction is achieved (10-6) it will reduce
a million organisms to very close to zero. Generally, in the health care environment, a
SAL of 10-6 is an acceptable SAL meaning that there is one chance in one million that an
instrument, device or item is contaminated or unsterile.
Several factors affect the success of the sterilization process. These factors include:
• The sterilizer or sterilizing system must be properly designed and achieve the
correct combination of temperature, pressure, and sterilant concentration.
• The bioburden (the number of microorganisms on the instrument, device, or item)
must be low enough to ensure the effectiveness of the sterilization process. The
instrument, device, or item must be as clean as possible, therefore reducing the
bioburden to as low as possible, before sterilization is attempted.
• There must be adequate contact of the sterilant for a sufficient amount of time,
and the packaging and loading of instruments, devices, and items must allow for
the sufficient contact of the sterilant.
METHODS OF STERILIZATION
Steam Sterilization
17,18
Saturated steam under pressure is the preferred sterilization method. Steam sterilization
is the oldest, safest, most economical and reliable method of sterilization available in
the health care environment. Steam sterilization should be used to sterilize heat- and
moisture-stable instruments, devices, and items unless otherwise indicated by the
sterilizer or instrument, device, or item manufacturer. Steam sterilization is dependent
upon steam pressure, exposure time, drying time, and steam quality.
Cycle parameters recommended by the device manufacturer should be reconciled
with the sterilizer manufacturer’s written instructions for the specific sterilization cycle
and load configuration. In addition, certain types of equipment and implants (eg, some
pneumatically powered instruments) may require prolonged exposure times or drying
times. Following steam sterilization, the contents of the sterilizer should be removed from
the chamber and left untouched for a period of 30 minutes to two hours, depending on
the load content.
Manufacturers’ written instructions for operating steam sterilizers should be followed
because steam sterilizers vary in design and performance characteristics. A variety of
steam sterilization cycles are used in health care organizations. The practitioner should
be informed regarding the differences and performance of the following:
• Gravity-displacement cycles.
• Dynamic air-removal (ie, prevacuum).
• Steam flush pressure cycles.
• Immediate use “flash” cycles and express cycles.
18
Recommendations from the sterilizer manufacturer may need to be reconciled with
the instrument, device, or item manufacturer regarding specific instructions for specific
sterilization cycle times and load configuration. Certain instruments, devices, and items
may require prolonged exposure times and drying times. Once the steam sterilization
cycle is complete, the load should be removed from the sterilizer and left untouched until
adequate cool down and drying has been achieved.
Immediate use sterilization of instruments, devices, and items should be used only in
selected clinical circumstances where sterilization by the preferred wrapped method
is not possible. Immediate use sterilization should not be used as a substitute for
insufficient inventory. Immediate use sterilization is not recommended due to the increase
risk of infection to the patient. This results from the tendency to eliminate one or more of
the essential steps in the cleaning and sterilization process due to the pressure of time
constraints to deliver a sterile product. The cycle time must be correct for the instrument,
device, or item. Disassembly and thorough cleaning must be performed; instruments,
devices, or items must be used immediately and not stored. In addition, transfer to the
sterile field must occur without risk of contamination.
Chemical Sterilization
Today’s technology has allowed for the development of materials used in instruments,
devices, and items that may not be heat- and moisture-stable, thus requiring the use
of other sterilization methods. These methods are often referred to as low-temperature
sterilization and include ethylene oxide (ETO), low-temperature gas plasma, peracetic
acid, ozone, and dry heat.19
Ethylene Oxide (ETO)
Ethylene oxide is a colorless gas that has an odor similar to ether in high concentrations,
but is odorless in lower concentrations. ETO is an effective alkylating agent making it
a good sterilant against a wide range of microorganisms. ETO is non-corrosive and
non-damaging to a wide variety of heat and moisture sensitive materials. Although an
effective sterilant, ETO must be used with care due to its known toxicity and the fact that
it is a known carcinogen and may contribute to adverse reproductive effects. It is also
highly explosive and very flammable in the presence of air and is usually diluted with inert
gases. Factors that affect sterilization with ETO include:
• Time of exposure.
• Gas concentration.
• Temperature, humidity, and penetration.
• Instruments, devices, and items must be thoroughly dried to prevent the formation
of ethylene glycol during the sterilization cycle.
The manufacturer of any instrument, device, or item should provide written instructions
for compatibility with ETO before sterilization. Instruments, devices, and items sterilized
in ETO must be aerated to make them safe to handle by personnel and for patient use.
