TITLE:



TITLE: CLEANING & DISINFECTION OF PATIENT CARE EQUIPMENT

PURPOSE:

The need for appropriate cleaning, disinfection and sterilization of patient-care items has been emphasized by published reports documenting infection after improper decontamination practices. Clinical policies are needed to identify whether cleaning, disinfection or sterilization is indicated, based primarily on an item’s use. This policy provides a practical approach to the prudent selection and use of proper cleaning, disinfection and sterilization processes.

POLICY:

The Hospital will implement and maintain policies, procedures and surveillance to assure equipment will be clean and free of contamination when used to provide direct patient care.

DEFINITIONS:

Cleaning

Cleaning is the physical removal of foreign material, e.g., dust, soil, organic material such as blood, secretions, excretions and microorganisms. Cleaning physically removes rather than kills microorganisms. It is accomplished with water, detergents and mechanical action. Cleaning is always essential prior to disinfection or sterilization. An item that has not been cleaned cannot be assuredly disinfected or sterilized. Organic material left on a medical device can shield microorganisms and protect them from the action of disinfectants or sterilants or interact with the disinfectant or sterilant to neutralize the activity of the process.

Disinfection

Disinfection is the inactivation of disease producing microorganisms. Disinfection does not destroy bacterial spores. Disinfectants are used on inanimate objects; antiseptics are used on living tissue. Disinfection usually involves chemicals, heat, or ultraviolet light. Levels of disinfection vary with the type of product used.

Levels of Disinfection

Low Level Disinfection: required when processing non-critical items or some environmental surfaces. Low-level disinfectants kill most vegetative bacteria and some fungi as well as enveloped (lipid) viruses (e.g., hepatitis B, C, Hantavirus, and HIV). Low-level disinfectants do not kill mycobacteria or bacterial spores. Low levels disinfectants-detergents are used to clean environmental surfaces

Intermediate Level Disinfection: required for some semi-critical items. Intermediate level disinfectants kill vegetative bacteria, most viruses and most fungi but not resistant bacterial spores

High Level Disinfection: required when processing semi-critical items. High-level disinfection processes destroy vegetative bacteria, mycobacteria, fungi and enveloped (lipid) and non-enveloped (non lipid) viruses, but not necessarily bacterial spores. High-level disinfectant chemicals must be capable of sterilization when contact time is extended. Items must be thoroughly cleaned prior to high-level disinfection.

Sterilization

Sterilization is the destruction of all forms of microbial life including bacteria, viruses, spores and fungi. Items must be cleaned thoroughly before effective sterilization can take place.

Critical Items: instruments and devices that enter sterile tissues, including the vascular system. Critical items present a high risk of infection. Reprocessing critical items requires meticulous cleaning followed by sterilization.

Semi-critical Items: devices that come in contact with non-intact skin or mucous membranes but ordinarily do penetrate them. Reprocessing semi-critical items involves meticulous cleaning followed by high-level disinfection.

Non-Critical Items: those that either touch only intact skin (but not mucous membrane) or do not directly touch the patient. Reprocessing of non-critical items involves cleaning or low level disinfection.

PROCEDURE:

1. All Hospital staff are required to inspect an equipment item for cleanliness and evidence of contamination before rendering direct care to a patient with the piece of equipment.

o Where there is evidence of dirt or contamination, the patient care equipment item must be taken out of service immediately.

i. If the item is non-critical and can be cleaned and disinfected with low-level disinfectants, the cleaning and disinfection must be done before the item is subsequently put back into service and used for patient care.

ii. If the item is classified as a critical or semi-critical risk of potential infection, the piece of equipment must be cleaned and subjected to high-level disinfection or sterilized by standardized methods established for that piece of equipment in the owning department or by the Central Services department. Cleaning and high-level disinfection/sterilization must be performed after each use.

2. Guidelines for cleaning and disinfection are listed below in Table 1:

Table 1.

|Object Classification |Use of Item |Example |Decontamination required after |

| | | |cleaning |

|Critical |Enters vascular system |Scalpels and other surgical |Sterilization and holding in |

| |or sterile body tissues|instruments, intravascular |sterilized state. High level |

| | |instruments, biopsy forceps |disinfection is not sufficient |

|Semi-Critical |Comes in contact with |Thermometer, vaginal speculum, |High level disinfection (by heat or|

| |mucous membranes |endoscopes, vaginal ultrasound |chemicals) |

| | |probes, nasal specula, | |

| | |Laryngoscope blades and handles | |

|Non-Critical |Comes in contact with |Examination table top, blood |Intermediate or low level |

| |intact skin |pressure cuff, stethoscope, baby|disinfection |

| | |weigh scales, glucometers & | |

| | |other transportable medical | |

| | |devices | |

3. Approved Sterilization Methods are listed below in Table 2:

Table 2.

