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William A.

Rutala_Cali-Col

Role of Cleaning, Disinfection and


Sterilization to Prevent HealthcareAssociated infections
William A. Rutala, PhD, MPH
Director, Hospital Epidemiology, Occupational Health and Safety,
UNC Health Care; Research Professor of Medicine and Director,
Statewide Program for Infection Control and Epidemiology,
University of North Carolina School of Medicine, Chapel Hill, NC
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DISCLOSURES
Consultation and Honoraria
Clorox
Honoraria
3M
Grants
CDC, CMS

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Learning Objective
Discuss a rational approach to cleaning, disinfection and

sterilization
Identify best practices for low level disinfection, high level
disinfection and sterilization
Describe methods to prevent HAIs related to reusable
medical and surgical instruments as well as the
environment

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CDC Guideline for Disinfection and Sterilization


Rutala, Weber, HICPAC. November 2008. www.cdc.gov

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Disinfection and Sterilization


Rutala, Weber, HICPAC. November 2008. www.cdc.gov

EH Spaulding believed that how an object will be disinfected


depended on the objects intended use.
CRITICAL - objects which enter normally sterile tissue or the
vascular system or through which blood flows should be
sterile.
SEMICRITICAL - objects that touch mucous membranes or
skin that is not intact require a disinfection process (highlevel disinfection [HLD]) that kills all microorganisms and
some bacterial spores.
NONCRITICAL -objects that touch only intact skin require
low-level disinfection (or non-germicidal detergent).
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Microbiological Disinfectant Hierarchy

Microbes Exhibit a Wide Variation in Intrinsic Resistance to Disinfectants


Rutala WA, Weber DJ, HICPAC. www.cdc.gov
William A. Rutala_Cali-Col

Most Resistant

Sterilization

Spores (C. difficile)


Mycobacteria (M. tuberculosis)
Non-Enveloped Viruses (norovirus, HAV, polio)
Fungi (Candida, Trichophyton)
Bacteria (MRSA, VRE, Acinetobacter)
Enveloped
Viruses
(HIV, HSV, Flu)
Most Susceptible
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Cleaning
Items must be cleaned using water with detergents or

enzymatic cleaners before processing.


Cleaning reduces the bioburden and removes foreign
material (organic residue and inorganic salts) that
interferes with the sterilization process.
Cleaning and decontamination should be done as soon as
possible after the items have been used as soiled
materials become dried onto the instruments.

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Washer/Disinfector

Five Chambers

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Pre-wash: water/enzymatic is circulated over the load for 1 min


Wash: detergent wash solution (150oF) is sprayed over load for 4 min
Ultrasonic cleaning: basket is lowered into ultrasonic cleaning tank
with detergent for 4 min
Thermal and lubricant rinse: hot water (180oF) is sprayed over load
for 1 min; instrument milk lubricant is added to the water and is
sprayed over the load
Drying: blower starts for 4 min and temperature in drying chamber
180F

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Washer/Disinfector

Removal/Inactivation of Inoculum (Exposed) on Instruments


Rutala et al. Infect Control Hosp Epidemiol 2014. 35:883-885.

WD Conditions

Organism

Inoculum

Log Reduction

Routine

MRSA

2.6x107

Complete

0/8

Routine

VRE

2.6x107

Complete

0/8

Routine

P aeruginosa 2.1x107

Complete

0/8

Routine

M terrae

1.4x108

7.8

2/8

Routine

GS spores

5.3x106

4.8

11/14

2.5x107

Complete

0/10

8.3x106

5.5

8/10

No Enz/Det VRE
No Enz/Det GS spores
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Positives

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Washer/disinfectors are very effective (>7


log10 reduction) in removing/inactivating
microorganisms from instruments

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Cleaning Indicators for Washer Disinfector

Monitor the automated washer and


instrument cleaning chemistry
functionality; AAMI recommends
weekly (preferably daily)
Washer indicators have been used in
Europe and Canada and some US
hospitals
Indicator includes proteins, lipids, and
polysaccharides to mimic common
challenging test soils
Washer indicators are chemical
indicators imprinted with a dried test
soil formula and a dye