Any ETO residual that is absorbed into these items may pose a hazard to both personnel
19
and patients. Any instrument, device, or item that is not sufficiently aerated may cause
personnel or patient injury. Exposure to ETO can cause skin irritation, burns of body
tissue, and hemolysis. Adequate aeration times reduce ETO vapors and residue to
a level safe for both personnel and patients. Instruments, devices and items that are
removed prematurely from an aeration cycle cannot be rinsed to remove ETO and may
create a hazardous by-product. Long sterilization exposure times and aeration periods
make ETO a lengthy sterilization process that can add additional costs for processing. All
instruments, devices, and items should first be evaluated for steam sterilization before
being placed in ETO. Personnel who have the potential for ETO exposure should wear
monitoring devices that meet the National Institute for Occupational Safety and Health
(NIOSH) standards.
Low-Temperature Hydrogen Peroxide Gas Plasma
Low-temperature hydrogen peroxide gas plasma is an oxidizing sterilization process
that uses hydrogen peroxide as a precursor which is then vaporized. Radiofrequency
energy is then used to create an electromagnetic field to excite the precursor. Hydrogen
peroxide vapor kills microorganisms. The hydrogen peroxide vapor is then charged with
radiofrequency, and the plasma that is created removes hydrogen peroxide from the
sterilized instruments, devices, and items. The by-products of this sterilization process
are oxygen and water (in the form of humidity). The sterilized items are dry at the end of
the completed cycle and aeration is not required because there are no toxic by-products.
Contact with hydrogen peroxide may cause irritation, but is considered to be noncarcinogenic and non-mutagenic. Factors that affect sterilization with gas plasma include:
• Selection of appropriate packaging materials; cellulosic-based products such as
paper and linen are not recommended.
• Lumen restrictions on certain instruments, devices and items may apply.
• Instruments, devices, and items must be dry at the time of packaging.
• Trays and container systems must be approved for the sterilization process.
• Sterilization cycle times may vary due to the contents of the sterilizer load.
Peracetic Acid
Peracetic acid is an oxidizing agent that is an effective biocide at low temperatures.
Peracetic acid solution contains acetic acid and hydrogen peroxide; it is acetic acid
plus an extra oxygen atom. Peracetic acid disrupts protein bonds and cell systems. The
extra oxygen inactivates cell systems and causes immediate death. Peracetic acid does
not leave any toxic residuals on instruments, devices, and items that have been rinsed
properly. However, serious injuries can occur if peracetic acid is not handled, neutralized,
and rinsed properly. Peracetic acid is a low-temperature nonterminal sterilization method
for instruments, devices, and items that are immersable. This method of sterilization
is primarily used for rigid and flexible endoscopes and accessories. The method offers a
relatively quick turnaround time, but the instruments, devices, and items are wet at the end
of the cycle and should be transported and used immediately and not allowed to remain
in the processor or be stored. Factors that affect peracetic acid sterilization include:
20
• Water temperature, pressure, and fill time.
• Materials compatibility; may be corrosive to some instruments, devices, and
items.
• Selection of appropriate adapters and connection devices for instruments,
devices, and items with lumens.
• Transportation to the point of use.
• Instruments, devices, and items cannot be stored.
Ozone
Ozone is an oxidizing sterilization process and is a low-temperature sterilization
method. Ozone is an oxidative gas that deactivates microorganisms by denaturing
cell membranes. Ozone is generated within the sterilizer using water and oxygen. The
oxygen is subjected to an electrical discharge in an enclosed space. The by-products
of the ozone sterilization process are oxygen and low-humidity water vapor. Therefore,
there is no need for aeration. The end product is dry and ready for immediate use after
approximately 4.5 hours. Factors that affect ozone sterilization include:
• Selection of appropriate packaging materials; cellulosic-based packaging
materials such as paper and linen are not recommended.
• Lumen restrictions on certain instruments, devices, and items may apply.
• Trays and container systems must be approved for the sterilization process.
Dry Heat Sterilization
Dry heat sterilization is generally used only for specialized purposes in most health care
facilities. Dry heat should be used only for instruments, devices, or items that cannot be
sterilized by other methods, when the moisture of other processes would damage the
materials, or the materials would be impermeable to another sterilization method. Dry
heat is an oxidation or slow burning process that coagulates protein in microbial cells.
Dry heat sterilization is accomplished by conduction. The heat is absorbed by the exterior
surface of the instrument, device, or item and then passed inward to the next layer.
