Infection Control Manual
Section V - Disinfection & Sterilization

Cleaning, Disinfection and- Sterilization of Patient- Care Equipment
        Table 1: Reprocessing of Medical Devices and Patient Care Items
Microbiological Sampling
Toy Cleaning
Prion Disease Management

CLEANING, DISINFECTION AND STERILIZATION OF PATIENT CARE EQUIPMENT

POLICY:
The goal of reprocessing shared patient care equipment is to achieve a level of cleaning, disinfection or sterilization which eliminates the risk of these objects as the source of microorganisms causing infections. Decisions regarding cleaning, disinfecting or sterilizing patient care equipment/supplies are based on the potential risk of infection associated with their use. "Table 1. Reprocessing of Medical Devices and Patient Care Items," provides direction for these decisions. Information of specific methods can be found in "Table 2. Methods of Sterilization and Disinfection." Consultation with the Epidemiology Department is also available at 744-9560.

PROCEDURE:

CLEANING:
All objects to be disinfected or sterilized should first be thoroughly cleaned to remove all organic matter and other residue. Cleaning can be done manually (using friction) or mechanically (ultrasonic cleaners, washer-sterilizers). Whenever possible, cleaning in a washer is preferred. Manual cleaning is done by gloved personnel. Hinged items and items with lumens take special attention and inspection to ensure that debris has been removed. Sharp objects (such as scalpels, needles, blades, etc.) that are immersed during cleaning, are removed from the soaking solution using a strainer-type lifter, forceps or other tool, not by reaching into the solution by hand.

INDICATIONS FOR STERILIZATION AND HIGH-LEVEL DISINFECTION:

1. Critical medical devices or patient care equipment that enter normally sterile tissue, the vascular system or through which blood flows are subjected to a sterilization procedure before each use.

2. Scopes, such as laparoscopes, arthroscopes and other fiberoptics that enter normally sterile tissue are subjected to a sterilization procedure before each use. Accessories designed to break mucosal surfaces, such as biopsy forceps or snares, are sterilized.

3. Equipment that touches mucous membranes, e.g., endoscopes, endotracheal tubes, anesthesia breathing circuits, and respiratory therapy equipment, receives high-level disinfection at a minimum.

4. Items that are sheathed during use, such as vaginal probes covered with condoms, reduce the level of microbial contamination. However, these items must still receive high level disinfection between patients since the sheaths and condoms may fail.

5. Sterile water is used to rinse items following cold soak sterilization (chemical soak). Tap water may be used to rinse items following cold chemical soaking for high level disinfection. When tap water is used to rinse off chemical soak solutions used in high level disinfection of scopes, these scopes have a 70% alcohol rinse following the tap water rinse, and forced air is used to dry lumens.

6. Noncritical patient care surfaces (bedrails, overbed tables) and equipment (stethoscopes, hammars) that touches intact skin receives low level disinfection when visibly soiled and before use by another patient.

7. To eliminate the chance of disinfection contamination, certain control measures are implemented. The disinfectant is prepared correctly to achieve the manufacturer's recommended use-dilution. Preparation is done using clean containers and in a clean work area.

METHODS OF STERILIZATION:

1. Whenever sterilization is indicated, a steam sterilizer is used unless the object to be sterilized will be damaged by heat, pressure, or moisture or is otherwise inappropriate for steam sterilization. In this case, another acceptable method of sterilization is used, e.g., cold chemical soak sterilization, Steris system or Sterrad autoclave.

2. Flash sterilization (270 F or 132 C for 3 minutes in a gravity displacement steam sterilizer) is not recommended for implantable items and should only be used for emergent needs. For implants that are flash sterilized, a biological indicator is used for each implant load.

3. The only infectious agent that requires unique decontamination recommendations is the CJD prion. The need for such recommendations is due to an extremely resistant subpopulation of prions and the protection afforded this tissue-associated agent. Whenever possible, disposable equipment is used in procedures for CJD patients (See Prion Disease Management).