|Method |Processing Times |Application examples |

|Steam |~ 4 min. @ 270°F |Heat tolerant critical and semi-critical patient care items|

|Hydrogen peroxide gas plasma |~ 50 min. |Heat sensitive critical and semi-critical patient care items|

|Chemical Sterilants | |Heat sensitive critical and semi-critical patient care items|

| | |that can be immersed |

|7.35% hydrogen peroxide and 0.23% peracetic| | |

|acid | | |

| |3 hrs @ 20◦C | |

|7.5% hydrogen peroxide | | |

| |6 hrs @ 20◦C | |

|1.0% hydrogen peroxide and 0.08% peracetic | | |

|acid |8 hrs | |

| | | |

|> 0.2% peracetic acid |~50 min | |

| | | |

| | | |

4. Approved methods for disinfection are listed below in Table 3:

Table 3.

|Agent |Advantages |Disadvantages |Efficacy |Indications |

|Alcohol |Fast acting, |Flammable, drying, |Excellent activity |Intermediate level disinfectant. Used |

|Ethyl and isopropyl 60-90% |Non-staining |evaporates quickly |against gram + and |primarily for disinfecting external |

| | | |gram- organisms; |surfaces (e.g., stethoscopes) and as an |

| | | |rapidly bactericidal |antiseptic for disinfection of the skin |

| | | |against vegetative | |

| | | |bacterial; | |

| | | |tuberculocidal, | |

| | | |virucidal, and | |

| | | |fungicidal but not | |

| | | |sporicidal | |

|Hydrogen peroxide |Sporicidal at higher|Oxidizing properties may |Bactericidal, |Used for disinfection of soft contact |

| |concentrations; |be damaging to endoscopes;|fungicidal, virucidal, |lens, tonometers, and ventilators; 7.5% |

| |by-products |some reports of pseudo- |sporicidal; MEC is 6% |hydrogen peroxide/0.85% phosphoric acid |

| |environmentally |membranous colitis |for 7.5% hydrogen |solution acceptable for endoscope |

| |friendly |associated with 3% |peroxide and 0.85% |reprocessing unless incompatible with |

| | |hydrogen peroxide |phosphoric acid |endoscopic material |

| | | |combination; no | |

| | | |difference in | |

| | | |germicidal | |

| | | |effectiveness between | |

| | | |2% gluteraldehyde and | |

| | | |7.5% hydrogen peroxide;| |

| | | |30 min at 20◦ HLD claim| |

|Chlorine |Fast acting, low |Corrosive; inactivated by |Effective against |Depending on concentration, is HLD, ILD, |

|Household bleach (5% sodium |level of toxicity; |organic material; |bacteria, mycobacteria,|LLD |

|hypochlorite solution with |low cost; broad |unstable; efficacy |fungi, and viruses, |Use 1 part bleach with 9 parts water |

|50,000 ppm available chlorine, |spectrum activity |decreases with increase in|high concentrations of |(1:10 or 500 ppm) for disinfection of |

|Dispatch™ wipes, Activate™ | |pH; CDC guidelines |chlorine required to |blood spills |

|5.25% Bleach dispensers) | |recommend that chlorine |kill mycobacterium |Use 1 part bleach to 99 parts water (1:100|

| | |solutions be made fresh |tuberculosis ; not |or 5,000 ppm)) for disinfection of |

| | |daily; Should not be used |sporicidal |countertops and floors |

| | |on instruments and medical| | |

| | |devices | | |

|Iodophors (combination of |Rapid action; low |Corrosive; inactivated by |Bactericidal, |Primarily used as an antiseptic; has also |

|iodine and carrier; best known |toxicity and |organic material; |virucidal, |been used to disinfect blood culture |

|is povidone-iodine) |irritation; |staining; may burn tissue |mycobacteriocidal, |tubes, thermometers and hydrotherapy |

|Manufacturer instructions must |effective carrier | |fungicidal; not |tanks; concentrations differ significantly|

|be followed for dilution | | |sporicidal |between iodophor antiseptics and |

| | | | |disinfectants; therefore antiseptic |

| | | | |formulations are not indicated for |

| | | | |disinfectant use |

|Phenolics (used in 0.4%-5% |Broad spectrum |Leaves film on surfaces; |Bactericidal, |Considered ILD to LLD; Used to |

|aqueous solutions; (Vesphene™ | |inactivated by organic |virucidal, fungicidal, |decontaminate hospital environment (walls,|

|IIse) | |matter; may cause tissue |and tuberculocidal; not|floors, furnishings); should not be used |

| | |irritation; corrosive to |sporicidal |on instruments and medical devices |

| | |certain materials; has | | |

| | |been associated with | | |

| | |hyperbilirubinemia when | | |

| | |used in nursery | | |

|QACs Quaternary Ammonium |Good cleaning agent;|Not sporicidal, |Bactericidal, |Considered LLD; Used for decontamination |

|Compounds |less irritating to |tuberculocidal, or |fungicidal; effective |of hospital environment (walls, floors, |

|(used in 0.4%-1.6 aqueous |hands than some |virucidal against |against lipophilic |furnishings); should not be used for |

