CLEANING, DISINFECTION AND STERILIZATION OF PATIENT CARE EQUIPMENT

I. PURPOSE CLEANING, DISINFECTION AND STERILIZATION OF PATIENT CARE EQUIPMENT This policy delineates responsibility and methods to be used in the cleaning, disinfection, and sterilization of patient care equipment. II. DEFINITIONS A. Sterilization The complete elimination or destruction of all forms of microbial life. It is accomplished in the hospital by either physical or chemical processes. Steam under pressure, dry heat, low temperature sterilization processes (plasma sterilization), and liquid chemicals are the principal sterilizing agents used in the hospital. Sterilization is intended to convey an absolute meaning, not a relative one. B. Disinfection A process that eliminates many or all pathogenic microorganisms with the exception of bacterial spores from inanimate objects. This is generally accomplished by the use of liquid chemicals or wet pasteurization. The efficacy of disinfection is affected by a number of factors, each of which may nullify or limit the efficacy of the process. Some of the factors that have been shown to affect disinfection efficacy are the previous cleaning of the object, the organic load on the object, the type and level of microbial contamination, the concentration of and exposure time to the germicide, the physical configuration of the object (e.g., crevices, hinges, lumens), and the temperature and ph of the disinfection process. 1. High-level disinfection can be expected to destroy all microorganisms, with the exception of high numbers of bacterial spores. 2. Intermediate-level disinfection inactivates Mycobacterium tuberculosis, vegetative bacteria, most viruses, and most fungi but does not necessarily kill bacterial spores. 3. Low-level disinfection can kill most bacteria, some viruses, and some fungi but cannot be relied on to kill resistant microorganisms such as tubercle bacilli or bacterial spores. C. Cleaning The removal of all foreign material (e.g., soil, organic material) from objects. It is normally accomplished with water, mechanical action, and detergents or enzymatic products. Cleaning must precede disinfection and sterilization procedures. 1. A germicide is an agent that destroys microorganisms, particularly pathogenic organisms ("germs"). Other agents designated by words with the suffix "cide" (e.g., virucide, fungicide, bactericide, sporicide, tuberculocide) -1-

destroy the microorganism identified by the prefix. For example, a bactericide is an agent that kills bacteria. 2. A chemical sterilant is a chemical used for the purpose of destroying all forms of microbial life, including fungal and bacterial spores. These same chemical germicides may also be part of the high-level disinfection process when used for shorter exposure periods. 3. A disinfectant is a germicide that inactivates virtually all recognized pathogenic microorganisms but not necessarily all microbial forms (e.g., bacterial endospores) on inanimate objects. Germicides, including sterilants and disinfectants are registered and regulated by the Environmental Protection Agency (EPA). 4. An antiseptic is a chemical germicide formulated for use on skin or tissue and should not be used to decontaminate inanimate objects. Antiseptics are registered and regulated by the Food and Drug Administration (FDA). D. Critical Items Items assigned to the critical items category present a high risk of infection if the item is contaminated with any microorganism, including bacterial spores. Thus, it is critical that objects which enter sterile tissue or the vascular system be sterile. This category includes surgical instruments, cardiac and urinary catheters, implants, and needles. Most of the items in this category should be purchased as sterile or be sterilized by steam under pressure, if possible. If heat-labile, the object may be treated by a low temperature sterilization processes, or, if other methods are unsuitable, a chemical sterilant. The attached Appendix D, Methods of Sterilization and Disinfection, lists several germicides categorized as chemical sterilants. These include 2% glutaraldehydebased formulations, ortho-phthalaldehyde, and 6% stabilized hydrogen peroxide. Chemical sterilants can be relied upon to produce sterility only if adequate cleaning precedes treatment and if proper guidelines as to organic load, contact time, temperature and ph are met. E. Semicritical Items Those objects which come in contact with mucous membranes or skin that is not intact. These items must be free of all microorganisms with the exception of high numbers of bacterial spores. Intact mucous membranes are generally resistant to infection by common bacterial spores but susceptible to other organisms such as tubercle bacilli and viruses. Respiratory therapy and anesthesia equipment, endoscopes, diaphragm fitting rings and ultrasound vaginal transducer probes are included in this category. Semicritical items generally require high-level disinfection using wet pasteurization or chemical disinfectant. Glutaraldehyde, ortho-phthalaldehyde, stabilized hydrogen peroxide, chlorine, and peracetic acid are dependable high-level disinfectants, provided the factors influencing germicidal procedures are considered (see attached table). Semicritical items should be rinsed with sterile water after high-level -2-