Eventually, the entire instrument, device, or item reaches the proper temperature for
sterilization. Sterilization by dry heat is accomplished in hot-air convection ovens which
are typically either gravity convection or mechanical convection. Instruments, devices,
and items that are suitable for dry heat sterilization are anhydrous oils (contain no
water), syringes, and needles which must be pyrogen; also free, petroleum ointment and
gauze, powders, and other oil-based products that will not allow adequate penetration of
moisture. Today, many of these items are available in a sterile, single-use form.
Factors that affect dry heat sterilization include:
• Longer sterilization time due to the lack of moisture.
• Dry heat penetrates materials slowly and unevenly.
• High temperatures are required, so rubber goods and fabrics are not
recommended in this method.
21
• Packaging selection is limited.
• Temperature parameters refer to the temperature of the load and not the sterilizer
chamber.
• The higher the temperature, the shorter the exposure time needed to achieve
sterilization.
Liquid Chemical Sterilization
Liquid chemical sterilization is possible with chemical disinfectants such as
glutaraldehyde and peracetic acid. Liquid chemical sterilization is dependent upon the
concentration of the active chemical, temperature, and the amount of contact time the
instrument, device, or item is submersed. In addition, the instrument, device, or item
must be submersible. This is a lengthy process that can require from 6-10 hours. Liquid
chemical sterilization is not generally used in health care facilities for these reasons. If
this method of sterilization is considered, the manufacturer of the chemical sterilant and
the instrument, device, or item manufacturer’s recommendations should be consulted.
STERILIZATION MONITORING
Many variables affect the achievement of sterility, therefore monitoring the sterilization
process is essential. Mechanical, chemical, and biological monitoring methods are used
to assist in identifying and preventing sterilizer malfunctions and operational errors made
by personnel.20
Mechanical monitoring devices provide real-time assessment of sterilizer cycle conditions
and permanent records by means of either a chart recording or computer printout. The
operator can physically assess time, temperature, pressure, printouts, and gauges as a
means to verify that all “cycle parameters” have been met. This also allows for a physical
assessment to warn if a sterilizer failure may have occurred.
Chemical monitoring in the form of a sterilization chemical indicator should be used
inside and outside of each package and load sterilized. External chemical indicators
are used on the outside of packages and are often used as packaging closures such as
sterilizer indicator tape. The purpose of the external chemical indicator is to differentiate
between processed and unprocessed items. An internal chemical indicator or integrator
should be placed inside packaging to indicate whether the contents have been exposed
to one or more of the conditions necessary for sterilization. These should be placed in
an area of the package that is believed to be least accessible to sterilant penetration,
therefore presenting the greatest challenge. Internal chemical indicators do not establish
whether or not an item is sterile, but demonstrate that the contents were exposed to the
sterilant. There are a variety of internal chemical indictors available and manufacturers’
instructions should be reviewed for selection with the appropriate sterilant and outcome.
A biological indicator is the most accurate method of monitoring sterilization
effectiveness. A biological indicator is commercially prepared with a known population
of highly resistant spores that tests the effectiveness of the method of sterilization
being used. The biological indicator is used to demonstrate that conditions necessary
22
to achieve sterilization were met during the sterilization cycle. Different sterilization
methods require different biological organisms to be used for routine load release, routine
sterilizer efficacy monitoring, sterilization qualification testing, and periodic product
quality assurance. Biological indicators require incubation for various amounts of time
to obtain results. The manufacturer’s instructions, as well as professional organizational
guidelines, such as the Association for the Advancement of Medical Instrumentation
should be reviewed for frequency, load related requirements, and sterilizer qualification
testing. The organisms used in biological indicators are specific to the type of sterilant
and have been tested to be the most resistant to that specific sterilization process.
• Steam sterilizers: Goebacillus sterothermophilus.
• Ethylene oxide sterilizers: Bacillus atropheus (formerly Bacillus subtilis).
• Low-temperature hydrogen peroxide gas plasma: Geobacillus sterothermophilus.
• Ozone sterilizers: Geobacillus sterothermophilus.
• Liquid peracetic acid sterilizers: Geobacillus sterothermophilus.
• Dry heat sterilizers: Bacillus atropheus.
Sterilization records should include information on each load that is processed and
include a lot control number designating the sterilizer used, the date of sterilization,
and the cycle number. The purpose of labeling each package with a lot number and
maintaining detailed sterilization records is to allow items processed in a particular load
to be retrieved if their sterility becomes suspect. If items from a suspect load can be
easily traced, it is then possible to retrieve or recall them quickly and attempt to identify
the patients on whom they may have been used.
