PURPOSE: The purpose of this policy is to provide current infection control guidelines regarding cleaning, disinfecting, and sterilization of patient care equipment, instruments, and the patient care environment

POLICY All reusable instruments, equipment, and used surfaces will be decontaminated, disinfected,

or sterilized prior to use on a patient. The infection control guidelines for cleaning, disinfecting and sterilization of patient care equipment, instruments and patient care environment listed in Table 1 must be followed. A quality control program is important to assure appropriate disinfection and sterilization.

Manufacturers’ directions and facility policies and procedures for reprocessing reusable instruments and equipment, including directions for use of the reprocessing equipment (i.e., sterilizer, tunnel washers, etc.) should be available to staff at all times.

Personnel

o Personnel wear clean scrub attire

o Wear a fluid resistant cover gown (tied in back) and heavy-duty gloves during the decontamination process

o Completely cover all head and facial hair with a surgical-type hair covering

o Wear mask and goggles or a face shield to protect against splashes or sprays

o Staff will follow the hand hygiene policy

o Personnel must have proper training on processing instruments with competency testing on orientation to their jobs. Documentation of training should be maintained in the employees personnel file. Continuing education (including training for all new instrumentation, devices, and equipment) is conducted at regular intervals.

o All sterilization and reprocessing policies and procedures are readily available for staff

DEFINITIONSCleaning: The removal of all soil from surfaces. This can be accomplished by using water with detergents. Thorough cleaning is necessary before proceeding to high-level disinfection and sterilization. This includes pre-cleaning, manual/ultrasonic, washer/sterilizers, decontaminators, or point of use cleaning/disinfection processes.

Disinfection: A process that kills or destroys many or all disease-producing microorganisms on the inanimate object. It usually does not kill spores

High Level Disinfection: A process that destroys all vegetative microorganisms, tubercle bacilli, fungi, nonlipid and small viruses and medium-sized viruses with the exception of high numbers of bacterial spores through a chemical process

Sterilization: The complete elimination/destruction of all forms of microbial life by physical or chemical procedures

3.01 CLEANING, DISINFECTION, & STERILIZATION POLICY & PROCEDURE 1

CLEANING, DISINFECTION, & STERILIZATION

POLICY & PROCEDURE

PROCEDURE1. Pre-cleaning

a. Contaminated items should be wiped or sprayed at point of use to keep them moist prior to cleaning; they should not be cleaned or decontaminated in the scrub or hand sinks

b. Transport contaminated items in covered containers or bags marked as “bio hazardous”

c. Sharps and delicate instruments should be kept separate from other items

2. Cleaning in decontamination area

a. Cleaning of patient care items must occur prior to beginning high-level disinfection or sterilization, should remove all visible soil, and should occur as soon as practical after use. Cleaning solutions and/or detergents should be measured, mixed, labeled, and discarded appropriately according to the manufacturer’s directions for use and should be compatible with the instruments and equipment for which they are used.

b. Proper protective equipment must be used when cleaning an item if a risk of aerosolization exists (spraying of particles into air) and for protection against exposure to the chemicals used as directed by the Material Safety Data Sheet (MSDS)

c. The manufacturers’ specifications for the quality of water used for cleaning should be followed (i.e., sterile, distilled, de-ionized)

d. Completely disassemble each item prior to cleaning; all jointed instruments must be open and/or unlocked

e. The brushes used for cleaning should be disposable or decontaminated at least once a day. Worn out brushes should be disposed of. Single-use brushes should be used for cleaning ophthalmic surgical instruments. All brushing should be done underwater.

f. Mechanical cleaning equipment should be used whenever possible; test and maintain equipment as per manufacturer’s instructions

g. Appropriate sharps which are contaminated with blood or other potentially infectious materials should not be stored or processed in a manner which requires employees to reach by hand into the container where these sharps have been placed; rather, such instruments should be placed in drainage type baskets prior to submerging in cleaning solutions

h. Traffic between the decontamination, preparation, and assembly areas must be minimized; decontamination attire should be removed and personnel should wash their hands upon leaving the decontamination area

i. Visually inspect items to be certain they are clean

3. In conjunction with the manufacturer’s instructions, refer to Tables 1 and 2 to determine if disinfection or sterilization of the item is required. If high-level disinfection is required, proceed to LIQUID STERILANTS/HIGH-LEVEL DISINFECTANTS on page 3. If sterilization is required, proceed to STERILIZATION on page 3.