disinfection. In circumstances under which a sterile water rinse is not feasible, the item should be rinsed with tap water followed by an alcohol rinse and forced air drying. Introduction of forced air drying significantly reduces bacterial contamination of stored endoscopes presumably by removing the wet environment favorable for bacterial growth. Some semicritical items (e.g., hydrotherapy tanks used for patients whose skin is not intact, thermometers) may require only intermediate-level disinfection. Intermediate-level disinfectants (e.g., chlorine, phenolics, iodophor) inactivate M. tuberculosis, vegetative bacteria, most viruses and most fungi but do not necessarily kill bacterial spores. F. Noncritical Items Items that come in contact with intact skin but not with mucous membranes. Intact skin acts as an effective barrier to most microorganisms, and sterility is not critical. Examples of noncritical items include bedpans, blood pressure cuffs, crutches, bed rails, linens, some food utensils, bedside tables and patient furniture. There is generally little risk of transmitting infectious agents to patients via noncritical items; however, these items could potentially contribute to secondary transmission by contaminating hands of healthcare workers or by contact with medical equipment which subsequently come in contact with patients. The low-level disinfectants listed for noncritical items in the attached table may be used. III. IV. RESPONSIBILITY The Manager of Sterile Processing Department of Materials Management shall supervise the cleaning, disinfection and sterilization of instruments, endoscopes and patient care equipment used in patient care departments/areas in the Hospital and Clinics and the sterilization of cleaned and packaged instruments used in the Main Operating Room and Ambulatory Surgery Center. IMPLEMENTATION A. The Sterile Processing Department is responsible for developing written procedures for processing and monitoring of reusable patient care items. These procedures are reviewed and approved every three years or more frequently if necessary, by the Infection Control and Epidemiology Department and the Infection Control Committee. Activities requiring written procedures and approval include the following. 1. Receiving, decontaminating, cleaning, preparing, and disinfecting or sterilizing reusable items. 2. Provision of evidence that steam sterilizers are tested at least daily with live bacterial spores. 3. Chemical indicators and integrators are to be used with each package sterilized. -3-

4. Use of sterilization process monitors, including temperature and pressure recording, and use and frequency of appropriate chemical indicators and/or bacteriologic spore tests for all sterilizers. 5. Preventive maintenance of all processing equipment, including performance verification records and reports. 6. The assembly, wrapping, storage, distribution, and quality control of sterile equipment and medical supplies. 7. Shelf-life policy 4.80 in the Infection Control Manual indicates that package sterility is guaranteed only if package integrity is intact. 8. All sterile items must be inspected by the user before the package is opened. B. Indications for Sterilization and High-level Disinfection 1. Refer to Appendix A for classification of devices, processes and germicidal products. 2. Critical medical devices or patient-care equipment that enter normally sterile tissue or the vascular system or through which blood flows must be sterilized according to manufacturer's guidelines before each use. Sterilization shall be monitored with appropriate sterilization process monitors. 3. Endoscope accessories: Biopsy forceps or other cutting instruments which break the mucosal barrier should be sterilized. Other endoscope accessories (e.g., suction valves) should be sterilized after each patient use; if this is not feasible, they should receive at least high-level disinfection. 4. Laparoscopes, arthroscopes, and other scopes that enter normally sterile tissue should be subjected to a sterilization procedure before each use; if this is not feasible, they should receive as least high-level disinfection. Disinfection should be followed by a rinse with sterile water. 5. Equipment that touches mucous membranes, (e.g., endoscopes, endotracheal tubes, anesthesia breathing circuits, prostate ultrasound probes) should receive at least high-level disinfection. 6. Flexible and rigid laryngoscopes, both blades and handles are classified as semi-critical devices and therefore require: a. cleaning and b. high-level disinfection or sterilization. 1) The blade and handle should be packaged and steam sterilized. C. Chemical methods for sterilization (see Appendix D): When sterilization is indicated and other sterilization methods (e.g., steam) cannot be used, any one of three chemical sterilants may be employed. The manufacturer's instruction for use specify the recommended exposure time. D. Selection and Use of High-level Disinfectants for Semicritical Patient Care Items -4-

