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Disinfection and Sterilization: Current Issues and New Technologies 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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Page 1: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Disinfection and Sterilization: Current Issues and New Technologies

William A. Rutala, PhD, MPHDirector, 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, NCDisclosure: Clorox

Page 2: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Disinfection and Sterilization: Current Issues and New Technologies

• Current Issues and New Technologies Sterilization of critical items

Cleaning, washer disinfectors, biological indicators High-level disinfection for semi-critical items

New HLDs, prostate probes, cystoscopes, laryngoscopes Low-level disinfection of non-critical items

Role of the environment, curtain decontamination, room decontamination, thoroughness of cleaning

D/S and Emerging PathogensMERS-CoV, Enterovirus D68, Ebola

Page 3: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Disinfection and Sterilization: Current Issues and New Technologies

• Current Issues and New Technologies Sterilization of critical items

Cleaning, washer disinfectors, biological indicators High-level disinfection for semi-critical items

New HLDs, prostate probes, cystoscopes, laryngoscopes Low-level disinfection of non-critical items

Role of the environment, curtain decontamination, room decontamination, thoroughness of cleaning

D/S and Emerging PathogensMERS-CoV, Enterovirus D68, Ebola

Page 4: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

DISINFECTION AND STERILIZATIONWA Rutala, DJ Weber, and HICPAC, www.cdc.gov

• EH Spaulding believed that how an object will be disinfected depended on the object’s 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 low numbers of bacterial spores

NONCRITICAL - objects that touch only intact skin require low-level disinfection

Page 5: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Sterilization of “Critical Objects”

Steam sterilization-1970sHydrogen peroxide gas plasma-1993

Ethylene oxide-1970sVaporized hydrogen peroxide-2011

Page 6: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Some Potential Future Low-Temperature Sterilization Technologies Rutala WA, Weber WA. Infect Control Hosp Epidemiol 2015, In press

• Ozone plus hydrogen peroxide vapor• Nitrogen dioxide

• Supercritical CO2

• Peracetic acid vapor

Page 7: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Cleaning• Purpose: remove all adherent debris from an item and to

reduce the number of particulates, microorganisms, and pyrogens. Removes debris such as blood, mucus, oil, salts or other

foreign matter interferes with the sterilization process Reduces the bioburden and enhances the probability of

sterilization

Page 8: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.
Page 9: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Bioburden on Surgical Devices• Bioburden on instruments used in surgery (Nystrom, 1981)

62% contaminated with <101

82% contaminated with <102

91% contaminated with <103

• Bioburden on surgical instruments (Rutala, 1997) 72% contained <101

86% contained <102

• Bioburden on surgical instruments (50) submitted to CP (Rutala, 2014) 58% contained <10 20% contained < 102

16% contained <5x102

6% contained <103

Page 10: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.
Page 11: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Washer/DisinfectorRutala et al. Infect Control Hosp Epidemiol 2014. 35:883-885.

• Five Chambers 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

Page 12: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.
Page 13: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Washer/DisinfectorRemoval/Inactivation of Inoculum (Exposed) on Instruments

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

WD Conditions Organism Inoculum Log Reduction Positives

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

No Enz/Det VRE 2.5x107 Complete 0/10

No Enz/Det GS spores 8.3x106 5.5 8/10

Page 14: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Bioburden on surgical instruments is low

Washer/disinfectors are very effective (>7 log10 reduction) in removing/inactivating

microorganisms from instruments

Huge margin of safety

Page 15: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Rapid Readout BIs for Steam Now Require a 1-3h Readout Compared to 24-48h

Page 16: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Super Rapid Readout Biological IndicatorsCommercially available

1491 BI (blue cap)• Monitors 270°F and 275°F gravity –displacement steam sterilization cycles• 30 minute result (from 1 hour)

1492V BI (brown cap)• Monitors 270°F and 275°F dynamic-air-removal (pre-vacuum) steam sterilization cycles• 1 hour result (from 3 hours)