3.01 CLEANING, DISINFECTION, & STERILIZATION POLICY & PROCEDURE 2

LIQUID STERILANTS/HIGH-LEVEL DISINFECTANTS1. Liquid sterilants and high-level disinfectants should be measured and mixed according to

manufacturer’s instructions and placed in appropriate containers compatible with the solutions. Appropriate solution, including chemical activation and expiration dates, and hazardous material labeling should be placed on containers holding these chemicals. They should be used in locations meeting all ventilation requirements listed by the manufacturer or MSDS.

2. Routine testing of liquid sterilants and high-level disinfectants should be performed to ensure effective concentration of active ingredient. Documentation of quality control testing of the solution and testing results should be maintained in a log. If required by the manufacturer, quality control checks of the testing strips should be performed when opening a new test strip vial and appropriately documented on the log sheet. Expiration date of the test strip vials should be documented on the container when opened.

3. Liquid sterilants and high-level disinfectant temperatures should be checked and recorded prior to use; temperatures should be maintained in the range recommended by the manufacturer.

4. The FDA label claim for liquid sterilants or high-level disinfection soak times should be used unless scientific studies can show an alternate effective exposure time

5. Semi-critical devices such as rectal probes, vaginal probes, and cryosurgical probes can be cleaned with high-level disinfection with a non-toxic product; use of probe covers/condoms over the instrument is encouraged but still requires the above cleaning and disinfection procedures

STERILIZATION1. Select the appropriate method of sterilization according to the instrument or equipment’s

manufacturer’s instructions. Refer to Table 2 for additional information. The sterilization process, including critical parameters (time, pressure, temperature) and chemical indicators should be identified and followed accordingly.

2. Steam is the preferred method for sterilization of critical instruments not damaged by heat

3. Alternative sterilization methods may be used (ethylene oxide, hydrogen peroxide, gas plasma) for heat or moisture-sensitive equipment

4. Special processing may be indicated for use with brain, dura mater, spinal cord and eye (high-risk tissues) from high-risk patients (those known or suspected of having CJD)

I. Sterilization Packaging1. Assure adequate drying time of instruments and equipment prior to packaging for

sterilization

2. If lubrication is necessary, use a non-toxic, water-soluble lubricant

3. Review and follow the manufacturer’s instructions for type of wrap or container that may be used, shelf life, and storage recommendations; wrap all packages separately

4. When double wrapping, all wrapped items must be double-wrapped by using one of the following:

a. Double-thickness woven or non-woven wrappers

b. Two non-woven wrappers-may be sealed

3.01 CLEANING, DISINFECTION, & STERILIZATION POLICY & PROCEDURE 3

c. Peel-pack pouches

5. Glass, delicate instruments and sharp points must be adequately protected with padding before final wrap

6. Hinged instruments must be in open position when wrapped and processed

7. A wrap within a wrap of some items is recommended for ease in dispensing onto a sterile field; if using double pouches, a smaller pouch should be used inside a larger pouch. Double pouching should only be performed if validated by the manufacturer for that purpose.