MONITORING OF STERILIZERS:

1. Each load is monitored with mechanical and chemical indicators. If the mechanical or chemical indicators suggest inadequate monitoring, the items are not used until adequately sterilized.
2. All high vac, pre-pac and gravity stream sterilizers are monitored at least once a week with commercial preparations of spores intended specifically for that type of sterilizer (i.e., Bacillus stearothermophilus for steam sterilizers and Bacillus subtilis for ethylene oxide and dry heat sterilizers).
3. Biological testing is run daily for the Sterrad & Steris Processors.
4. Every autoclave load which contains an implantable device is monitored using a biological indicator. Documentation is maintained of implantable devices placed in specific patients.
5. If spores are not killed in routine spore tests, the sterilizer is immediately shut down, checked for proper use and function, in conjunction with Engineering, and the spore test repeated. The sterilizer is not used until spore testing is negative. Objects, other than implantable objects, do not need to be recalled because of a single positive spore test unless the sterilizer or the sterilization procedure is found to be defective.
6. If spore tests remain positive, use of the sterilizer is discontinued until it is serviced.

USE AND PREVENTIVE MAINTENANCE:

Manufacturers' instructions are followed for use and maintenance of mechanical cleaning equipment and sterilizers. Preventive maintenance is performed on sterilizers by qualified personnel and guided by the manufacturer's instructions.

STORAGE AND USE OF STERILE ITEMS:

1. Storage areas for clean and sterile items provide protection against dust, moisture, insects and temperature and humidity extremes. These items are stored so that the packaging is not compromised (punctured, bent, etc.).

2. Sterilized items without expiration dates can be used unless its sterility is questionable, e.g., the package is punctured, torn or wet (event related shelf life). Items with expiration dates are not used if the expiration date has passed.

REPROCESSING SINGLE-USE OR DISPOSABLE ITEMS:

Single use devices are not reprocessed by HMC. However, if these devices are reprocessed, they are reprocessed by contractors who provide reprocessing of disposables service according to the FDA enforcement document for single-use devices.

RESPONSIBILITY:

All department managers involved are responsible for implementing this policy as it relates to their area of service and as specified by the following Tables 1 and 2. Consultation regarding proper cleaning, disinfection and sterilization is available from Epidemiology/Infection Control at 744-9560.

TABLE 1: REPROCESSING OF MEDICAL DEVICES AND PATIENT CARE ITEMS

TABLE 2: METHODS OF STERILIZATION AND DISINFECTION

Modified from Rutala WA. Weber DJ and the Healthcare Infection Control Practices Advisory Committee . In: CDC Draft Guideline for Disinfection and Sterilization in Healthcare Facilities, Federal Register, April 30, 2002.

A. Heat sterilization, including steam or hot air (see manufacturer's recommendations)

B. Ethylene oxide gas (see manufacturer's recommendations)

C. Hydrogen peroxide gas plasma (see manufacturer’s recommendations).

D. Glutaraldehyde-based formulations (>2%) Caution should be exercised with all glutaraldehyde formulation when further in-use dilution is anticipated.)

E. Ortho-phthaladehyde 0.55%

F. Hydrogen peroxide 7.5% (will corrode copper, zinc and brass)

G. Peracetic acid, concentration variable but <1% is sporicidal.

H. Hydrogen peroxide 7.35% and peracetic acid 0.23%; hydrogen peroxide 1% and paracetic acid 0.08% (will corrode metal instruments)

I. Wet pasteurization at 70°C for 30 minutes after detergent cleaning

J. Sodium hypochlorite (5.25% household bleach diluted 1:50 provides 1000 ppm available chlorine; will corrode metal instruments)

K. Ethyl or isopropyl alcohol (70% to 90%)

L. Sodium hypochlorite (5.25% household bleach diluted 1:500 provides 100 ppm available chlorine)

M. Phenolic germicidal detergent solution (follow product label for use-dilution)

N. Iodophor germicidal detergent solution (follow product label for use-dilution)

O. Quaternary ammonium germicidal detergent solution (follow product label for use-dilution)

MR: Manufacturer's Recommendation

NA: Not applicable

¹ See text for discussion of hydrotherapy.

² 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 which are difficult to clean, because they have narrow channels or other areas that can harbor organic material and bacteria. Twenty minutes exposure at 20°C is the minimum time needed to reliably kill M. tuberculosis and other nontuberculous mycobacteria with a 2% glutaraldehyde. With the exception of 2% glutaraldehydes, follow the FDA-cleared high-level disinfection claim. Some high-level disinfectants have a reduced exposure time (e.g., ortho-phthalaldehyde at 12 minutes at 20°C) because of their rapid activity against mycobacteria or reduced exposure time due to increased mcobactericidal activity at elevated temperature (2.5% glutaraldeyde at 5 minutes at 35°C).