Page 17: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Disinfection and Sterilization: Current Issues and New Technologies

• Current Issues and New Technologies Sterilization of critical items

Cleaning, washer disinfectors, biological indicators High-level disinfection for semi-critical items

New HLDs, prostate probes, cystoscopes, laryngoscopes Low-level disinfection of non-critical items

Role of the environment, curtain decontamination, room decontamination, thoroughness of cleaning

D/S and Emerging PathogensMERS-CoV, Enterovirus D68, Ebola

Page 18: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

DISINFECTION AND STERILIZATION WA Rutala, DJ Weber, and HICPAC, www.cdc.gov

• EH Spaulding believed that how an object will be disinfected depended on the object’s 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 low numbers of bacterial spores

NONCRITICAL - objects that touch only intact skin require low-level disinfection

Page 19: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

High-Level Disinfection of “Semicritical Objects”

Exposure Time > 8m-45m (US), 20oCGermicide 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 ppmAccelerated 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

Page 20: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

ResertTM HLD High Level Disinfectant - Chemosterilant 2% hydrogen peroxide, in formulation

pH stabilizers Chelating agents Corrosion inhibitors

Efficacy (claims need verification) Sporicidal, virucidal, bactericidal, tuberculocidal, fungicidal

HLD: 8 mins at 20oC Odorless, non-staining, ready-to-use No special shipping or venting requirements Manual or automated applications 12-month shelf life, 21 days reuse Material compatibility/organic material resistance (Fe, Cu)?

*The Accelerated Hydrogen Peroxide technology and logo are the property of Virox Technologies, Inc. Modified from G MacDonald. AJIC 2006;34:571

Page 21: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Reprocessing Semicritical Items

• New Developments in Reprocessing Endoscopes Cystoscopes, ureteroscopes, hysteroscopes Prostate biopsy probes Laryngoscopes

Page 22: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Reprocessing Channeled EndoscopesCystoscopes, Ureteroscopes, Hysteroscopes

Page 23: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Reprocessing Channeled EndoscopesRutala, Gergen, Bringhurst, Weber, 2015

Exposure Method

VRE Contamination Before HLD (glutaraldehyde)

VRE Contamination After HLD

Passive HLD(immersed, not perfused)

3.6x108

2.0x108

1.1x108

7.5x108

1.0x108

6.8x107

Active HLD (HLD perfused with syringe)

8.4x107

1.5x108

2.8x108

1 CFU00

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, complete inactivation

Air pressure in channel stronger than fluid pressure at fluid-air interface

Page 24: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Reprocessing Semicritical Items

• New Developments in Reprocessing Endoscopes Cystoscopes, ureteroscopes, hysteroscopes Prostate biopsy probes Laryngoscopes

Page 25: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Prostate Biopsy ProbeRutala, Gergen, Weber. ICHE. 2007;28:916

• Evaluated effectiveness of HLD when assembled (needle biopsy holder in probe) and unassembled.

• Inoculated (106-107 P.aeruginosa): internal lumen/outside surface of needle biopsy holder; internal lumen of probe with and without needle biopsy holder in place

• Conclusion: HLD achieved when unassembled but not when assembled

Page 26: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.
Page 27: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Disinfection of Prostate ProbeRutala, Gergen, Weber. ICHE. 2007;28:916

Needle guide must be removed from the probe for disinfection

Page 28: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Disinfection of Prostate ProbeRutala, Gergen, Weber. ICHE; 2007;28:916

Page 29: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Do Not Reuse Single Use Devices Federal judge convicted a

urologist who reused needle guides meant or single use during prostate procedures (Sept 2014)

Criminal prosecution (conspiracy to commit adulteration)

Page 30: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Reprocessing Semicritical Items

• New Developments in Reprocessing Endoscopes Cystoscopes, ureteroscopes, hysteroscopes Prostate biopsy probes Laryngoscopes

Page 31: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.
Page 32: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Reprocessing of Rigid LaryngoscopesJHI 2008, 68:101; ICHE 2007, 28:504; AJIC 2007, 35: 536

• Limited guidelines for reprocessing laryngoscope’s blades and handles

• Many hospitals consider blade as semicritical (HLD) and handle as noncritical (LLD)

• Blades linked to HAIs; handles not directly linked to HAIs but contamination with blood/OPIM suggest its potential and blade and handle function together

• Ideally, clean then HLD/sterilize blades and handles (UNCHC-blades wrapped in a tray-Sterrad; handle wrapped in tray [without batteries]-steam); the blades and handles placed together in a Ziploc bag. Blades and handles checked for function prior to packaging.