8. Placement of equipment on trays should be in order of use

9. Articles which have surfaces in close contact must be separated for steam penetration

10. Linen packs are prepared with articles arranged and folded according to the department standards

11. Peel packs should not be placed inside of wrapped packages or containerized sets

12. Count sheets or instrument inventory lists should not be placed inside wrapped sets or rigid containers

13. Total weight of instrument trays must not exceed 25 pounds or the weight specified by the manufacturer of the sterilizer or container system, whichever is less

II. Monitoring1. Mechanical (physical), chemical, and biological monitors must be used to assure that the

sterilization process has been effective. In the event of a failed biological monitor, follow the “Management of Positive Biological Indicator in a Steam Sterilizer” policy.

a. Physical monitors include time, temperature, and pressure gauges, displays, recorders, and digital printouts. At the end of each cycle, the operator should examine the printout to verify that:

i. The printer is functioning properly

ii. The cycle identification number has been recorded

iii. All cycle parameters have been meet

b. Chemical monitors (internal and external) should be used with every load

c. Internal chemical indicators should be placed on all levels within the instrument sets; they should be placed in the geometric center of wrapped packages and in two opposite corners of rigid containers

d. For a dynamic-air-removal sterilizer, use a Class 2 indicator every day prior to the first load but after a warm up cycle

e. Class 5 indicators (integrators) should be used for each immediate-use steam sterilization load

f. Use a biological indicator as follows:

i. Steam sterilization: at least weekly, preferably daily, and for every load containing an implant. Quarantine implantable items, whenever possible, until the biologic indicator is positive.

ii. Ethylene oxide and ozone sterilization: for every load

3.01 CLEANING, DISINFECTION, & STERILIZATION POLICY & PROCEDURE 4

iii. Hydrogen peroxide sterilization: at least daily and preferably for every load

2. Package identification should include the lot control number, year and date of sterilization (Julian date), packet contents, and initials of processor; writing directly on peel packs should only be performed on the plastic side of the pouch. For wrapped packages, labeling should only be done on tape.

III. Loading of Sterilizer1. Arrange on rack or carriage so as to present least possible resistance to the passage of

steam; textile packages on top, peel pouches on edge, instrument sets flat, rigid containers under wrapped packages

2. Do not overload sterilizer; items should never touch sterilizer chamber walls

3. When possible, sterilize like materials together (e.g., linen packs with soft goods, all hard goods with other hard goods)

4. Basins, trays, test tubes, etc. must be set on edge or upside down so air will flow out freely as steam flows in

IV. Removing Load from Sterilizer1. Proper temperature and exposure time must be known; chart and temperature gauge must

be checked to see that these are achieved

2. Load should be dry and cool when removed

3. It is critical to follow the recommendations and time frames for drying the instruments and trays that have been sterilized

4. If packs are wet when removed, they must be re-sterilized

5. Care must be taken to keep sterile items separated from non-sterile items

V. Documentation1. Documentation of each sterilizer load so that all sterilized items can be traced back to the

patient should include the following:

a. The sterilizer identification

b. The type of sterilizer and cycle used

c. The lot control number

d. The specific load contents

e. The critical parameters such as time, temperature, and pressure

f. The results of the sterilization process monitors

g. The operator’s name, initials, or identification

VI. Supply and Equipment Management1. Integrity of clean and sterile equipment and supplies shall be assessed prior to use

2. Determination of shelf life of packaged items:

a. Inspect all packages before use; if intact, they are considered sterile

b. Packaging will be considered non-sterile (compromised) when certain events occur:

i. Holes/tears

ii. Broken or no seal

iii. Dropped

3.01 CLEANING, DISINFECTION, & STERILIZATION POLICY & PROCEDURE 5

iv. Moisture

v. Unsealed dust cover

vi. Broken tape

vii. Lids improperly applied

3. Store items in a manner that prevents crushing or binding together

4. Place lighter items on heavier ones

5. Store items in closed cabinets; if this is not possible, store items on wire shelves in a restricted storage area with the bottom shelf being solid

