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EVIDENCE-BASED PREVENTION

OF HOSPITAL-ACQUIRED

AND VENTILATOR-ASSOCIATED

PNEUMONIA

Dennis G. Maki, MD University of Wisconsin School of Medicine

and Public Health

dgmaki@medicine.wisc.edu

94th Annual Meeting of the AATS – Minneapolis – May 5, 2013

EVIDENCE-BASED PREVENTION

OF HOSPITAL-ACQUIRED

AND VENTILATOR-ASSOCIATED

PNEUMONIA

Dennis G. Maki, MD Division of Infectious Diseases

Department of Medicine

Center for Trauma and Life Support

University of Wisconsin

Hospital & Clinics

Madison, Wisconsin U.S.A.

dgmaki@medicine.wisc.edu

FINANCIAL CONFLICTS OF INTEREST:

PREVENTION OF

HAP AND VAP

GOALS: To Understand 1. The nature of nosocomial infections in modern-

day ICUs in the early 21st Century and their

impact

2. The epidemiology and pathogenesis of these

infections, especially HAP/VAP

3. Control measures for prevention of HAP and VAP

4. New technologies for prevention of VAP,

nosocomial Legionella pneumonia and invasive

Aspergillus infection in the ICU

PROFILE OF NOSOCOMIAL INFECTION IN CRITICAL CARE

UNITS CONTRASTED WITH NON-ICU PATIENT CARE UNITS

• Overall rates 3- to 5-fold higher

• Overall rate 3- to 5-fold higher

• Much higher rates: 1° Bacteremia

Pneumonia

• Overall rate 3- to 5-fold higher

• Much higher rates: 1° Bacteremia Pneumonia

• Overall rate 3- to 5-fold higher • Much higher rates:

1° Bacteremia Pneumonia

• Many more infections with ANTIBIOTIC-RESISTANT ORGANISMS

Methicillin-Resistant S. aureus, Coag-neg staphylococci Multi-resistant gram-negative bacilli Candida

TRENDS IN ANTIMICROBIAL

RESISTANCE IN U.S. ICUs

Percen

t resi

1989 1993 1997 2002 2004

S.aureus (methicillin)

Enterococcus (vancomycin)

K.pneumoniae(Ceph 3rd)

P.aeruginosa (Fluoroquinolones)

HOSPITAL-ACQUIRED

PNEUMONIA

• ~1% risk to hospitalized patients,

~10-fold increased risk if

mechanically ventilated

• Attributable mortality ~ 25%

• Incremental costs ~ $50,000/case

• ~100,000 cases/ year

in U.S. centers, ~30,000 deaths

PREVENTION OF HAP AND VAP

TRENDS IN DEVICE-ASSOCIATED HCAIs

1992 -- 2008 IN THE NNIS-NHSN U.S.

TEACHING HOSPITAL MED-SURG ICUs

per 1000 device-days 1992-98

CLABSIs 6.0

VAP 11.0

CAUTI 6.5

ICHE 2000

THE TRAIN HAS LEFT THE STATION

EVIDENCE-BASED GUIDELINES

per 1000 device-days 1992-98 1995-2003

CLABSIs 6.0 4.9

VAP 11.0 4.9

CAUTI 6.5 4.9

ICHE 2000 AJIC 2003

per 1000 device-days 1992-98 1995-2003 2007-8

CLABSIs 6.0 4.9 1.5

VAP 11.0 4.9 2.3

CAUTI 6.5 4.9 2.9

ICHE 2000 AJIC 2003 AJIC 2008

SUCCESSFUL IMPLEMENTATION OF

A VAP BUNDLE TO PREVENT VAPs

• Bonello et al. Jt Comm J Qual Patient Saf. 2008;34:639-45.

• Westwell. Nurs Crit Care. 2008;13:203-7.

• Unahalekhaka et al. Jt Comm J Qual Patient Saf. 2007;33:387-94.

• Cocanour et al. J Trauma. 2006;61:122-9.

• Burger et al. Mayo Clin Proc. 2006;81:849-50.