Page 33: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Contamination of Laryngoscope Handles

J Hosp Infect 2010;74:123

• 55/64 (86%) of the handles deemed “ready for patient use” positive for S. aureus, enterococci, Klebsiella, Acinetobacter

Anesth Analg 2009;109:479

• 30/40 (75%) samples from handles positive (CONS, Bacillus, Streptococcus, S. aureus, Enterococcus) after cleaning

AANA J 1997;65:241

• 26/65 (40%) of the handles and 13/65 (20%) of the blades were positive for occult blood. These blades and handles were identified as ready for patient use.

Page 34: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.
Page 35: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.
Page 36: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Laryngoscopes BladesThe Joint Commission, FAQ, October 24, 2011

• How should we process and store laryngoscope blades? Processed via sterilization or HLD Packaged in some way Stored in a way that prevents recontamination. Examples

of compliant storage include, but are not limited to, a peel pack post steam sterilization (long-term) or wrapping in a sterile towel (short term)

Should not place unwrapped blades in an anesthesia drawer

Page 37: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Disinfection and Sterilization: Current Issues and New Technologies

• Current Issues and New Technologies Sterilization of critical items

Cleaning, washer disinfectors, biological indicators High-level disinfection for semi-critical items

New HLDs, prostate probes, cystoscopes, laryngoscopes Low-level disinfection of non-critical items

Role of the environment, curtain decontamination, room decontamination, thoroughness of cleaning

D/S and Emerging PathogensMERS-CoV, Enterovirus D68, Ebola

Page 38: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.
Page 39: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

DISINFECTION AND STERILIZATION

• EH Spaulding believed that how an object will be disinfected depended on the object’s 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 low numbers of bacterial spores

NONCRITICAL - objects that touch only intact skin require low-level disinfection

Page 40: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

LOW-LEVEL DISINFECTION FOR NONCRITICAL EQUIPMENT AND SURFACES

Exposure time > 1 minGermicide Use Concentration

Ethyl or isopropyl alcohol 70-90%Chlorine 100ppm (1:500 dilution)Phenolic UDIodophor UDQuaternary ammonium UDImproved hydrogen peroxide (HP) 0.5%, 1.4%____________________________________________________UD=Manufacturer’s recommended use dilution

Page 41: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

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

Page 42: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

KEY PATHOGENS WHERE ENVIRONMENTIAL SURFACES PLAY A ROLE IN TRANSMISSION

Weber, Rutala et al. AJIC 2010. 38:S25-33

• MRSA• VRE• Acinetobacter spp.• Clostridium difficile

• Norovirus• Rotavirus• SARS

Page 43: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

ENVIRONMENTAL CONTAMINATION ENVIRONMENTAL CONTAMINATION ENDEMIC AND EPIDEMIC MRSAENDEMIC AND EPIDEMIC MRSA

Dancer SJ et al. Lancet ID 2008;8(2):101-13

Page 44: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

ENVIRONMENTAL SURVIVAL OF KEY PATHOGENS ON HOSPITAL SURFACES

Pathogen Survival Time

S. aureus (including MRSA) 7 days to >12 months

Enterococcus spp. (including VRE) 5 days to >46 months

Acinetobacter spp. 3 days to 11 months

Clostridium difficile (spores) >5 months

Norovirus (and feline calicivirus) 8 hours to >2 weeks

Pseudomonas aeruginosa 6 hours to 16 months

Klebsiella spp. 2 hours to >30 months

Adapted from Hota B, et al. Clin Infect Dis 2004;39:1182-9 andKramer A, et al. BMC Infectious Diseases 2006;6:130