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Sterilization of Critical Objects

Rutala WA, Weber DJ, HICPAC. CDC Disinfection and Sterilization Guideline www.cdc.gov

Heat Resistant
Steam sterilization
Heat Sensitive
Hydrogen peroxide (HP) gas plasma
Ethylene oxide
HP and ozone
Vaporized hydrogen peroxide
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Recommendations

Methods of Sterilization

Rutala WA, Weber DJ, HICPAC. CDC Disinfection and Sterilization Guideline www.cdc.gov

Steam is preferred for critical items not damaged by heat


Follow the operating parameters recommended by the

manufacturer
Use low temperature sterilization technologies for
reprocessing critical items damaged by heat
Use immediately critical items that have been sterilized by
peracetic acid immersion process (no long term storage)

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Sterilization Practices

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Sterilization Monitoring

Rutala WA, Weber DJ, HICPAC. CDC Disinfection and Sterilization Guideline www.cdc.gov

Sterilization monitored routinely by combination of


mechanical, chemical, and biological parameters
Physical - cycle time, temperature, pressure
Chemical - heat or chemical sensitive inks that change
color when germicidal-related parameters present
Biological - Bacillus spores that directly measure
sterilization
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Recommendations

Monitoring of Sterilizers

Rutala WA, Weber DJ, HICPAC. CDC Disinfection and Sterilization Guideline www.cdc.gov

Monitor each load with mechanical and chemical (internal

and external) indicators.


Use biological indicators to monitor effectiveness of
sterilizers at least weekly with spores intended for the type
of sterilizer.
Use biological indicators for every load containing
implantable items

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Recommendations

Storage of Sterile Items

Sterile storage area should be well-ventilated area that

provides protection against dust, moisture, and


temperature and humidity extremes.
Sterile items should be stored so that packaging is not
compromised
Sterilized items should be labeled with a load number that
indicates the sterilizer used, the cycle or load number, the
date of sterilization, and the expiration date (if applicable)

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Recommendations

Storage of Sterile Items

Event-related shelf life recognizes that the product

remains sterile until an event causes it to become


contaminated (e.g., tear, wetness). Packages should be
evaluated before use for lose of integrity.
Time-related shelf life (less common) considers items
remain sterile for varying periods depending on the type of
material used to wrap the item/tray. Once the expiration
date is exceeded the pack should be reprocessed.

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DISINFECTION AND STERILIZATION

EH Spaulding believed that how an object will be disinfected depended on


the objects intended use
CRITICAL - objects which enter normally sterile tissue or the
vascular system or through which blood flows should be sterile
SEMICRITICAL - objects that touch mucous membranes or skin
that is not intact require a disinfection process (high-level
disinfection[HLD]) that kills all microorganisms except for high
numbers of bacterial spores
NONCRITICAL - objects that touch only intact skin require lowlevel disinfection

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Microbiological Disinfectant Hierarchy


Rutala WA, Weber DJ, HICPAC. www.cdc.gov

Most Resistant

Spores (C. difficile)


HLD
Mycobacteria (M. tuberculosis)
Non-Enveloped Viruses (norovirus, HAV, polio)
Fungi (Candida, Trichophyton)
Bacteria (MRSA, VRE, Acinetobacter)
Enveloped Viruses (HIV, HSV, Flu)

Most Susceptible
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Reprocessing Semicritical Items

New Developments in Reprocessing


Endoscopes
Laryngoscopes
Infrared coagulation device
Nasopharyngoscopes
Endocavitary probe
Prostate biopsy probes
Tonometers

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Transmission of Infection by Endoscopy


Kovaleva et al. Clin Microbiol Rev 2013. 26:231-254

Scope

Outbreaks

Micro (primary)

Pts
Pts Infected
Contaminated

Cause
(primary)

Upper GI

19

Pa, H. pylori,
Salmonella

169

56

Cleaning/Disinfection (C/D)

Sigmoid/Colon 5
oscopy

Salmonella, HCV 14

Cleaning/Disinfection

ERCP

Pa

152

89

C/D, water
bottle, AER

Pa, Mtb,
Mycobacteria

778

98

C/D, AER,
water

1113

249

23

Bronchoscopy 51
Totals

98

Based on outbreak data, if eliminated deficiencies associated with cleaning, disinfection, AER , contaminated
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water and drying would eliminate about 85% of the outbreaks.