Monitoring of chemical disinfectants used for high-level disinfection should be performed
using a test strip or other FDA-cleared testing device specific for the disinfectant and
minimum effective concentration (MEC) of the active ingredient.21 These should be used
according to the manufacturer’s written instructions for monitoring the disinfectant’s
potency. Testing devices may be available from manufacturers of individual products and
may have been designed specifically for that product and other testing devices may not
be able to be substituted. If a solution falls below the recommended MEC, the solution
should be discarded, even if the designated expiration date has not been reached.
When the solution is poured into a sterile container and labeled with an expiration date,
this date indicates only the date on which the solution was prepared for use and when
the solution is no longer active. The solution may become diluted with use as items are
processed and therefore, may lose its MEC before the expiration date.
SPECIAL CONSIDERATIONS
Creutzfeldt-Jakob Disease (CJD)22,23,24
Creutzfeldt-Jacob disease (CJD) is an infectious, neurodegenerative, and fatal disease
of the central nervous system. CJD is classified as a human transmissible spongiform
encephalopathy (TSE). CJD is considered a slow viral infection caused by a selfreplicating protein known as a prion. Prions are a unique class of pathogens because
23
an agent, specific nucleic acid (DNA or RNA), has not been detected. Prions occur in
humans and animals, primarily affecting the central nervous system. Prions can be
sporadic (spontaneous; no family history and no known source of transmission), familial
(genetic/inherited; inherited in the form of a mutant gene) or acquired (transmitted by
infection). Iatrogenic transmissions of CJD have been reported and are transmissions
of the disease due to medical interference, such as the transmission by contaminated
instruments, devices, or items. Most of these exposures and transmissions have been
as a result of inadequately cleaned and sterilized instruments and devices; or items that
have retained infectious brain, dura mater, pituitary gland, and/or eye tissue.
CJD and TSE are usually resistant to conventional chemical and physical
decontamination methods. The causative prions are resistant to steam, dry heat, and
ethylene oxide sterilization and chemical disinfection. Special protocols for instruments,
devices, and items after exposure to prions need to be followed. Single-use instruments,
devices, and items should be used whenever possible. Facility policies and procedures
should be developed by a current literature review of the following:
• World Health Organization (WHO);
• Centers for Disease Control and Prevention (CDC);
• Association of periOperative Nurses (AORN); and
• Association for Practitioners in Infection Control and Epidemiology (APIC).
According to the CDC, inactivation studies have not rigorously evaluated the
effectiveness of actual cleaning and reprocessing methods used in health care facilities.
Recommendations to reprocess instruments potentially contaminated with the CJD
agent are primarily derived from in vitro inactivation studies that used either brain tissue
or tissue homogenates, both of which pose enormous challenges to any sterilization
process.
Annex III of the World Health Organization (WHO) has developed CJD infection control
guidelines that can be a valuable guide to infection control personnel and other health
care workers involved in the care of CJD patients. One of the three most stringent
chemical and autoclave sterilization methods outlined in Annex III should be used to
reprocess heat-resistant instruments that come in contact with high infectivity tissues
(brain, spinal cord, and eyes) and low infectivity tissues (cerebrospinal fluid, kidneys,
liver, lungs, lymph nodes, spleen, olfactory epithelium, and placenta) of patients with
confirmed or suspected CJD.
The three most stringent methods for heat-resistant instruments are listed below, and
are listed in order of more to less severe treatments. Sodium hypochlorite may be
corrosive to some instruments, such as gold-plated instruments. Before instruments are
immersed in sodium hypochlorite, the instrument manufacturer should be consulted.
The instruments should be decontaminated by a combination of the chemical and
recommended autoclaving methods before subjecting them to cleaning in a washer cycle
and routine sterilization.
24
Autoclave/chemical methods for heat-resistant instruments:
1. Immerse in a pan containing 1N sodium hydroxide (NaOH) (ie, 1 Normal or
1 Molar concentration of NaOH) and heat in a gravity displacement sterilizer
autoclave at 121°C for 30 minutes; clean; rinse in water and subject to routine
sterilization.
a.The pan containing sodium hydroxide should be covered, and care
should be taken to avoid sodium hydroxide spills in the autoclave. To
avoid autoclave exposure to gaseous sodium hydroxide condensing on
the lid of the container, the use of containers with a rim and lid designed
for condensation to collect and drip back into the pan is recommended.