Page 45: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

FREQUENCY OF ACQUISITION OF MRSA ON GLOVED HANDS AFTER CONTACT WITH SKIN AND ENVIRONMENTAL SITES

No significant difference on contamination rates of gloved hands after contact with skin or environmental surfaces (40% vs 45%; p=0.59)

Stiefel U, et al. ICHE 2011;32:185-187

Page 46: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Thoroughness of Environmental CleaningCarling et al. Am J Infect Control. 2013;41:S20-S25

0

20

40

60

80

100

%

DAILY CLEANING

TERMINAL CLEANING

Cle

an

ed

Mean = 32%

>110,000 Objects

Page 47: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

EVALUATION OF HOSPITAL ROOM ASSIGNMENT AND ACQUISITION OF CDI

Study design: Retrospective cohort analysis, 2005-2006

Setting: Medical ICU at a tertiary care hospital

Methods: All patients evaluated for diagnosis of CDI 48 hours after ICU admission and within 30 days after ICU discharge

Results (acquisition of CDI) Admission to room previously occupied

by CDI = 11.0% Admission to room not previously

occupied by CDI = 4.6% (p=0.002)

Shaughnessy MK, et al. ICHE 2011;32:201-206

Page 48: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

RELATIVE RISK OF PATHOGEN ACQUISITIONIF PRIOR ROOM OCCUPANT INFECTED~120%

0 0.5 1 1.5 2 2.5 3 3.5 4

MDR Acinetobacter (Nseir S, 2011)

C. diff (Shaughnessy M, 2011)

VRE^ (Drees M, 2008)

MDR Pseudomonas (Nseir S, 2011)

VRE (Huang S, 2006)

VRE* (Dress M, 2008)

MRSA (Huang S, 2006)

* Prior room occupant infected; ^Any room occupant in prior 2 weeks infected. Otter , Yezli, French. ICHE. 2012;32:687-699

Page 49: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

ACQUISITION OF MRSA ON HANDS AFTER CONTACT WITH ENVIRONMENTAL SITES

Page 50: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

TRANSFER OF MRSA FROM PATIENT OR ENVIRONMENT TO IV DEVICE AND TRANSMISSON OF PATHOGEN

Page 51: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Effective Surface Decontamination

Product and Practice = Perfection

Page 52: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

LOW-LEVEL DISINFECTION FOR NONCRITICAL EQUIPMENT AND SURFACES

Exposure time > 1 minGermicide Use Concentration

Ethyl or isopropyl alcohol 70-90%Chlorine 100ppm (1:500 dilution)Phenolic UDIodophor UDQuaternary ammonium UDImproved hydrogen peroxide 0.5%, 1.4%____________________________________________________UD=Manufacturer’s recommended use dilution

Page 53: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Daily Disinfection of High-Touch SurfacesKundrapu et al. ICHE 2012;33:1039

Daily disinfection of high-touch surfaces (vs cleaned when soiled) with sporicidal disinfectant (PA) in rooms of patients with CDI and MRSA reduced acquisition of pathogens on hands after contact with surfaces and of hands caring for the patient

Page 54: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Alfa et al. AJIC 2015;43:141-146

Page 55: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Use of a Daily Disinfectant Cleaner Instead of a Daily Cleaner Reduced HAI Rates

Alfa et al. AJIC 2015.43:141-146

• Method: Improved hydrogen peroxide disposable wipe was used once per day for all high-touch surfaces to replace cleaner

• Result: When cleaning compliance was ≥ 80%, there was a significant reduction in cases/10,000 patient days for MRSA, VRE and C. difficile

• Conclusion: Daily use of disinfectant applied to environmental surfaces with a 80% compliance was superior to a cleaner because it resulted in significantly reduced rates of HAIs caused by C. difficile, MRSA, VRE

Page 56: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Key Considerations for Selecting the Ideal Disinfectant for Your Facility

Rutala, Weber. Infect Control Hosp Epidemiol. 2014;35:855-865

Consideration Question to Ask Score (1-10)

Kill Claims Does the product kill the most prevalent healthcare pathogens

Kill Times and Wet-Contact Times

How quickly does the product kill the prevalent healthcare pathogens. Ideally, contact time greater than or equal to the kill claim.