AN AXIOM OF CLINICAL

INFECTIOUS DISEASE

That is Highly Relevent to

HAP/VAP

Preventive strategies are most likely to be effective if based on a full understanding of pathogenesis and epidemiology.

EPIDEMIOLOGY OF NOSOCOMIAL

INFECTION

EPIDEMIOLOGIC MECHANISMS OF

ACQUISITION OF NOSOCOMIAL

INFECTION CONTACT(HCW hands)

Enteric GNB

Pseudomonads

S. aureus / MRSA

Coag-neg Staph

Enterococcus

Rotaviruses

SARS virus(?)

M. tuberculosis

Aspergillus

Influenza virus

Measles, mumps viruses

SARS virus

Legionella

Pseudomonads

HCW CARRIERS

S. aureus / MRSA

Coag-neg Staph

Gr A Streptococci

Acinetobacter

Proteus mirabilis

Citrobacter

Salmonella

HBV, HSV, HIV

Enteric GNB Pseudomonads S. aureus / MRSA Coag-neg Staph Enterococcus/VRE Acinetobacter C. difficile RSV Rotaviruses SARS virus(?) Mites Lice

M. tuberculosis

Aspergillus

Influenza virus

SARS virus

Legionella

Pseudomonads

HCW CARRIERS

S. aureus / MRSA

Coag-neg Staph

Gr A Streptococci

Acinetobacter

Proteus mirabilis

Citrobacter

Salmonella

HBV, HSV, HIV

Enteric GNB

Pseudomonads

S. aureus / MRSA

Coag-neg Staph

Enterococcus

Rotaviruses

SARS virus(?)

M. tuberculosis

Aspergillus

Influenza virus

SARS virus

Legionella

Pseudomonads

HCW CARRIERS

S. aureus / MRSA

Coag-neg Staph

Gr A Streptococci

Acinetobacter

Proteus mirabilis

Citrobacter

Salmonella

HBV, HSV, HIV

Enteric GNB

Pseudomonads

S. aureus / MRSA

Coag-neg Staph

Enterococcus

Rotaviruses

SARS virus(?)

M. tuberculosis

Aspergillus

Influenza virus

SARS virus

Legionella

Pseudomonads

HCW CARRIERS

S. aureus / MRSA

Coag-neg Staph

Gr A Streptococci

Acinetobacter

Proteus mirabilis

Citrobacter

Salmonella

HBV, HSV, HIV

EIDEMIOLOGY AND PATHOGENESIS OF

HAP, VAP AND HCAP

Crnich, Safdar and Maki. Resp Ther (2005)

PATHOGENESIS OF VENTILATOR-

ASSOCIATED PNEUMONIA

• Pooling of hypophayngeal secretions above

the ETT cuff (and aspiration around the cuff)

Pathogenesis of VAP

Stomach

Oropharynx

Trachea

Ventilator-Associated Pneumonia

Exogenous

Sources

Endogenous

Sources

Microbiology of VAP NNIS, Crit Care Med 1999; 27(5): 887-92 [N = 4,389]

PREVENTION OF HAP-VAP

•Hand Hygiene…preemptive barrier precautions

•Noninvasive ventilation

•Protocolized weaning

•Semi-recumbent positioning

•Ventilation Circuit Management

•Heat Moisture Exchangers

•Selective (antimicrobial) digestive decontamination (SDD)

•Oral care with CHG

•Novel endotracheal tubes

•Prevention of Legionella infection

•Prevention of invasive Aspergillus infection

PREVENTION OF

NOSOCOMIAL PNEUMONIA

•Hand Hygiene

HAND HYGIENE

• Transient carriage on hands of HCWs

major mode of spread of most

nosocomial pathogens

• Hand hygiene compliance rates

25-50%, at best

MICROORGANISMS CARRIED ON THE

HANDS OF ICU PERSONNEL

UNIVERSITY OF WISCONSIN HOSPITALS

Microorganisms

Gram-Negative

Bacilli Staph aureus

Mean Log CFU

Recovered from

persons’ hands

4.59 1.04 0.44

[Range of Individual

Means] [3.31-5.76] [0.29-1.93] [0-1.45]