Persons who use this procedure should be cautious in handling hot sodium
hydroxide solution (post-autoclave) and in avoiding potential exposure to
gaseous sodium hydroxide, exercise caution during all sterilization steps,
and allow autoclave, instruments, and solutions to cool before removal.
2. Immerse in NaOH or sodium hypochlorite for 1 hour; transfer instruments to
water; heat in a gravity displacement autoclave at 121°C for 1 hour; clean, and
subject to routine sterilization.
3. Immerse in NaOH or sodium hypochlorite for 1 hour; remove and rinse in water,
then transfer to open pan and heat in a gravity displacement (121°C) or porous
load (134°C) autoclave for 1 hour; clean, and subject to routine sterilization.
4. Immerse in NaOH and boil for 10 minutes at atmospheric pressure; clean, rinse in
water, and subject to routine sterilization.
5. Immerse in sodium hypochlorite (preferred) or NaOH (alternative) at ambient
temperature for 1 hour; clean, rinse in water, and subject to routine sterilization.
6. Autoclave at 134°C for 18 minutes.
According to the AORN Recommended Practices for Cleaning and Care of Surgical
Instruments and Powered Equipment, Recommendation XVII25:
XVII.h.If a patient is identified postoperatively as having a prion disease at the time
of surgery, special precautions should be taken. Devices determined to be
potentially contaminated with highly infectious tissue of this patient should
be pulled from service and decontaminated as described above after the
device has been reprocessed. Prions can survive for years. Inadequately
decontaminated instruments pose a risk to subsequent patients who have
had contact with the instruments.
XVII.i.Perioperative nurses and other health care personnel should review current
research on methods of detecting prion infectivity and decontamination
methods. Knowledge about detection of prion contamination on instruments
and the effectiveness of various methods of deactivation is evolving as new
research is published.
25
Loaner Equipment
Loaner equipment presents a significant challenge for health care facilities. As
technology develops and expands, there are requests for instruments, devices, and
items that are not present in the facilities’ current inventory and then often arrive within
a limited time for appropriate processing before a scheduled procedure. The health
care facility must develop policies and procedures to provide for the receipt and use
of loaner instruments, devices, and items that are requested by physicians and are
then provided on a case by case basis. It is imperative that instruments, devices, and
items are scheduled to arrive in enough time for proper inspection, decontamination,
packaging, and sterilization before the scheduled procedure. In addition, enough time
must be scheduled for a similar process to occur at the end of the procedure before any
instruments, items, or devices are retrieved and sent to another facility for use.
It is important to note here that new, repaired, refurbished, and borrowed or consigned
(ie, loaner) battery powered equipment should be examined, cleaned, and sterilized
according to manufacturers’ written instructions before use in the facility.26 When new,
repaired, or refurbished instruments are received into a facility, all moving parts, tips,
box locks, ratchets, screws, and cutting edges should be examined for defects and to
ensure proper working order. Inspecting the instrument verifies that the instrument has
no obvious defects and has not sustained damage during shipping. If indicated, new
instruments should be pretreated according to the instrument manufacturer’s written
instructions.
The Association of periOperative Nurses provides the following guidance in the
“Recommended Practices for Sterilization in the Perioperative Practice Setting”, 2008
Perioperative Standards and Recommended Practices regarding the establishment of
policies and procedures for the receipt and use of loaner equipment.27
Recommendation X
A formalized program between health care organizations and health care industry
representatives should be established for the receipt and use of loaner instrumentation.
Implementation of tracking and quality controls and procedures are necessary to manage
instrumentation and implants brought in from outside organizations and companies.
X.a.
Interdisciplinary collaboration between the health care organizations’
sterile processing, operative services, and commercial health care industry
representatives should be established. The systematic management of
loaner equipment reduces loss and ensures proper decontamination and
sterilization through increased communication and accountability.
X.a.1 The loaner instrumentation process should include, but not be limited to:
• Requesting loaner instrumentation or implant;
• Receiving loaner items, including a detailed inventory list;
• Obtaining manufacturer’s written instructions for instrument care, cleaning,
assembly, and sterilization;
26
• Cleaning, decontaminating, and sterilizing borrowed instrumentation by
the receiving facility, performed in accordance with AORN Recommended
Practices for Cleaning and Care of Surgical Instruments and Powered
Equipment;
• Transporting processed loaner instrumentation to the point of use;
• Returning items to the sterile processing department following the
procedure for decontamination, processing, inventory, and return to the
health care industry representative; and
• Maintaining historical records of the transactions.
X.b.