Safety Does the product have an acceptable toxicity rating, flammability rating

Ease-of-Use Odor acceptable, shelf-life, in convenient forms (wipes, spray), water soluble, works in organic matter, one-step (cleans/disinfects)

Other factors Supplier offer comprehensive training/education, 24-7 customer support, overall cost acceptable (product capabilities, cost per compliant use, help standardize disinfectants in facility)

Note: Consider the 5 components shown, give each product a score (1 is worst and 10 is best) in each of the 5 categories, and select the product with the highest score as the optimal choice (maximum score is 50).

Page 57: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Effective Surface Decontamination

Product and Practice = Perfection

Page 58: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

SURFACE DISINFECTIONEffectiveness of Different Methods

Technique (with cotton) MRSA Log10 Reduction (QUAT)

Saturated cloth 4.41

Spray (10s) and wipe 4.41

Spray, wipe, spray (1m), wipe 4.41

Spray 4.41

Spray, wipe, spray (until dry) 4.41

Disposable wipe with QUAT 4.55

Control: detergent 2.88

Rutala, Gergen, Weber. Unpublished data.

Page 59: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

WipesCotton, Disposable, Microfiber, Cellulose-Based, Nonwoven Spunlace

Page 60: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

WIPESRutala, Weber. Infect Control Hosp Epidemiol. 2014;35:855-865

• Wipes-cotton, disposable, microfiber• Wipe should have sufficient wetness to achieve the disinfectant

contact time. Discontinue use of the wipe if no longer leaves the surface visible wet for > 1 minute.

• When the wipe is visibly soiled, flip to a clean/unused side and continue until all sides of the wipe have been used (or get another wipe)

• Dispose of the wipe/cloth wipe appropriately• Do not re-dip a wipe into the clean container of pre-saturated wipes

Page 61: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

WIPESRutala, Weber. Infect Control Hosp Epidemiol. 2014;35:855-865

• Wipes-cotton, disposable, microfiber• Wipe should have sufficient wetness to achieve the disinfectant

contact time. Discontinue use of the wipe if no longer leaves the surface visible wet for > 1 minute.

• When the wipe is visibly soiled, flip to a clean/unused side and continue until all sides of the wipe have been used (or get another wipe)

• Dispose of the wipe/cloth wipe appropriately• Do not re-dip a wipe into the clean container of pre-saturated wipes

Page 62: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

ALL “TOUCHABLE” (HAND CONTACT) SURFACES SHOULD BE WIPED WITH DISINFECTANT

“High touch” objects only recently defined (no significant differences in microbial contamination of different surfaces) and

“high risk” objects not epidemiologically defined.

Page 63: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.
Page 64: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

FREQUENCY (mean) OF HCP CONTACT FOR SURFACES IN AN ICU (N=28) AND WARD (N=24)

ICU WARD

Huslage K, Rutala WA, Sickbert-Bennett E, Weber DJ. ICHE 2010;31:850-853

Page 65: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.
Page 66: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

MICROBIAL BURDEN ON ROOM SURFACES AS A FUNCTION OF FREQUENCY OF TOUCHINGHuslage K, Rutala WA, Weber DJ. ICHE. 2013;34:211-212

Surface Prior to CleaningMean CFU/RODAC (95% CI)

Post Cleaning (mean)Mean CFU/RODAC (95% CI)

High 71.9 (46.5-97.3) 9.6

Medium 44.2 (28.1-60.2) 9.3

Low 56.7 (34.2-79.2) 5.7

The level of microbial contamination of room surfaces is similar regardless of how often they are touched both before and after cleaning