William A. Rutala_Cali-Col

FEATURES OF ENDOSCOPES THAT PREDISPOSE


TO DISINFECTION FAILURES

Require low temperature


disinfection
Long narrow lumens
Right angle turns
Blind lumens
May be heavily contaminated
with pathogens (9-10 logs
inside)
Cleaning (4-6 log10 reduction)
and HLD (4-6 log10 reduction)
essential for patient safe
instrument

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ENDOSCOPES

Widely used diagnostic and therapeutic procedure (11-22 million


GI procedures annually in the US)
GI endoscope contamination during use (109 in/105 out)
Semicritical items require high-level disinfection minimally
Inappropriate cleaning and disinfection has lead to crosstransmission
In the inanimate environment, although the incidence remains very
low, endoscopes represent a significant risk of disease
transmission

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MULTISOCIETY GUIDELINE ON
REPROCESSING GI ENDOSCOPES, 2011
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Petersen et al. ICHE. 2011;32:527

William A. Rutala_Cali-Col

CDC Guideline for Disinfection and Sterilization


Rutala, Weber, HICPAC. November 2008. www.cdc.gov

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ENDOSCOPE REPROCESSING
Multi-Society Guideline on Endoscope Reprocessing, 2011

PRECLEAN- point-of-use (bedside) remove debris by wiping


exterior and aspiration of detergent through air/water and biopsy
channels; leak testing
CLEAN- mechanically cleaned with water and enzymatic cleaner
HLD/STERILIZE- immerse scope and perfuse HLD/sterilant
through all channels for exposure time (>2% glut at 20m at 20oC). If
AER used, review model-specific reprocessing protocols from both
the endoscope and AER manufacturer
RINSE- scope and channels rinsed with sterile water, filtered water,
or tap water. Flush channels with alcohol and dry
DRY-use forced air to dry insertion tube and channels
STORE- hang in vertical position to facilitate drying; stored in a
manner to protect from contamination

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High-Level Disinfection of
Semicritical Objects
Exposure Time > 8m-45m (US), 20oC
Germicide
Concentration_____
Glutaraldehyde
> 2.0%
Ortho-phthalaldehyde
0.55%
Hydrogen peroxide*
7.5%
Hydrogen peroxide and peracetic acid*
1.0%/0.08%
Hydrogen peroxide and peracetic acid*
7.5%/0.23%
Hypochlorite (free chlorine)*
650-675 ppm
Accelerated hydrogen peroxide
2.0%
Peracetic acid
0.2%
Glut and isopropanol
3.4%/26%
Glut and phenol/phenate**
1.21%/1.93%___

*May cause cosmetic and functional damage; **efficacy not verified


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Endoscope Reprocessing Methods


Ofstead , Wetzler, Snyder, Horton, Gastro Nursing 2010; 33:204

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Endoscope Reprocessing Methods


Ofstead , Wetzler, Snyder, Horton, Gastro Nursing 2010; 33:204

Performed all 12 steps with only 1.4% of endoscopes using manual versus 75.4% of those processed
using AER

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RECENT ENDOSCOPY-RELATED OUTBREAKS OF


MRDO WITHOUT REPROCESSING BREACHES
MDRO

Scope

No. Recovered From Scope

Molecular Link

Reference

P. aeruginosa (VIM-2)

Duodenoscope

22

Yes, under forceps elevator

Yes

Verfaillie CJ, 2015

E. coli (AmpC)

Duodenoscope

Yes (2 scopes)

Yes (PFGE)

Wendort, 2015

K. pneumoniae (OXA) Duodenoscope

No

39

Yes

E. coli (NDM-CRE)

Duodenoscope

Kola A, 2015

Yes (PFGE)