6. Arrange storage areas in a manner that prevents splashing from personnel or housekeeping

7. Rotate stock so that older items are used first

8. Store liquids below dry sterile goods or in a separate section

9. Store materials at least 18” below the ceiling and/or sprinkler head

10. Do not store sterile items under plumbing values and traps

11. Cleaned delivery carts shall be used to transport clean and sterile supplies

CLEANING NON-CRITICAL PATIENT CARE ITEMS1. All non-disposable patient care equipment shall be cleaned the same regardless of the

patient’s infection status

2. In the exam/treatment rooms of patients with MDROs, the amount of non-disposable equipment taken into the room shall be limited as much as feasible

a. The items will be cleaned and disinfected using a low to intermediate level disinfectant before taking them out of the room

b. If not disinfected in the room, the items shall be placed in a plastic bag for transport and subsequent cleaning and disinfection

Table 1. Classification of Devices, Processes, and Germicidal Products

Device classification Devices (examples) Spaulding process classification

EPA product classification

Critical (enters sterile tissue or vascular system)

Implants, scalpels, needles, other surgical instruments, etc.

Sterilization – sporicidal chemical; prolonged contact

Sterilant/disinfectant

Semicritical (touches mucous membranes, except dental)

Flexible endoscopes, laryngoscopes, endotracheal tubes, and other similar instruments

High-level disinfection – sporicidal chemical; short contact

Sterilant/disinfectant

Thermometers, hydrotherapy tanks

Intermediate-level disinfection

Hospital disinfectant with label claim for tuberculocidal activity

Noncritical (touches intact skin)

Stethoscopes, tabletops, bedpans, etc.

Low-level disinfection Hospital disinfectant without label claim for tuberculocidal activity

Modified from 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

3.01 CLEANING, DISINFECTION, & STERILIZATION POLICY & PROCEDURE 6

Table 2. Methods of Sterilization and DisinfectionSterilization Disinfection

Critical items (will enter tissue or vascular system or blood will flow through them)

High-level (semicritical items; [except dental] will come in contact with mucous membrane or nonintact skin)

Intermediate-level (some semicritical items1 and noncritical items)

Low-level (noncritical items; will come in contact with intact skin)

Object Procedure Exposure time Procedure (exposure time 12-30 min at ≥20ºC)2,3

Procedure (exposure time > 1 min) 9

Procedure (exposure time > 1 min) 9

Smooth, hard Surface1,4

ABCDFGH

MRMRMR10 h at 20-25ºC6 h12 m at 50-56ºC3-8 h

DEFHI6

J

KL5

MN

KLMNO

Rubber tubing and catheters3,4

ABCDFGH

MRMRMR10 h at 20-25º C6 h12 m at 50-56º C3-8 h

DEFHI6

J

Polyethylene tubing and catheters3,4,7

ABCDFGH

MRMRMR10 h at 20-25º C6 h12 m at 50-56º C3-8 h

DEFHI6

J

Lensed instruments4 ABCDFGH

MRMRMR10 h at 20-25ºC6 h12 m at 50-56ºC3-8 h

DEFHJ

Thermometers (oral and rectal)8

K8

Hinged instruments4 ABCDFGH

MRMRMR10 h at 20-25ºC6 h12 m at 50-56ºC3-8 h

DEFHI6

J

Rutala and Weber, 2008.

The selection and use of disinfectants in the healthcare field is dynamic, and products may become available that are not in existence when this guideline was written. As newer disinfectants become available, persons or committees responsible for selecting disinfectants and sterilization processes should be guided by products cleared by the FDA and the EPA as well as information in the scientific literature.

A: Heat sterilization, including steam or hot air (see manufacturer's recommendations, steam sterilization processing time from 3-30 minutes)

B: Ethylene oxide gas (see manufacturer's recommendations, generally 1-6 hours processing time plus aeration time of 8-12 hours at 50-60ºC)

C: Hydrogen peroxide gas plasma (see manufacturer’s recommendations for internal diameter and length restrictions, processing time between 45-72 minutes).

D: Glutaraldehyde-based formulations (>2% glutaraldehyde, caution should be exercised with all glutaraldehyde formulations when further in-use dilution is anticipated); glutaraldehyde (1.12%) and

3.01 CLEANING, DISINFECTION, & STERILIZATION POLICY & PROCEDURE 7

1.93% phenol/phenate. One glutaraldehyde-based product has a high-level disinfection claim of 5 minutes at 35ºC.