Therefore, all surfaces that are touched must be cleaned and disinfected

Page 67: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Thoroughness of Environmental CleaningCarling et al. Am J Infect Control. 2013;41:S20-S25

0

20

40

60

80

100

%

DAILY CLEANING

TERMINAL CLEANING

Cle

an

ed

Mean = 32%

>110,000 Objects

Page 68: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

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

Page 69: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

MONITORING THE EFFECTIVENESS OF CLEANINGCooper et al. AJIC 2007;35:338

• Visual assessment-not a reliable indicator of surface cleanliness• ATP bioluminescence-measures organic debris (each unit has

own reading scale, <250-500 RLU) • Microbiological methods-<2.5CFUs/cm2-pass; can be costly and

pathogen specific• Fluorescent marker-transparent, easily cleaned, environmentally

stable marking solution that fluoresces when exposed to an ultraviolet light (applied by IP unbeknown to EVS, after EVS cleaning, markings are reassessed)

Page 70: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

DAZO Solution (AKA – Goo)

Page 71: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Target Enhanced

Page 72: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

TERMINAL ROOM CLEANING: DEMONSTRATION OF IMPROVED CLEANING

• Evaluated cleaning before and after an intervention to improve cleaning

• 36 US acute care hospitals• Assessed cleaning using a

fluorescent dye• Interventions

Increased education of environmental service workers

Feedback to environmental service workers

†Regularly change “dotted” items to prevent targeting objects

Carling PC, et al. ICHE 2008;29:1035-41

Page 73: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Cleaning/Disinfection

• ES and nursing need to agree on who is responsible for cleaning what (especially equipment)

• ES needs to know Which disinfectant/detergent to use What concentration would be used (and verified) What contact times are recommended (bactericidal) How often to change cleaning cloths/mop heads How important their job is to infection prevention

Page 74: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Percentage of Surfaces Clean by Different Measurement Methods

Rutala, Gergen, Sickbert-Bennett, Huslage, Weber. 2013

Fluorescent marker is a useful tool in determining how thoroughly a surface is wiped and mimics the microbiological data better than ATP

Page 75: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Touch (Wiping) vs No-Touch (Mechanical)

No Touch(supplements but do not replace surface

cleaning/disinfection)

Page 76: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

NEW “NO TOUCH” APPROACHES TO ROOM DECONTAMINATIONSupplement Surface Disinfection

Rutala, Weber. Infect Control Hosp Epidemiol. 2011;32:743

Page 77: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

EFFECTIVENESS OF UV-C FOR ROOM DECONTAMINATION (Inoculated Surfaces)

Pathogens Dose* Mean log10 Reduction Line of Sight

Mean log10 Reduction Shadow

Time Reference

MRSA, VRE, MDR-A 12,000 3.90-4.31 3.25-3.85 ~15 min Rutala W, et al.1

C. difficile 36,000 4.04 2.43 ~50 min Rutala W, et al.1

MRSA, VRE 12,000 >2-3 NA ~20 min Nerandzic M, et al.2

C. difficile 22,000 >2-3 NA ~45 min Nerandzic M, et al.2

C. difficle 22,000 2.3 overall 67.8 min Boyce J, et al.3

MRSA, VRE, MDR-A, Asp 12,000 3.-5->4.0 1.7->4.0 30-40 min Mahida N, et al.4

MRSA, VRE, MDR-A, Asp 22,000 >4.0* 1.0-3.5 60-90 min Mahida N, et al.4

C. difficile, G. stear spore 22,000 2.2 overall 73 min Havill N et al5

VRE, MRSA, MDR-A 12,000 1.61 1.18 25 min Anderson et al6

1ICHE 2010;31:1025; 2BMC 2010;10:197; 3ICHE 2011;32:737; 4JHI 2013;84:323l 5ICHE 2012;33:507-12 6ICHE 2013;34:466 * Ws/cm2; min = minutes; NA = not available