Epstein L, 2014

Additional Outbreaks (not published; news media reports)

UCLA, 2015, CRE, 179 patients exposed (2 deaths), 2 colonized duodenoscopes


CMC, 2015, CRE, 18 patients exposed (7 infected), duodenoscopes
Cedars-Sinai, 2015, CRE, 67 patients exposed (4 infected), duodenoscopes
Wisconsin, 2013, CRE, (5 infected), duodenoscopes
University of Pittsburgh, 2012, CRE, 9 patients, duodenoscopes

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Reason for Endoscope-Related Outbreaks


Rutala WA, Weber DJ. Infect Control Hosp Epidemiol 2015;36:643-648

Margin of safety with endoscope reprocessing minimal or

non-existent for two reasons:


Microbial load
GI

endoscopes contain 107-10


Cleaning results in 2-6 log10 reduction
High-level disinfection results in 4-6 log10 reduction
Results in a total 6-12 log10 reduction of microbes
Level of contamination after processing: 4 log10 (maximum
contamination, minimal cleaning/HLD)

Complexity of endoscope

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GI Endoscopes:
Shift from Disinfection to Sterilization

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Rutala, Weber. JAMA 2014. 312:1405-1406

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To protect the public health we (FDA,


industry, professional organizations)
must shift duodenoscope reprocessing
from HLD to sterilization..
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Reprocessing Channeled Endoscopes

Cystoscope- completely immerse in HLD (J Urology 2008.180:588)

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Reprocessing Channeled Endoscopes

Cystoscope-HLD perfused through lumen with syringe (luer locks onto


port and syringe filled and emptied until no air exits the scope nor air in
barrel of syringe-syringe and lumen filled with HLD)
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Reprocessing Channeled Endoscopes


Rutala, Gergen, Bringhurst, Weber. ICHE. 2016;36:228-230

Exposure
Method

VRE
VRE
Contamination
Contamination
Before HLD
After HLD
(glutaraldehyde)

Passive HLD
(immersed,
not
perfused)

3.6x108
2.0x108
1.1x108

5.0x107
1.0x108
6.8x107

Active HLD
(perfused
HLD into
channel with
syringe)
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8.4x107
1.5x108
2.8x108

1 CFU
0
0

Pathogens must have exposure to


HLD for inactivation
Immerse channeled flexible scope
into HLD will not inactivate channel
pathogens
Completely immerse the
endoscope in HLD and ensure all
channels are perfused
Air pressure in channel stronger
than fluid pressure at fluid-air
interface

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Minimum Effective Concentration


Chemical Sterilant

Dilution of chemical sterilant occurs during use


Test strips are available for monitoring MEC
Test strips for glutaraldehyde monitor 1.5%
Test strip not used to extend the use-life beyond the
expiration date (date test strips when opened)
Testing frequency based on how frequently the solutions
are used (used daily, test at least daily)
Record results

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DISINFECTION AND STERILIZATION

EH Spaulding believed that how an object will be disinfected depended on


the objects intended use
CRITICAL - objects which enter normally sterile tissue or the
vascular system or through which blood flows should be sterile
SEMICRITICAL - objects that touch mucous membranes or skin
that is not intact require a disinfection process (high-level
disinfection[HLD]) that kills all microorganisms except for high
numbers of bacterial spores
NONCRITICAL - objects that touch only intact skin require lowlevel disinfection

CIDEIM

William A. Rutala_Cali-Col

Microbiological Disinfectant Hierarchy


Rutala WA, Weber DJ, HICPAC. www.cdc.gov

Most Resistant

Spores (C. difficile)


Mycobacteria (M. tuberculosis)
Non-Enveloped Viruses (norovirus, HAV, polio) LLD
Fungi (Candida, Trichophyton)
Bacteria (MRSA, VRE, Acinetobacter)
Enveloped Viruses (HIV, HSV, Flu)

Most Susceptible
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ENVIRONMENTAL CONTAMINATION LEADS TO HAIs