³ Tubing must be completely filled for disinfection; care must be taken to avoid entrapment of air bubbles during immersion.

⁴ Material compatibility should be investigated when appropriate.

⁵ Used in laboratory where cultures or concentrated preparations or microorganisms have spilled. This solution may corrode some surfaces.

⁶ 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.

⁷ Thermostability should be investigated when indicated.

⁸ Do not mix rectal and oral thermometers at any stage of handling or processing.

MICROBIOLOGICAL SAMPLING

POLICY:

1. Routine environmental culturing of air and environmental surfaces is not done.

2. Monthly sampling of water used to prepare dialysis fluid is monitored by Northwest Kidney Center, who receives, evaluates and interprets sampling results. HMC Microbiology may provide laboratory services.

3. Microbiologic sampling, when indicated, is done as part of an epidemiological investigation.

4. Routine microbiologic sampling of patient-care objects purchased as sterile is not recommended. If contamination of a commercial product sold as sterile is suspected, Infection Control is notified, suspected lot numbers are recorded and items from suspected lots are segregated and not used. The Infection Control Committee or designee of the chair makes decisions regarding microbiological assays and notification of outside agencies (e.g. FDA, CDC, etc.).

TOY CLEANING

POLICY:

1. Children who do not have airborne communicable diseases (e.g. measles, mumps, rubella, pertussis, chickenpox, influenza, TB), may use playrooms. Playrooms are cleaned daily. Area staff and Environmental Services staff share the cleaning responsibilities for playrooms and large toys (e.g., slides, castles, gym mats, wall-mounted toys).

2. Toys are shared between patients and toy washing is done daily by area staff using soap and water. Toys that cannot be cleaned are dedicated to that child and are sent home on discharge or discarded.

3. Individual toys belonging to the child are kept with the patient in the patient's room and are cared for by family and staff. These toys are not shared with other patients.

PROCEDURE:

1. Dirty toys are separated into three categories

1. Immersible toys have no moving parts, no hollow spaces and a non-porous surface. They will not soak up water into closed cracks or spaces (e.g. Lego's, stacking cups).
2. Non-Immersible toys have inside spaces, small openings or hinges (e.g. dolls, cars) or are too large to be immersed (e.g. castles, slides).
3. Uncleanable toys soak up water and are damaged by immersion (e.g. games, books, puzzles, activity books, crayons, stuffed animals).

2. Immerse, surface wash, and rinse immersible toys

3. Wipe surface of non-immersible toy, using a washcloth. Wipe the surface thoroughly and clean all the nooks and crannies.

4. Uncleanable toys are discarded if soiled or wiped down with a damp cloth and ultimately sent home with child.

5. Dry and replace toys in exam and/ or waiting rooms.

Prion Disease Management

1. Purpose:
1. To provide guidelines in order to contain, confine and prevent the transmission of prion diseases, including Creutzfeldt-Jacob Disease (CJD) and other forms of Transmissible Spongiform Encephalopathy to patients and staff.
2. To prevent cross-contamination of instruments and equipment.
3. To safeguard patients and staff.
4. To provide a safe environment.


2. Policy:

All patients undergoing a brain biopsy for other than a known non-prion lesion will be treated according to the following protocol in order to minimize the risk of spreading prion disease to other patients or healthcare workers, and to safely dispose of supplies and equipment used for these patients. Precautions are to be used for all patients with known or suspected prion disease, including one or more of the following:
• Rapidly progressing dementia.
• Possible Creutzfeldt-Jakob Disease (CJD), Gerstmann-Straussler-Scheinker Syndrome (GSS), or Fatal Familial Insomnia (FFI).
• Family history of CJD, GSS or FFI.
• Recipients of human pituitary hormone, corneal transplants or dura mater grafts.
• Any brain biopsy patient without a specific lesion as the target of the biopsy.

HIGH Infectivity Tissue: Brain, dura mater, spinal cord and cornea.

MEDIUM Infectivity Tissue: Cerebrospinal fluid, liver, lymph nodes, lung, kidney and spleen.

LOW/NO Infectivity tissue: Heart, skeletal muscle, thyroid gland, adrenal glands, intestine, peripheral nerves, bone marrow, whole blood, leukocytes, serum, adipose tissue, prostate, testis, semen, placenta, vaginal secretions, milk, tears, gingiva, nasal mucus, saliva, sputum, urine and feces.