Page 78: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

HP for Decontamination of the Hospital EnvironmentFalagas et al. J Hosp Infect. 2011;78:171

Author, Year HP System Pathogen Before HPV After HPV % Reduction

French, 2004 VHP MRSA 61/85-72% 1/85-1% 98

Bates, 2005 VHP Serratia 2/42-5% 0/24-0% 100

Jeanes, 2005 VHP MRSA 10/28-36% 0/50-0% 100

Hardy, 2007 VHP MRSA 7/29-24% 0/29-0% 100

Dryden, 2007 VHP MRSA 8/29-28% 1/29-3% 88

Otter, 2007 VHP MRSA 18/30-60% 1/30-3% 95

Boyce, 2008 VHP C. difficile 11/43-26% 0/37-0% 100

Bartels, 2008 HP dry mist MRSA 4/14-29% 0/14-0% 100

Shapey, 2008 HP dry mist C. difficile 48/203-24%; 7 7/203-3%; 0.4 88

Barbut, 2009 HP dry mist C. difficile 34/180-19% 4/180-2% 88

Otter, 2010 VHP GNR 10/21-48% 0/63-0% 100

Page 79: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

USE OF HPV TO REDUCE RISK OF ACQUISITION OF MDROs

• Design: 30 mo prospective cohort study with hydrogen peroxide vapor (HPV) intervention to assess risks of colonization or infection with MDROs

• Methods:12 mo pre-intervention phase followed by HPV use on 3 units for terminal disinfection • Results

Prior room occupant colonized or infected with MDRO in 22% of cases Patients admitted to HPV decontaminated rooms 64% less likely to acquire any MDRO (95%

CI, 0.19-0.70) and 80% less likely to acquire VRE (95% CI, 0.08-0.52) Risk of C. difficile, MRSA and MDR-GNRs individually reduced but not significantly Proportion of rooms environmentally contaminated with MDROs significantly reduced (RR,

0.65, P=0.03)

• Conclusion-HPV reduced the risk of acquiring MDROs compared to standard cleaning

Passaretti CL, et al. Clin Infect Dis 2013;56:27-35

Page 80: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

A Four-Arm Prospective, Multicenter Study to Assess Efficacy, Effectiveness and Feasibility of Enhanced Room Disinfection with Chlorine and UV Light Using Clinical and Microbiologic Outcomes

Anderson, Sexton, Chen, Moehring, Knelson, Rutala, Weber, et al. 2014

Patient with colonization or infection due to MRSA, VRE, or

MDR-Acinetobacter

Discharge

EVS Notified

Room Disinfection

New patient admitted

4 ARMS

Surveillance for HAI

QUAT No UV Light

UV Light

No UV Light

UV Light

BLEACH

Page 81: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.
Page 82: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

LOW-LEVEL DISINFECTION FOR NONCRITICAL EQUIPMENT AND SURFACES

Exposure time > 1 minGermicide Use Concentration

Ethyl or isopropyl alcohol 70-90%Chlorine 100ppm (1:500 dilution)Phenolic UDIodophor UDQuaternary ammonium UDImproved hydrogen peroxide (HP) 0.5%, 1.4%____________________________________________________UD=Manufacturer’s recommended use dilution

Page 83: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Hospital Privacy Curtains(pre- and post-intervention study; sampled curtain, sprayed “grab area” 3x from

6-8” with 1.4% IHP and allowed 2 minute contact; sampled curtain)

Page 84: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Decontamination of Curtains with Activated HP (1.4%)Rutala, Gergen, Weber. Am J Infect Control. 2014;42:426-428

CP for: Before DisinfectionCFU/5 Rodacs (#Path)

After DisinfectionCFU/5 Rodacs (#Path)