Percentage all cultures

positive 100 44 11

Percentage of

individuals positive

at least once

100 100 64

Maki, Ann Intern Med 89 (Part 2):777-80 (1980)

IMMEDIATE BACTERIAL REMOVAL WITH

THREE HANDWASHING AGENTS Maki et al (1978)

Each agent studied in 10 individuals; one week between tests. Cultures

obtained immediately before (B) and after (A) handwashing with the agent

ANTISEPTIC-CONTAINING HANDWASHING

AGENTS REDUCE NOSOCOMIAL INFECTIONS A PROSPECTIVE STUDY IN A SICU

Nongermicidal

Povidone-Iodine 4% Chlorhexidine

No. Patients 36 37 39

Infections (%):

Urinary tract 13 (36.1) 7 (18.9)* 10 (25.6)

Respiratory 16 (44.4) 15 (40.6) 7 (17.9)+

Surgical Wound 2 (5.6) 1 (2.70) 2 (5.1)

Bacteremia 1 (2.8) 3 (8.1) 2 (5.1)

Overall 33 (91.7) 27 (72.9)* 20 (51.3)+

Rate per 10,000 ICU

_________________

957 692* 645+

*P < .05, +P < .01. Maki et al (1980)

STUDY OF HANDWASHING AGENTS ON

RATE OF NOSOCOMIAL INFECTION

Prospective study: Chlorhexidine group (Hibiclens®)

Lotion soap (Kindest Kare®)

Lotion soap + alcohol rinse (Calstat®)

Three agents used in alternating cycles in 3 ICUs over 8 months

Rates nosocomial infection lowest with chlorhexidine:

40 NI/1000 patients

52 NI/1000 patients

Higher volume of chlorhexidine used by personnel (P<.001)

All three agents tolerated comparably by users.

OR 0.73

P = 0.01

Doebbeling et al, N Engl J Med 327:88 (92)

CDC HICPAC Hand Hygiene

Recommendations • Use an alcohol-

based hand rub: – Before and after

direct contact with patients or their environment (includes equipment)

– Before performing invasive procedures

Hands should be washed with antiseptic

and water after contact with patients with

diarrhea or known C. difficile +

Project to

~450-750,000

cases/yr

in U.S

McFarland et al. Curr Opinion GE 2008

Zilberberg et al. ICHE 2009

INCIDENCE AND

TRENDS CDAD

IN U.S. POPULATION

THE NEEDFOR A NEW PARADIGM

FOR NOSOCOMIAL INFECTION CONTROL

• Large, multicenter RCT(s) of waterless alcohol handrubs vs conventional handwashing with CHG

PREVENTION OF

•Hand Hygiene…preemptive barrier isolation precautions

Non-ICU ICU

MRSA in U.S. Hospitals: National

Nosocomial Infections Surveillance

(NNIS) System Report

VRE in U.S. Hospitals: National

Nosocomial Infections Surveillance

(NNIS) System Report

Non-ICU ICU

The Iceberg of Resistance Safdar and Maki (2003)

23% 21% 39% 29%

(2134) (1622) (381) (314)

MRSA VRE ESBL+

Gram-negative

Bacilli

C. difficile

No. of patients developing nosocomial infection

/ No. of colonized patients (%)

Pathogen Studies Overall General

inpatients

Immuno-

compromised ICU patients

MRSA 17 409/1708 (24) 106/734 (14) 34/205 (17) 269/769 (35)

VRE 20 531/2862 (19) 433/2248 (19) 51/389 (13) 54/293 (18)

Resistant

9 217/873 (25) 59/359 (16) 15/71 (21) 143/443 (32)

C. difficile 5 30/380 (8) 30/380 (8) NA NA

Safdar and Maki (2004)