Personnel should coordinate requests for loaner instrumentation in sufficient
time for loaner items to be processed by conventional sterilization methods.
Advance delivery of loaner items to the receiving health care organization
ensures sufficient time to permit in-house disassembly, cleaning, packaging,
quality assurance testing, and sterilization of the instruments before
scheduled procedures.
X.b.1. Personnel requesting loaner items should specify quantities, estimated time
of use and return, and restocking requirements to circumvent the need for
immediate use steam sterilization.
X.b.2. Immediate use sterilization should not be used as a substitute for
sufficient instrument inventory resulting from the late delivery of loaner
instrumentation.
X.b.1. Loaner instrumentation sterility assurance should begin at the point where
the health care organization personnel assume responsibility for the items.
Failure in instrument cleaning has resulted in the transmission of infectious
agents.
X.c.1. All loaner instruments should be considered contaminated and delivered
directly to the decontamination area for processing. Instruments should
be thoroughly cleaned and dried in a manner consistent with AORN
Recommended Practices for Cleaning and Care of Surgical Instruments
and Powered Equipment and the standards of the Association for the
Advancement of Medical Instrumentation (AAMI) before sterilization.
X.c.2. Newly manufactured loaner items should be properly decontaminated
before sterilization to remove bioburden and substances (eg, oils, greases)
remaining on the item during the manufacturing process.
X.c.3. Clean or sterile items transported to sterile processing should be removed
from external shipping containers. External shipping containers may have
potential microbial contamination due to environmental exposures during
transport.
X.c.4. Rigid sterilization containers should be thoroughly inspected on receipt
and cleaned and decontaminated according to manufacturers’ instructions.
Containers should be inspected for integrity and function.
27
X.c.5. Loaner items, type, and quantity should be inventoried and documented.
X.c.6. Implants and instruments should be visually inspected for damage.
X.c.7. Manufacturers’ instructions on processing and sterilizing loaner items should
be followed.
X.c.8. Loaner items should be decontaminated and handled in accordance with
organizational policy following the procedure.
X.c.9. Implantable devices should be sterilized with a BI and a Class 5 integrating
indicator and documented in accordance with FDA regulations and AORN
recommended practices.
Reuse of Single-Use Devices (SUDs)
The practice of reprocessing single-use devices (SUDs) for reuse began in hospitals
during the 1970’s. With the increase in technological advances and minimally invasive
surgeries, the number and demand for SUDs increased and still continues to rise. In
response to these trends, the practice of reprocessing and reusing single-use devices
grew as well. Health care facilities sought to reduce costs and waste associated with
SUDs, therefore trying to improve their financial and environmental performance. Then
concerns and reports of patient safety issues began to surface questioning the safety,
efficacy, ethics, and liabilities associated with this practice by health care facilities.
In the late 1990’s, the FDA determined that increased regulation of reprocessing was
needed to promote safe practice and protect the public’s safety. Although original
equipment manufacturers (OEMs) were regulated for many years, the FDA concluded
that OEMs, third-party reprocessor, and hospital reprocessors should all be regulated
uniformly according to the Food, Drug, and Cosmetic Act. When a single-use medical
device is reprocessed for reuse by cleaning, repairing, or refurbishing, the FDA considers
the device to be “remanufactured” and the entity reprocessing the device, whether it
is the OEM, third-party reprocessor, or hospital, is considered to be the manufacturer.
The FDA’s Center for Devices and Radiologic Health (CDRH) finalized its policy on the
reprocessing of single-use devices for reuse through a guidance document issued in
August 2000. This document, Enforcement Policies for Single-Use Devices Reprocessed
by Third Parties and Hospitals, details a regulatory framework subjecting hospitals and
third-party reprocessors to the same regulatory requirements applicable to the original
equipment manufacturers, including premarket submission requirements.28,29,30
A health care facility has the responsibility to form a committee and decide if it wants
to take on the responsibility of reprocessing, and therefore be considered a device
manufacturer, or due to considerations of reducing cost and waste, employ the services
of a third-party reprocessor. In considering and making this decision, there is multiple
information to review. This information includes, but is not limited to:
• U.S. Food and Drug Administration, Center For Device and Radiological
Healthwebsite: http://www.fda.gov/cdrh/reprocessing/faq/html.
• U.S. Food and Drug Administration, Center for Device and Radiological Health
website: http://www.fda.gov/training/cdrhlearn/default.htm.
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• United States Government Accountability Office (GAO) Report to Committee on
Oversight and Government Reform, House of Representatives. Reprocessed
Single-Use Medical Devices.