|solution, Virex™ 256) |detergents |hydrophilic viruses; less |viruses |disinfecting instruments and medical |

| | |microbiocidal in presence | |devices |

| | |of organic matter; less | | |

| | |microbiocidal in presence | | |

| | |of materials such as gauze| | |

| | |and cotton’ incompatible | | |

| | |with soap | | |

|Peracetic Acid (chemical |By products not |Can be corrosive to |Bactericidal, |Chemically sterilize medical, surgical, |

|sterilant formed by reaction |harmful; no residue;|copper, brass, bronze, |tuberculocidal, |and dental instruments; also used with |

|between hydrogen peroxide, |effective in |plain steel, and |fungicidal, virucidal, |automated endoscopic reprocessing systems |

|acetic acid and water) |presence of organic |galvanized iron; unstable |and sproicidal |(for use with immersible endoscopes) |

| |matter; sporicidal |when diluted; severe burns| | |

| |at low temperatures;|may result from direct | | |

| |rapid action |contact to skin; | | |

| | |irreversible damage or | | |

| | |blindness can occur | | |

| | |following direct contact | | |

| | |of eyes; inhalation of | | |

| | |vapor or mist may irritate| | |

| | |nose, throat, and lungs | | |

|Peracetic acid/hydrogen |No activation |Materials compatibility |Effective against all |Has been used for disinfecting |

|peroxide (sterilant primarily |required; mild odor |issues with lead, brass, |microorganisms except |hemodialyzers; consult with manufacturers |

|used as HLD; 25min at 20◦C HLD | |copper, and zinc |bacterial spores |for product compatibility |

|claim; product containing 0.08%| | | | |

|peracetic acid plus 1.0% | | | | |

|hydrogen peroxide has been | | | | |

|cleared by FDA as liquid | | | | |

|chemical sterilant, Viracept) | | | | |

5. FDA-cleared sterilants and high-level disinfectants available through MCDH Materials Management are listed below in Table 4:

Table 4.

|Manufacturer |Active Ingredients |Sterilant Contact Conditions |High level Disinfectant contact |

| | | |conditions |

|K875280 STERIS 20TM Sterilant |

|Note: Cleared for use with the STERIS System Sterrad 50 Processor only. |

|STERIS Corporation |0.2% peracetic acid |Indication for device sterilization. |No indication for high-level |

| | |45 minutes; Single use only; Suitable |disinfection. MCDH Central |

| | |for instruments sensitive to heat and |Services performs sterilization |

| | |moisture. Contact conditions established|of critical & semi-critical |

| | |by simulated use testing with endoscopes|patient care equipment when HLD |

| | |and passing a modified AOAC Sporicidal |is indicated. |

| | |Activity Test. | |

6. EPA Registered Intermediate and Low Level Disinfectants available from Materials Management or from Housekeeping are listed below in Table 5:

Table 5

|Product |EPA Reg. # |Active Ingredient |Contact Time |

|Clorox Bleach (not a cleaner, must first |5813-1 |Sodium hypochlorite |1:10 dilution at 2min. for blood and body fluids|

|remove blood or other organic matter prior to| |5.25% |If stored in closed opaque bottle, at room temp |

|disinfection) | | |, this dilution may be used up to 30 days. |

| | | | |

| | | |1:500 dilution at 1 ½ min. or air dry for |

| | | |general cleaning (e.g., walls, floors, counter |

| | | |tops, etc.). This dilution must be mixed fresh |

| | | |daily |

|PDI Sani Cloth Germicidal Wipes |9480 |Isopropanol 55% |2 min. |

|Dispatch Hospital Cleaner with Bleach (can be|56392-7 |Sodium hypochlorite |2 min. |

|used as a cleaner due to added surfactants | |0.55% | |

|and deodorizer) | | | |

| | | | |

7. Removable parts and equipment with multiple parts must be thoroughly disassembled so all parts are free of harbored bacteria.

o Manufacturer's instructions will be reference for cleaning specific equipment.

o Electronic cables must never be submerged or held under running water.

References:

1. Eastern Carolina Infection Control Policy Manual (2008). Cleaning, Disinfection, and Sterilization of Patient Care Items. Retrieved from

2. For a complete listing of FDA cleared sterilants and high-level disinfectants with general claims for processing reusable medical equipment and dental devices, refer to .

3. For a complete listing of all EPA registered disinfectants refer to:

.

New: 10/94 Revised: 11/2008, 10/2010

Approval Signatures:

________________________________ ______________________

Infection Control Coordinator Date

________________________________ ______________________

Housekeeping Manager Date

________________________________ ______________________

Surgery Manager Date

______________________________________________ ___________

Chairperson, Infection Control Advisory Committee Date

______________________________________________ ___________

Chairperson, Integrated Quality Management Committee Date

________________________________ ______________________

Medical Chief of Staff Date

________________________________ ______________________

Chief Executive Officer Date

________________________________ ______________________

President, Board of Directors Date

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