% Reduction

MRSA 330 (10 MRSA) 21*(0 MRSA) 93.6%

MRSA 186 (24 VRE) 4* (0 VRE) 97.9%

MRSA 108 (10 VRE) 2* (0 VRE) 98.2%

VRE 75 (4 VRE) 0 (0 VRE) 100%

VRE 68 (2 MRSA) 2* (0 MRSA) 97.1%

VRE 98 (40 VRE) 1* (0 VRE) 99.0%

MRSA 618 (341 MRSA) 1* (0 MRSA) 99.8%

MRSA 55 (1 VRE) 0 (0 MRSA) 100%

MRSA, VRE 320 (0 MRSA, 0 VRE) 1* (0 MRSA, 0 VRE) 99.7%

MRSA 288 (0 MRSA) 1* (0 MRSA) 99.7%

Mean 2146/10=215 (432/10=44) 33*/10=3 (0) 98.5%

* All isolates after disinfection were Bacillus sp; now treat CP patient curtains at discharge with IHP

Page 85: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

TERMINAL CLEANING PRACTICE

• Some hospitals change curtains after Contact Precaution patients

• At UNC Health Care, privacy curtains are changed routinely every 3 months or when visible soiled

• In all discharge rooms, frequently touched surfaces of the curtains are sprayed with approved disinfectant (e.g., improved HP)

• Vinyl shower curtains are cleaned when visibly soiled or replaced as needed

Page 86: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Disinfection and Sterilization: Current Issues and New Technologies

• Current Issues and New Technologies Sterilization of critical items

Cleaning, washer disinfectors, biological indicators High-level disinfection for semi-critical items

New HLDs, prostate probes, cystoscopes, laryngoscopes Low-level disinfection of non-critical items

Role of the environment, curtain decontamination, room decontamination, thoroughness of cleaning

D/S and Emerging PathogensMERS-CoV, Enterovirus D68, Ebola

Page 87: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Decreasing Order of Resistance of Microorganisms to Disinfectants/Sterilants

PrionsBacterial spores (C. difficile)

MycobacteriaSmall, non-enveloped viruses (HPV, polio, EV-D68)

Fungal sporesGram-negative bacilli (Acinetobacter)

Vegetative fungi and algaeLarge, non-enveloped viruses

Gram-positive bacteria (MRSA, VRE)Enveloped viruses (Ebola, MERS-CoV)

Most Resistant

Most Susceptible

Page 88: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

New and Emerging PathogensMERS-CoV, Ebola, Enterovirus D68

• Will likely not have an EPA-registered disinfectant on the market to kill it• Manufacturers may not make claims about emerging pathogens without

EPA approval, which may take 18-24 months for new pathogens• Until an EPA-approved claim is available, users may refer to the hierarchy

of microbial susceptibility to select the appropriate disinfectant• For example, use EPA-registered disinfectant suitable for non-enveloped

viruses (norovirus, rotavirus, adenovirus, poliovirus) to disinfectant surfaces for Ebola

Page 89: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Disinfection and Sterilization: Current Issues and New Technologies

• Current Issues and New Technologies Sterilization of critical items

Cleaning, washer disinfectors, biological indicators High-level disinfection for semi-critical items

New HLDs, prostate probes, cystoscopes, laryngoscopes Low-level disinfection of non-critical items

Role of the environment, curtain decontamination, room decontamination, thoroughness of cleaning

D/S and Emerging PathogensMERS-CoV, Enterovirus D68, Ebola

Page 90: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Disinfection and Sterilization:

Current Issues and New Technologies

• Disinfection and sterilization technologies and practices reduce risk of infection associated with medical devices and surfaces.

• Washer-disinfector extremely effective in removing/inactivating pathogens• All channeled endoscopes must be perfused with HLD to inactivate pathogens.• Do not reuse single-use medical devices • 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).

• No-touch technologies (UV, VHP) kill pathogens and may reduce HAIs.• Emerging pathogens, such as Ebola, are susceptible to currently available

disinfectants.

Page 91: Disinfection and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and.

Quality Control• Provide comprehensive and intensive training for all staff

assigned to reprocess medical/surgical instruments• To achieve and maintain competency, staff should:

hands-on training all work supervised until competency is documented competency testing should be conducted at commencement

of employment and regularly review written reprocessing instructions to ensure

compliance


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