PROSPECTIVE STUDIES OF THE RISK OF

INFECTION FOLLOWING COLONIZATION

BY MULTIRESISTANT NOSOCOMIAL

PATHOGENS

STRATEGIES FOR CONTROLLING

SPREAD OF RESISTANT ORGANISMS,

VIEWING THE “ICEBERG” PRINCIPLE

1. MICROBIOLOGIC SURVEILLANCE, ie for

MRSA or VRE, WITH TARGETED

PRECAUTIONS ONLY FOR CARRIERS

PROSPECTIVE STUDIES OF MICROBIOLOGIC SURVEILLANCE

WITH TARGETED PRECAUTIONS TO CONTROL NOSOCOMIAL

INFECTION WITH MULTIRESISTANT PATHOGENS

Author, year Organism Outbreak Outcome Effect

Thompson et al, 1982 MRSA yes successful C/I 33 to 6/mo

Walsh et al, 1987 MRSA yes successful C >2 to <1/mo

Murray-Leisure et al, 1990 MRSA yes successful C/I 16 to <3/mo

Handwerger et al, 1993 VRE yes successful outbreak eradicated

Boyce et al, 1994 VRE yes successful outbreak eradicated

Wells et al, 1995 VRE yes unsuccessful controlled, not eradicated

Morris et al, 1995 VRE no unsuccessful no change in endemic rates of

Jernigan et al, 1996 MRSA yes successful C from 0.14 to 0.009

cases/day

Back et al, 1996 MRSA yes successful outbreak eradicated

Girou et al, 1998 MRSA no successful C/I 5.8% to 2.6%

Goetz et al, 1998 VRE yes unsuccessful outbreak persisted

Brown et al, 1998 VRE yes successful outbreak eradicated

Lai et al, 1998 VRE yes unsuccessful controlled, not eradicated

Montecalvo et al, 1999 VRE yes unsuccessful outbreak persisted, isolation of

all high risk patients necessary

to contain spread

Jochimsen et al, 1999 VRE yes unsuccessful outbreak persisted

Byers et al, 2001 VRE yes successful C/I

Ostrowsky et al, 2001 VRE yes successful C from 2.2% to 0.,5%

Siddiqui et al, 2002 VRE no successful C/I from 11.4 to 7.7 per 10,000

patient-days

1. MICROBIOLOGIC SURVEILLANCE, ie for

MRSA or VRE, WITH TARGETED

PRECAUTIONS ONLY FOR CARRIERS

However:

Screening is expensive

1. MICROBIOLOGIC SURVEILLANCE, ie for MRSA or VRE, WITH TARGETED PRECAUTIONS ONLY FOR CARRIERS

However:

24-48 hour delay

However:

24-48 hour delay in getting results

It has to be repeated 5-7 days

However:

24-48 hour delay in getting results

It has to be repeated every 5-7 days

It only addresses 1 pathogen

THE STAR-ICU TRIAL • A multi-center, cluster-randomized trial of admission

screening for MRSA-VRE and targeted isolation

vs standard ICU care

• 19 ICUs, ~10,000 patients, ~50,000 ICU patient-days

• >25% of patients MRSA or VRE positive on admission

• Outcome Measure: new MRSA or VRE colonization or infection in ICU

• RESULTS: screened 40 vs controls 34

cases/1000 ICU-days, P=0.80

Huskins et al. New Engl J Med 2009

1. MICROBIOLOGIC SURVEILLANCE, ie for MRSA or

VRE, WITH TARGETED PRECAUTIONS ONLY FOR

CARRIERS

2. PREEMPTIVE BARRIER PRECAUTIONS FOR

ALL HIGH RISK PATIENTS

PROSPECTIVE A RANDOMIZED TRIAL IN A PEDIATRIC ICU

STANDARD CARE vs PROTECTIVE ISOLATION

Variable Standard Care Isolation

No. of patients studied 38 32

Total no. of infections (per 100 days) 40 (8.6) 15 (4.4)

Definite 30 12

Probable 10 3

Mean no. of infections/patient 1.05 0.47

Mean no. of infections/patient/day 0.064 0.029

(95% confidence interval) (0.022-0.185) (0.018-0.049)*

Type of infection (no./100 days)