1. Solutions containing glutaraldehyde, ortho-phthalaldehyde, hydrogen peroxide, ethyl alcohol, chlorine and chlorine dioxide can achieve high-level disinfection if the objects are properly cleaned. 2. See Appendix D for recommended concentrations. 3. The disinfectant or chemical sterilant selected should have no or minimal deleterious effects on the object (e.g., chlorine may corrode metals; see Appendix D). E. Selection and Use of Low-level Disinfectants for Non-critical Patient Care Items. Solutions for use on noncritical patient care equipment and recommended concentrations are listed in Appendix D. F. Processing HIV- or HBV-contaminated Patient Care Equipment 1. Standard sterilization and disinfection procedures for patient care equipment (as recommended in this Policy) are adequate to sterilize or disinfect instruments or devices contaminated with blood or other body fluids from persons infected with blood-borne pathogens including HIV. No changes in procedures for cleaning, disinfecting, or sterilizing need to be made. 2. Noncritical environmental surfaces contaminated with blood or blood contaminated body fluids should be cleaned before an EPA-registered hospital-grade disinfectant/detergent is applied to the surface for disinfection. Persons cleaning spills should wear disposable gloves. G. Processing Creutzfeldt-Jakob Disease (CJD) Contaminated Patient Care Equipment (See Policy C3.12, Creutzfeldt-Jakob Disease in the Operating Room Administrative Manual) 1. The following recommendations should be used with high-risk tissues (defined as brain, including dura mater, spinal cord and eyes) from high-risk patients (e.g., those with known or suspected CJD) and with critical/semicritical items: a. Those devices (e.g., surgical instruments) constructed so that cleaning procedures result in effective tissue removal can be cleaned and then sterilized by autoclaving either at 134ºC for greater than or equal to 18 minutes in a pre-vacuum sterilized or at 121ºC - 132ºC for 1-hour in a gravity displacement sterilizer. b. Those devices that are impossible or difficult to clean are discarded. c. To minimize drying of tissues and body fluids on the object, keep instruments moist until cleaned and decontaminated. d. Flash sterilization is not used for reprocessing. e. Items that permit only low-temperature sterilization (e.g., hydrogen peroxide gas plasma) are discarded. f. Environmental surfaces (non-critical) contaminated with high-risk tissues (e.g., laboratory surface in contact with brain tissue of a CJDinfected person) should be cleaned with a detergent and then spot decontaminated with a 1:10 dilution of sodium hypochlorite (e.g., -5-

References: bleach). In order to minimize environmental contamination, disposable cover sheets are used on work surfaces. g. Non-critical equipment contaminated with high-risk tissue should be cleaned and then disinfected with a 1:10 dilution of sodium hypochlorite or 1 N NaOH, depending on material compatibility. All contaminated surfaces must be exposed to the disinfectant. 2. The following recommendations should be used with low-risk tissues (defined as cerebrospinal fluid, kidney, liver, spleen, lung, lymph nodes) from high-risk patients and critical/semicritical medical devices: a. These devices can be cleaned and disinfected, or sterilized using conventional protocols of heat or chemical sterilants or high-level disinfection. b. Environmental surfaces contaminated with low-risk tissues require only standard disinfection (use disinfectants recommended by OSHA for disinfecting blood-contaminated surfaces). 3. The following recommendations should be used with no-risk tissues (defined as peripheral nerve, intestine, bone marrow, blood, leukocytes, serum, thyroid gland, adrenal gland, heart, skeletal muscle, adipose tissue, gingival, prostate, testis, placenta, tears, nasal mucus, saliva, sputum, urine, faces, semen, vaginal secretions, milk) from high-risk patients and critical/semicritical medical devices: a. These devices can be cleaned and disinfected, or sterilized using conventional protocols of heat or chemical sterilization or high-level disinfection. b. Endoscopes (except neurosurgical endoscopes) would be contaminated only with no-risk materials and hence, standard cleaning and high-level disinfection protocols are adequate for reprocessing. c. Environmental surfaces contaminated with no-risk tissues or fluids require only standard disinfection (use disinfectants recommended by OSHA for decontaminating blood-contaminated surfaces) (e.g., 1:10 to 1:100 dilution of 6.0% sodium hypochlorite)).. 1. Favero, MS, Bond WW. Chemical Disinfection of Medical and Surgical Materials. In: Block SS, ed. Disinfection, Sterilization and Preservation. 4th ed. Philadelphia, Lea & Febiger. 1991 : 627. 2. Rutala, WA. APIC Guideline for Selection and Use of Disinfectants. American Journal of Infection Control 1996; 24: 313-42. 3. CDC Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2002; 1-143. 4. State of California Health and Human Services; Inadequate Reprocessing of Semi-critical Instruments: Recommendation for Reprocessing of Rigid Laryngoscopes. AFL 07-09, April 30, 2007. Appendices: Appendix A: Classification of Devices, Processes and Germicidal Products -6-