Unless a clear non-prion disease diagnosis is established, these patients will be considered as potentially having prion disease.

NOTE: In the case of a patient diagnosed with a prion disease who comes to the OR for a procedure NOT involving the brain, dura mater, spinal cord or cornea, only standard precautions need be observed.

3. Procedure:

When a brain biopsy of known or suspected prion disease is scheduled:
1. Surgeon or Designee will notify the Operating Room of the brain biopsy of suspected prion disease.
2. The OR Scheduler or desk personnel booking the case will alert the charge nurse, Neuro RN3 or Nurse Manager of the Prion Precaution nature of the case.
3. The Charge Nurse, Neuro RN3, or Nurse Manager will consult with the Attending Surgeon to verify the patient's status warrants the Prion Precautions set forth in the policy.
4. If these precaustions are indicated, the Charge Nurse, Neuro RN3 or Nurse Manager will notify the surgical team that is assigned to the case, Infection Control (744-9562), Neuropathology (X6315), and Environmental Services (X3131).
5. The Charge Nurse will assign a "Runner" to the room.
6. The case will be scheduled as the last case of the day in the designated room.
7. The Charge Nurse will check to make sure necessary supplies and equipment are at hand for the case. These are located in the Neuro Viewing Room in the Prion Precaution Cart.
1. "Prion Precaution" signs
2. Disposable instruments and packs.
3. Gray incineration bins (X3)
4. Disposable equipment and supplies
5. Solidifier
6. 1:10 Dilute solution Sodium Hypochlorite (Bleach)



Case/Room Setup:

1. Only the Prion Precaution tray will be used for instrumentation. These instruments will be considered disposable and will be placed in the gray incineration bins at case end. Any instrument dropped or contaminated will be placed in the gray incineration bin and will be replaced by the runner as needed. Contaminated instruments will NOT be flash sterilized in the autoclave. Accompanying the Prion Precaution tray will be a disposable battery powered cranial perforator/drill (Acracut). A Hudson Brace will be on the Prion Precaution cart as a back-up should the Acracut be out of stock. There is also a sterile pack of burr-hole covers and self-drilling screws with screwdrivers as needed.
2. No reusable equipment, instruments or supplies of any kind will come in contact with patient tissues or fluids.
3. DO NOT use the Neptune machine for suction. Use canister suction carousels.
4. NO power equipment will be used except disposable cranial perforator/drill.
5. ONLY disposable items, sterile and non-sterile will be used. At case end, all items used on the case, including instrumentation, will be disposed of in the gray incineration bins.
6. All equipment and supplies will be removed from the room prior to the start of the case to prevent unnecessary contamination, except:
1. Skytron OR bed
2. Mayfield headrest with horseshoe (NO PINS)
3. Junior table
4. Mayo Stand
5. Bovie tower
6. Suction carousel (NO NEPTUNE)
7. Headlight box (ONE)
8. PACS cart
9. Anesthesia machine
10. Anesthesia cart (ONE, neuro-anesthesia cart items may be brought by runner or Anesthesia Tech
7. Traffic will be limited to the staff required for the procedure. The Runner will be stationed outside the OR door to obtain sterile core supplies/instruments, etc.
8. "Prion Precautions" signs will be placed on the OR doors.
9. Special short grey biohazard incineration bins will be used for instruments, supplies, garbage and linens.
10. A small sharps container will be designated for the case, and disposed of in the gray incineration bin at case end.
11. In order to minimize equipment contamination and to aid in decontamination at case end, room equipment will be covered with impervious draping as much as possible. Both ends of the Skytron table and it's base should be covered in impervious drapes or red biohazard bags. The Mayfield headrest and doughnut should be covered with a red biohazard bag. The bovie tower should be covered with a red biohazard bad and small holes cut to pass the wires to the electrocautery units. Vent holes should be cut on the back side of this bag to prevent equipment overheating.
12. No reusable needles, deep brain simulators, biopsy needles or suction devices will be used.
13. Do not use the Neptune for suction. Use traditional suction carousels, which are disposable.
14. No power equipment will be used. Use Hudson Brace and Gigli Saw for craniotomies.
15. Disposable items, sterile and non-sterile, will be used as much as possible. No material that needs laundering will be used unless there is no other choice. Used towels and all other linens will be placed in grey incineration bins.