Lower respiratory 10 (2.1) 5 (1.5)

Upper respiratory 5 (1.1) 1 (0.3)

Urinary tract 5 (1.1) 5 (1.5)

Gastroenteritis 9 (1.9) 2 (0.6)

Skin or skin structures 7 (1.5) 2 (0.6)

Primary or secondary bacteremia 6 (1.3) 1 (0.3)§

Days with temperature >38.5°C (%) 21 13¶

*P=0.007 §P = 0.08 ¶P = 0.001 Klein, Perloff and Maki. N Engl J Med 320:1714 (89)

Intensive Care Unit Day

N Engl J Med (1989)

PREVENTION OF C. DIFFICILE INFECTION BY

PREEMPTIVE USE OF GLOVES BY HCWs

Cases C. difficile infection/1000 pt-days

Before After

Study ward 7.7 1.5*

Control wards 5.7 4.2

Johnson et al, Am J Med (92). *P = 0.01

CONTROL OF MRSA IN A BURN UNIT BY

PREEMPTIVE BARRIER PRECAUTIONS

Safdar and Maki, Am J Infect Control 2006; 34: 476-83.

STUDIES OF PREEMPTIVE BARRIER PRECAUTIONS FOR ALL

HIGH RISK PATIENTS (GOWNS AND NONSTERILE GLOVES) FOR

PREVENTION OF NOSOCOMIAL INFECTION

Author, year Organism Outbreak Outcome Effect

Agbayani et al, 1981 all no successful 86% RRR in NEC

LeClair et al, 1987 RSV no successful 65% RRR

Klein et al, 1989 all no successful 60% RRR

Johnson et al, 1990 C. difficile no successful 65% RRR

Maki et al, 1996 VRE yes successful outbreak eradication

Maki et al, 1996 MRSA yes successful outbreak eradication

Slaughter et al, 1996 VRE no unsuccessful no added advantage of gowns

McManus et al, 1998 GNB no successful 60% RRR

Passweg et al, 1998 all no successful 24% RRR

McCartney et al, 2000 RSV no successful 39% RRR

Koss et al, 2001 all no unsuccessful higher incidence of nosocomial pneumonia in isolation group

Slota et al, 2001 all no successful 57% RRR

PREVENTION OF

•Hand Hygiene

USE OF NON-INVASIVE VENTILATION IN AN ICU

A Case-Control Study NIV

(CPAP-BiPAP)

Intubation

P-value

No. patients 50 50

SAPS II 35.6 37.3 NS

Age 72 yrs 70 yrs NS

PaO2 208 mm 194 mm NS

PCO2 70 mm 73 mm NS

Nosocomial infections

Any 7 (14%) 19 (38%) 0.006

Pneumonia 4 (8%) 11 (22%) 0.04

Antibiotic therapy 4 (8%) 13 (26%) 0.01

Duration ventilation 6 days 10 days 0.01

LOS ICU 9 days 15 days 0.02

Overall Mortality 2 (4%) 13 (26%) 0.002

Girou et al, JAMA 284:2361-7 (2000)

• Burke KE et al. Noninvasive positive pressure

ventilation as a weaning strategy for intubated

adults with respiratory failure. Cochrane

Database Syst Rev. 2010 Aug 4;(8).

• 12 RCTs, most in COPD

• ICU LOS -6 days

• HAP/VAP RR 0.29 (0.19-0.45) • Mortality RR 0.55 (0.38-0.79)

•Hand Hygiene

•Noninvasive ventilatio

PROTOCOLIZED WEANING BY

RESPIRATORY THERAPISTS

Protocolized weaning clearly reduces LOT on MV

by ~25 % and the frequency of tracheostomies

and prolonged MV, and can be assumed to

reduce the incidence of VAP.

• Blackwood B et al. Protocolized versus non-protocolized weaning

for reducing the duration of mechanical ventilation in critically ill

adult patients. Cochrane Reviews 2010

• Burns KE et al. Wean earlier and automatically with new

technology (the WEAN Study): A multicentre, pilot randomized

controlled trial. Am Rev Resp CCM 2013 Mar 22.