Appendix B: Methods of Sterilization and Disinfection Appendix C: Disinfectants List Sterile Processing Department Appendix D: Housekeeping Chemical Product List Approved by: Infection Control Committee, 11/10 Quality Improvement and Patient Safety Committee, 12/10 Stanford Hospital and Clinics Medical Executive Committee, 1/11 Stanford Hospital and Clinics Board Credentials, Policies and Procedures Committee, 1/11 Original Date: 8/93 Reviewed Date: 8/96, 6/97, 1/98, 3/10 Revised Date: 8/96, 6/97, 1/98, 1/01, 9/03, 8/06, 11/10 This document is intended for use by staff of Stanford Hospital and Clinics. No representations or warranties are made for outside use. Not for outside reproduction or publication without permission. Direct inquiries to: Infection Control and Epidemiology -- (650) 725-1106 Stanford Hospital and Clinics Stanford, CA 94305-7-

Appendix A CLASSIFICATION OF DEVICES, PROCESSES, AND GERMICIDAL PRODUCTS Spaulding process EPA product Device classification Devices (examples) classification classification Critical (enters sterile tissue Implants, scalpels, Sterilization -- sporicidal Sterilant/disinfectant vascular system) needles, other chemical; prolonged surgical instruments contact Semicritical (touches mucuous Flexible endoscopes, High-level disinfectant -- Sterilant/disinfectant membranes) laryngoscopes, sporicidal chemical; endotracheal short contact tubes and other similar instruments Non-critical (touches intact skin) Stethoscopes, Low-level disinfection Hospital approved table tops, disinfectant bed pans, etc. -8-

METHODS OF STERILIZATION AND DISINFECTION Appendix B Sterilization High-Level Disinfection Low-Level Critical Items (Semicritical item; Intermediate Level (Noncritical items; (Enter tissue or vascular come in contact with (Some semicritical come in contact with system or blood flows mucous membrane items and non-critical intact skin) through them) or non intact skin) items) Object Procedure Exposure Procedure Procedure Procedure Smooth, hard surface a A MR C I I B MR D K J C MR E L K D 6 F L E 6 G d M O MR O Rubber tubing and catheters c A MR C B MR D C MR E D 6 F E 6 G d O MR O Polyethlene tubing and A MR C catheters c,e B MR D C MR E D 6 F E 6 G d O MR O Lensed instruments B MR C C MR D D 6 E E 6 F O MR O Thermometers (oral and rectal) f I f Hinged instruments A MR C B MR D C MR F D 6 O E 6 O MR -9-