There is increasing evidence to support the contribution of

the environment to disease transmission


This supports comprehensive disinfecting regimens (goal
is not sterilization) to reduce the risk of acquiring a
pathogen from the healthcare environment/equipment

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KEY PATHOGENS WHERE ENVIRONMENTIAL


SURFACES PLAY A ROLE IN TRANSMISSION

MRSA
VRE
Acinetobacter spp.
Clostridium difficile
Norovirus
Rotavirus
SARS

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Donskey CJ. Am J Infect Control 2013;41:S12

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Environmental Disinfection Interventions


Donskey CJ. Am J Infect Control 2013;41:S12

Cleaning product substitutions


Improvements in the effectiveness of cleaning and disinfection
practices

Education
Audit and feedback
Addition of housekeeping personnel or specialized cleaning staff

Automated technologies

Conclusion: Improvements in environmental disinfection

may prevent transmission of pathogens and reduce HAIs

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LOW-LEVEL DISINFECTION FOR NONCRITICAL


EQUIPMENT AND SURFACES
Germicide

Exposure time > 1 min

Use Concentration

Ethyl or isopropyl alcohol


70-90%
Chlorine
100ppm (1:500 dilution)
Phenolic
UD
Iodophor
UD
Quaternary ammonium
UD
Improved hydrogen peroxide (HP)
0.5%, 1.4%
____________________________________________________
UD=Manufacturers recommended use dilution
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REVIEW THE BEST PRACTICES FOR


CLEANING AND DISINFECTING
Cleaning and disinfecting is one-step with
disinfectant-detergent (EPA claim in presence of
soil). No pre-cleaning necessary unless spill or
gross contamination.
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Blood Pressure Cuff


Non-Critical Patient Care Item

William A. Rutala_Cali-Col

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Surface Disinfection
Noncritical Patient Care

Rutala, Weber, HICPAC. www.cdc.gov

Disinfecting Noncritical Patient-Care Items


Process noncritical patient-care equipment with a EPAregistered disinfectant at the proper use dilution and a contact
time of at least 1 min. Category IB
Ensure that the frequency for disinfecting noncritical patientcare surfaces be done minimally when visibly soiled and on a
regular basis (such as after each patient use or once daily or
once weekly). Category IB

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Surface Disinfection
Environmental Surfaces

Rutala, Weber, HICPAC. www.cdc.gov

Disinfecting Environmental Surfaces in HCF


Disinfect (or clean) housekeeping surfaces (e.g., floors,
tabletops) on a regular basis (e.g., daily, three times per week),
when spills occur, and when these surfaces are visibly soiled.
Category IB
Use disinfectant for housekeeping purposes where: uncertainty
exists as to the nature of the soil on the surfaces (blood vs dirt);
or where uncertainty exists regarding the presence of multi-drug
resistant organisms on such surfaces. Category II

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Practical Approach to Cleaning


Disinfection of Hospital Surfaces
Thursday, 7am, Room Farallones

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Learning Objective
Discuss a rational approach to cleaning, disinfection and

sterilization
Identify best practices for low level disinfection, high level
disinfection and sterilization
Describe methods to prevent HAIs related to reusable
medical and surgical instruments as well as the
environment

CIDEIM

William A. Rutala_Cali-Col

Role of Cleaning, Disinfection and Sterilization to


Prevent Healthcare-Associated infections
Disinfection and sterilization technologies and practices reduce risk of

infection associated with medical devices and surfaces.


Endoscope represent a nosocomial hazard. Urgent need to understand the
gaps in endoscope reprocessing. Reprocessing guidelines must be followed
to prevent exposure to pathogens that may lead to infection. Endoscopes
have narrow margin of safety and manufacturers should be encouraged to
develop practical sterilization technology.
The contaminated surface environment in hospital rooms is important in the
transmission of healthcare-associated pathogens (MRSA, VRE, C. difficile,
Acinetobacter). Thoroughness of cleaning should be monitored (e.g.,
fluorescence).
Emerging pathogens, such as Ebola, are susceptible to currently available
disinfectants.

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THANK YOU!
www.disinfectionandsterilization.org

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