PREVENTION OF

•Hand Hygiene

RANDOMIZED TRIAL OF

SEMIRECUMBANT POSITIONING

ON THE INCIDENCE OF VAP

P = 0.003

P = 0.018

Risk Factors for VAP

Supine position: OR 6.8 (1.7 - 26.7)

Enteral feeding: OR 5.7 (1.5 - 22.8)

MV > 7 days: OR 10.9 (3.0 - 40.4)

Drakulovic et al, Lancet 1999; 354: 1851-8

PREVENTION OF

•Hand Hygiene

Circuit Condensate

Humidified Air

Heat Moisture Exchangers

Benefit of HMEs Comparative Clinical Trials

Pooled Analysis: OR 0.61, 95% CI 0.39 - 0.94, P = 0.03

0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1

Kirton, Chest 1997

Hurni, Chest 1997

Dreyfuss, AJRCCM 1995

Roustan, Int Care Med

Martin, Chest 1990

HME Humidified Air

Tubing changes Observational studies suggest that changes every 7 days is as safe as more frequent changes Changes >7d (i.e, no change) has been evaluated in a limited fashion

Open versus closed suctioning Closed suction systems reduce the risk of transient hypoxia and lung collapse Impact on infection is less clear with 2 studies finding no change in rates of VAP

MANAGEMENT OF THE

CIRCUIT

•Hand Hygiene

Prevention of VAP and all ICU-acquired Infections by

Topically-applied Antimicrobial or Antiseptic agents: a

Meta-analysis of RCTs in ICUs

Crit Care 2011; 15(3): R155.

VAP RR 0.64, P<0.001

All NI, RR 0.71, P=0.02

No impact ICU mortality

PREVENTION OF

•Hand Hygiene

ANTISEPTIC CHG ORAL CARE IN THE ICU

IMPACT OF SCHEDULED ORAL CARE IN

ICU WITH CHLORHEXIDINE

A Meta-analysis

• 7 prospective RCTs.

• Reduced VAP,

RR, 0.74 (0.56-0.96), P=.02.

• Greatest benefit in CV surgery,

• RR, 0.41 (0.17-0.98Z), P=.04.

• No mortality benefit

Cheblicki and Safdar, Crit Care Med. 2007;35(2):595-602

Vernon et al. Arch Intern Med 166:306-12, 2006

A NOVEL APPROACH TO CONTAINING RESISTANCE

Cleansing Patients with CHG Daily

A NOVEL APPROACH TO

PREVENTING IVD-RELATED BS Cleansing Patients with CHG Daily

Prospective cross-over trial on 4 medical units at

Cook County Stroeger Medical Center

Compared daily CHG sponge bath vs nonmedicated soap bath (control)

Results, daily CHG bath:

CVC-associated BSI RR 0.40, P<0.01

MRSA BSI RR 0.0, P<0.01

Bleasdale, Weinstein et al, Arch Intern Med 2007; 167:2073-2079

MRSA IS THE

800 POUND GORILLA

OF SSI

MRSA is the cause of 10-20% SSIs

In USA, 100-200,000 MRSA cases

annually

IMPACT OF MRSA vs MSSA

SURGICAL SITE INFECTIONS

MRSA vs MSSA

Excess Mortality Extra

LOS OR Costs

• Engelmann et al. 5 d 3.4 $40,000

CID 2003

• Anderson et al. 35 d 7.3 $62,000

PLOS One 2009

Vernon et al. Arch Intern Med 166:306-12, 2006

A NOVEL APPROACH TO CONTAINING RESISTANCE

Cleansing Patients with CHG Daily

THE ONLY RCT OF CULTURE SCREENING AND

DECOLONIZATION FOR PREVENTION OF STAPH

AUREUS SSI

THE ONLY RCT OF CULTURE SCREENING AND

DECOLONIZATION FOR PREVENTION OF STAPH

AUREUS SSI

There were no MRSA SSIs

PROSPECTIVE TIME-SEQUENCE STUDIES OF

PREOPERATIVE MRSA SCREENING WITH

DECOLONIZATION PRIOR TO SURGERY

Type of Surgery

Mupirocin

Antisepsis

Screen+

Decoln

P-Value

Cardiovascular

Currier et al.