Intraoperative Protocol:

1. Scrub setup: Use a junior table for instruments and basin, and use a mayo stand in the usual fashion.
2. Cover work surfaces with disposable impermeable materials.
3. No sharps will be passed directly from person to person. Always use a "neutral zone."
4. The use of surgical wound drains is not recommended.
5. Sponges used will not be tossed into a prep stand or onto the floor, but should be kept contained on the back table.
6. Gloves should will be donned before applying dressings to patient.
7. All surgical team members will remove gown, gloves, shoe covers, hats, masks, and eye shields before leaving the room. The Runner outside the door will have clean hats available.



Staff Exposure

1. All aspects of standard precautions will be followed. Use of personal protection equipment will be strictly enforced. Protective attire includes paper gowns, OSHA-approved eye shields and boot-style shoe covers. The scrub team MUST double glove.
2. Great caution should be utilized to prevent percutaneous or mucous membrane exposure.
3. If exposure occurs, rinse the skin with a 1:10 dilution of bleach, for one minute, wash with soap and water, and follow HMC policy for reporting blood-borne exposure to Employee Health Services (X3081) or the Emergency Department.
4. If exposure occurs to a mucous membrane, irrigate the area for several minutes with normal saline or water and report the exposure as above.


4. Handling Specimens:

When a pathology exam of tissue is needed:
1. The Circulator will notify Neuropathology to come to the room for the specimen.
2. A sterile specimen cup and Telfa will be given to the Scrub, who will in turn put the specimen in it from the sterile field.
3. The specimen will be safely transferred into a biohazard bag.
4. The specimen will be given to the pathologist in the room, fresh. There will be no frozen section.
5. The pneumatic tube system will not be used for any specimens due to possibility of breakage and to prevent unnecessary contamination.


5. Decontamination/Disinfection of Instruments, Equipment and the Room:



General Information:

1. Three large Grey Incineration Bins will be placed in the room for waste collection. These bins can be found in the Neuro viewing room, or by calling Environmental Services.
2. All the instruments, drapes, trash and linens will be placed in the gray incineration bins.
3. Sharps will be disposed of in the small sharps container. The sharps container will be also be placed in a Gray Incineration Bin.
4. All fluids will be contained and suctioned into suction canisters. The canisters will be solidified and placed in the Grey Incineration Bin. Fluid solidifier and instructions are kept in the Neuro Viewing room in the Prion Precautions Cart.



Anesthesia Machine:

1. Filter and tubes will be changed.
2. Flat surfaces of the machine are cleaned the same as other surfaces.
3. Anesthetic disposable supplies are to be discarded in gray incineration bins.



Environmental Cleaning:

1. Near the end of procedure, Housekeeping will be notified to send cleaning staff to the room for at least one hour. The OR doors will be kept closed after transfer of the patient.
2. Terminal cleaning of any area, including floors, will be done immediately in an organized way and supervised by housekeeping supervisory personnel.
3. Cleaning crew will use gown, boot-style shoe covers, gloves, mask and disposable eye shields.
4. Mops, cleaning cloths, and personal protective equipment (gowns, gloves, eye shields, bootees) will be treated as contaminated and placed in Gray Incineration Bins.
5. Surfaces of tables, equipment (including wheels) and floors will be cleaned and then spot-decontaminated with 1:10 dilute bleach solution, allowing the solution to remain in contact with the contaminated surfaces for at least one hour, followed with a generous clean water rinse. Then a terminal cleaning of the room will be performed.
6. All cleaning fluids will be suctioned into disposable canisters. The canisters will be solidified and placed in Grey Incineration Bins.
7. The lids of the gray incineration bins will be secured and Environmental Services will be notified for immediate pickup of the bins.

Documentation:

The Circulator will note the Prion Precaution case in the front desk Pass-Down Log, including any deviations from the above procedure. This will alert the Neuro RN3 or Nurse Manager to the need to check and restock the Prion Precaution Cart.

References:

Centers for Disease Control: Creutzfeldt-Jakob Disease Infection-Control Practices. http://www.cdc.gov/ncidod/dvrd/cjd/infection_control_cjd.htm

World Health Organization: WHO Infection Control Guidelines for Transmissible Spongiform Encephalopathies. http://www.who.int/csr/resources/publications/bse/WHO_CDS_CSR_APH_2000_3/en/.

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