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E The Role of Cleaning and Sterilization in Infection Control: A Focus on Powered Surgical Instruments

A Continuing Education ActivitySponsored 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 INSTRUCTIONSThis educational activity is being offered online and may be completed at any time.

STEPS FOR SUCCESSFUl COURSE COmPlETIONTo 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 re-read 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:

© 2013All rights reserved

Pfiedler Enterprises, 2101 S. Blackhawk Street, Suite 220, Aurora, Colorado 80014www.pfiedlerenterprises.com Phone: 720-748-6144 Fax: 720-748-6196

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OVERVIEWThe 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.

OBJECTIVESAfter 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 AUDIENCEThis 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 INFORmATIONState Board Approval for NursesPfiedler 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 ProfessionalsPfiedler 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 STATEMENTAs 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.

IAHCSMMThe 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.

CBSPDThe Certification Board for Sterile Processing and Distribution (CBSPD) has approved this program for 2.0 contact hours.

RElEASE AND EXPIRATION DATEThis 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.

DISClAImERAccredited status as a provider refers only to continuing nursing education activities and does not imply endorsement of any products.

SUPPORTGrant funds for the development of this activity were provided by Stryker.

AUTHORS/PlANNING COmmITTEE/REVIEWERRose Moss, MN, RN, CNOR Elizabeth, CONurse Consultant/AuthorMoss Enterprises

Julia A. Kneedler, RN, mS, EdD Aurora, COProgram Manager/ReviewerPfiedler Enterprises

Judith I. Pfister, RN, BSN, MBA Aurora, COProgram Manager/PlannerPfiedler Enterprises

Kathryn major, BSN, RN Aurora, COProgram Manager/PlannerPfiedler Enterprises

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DISClOSURE OF RElATIONSHIPS WITH COmmERCIAl ENTITIES FOR THOSE IN A POSITION TO CONTROl CONTENT FOR THIS ACTIVITYPfiedler 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 POlICYPfiedler 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 INFORmATIONIf 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 ClASSIFICATIONPotentially 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:

CriticalCritical 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-criticalSemi-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-criticalNon-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 INSTRUmENTATIONSurgical 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 INSTRUmENTATIONCleaning 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 nonoil-based 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 steam-sterilized 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 DISINFECTIONDisinfectionDisinfection 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

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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 DisinfectionHigh-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 DisinfectionIntermediate-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 DisinfectionLow-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”.

SterilizationSterilization 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

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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 STERIlIZATIONSteam Sterilization17,18

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.

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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 SterilizationToday’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

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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 PlasmaLow-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 non-carcinogenic 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 AcidPeracetic 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:

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• 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.

OzoneOzone 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 SterilizationDry 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.

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• 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 SterilizationLiquid 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 mONITORINGMany 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

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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 CONSIDERATIONSCreutzfeldt-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 self- replicating protein known as a prion. Prions are a unique class of pathogens because

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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.

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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.

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Loaner EquipmentLoaner 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 XA 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;

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• 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.

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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/.

SUmmARYPotentially 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.

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REFERENCES1. 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-surgical-instruments-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.

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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: Creutzfeldt-Jakob 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.

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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%20Statement%20on%20Reuse%20of%20Single%20Use%20Devices%202006.pdf. Accessed May 1, 2013.

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SUGGESTED READINGSAmerican 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-developments-sterilization-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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