JHI 2002

√ CHG 0.41 0.02

0,10 <.01

Schlenz et al.

JHI 2005

√ CHG 2.6 1.5 0.53 <0.02

Jag et al.

JHI 2008

Walsh et al.

Arch IM 2010

MRSA SSI (%)

PROSPECTIVE TIME-SEQUENCE STUDIES OF

PREOPERATIVE MRSA SCREENING WITH

DECOLONIZATION PRIOR TO SURGERY

Type of Surgery

Mupirocin

Antisepsis

Screen+

Decoln

P-Value

Orthopoedic

Nixom et al.

JBJS 2006

All Types

Harbarth

JAMA 2008

<0.001

Robicsec et al.

Ann IM 2008

√ CHG 2.83 1.63 0.52 <0.001

Pofahl et al..

JACS 2008

MRSA SSI (%)

•Hand Hygiene

Continuous aspiration of

subglottic secretions

SUBGLOTTIC SUCTIONING—A META-ANALYSIS

Dezfulian et al Am J Med 2005; 18

PATHOGENESIS OF VAP ROLE OF BIOFILM

MULTISPECIES BIOFILM AGGREGATES ON LUMINAL SURFACE OF AN

ENDOTRACHEAL TUBE IN A MECHANICALLY VENTILATED PATIENT

Costerton et al J. Clin. Invest. 112:1466-1477 (2003)

MULTICENTER RANDOMIZED TRIAL OF A SILVER-

COATED ENDOTRACHEAL TUBE FOR PREVENTION

OF VENTILATOR-ASSOCIATED PNEUMONIA

Control

Silver-

coated

P-Value

No. patients studied 964 968

No. developing VAP

with BAL>104 cfu

(5.8%)

(3.8%)

0.66 0.03

No. adverse events

possibly related to ETT

(14.3%)

(14.5%)

0.91 0.03

Kolef et al, JAMA 300:805-13, 2008

MULTICENTER RANDOMIZED TRIAL OF A SILVER-

COATED ENDOTRACHEAL TUBE FOR PREVENTION

OF VENTILATOR-ASSOCIATED PNEUMONIA

Kolef et al, JAMA 300:805-13, 2008

ENDOTRACHEAL TUBES WITH

SUPERCOMPLIANT POLYURETHANE

CUFFS TO PREVENT MICROASPIRATION

• RCT in 134 postop CV surgery patients,

RR VAP 0.33 (0.12-0.17), P=0.01, no impact ICU LOS.

Poelaert et al. J Thorac CV Surg 2008;136:771-6.

• RCT in 140 patients in med-surg ICU,

RR VAP 0.33 (0.11-0.88), P=0.01

Lorente et al. Am J Resp CCM 2007;176:179-83.

•Hand Hygiene

•Antimicrobial stewardship

STRATEGIES FOR CONTROLLING ANTIBIOTIC

RESISTANCE AND SUPERINFECTION

1. ANTIMICROBIAL STEWARDSHIP

Eliminate unnecessary use

Improve quality of use

• Surveillance of resistance

• Institutional guidelines

• Limited, focused formulary

• Educational programs

• Automatic Stop-orders

• ID, Pharmacy Consultation

• Microbiology Lab policies

• Restrictions on use of key drugs

• Antibiotic “rotations”

• Audits of use

STRATEGIES FOR CONTROLLING ANTIBIOTIC

RESISTANCE AND SUPERINFECTION

1. ANTIMICROBIAL STEWARDSHIP

Eliminate unnecessary use

Improve quality of use

• Surveillance of resistance

• Institutional guidelines

• Limited, focused formulary

• Educational programs

• Automatic Stop-orders

• ID, Pharmacy Consultation

• Microbiology Lab policies

• Restrictions on use of key drugs

• Antibiotic “rotations”