E: Ortho-phthalaldehyde (OPA) 0.55% F: Hydrogen peroxide 7.5% (will corrode copper, zinc, and brass) G: Peracetic acid, concentration variable but 0.2% or greater is sporicidal. Peracetic acid immersion system

operates at 50-56ºC. H: Hydrogen peroxide (7.35%) and 0.23% peracetic acid; hydrogen peroxide 1% and peracetic acid 0.08%

(will corrode metal instruments) I: Wet pasteurization at 70ºC for 30 minutes with detergent cleaning J: Hypochlorite, single use chlorine generated on-site by electrolyzing saline containing >650-675 active

free chlorine; (will corrode metal instruments) K: Ethyl or isopropyl alcohol (70-90%) L: Sodium hypochlorite (5.25-6.15% 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 recommendations NA: Not applicable

1 See text for discussion of hydrotherapy2 The longer the exposure to a disinfectant, the more likely it is that all microorganisms will be eliminated.

Follow the FDA-cleared high-level disinfection claim. Ten-minute 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-minute exposure at 20ºC is the minimum time needed to reliably kill M. tuberculosis and nontuberculous mycobacteria with a 2% glutaraldehyde. Some high-level disinfectants have a reduced exposure time (e.g., ortho-phthalaldehyde at 12 minutes at 20ºC) because of their rapid activity against mycobacteria or reduced exposure time due to increased mycobactericidal activity at elevated temperature (e.g., 2.5% glutaraldehyde at 5 minutes at 35ºC, 0.55% OPA at 5 min at 25ºC in automated endoscope reprocessor).

3 Tubing must be completely filled for high-level disinfection and liquid chemical sterilization; care must be taken to avoid entrapment of air bubbles during immersion.

4 Material compatibility should be investigated when appropriate. 5 A concentration of 1000 ppm available chlorine should be considered where cultures or concentrated

preparations of microorganisms have spilled (5.25% to 6.15% household bleach diluted 1:50 provides > 1000 ppm available chlorine). This solution may corrode some surfaces.

6 Pasteurization (washer-disinfector) of respiratory therapy or 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 appropriate. 8 Do not mix rectal and oral thermometers at any stage of handling or processing. 9 By law, all applicable label instructions on EPA-registered products must be followed. If the user selects

exposure conditions that differ from those on the EPA-registered products label, the user assumes liability from any injuries resulting from off-label use and is potentially subject to enforcement action under FIFRA.

3.01 CLEANING, DISINFECTION, & STERILIZATION POLICY & PROCEDURE 8

REFERENCESAssociation for Professionals in Infection Control. (2009). APIC Text of Infection Control and Epidemiology, 3 rd Edition . Washington, DC.

Association of PeriOperative Registered Nurses. 2009. Perioperative Standards and Recommended Practices.

Association for the Advancement of Medical Instrumentation. (2010). ANSI/AAMI ST79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. Washington, D.C.

Bennett, G. & Kassai, M. (2011). Infection Prevention Manual for Ambulatory Surgery Centers. ICP Associates: Rome, Georgia.

Rutala W.A., Weber D.J., and the Hospital Infection Control Practices Advisory Committee. (2008). Guideline for Disinfection and Sterilization in Healthcare Facilities , 2008 . Centers for Disease Control and Prevention: Atlanta, Georgia.

Rutala W.A., and Weber D.J., “Disinfection and Sterilization in Healthcare Facilities: What Clinicians Need to Know”, Clinical Infectious Diseases (2004);39:702-9.

DISCLAIMER: All data and information provided by the Oregon Patient Safety Commission is for informational purposes only. The Oregon Patient Safety Commission makes no representations that the patient safety recommendations will protect you from litigation or regulatory action if the recommendations are followed. The Oregon Patient Safety Commission is not liable for any errors, omissions, losses, injuries, or damages arising from the use of these recommendations.

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