• The American Society for Healthcare Central Service Professionals (ASHCSP)
Position Statement on Reuse of Single-Use Medical Devices.
• The Association of periOperative Nurses (AORN) Guidance Statement: Reuse of
Single-Use Devices, 2010 Perioperative Standards and Recommended Practices.
• Association of Medical Device Reprocessors (AMDR) website: http://www.amdr.org/.
• Practice Greenhealth website: https://practicegreenhealth.org/.
SUMMARY
Potentially pathogenic microorganisms are present everywhere in our daily lives. This is
significantly important for a patient receiving treatment and surgery where his or her body
may be compromised through an intervention in a health care facility. Every practitioner
should have the knowledge and expertise to limit iatrogenic transmission to any patient.
Sterile processing of instruments, devices, and items can greatly reduce and even
eliminate this opportunity of transmission.
29
REFERENCES
1. PRWeb. Nation’s Top Healthcare Organizations Announce Strategies to Prevent
Deadly Healthcare-Associated Infections: Strategies emphasize practical
implementation in acute healthcare settings. http://www.prweb.com/releases/
associated_infections/infection_control/prweb1447864.htm. Accessed April 30, 2013.
2. Nicolette L. Infection prevention and control in the perioperative setting. In:
Alexander’s Care of the Patient in Surgery, 14th Ed. JC Rothrock, ed. St. Louis, MO:
Elsevier Mosby; 2011: 68.
3. AORN. Recommended practices for cleaning and care of surgical instruments and
powered equipment. In: Perioperative Standards and Recommended Practices.
Denver, CO: AORN, Inc.; 2013: 485-504.
4. AORN. Recommended practices for cleaning and care of surgical instruments and
powered equipment. In: Perioperative Standards and Recommended Practices.
Denver, CO: AORN, Inc.; 2013: 485-504.
5. AORN. Recommended practices for cleaning and care of surgical instruments and
powered equipment. In: Perioperative Standards and Recommended Practices.
Denver, CO: AORN, Inc.; 2013: 485-504.
6. Infection Control Today. Providing safe surgical instruments: factors to consider.
http://www.infectioncontroltoday.com/articles/2008/04/providing-safe-surgicalinstruments-factors-to-co.aspx. Accessed May 9, 2013.
7. AORN. Recommended practices for cleaning and care of surgical instruments and
powered equipment. In: Perioperative Standards and Recommended Practices.
Denver, CO: AORN, Inc.; 2013: 485-504.
8. U.S. Department of Labor OSHA. 1910.1030 bloodborne pathogens. http://www.
osha.gov/pls/oshaweb/owadisp.show_document?p_ table=STANDARDS&p_
id=10051. Accessed July 5, 2011.
9. Fortunato N. Surgical instrumentation. In: Phillips N. Berry & Kohn’s Operating Room
Technique. 11th ed. St. Louis, MO: Mosby Elsevier; 2007:345.
10. AORN. Recommended practices for cleaning and care of surgical instruments and
powered equipment. In: Perioperative Standards and Recommended Practices.
Denver, CO: AORN, Inc.; 2013: 485-504.
11. AORN. Recommended practices for cleaning and care of surgical instruments and
powered equipment. In: Perioperative Standards and Recommended Practices.
Denver, CO: AORN, Inc.; 2013: 485-504.
12. Lind N, Ninemeier JD. Central Service Technical Manual. 7th ed. Chicago, IL:
International Association of Healthcare Central Service Material Management;
2007:137.
30
13. AORN. Recommended practices for selection and use of packaging systems for
sterilization. In: Perioperative Standards and Recommended Practices. Denver, CO:
AORN, Inc.; 2013: 505-512.
14. Center for Disease Control and Prevention. Appendix B – Decontamination and
Disinfection. http://www.cdc.gov/biosafety/publications/bmbl5/bmbl5_appendixb.pdf.
Accessed April 30, 2013.
15. AORN. Recommended practices for high-level disinfection. In: Perioperative
Standards and Recommended Practices. Denver, CO: AORN, Inc.; 2013: 459-469.
16. Center for Disease Control and Prevention. Appendix B – Decontamination and
Disinfection. http://www.cdc.gov/biosafety/publications/bmbl5/bmbl5_appendixb.pdf.
Accessed May 1, 2013.
17. AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health
Care Facilities, ST79. Arlington, VA: AAMI; 2011.
18. AORN. Recommended practices for sterilization in the perioperative practice setting.
In: Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc.;
2013: 513-540.