Modified from Simmons BP, Am J Infection Control 1983:11:97-115. A Heat sterilization, including steam or hot air (see mfr s recommendations) B Ethylene oxide gas (see mfr s recommendations) C Glutaraldehyde-based formulations (2%). (Caution should be exercised with all glutaraldehyde formulations when further in-use dilution is anticipated) D Stabilized hydrogen peroxide 6% (will corrode copper, zinc, and brass) E Peracetic acid, concentration variable but 1% is sporicidal F Wet pasteurization at 70 C for 30 minutes after detergent cleaning G Sodium hypochlorite (5.2% household bleach) 1:500 dilution (1000 ppm free chlorine) H Ethyl or isopropyl alcohol (70%-90%) I Sodium hypochlorite (5.2% household bleach) 1:500 dilution (1000 ppm free chlorine) J Phenolic germicidal detergent solution (follow product label for use-dilution) K Iodophor germicidal detergent solution (follow product label for use-dilution) L Quarterly ammonium germicidal detergent solution (follow product label for use-dilution) MR Manufactuer s recommendation O Orth-phthalaldehyde 0.55% a b c d e f See Policy for discussion for hydrotherapy The longer the exposure to a disinfectant, the more likely it is that all microorganisms will be eliminated. Ten minutes exposure is not adequate to disinfect many objects, especially those that are difficult to clean because they have narrow channels or other areas that can harbor organic material and bacteria. Twenty minutes exposure is the minimum time needed to reliably kill M. tuberculosis and non-tuberculosis Myobacteria with glutaraldehyde Tubing must be completely filled for disinfection; care must be taken to avoid entrapment of air bubbles during immersion. Pasteurization (washer disinfector) of respiratory therapy and anesthesia equipment is a recognized alternative to high-level disinfection (Some data challenge the efficacy of some pasteurization units) Thermostability should be investigated when appropriate Do not mix rectal and oral thermometers at any stage of the handling or processin -10-

Disinfectants List SURGICAL SERVICES STERILE PROCESSING DEPARTMENT Appendix C Chemical Name as Inventoried Manufacturer Product # Autoclave Cleaning Treatment (ACT) RUHOF Alkaline Detergent Concentrate Getinga 697N Adhesive Remover Medo-Sol 30037 Cidex OPA Solution Advanced Sterilization Products Desk & Office Cleaner 3-M Endozyme RUHOF Endozyme Sponge RUHOF Endure 300 Ecolab Endure 420 Ecolab Germa-Care Lotion Ecolab Hydrogen Peroxide Humco HU11316C6 Hydrogen Peroxide 3% Sigma Chemical Co. 477868 Instrument Lubricant Getinge 596 & 599 Isopropyl Alcohol 70% Humco HU 249169 Kem-Safe Neutralizer for OPA Kem Medical Products 9075 Klenzyme Steris Manu Klenz Steris Neutral PH detergent Concentrate Getinge 797 NPH Klenz Steris Nail Polish Remover Pads PDI B71200 Orthozyme Ruhof 345OT Pana Spray Nakanishi Pasteur-Sol Formula Corp OCOPS2WX Prepzyme Ruhof 345PRP Premixslip-Milk 345 PMX Ruhof Quik-Fill Deodorizer AirKem Ready to Use Renuzynme Foam Getinge 820 Renuzyme Getinge 818 Renuzyme Plus Getinge 816 Renuzyme Foam detergent Getinge 817 Resert Steris Sani-Cloth PDI Q85084 Sonic Detergent Getinge 796 Same Day Tape Remover Sterion 15-1-066SD Surgistain Ruhof Tergal Custom Ultrasonics Triple Enzyme Concentrate Getinga 812 Tec-Rinse Getinge 866-11-

Appendix D Cleaning Products Product Manufacturer Product Name Product Use PDI Super Sani Cloth Cleaner/Disinfectant PDI Sani Cloth Cleaner/Disinfectant PDI Sani Cloth HB Cleaner/Disinfectant Metrex Cavicide Spray Lab equipment disinfection Chlorox Dispatch Bleach Wipes/ Disinfectant Liquid Airkem Easy Scrub Liquid cleanser. Airkem A456-II Quat Disinfectant Cleaner Disinfectant Airkem QC-52E Glass Cleaner Glass and chrome cleaner. Airkem QC-51E General Purpose General purpose cleaner. Cleaner Airkem QC-91E Neutral Bathroom Cleaner Non-acid bathroom/porcelain cleaner. Airkem Easy Scrub Liquid cleanser. Mikro-quat, Alconox, Neutrawash, Sparkleen Laboratory glass cleaners/disinfectant Current Hand Hygiene Products Product Manufacturer Product Name Product Use Ecolab Endure 50 General use foam soap Ecolab Germa-Care General use hand soap Ecolab Endure 420/Cida Stat Surgical scrub; chlorhexidine gluconate 2%. Ecolab Endure 320 Alcohol-based hand gel Ecolab Endure 300 Alcohol-based hand gel Ecolab Endure Revitalizing Skin Hand lotion Lotion Ecolab Endure Revitalizing Skin Hand Cream Creme Ecolab Wash Hand soap for staff with skin Erie Handcare; Eric Scientific Softguard problems Hand cream -12-