RUTALA DSPreventHAIsColumbia16

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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William A. Rutala_Cali-Col
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

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
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
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
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
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
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
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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Most Resistant

HLD
Non-Enveloped Viruses (norovirus, HAV, polio)
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.
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
CDC Guideline for Disinfection and Sterilization

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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
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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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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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
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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Most Resistant

Non-Enveloped Viruses (norovirus, HAV, polio) LLD
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
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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
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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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William A.

Role of Cleaning, Disinfection and

CDC Guideline for Disinfection and Sterilization

Disinfection and Sterilization

EH Spaulding believed that how an object will be disinfected

Microbiological Disinfectant Hierarchy

Microbes Exhibit a Wide Variation in Intrinsic Resistance to Disinfectants

Spores (C. difficile)

enzymatic cleaners before processing.

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

Removal/Inactivation of Inoculum (Exposed) on Instruments

Washer/disinfectors are very effective (>7

Cleaning Indicators for Washer Disinfector

Monitor the automated washer and

Sterilization of Critical Objects

Steam is preferred for critical items not damaged by heat

Sterilization monitored routinely by combination of

Monitor each load with mechanical and chemical (internal

and external) indicators.

Storage of Sterile Items

Sterile storage area should be well-ventilated area that

provides protection against dust, moisture, and

Storage of Sterile Items

Event-related shelf life recognizes that the product

remains sterile until an event causes it to become

DISINFECTION AND STERILIZATION

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

Microbiological Disinfectant Hierarchy

Spores (C. difficile)

Reprocessing Semicritical Items

New Developments in Reprocessing

Transmission of Infection by Endoscopy

FEATURES OF ENDOSCOPES THAT PREDISPOSE

Require low temperature

Widely used diagnostic and therapeutic procedure (11-22 million

Petersen et al. ICHE. 2011;32:527

CDC Guideline for Disinfection and Sterilization

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

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

Endoscope Reprocessing Methods

Endoscope Reprocessing Methods

RECENT ENDOSCOPY-RELATED OUTBREAKS OF

No. Recovered From Scope

Yes, under forceps elevator

Verfaillie CJ, 2015

K. pneumoniae (OXA) Duodenoscope

Additional Outbreaks (not published; news media reports)

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

Reason for Endoscope-Related Outbreaks

Margin of safety with endoscope reprocessing minimal or

non-existent for two reasons:

endoscopes contain 107-10

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

To protect the public health we (FDA,

Reprocessing Channeled Endoscopes

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

Reprocessing Channeled Endoscopes

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

Reprocessing Channeled Endoscopes

Pathogens must have exposure to

Minimum Effective Concentration

Dilution of chemical sterilant occurs during use

DISINFECTION AND STERILIZATION