19. AORN. Recommended practices for sterilization in the perioperative practice setting.
In: Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc.;
2013: 513-540.
20. AORN. Recommended practices for sterilization in the perioperative practice setting.
In: Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc.;
2013: 513-540.
21. AORN. Recommended practices for high-level disinfection. In: Perioperative
Standards and Recommended Practices. Denver, CO: AORN, Inc.; 2013: 459-469.
22. Center for Disease Control and Prevention. Questions and Answers: CreutzfeldtJakob Disease Infection-Control Practices page. http://www.cdc.gov/ncidod/dvrd/cjd/
qa_cjd_infection_control.htm. Accessed May 1, 2013.
23. Infection Control Today. The Creutzfeldt-Jakob Disease: Risks and Prevention of
Nosocomial Acquisition page. http://www.infectioncontroltoday.com/articles/2001/08/
creutzfeldt-jakob-disease.aspx. Accessed May 1, 2013.
24. World Health Organization. WHO Infection Control Guidelines for Transmissible
Spongiform Encephalopathies. Report of a WHO Consultation Geneva, Switzerland,
23-26 March 1999. World Health Organization Emerging and other Communicable
Diseases, Surveillance and Control. http://www.who.int/csr/resources/publications/
bse/WHO_CDS_CSR_APH_2000_3/en/. Accessed May 1, 2013.
25. AORN. Recommended practices for cleaning and care of surgical instruments and
powered equipment. In: Perioperative Standards and Recommended Practices.
Denver, CO: AORN, Inc.; 2013: 485-504.
31
26. AORN. Recommended practices for cleaning and care of surgical instruments and
powered equipment. In: Perioperative Standards and Recommended Practices.
Denver, CO: AORN, Inc.; 2013: 485-504.
27. AORN. Recommended practices for sterilization in the perioperative practice setting.
In: Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc.;
2013: 513-540.
28. United States Government Accountability Office. Reprocessed Single-Use Medical
Devices: FDA Oversight has Increased and Available Information Does Not Indicate
That Use Presents an Elevated Health Risk. Report to the Committee on Oversight
and Government reform, House of Representatives: January 2008.
29. U.S. Food and Drug Administration. Reprocessing of Single-Use Devices:
Frequently Asked Questions. http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/ucm121093.
htm#. Accessed May 1, 2013.
30. AORN. AORN Guidance Statement: Reuse of Single-Use Devices. http://www.
ascquality.org/Library/singleusedevicereprocessingtoolkit/AORN%20Guidance%20
Statement%20on%20Reuse%20of%20Single%20Use%20Devices%202006.pdf.
Accessed May 1, 2013.
32
SUGGESTED READINGS
American Society for Healthcare Central Service Professionals. The ASHCSP Position on
Reuse of Single-use Medical Devices page. http://infohouse.p2ric.org/ref/05/04737.
htm. Accessed May 1, 2013.
AORN. Recommended practices for cleaning and care of surgical instruments and
powered equipment. In: Perioperative Standards and Recommended Practices.
Denver, CO: AORN, Inc.; 2013: 485-504.
Center for Disease Control and Prevention. The Severe Acute Respiratory Syndrome
(SARS) page. http://www.cdc.gov/sars/guidance/index.html. Accessed May 1, 2013.
IAHCSMM. IAHCSMM Position Paper on the Management of
Loaner Instrumentation. http://www.iahcsmm.org/pdfs/
IAHCSMMPositionPaperontheManagementofLoaner1.30.2012%20FINAL.pdf.
Accessed May 1, 2013.
Medical Device and Diagnostic Industry. Recent Developments in Sterilization
Technology page. http://www.mddionline.com/article/recent-developmentssterilization-technology. Accessed May 1, 2013.
National Institute of Neurological Disorders and Stroke. Creutzfeldt-Jakob Disease Fact
Sheet page. http://www.ninds.nih.gov/disorders/cjd/detail_cjd.htm. Accessed May 1,
2013.
Practice Greenhealth. The Single-Use Device Reprocessing page. http://www.medisiss.
com/documents/GreenhealthNewsletter.pdf. Accessed May 1, 2013.
World Health Organization. Environmental Management Practices. http://www.who.int/
water_sanitation_health/hygiene/envsan/infcontrolenv_mgmt.pdf. Accessed May 1,
2013.
World Health Organization. The World Health Organization page. http://www.who.int/en/.
Accessed May 1, 2013.
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Post-Test and Evaluation
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