• Audits of use

GUIDELINES FOR RESTRICTION

PROGRAMS: Rules of the Game • It must be efficient: 24/7,

telephone communication

• The program must never delay prompt therapy for potential lifethreatening infection: A first dose is always given on request

• Permission from a representitive of the P&T Committee is required for subsequent doses

RESTRICTED DRUGS:

“Last resort” Agents: Linezolid

Daptomycin

Tigecycline

Amikacin

Very costly drugs: L-Amphotericin B

Complex to Use or toxic: Foscarnet

Drugs restricted on epidemiologic grounds:

Vancomycin

3rd- gen cephalosporins

Imipenem

Voriconazole

RESTRICTION PROGRAMS

MARKEDLY REDUCES USAGE OF

RESTRICTED ANTIINFECTIVES

McGowan and Finland. J Infect Dis 1974;130:165-8

McGowan and Finland. South Med J 1976; 69:174-9

Craig et al. Ann Intern Med 1978;83:796-8

Recco et al. JAMA 1979;241:2283-6

Coleman et al. Am J Med 1991;90:439-44

Woodward et al. Am J Med 1987;83:817-23

Himmelberg et al. Am J Hosp Pharm 1991;48:1220-7

ANTIMICROBIAL

RESTRICTIONS: PRO

1. Global crisis in antibiotic resistance

2. Resistance = excess mortality,

3. Antimicrobial pressure drives resistance

4. Restrictions highly effective at limiting unnecessary use

5. Implementation of restrictions has been followed by greatly reduced usage of restricted antimicrobials

and reductions in rates of resistance.

6. “The needs of the many outweigh the needs of the few”

RESTRICTIONS OF KEY ANTIMICROBIALS HAVE

BEEN FOLLOWED BY REDUCED INFECTIONS

BY IN TARGETED RESISTANT PATHOGENS-1

• Macrolide-resistant Group A Streptococci

Seppela et al, N Engl J Med 1997

• Penicillin-resistant Strep pneumoniae

Stephenson et al. JAMA 1996

• VRE Quale et al. Clin Infect Dis 1996

Bradley et al. JAC 1999

May et al. Shock 2000

• Clostridium difficile

O’Connor et al. Quart J Med 2002

Wilcox et al.JAC 2002

RESTRICTIONS OF KEY ANTIMICROBIALS HAVE

BEEN FOLLOWED BY REDUCED INFECTIONS

BY IN TARGETED RESISTANT PATHOGENS-1

• MRSA

Landeman et al. Clin Infect Dis 1999

• ESBL-positive resistant GNRs

Rahal et al. JAMA 1998

Landeman et al. Clin Infect Dis 1999

Singh et al. Am J Resp Crit Care Med 2000

Carling et al. Infect Control Hosp Epidemiol 2003

Rice et al. Clin Infect Dis 1996

White et al. Clin Infect Dis 1997

Lan et al. J Microbiol Immunol 2003

• Piperacillin-tazobactam-resistant P aeruginosa

Allegranzi et al. J Hosp Infect 2002

ANTIMICROBIAL

RESTRICTIONS: PRO

1. Global crisis in antibiotic resistance

2. Resistance = excess mortality,

3. Antimicrobial pressure drives resistance

4. Restrictions are highly effective at limiting unnecessary use ….and provide a unique opportunity for real-time education

5. Restrictions = reductions in resistance.

6. “The needs of the many outweigh the needs of the few”

PREDICTION: MORE

RELIABLE, RAPID (MOLECULAR)

DIAGNOSTICS WILL SOON

GREATLY REDUCE

UNNECESSARY ANTIMICROBIAL

THERAPY.

•Hand Hygiene

•Antimicrobial Stewardship

Recirculating

Portable HEPA

Filtration Device

THE VALUE OF ASPERGILLUS-FREE AIR IN THE

CARE OF BONE MARROW TRANSPLANT PATIENTS

Control Period without

HEPA-Filtration

HEPA Air

Filtration+

Mean CFU/M3 Aspergillus

fumigatus 2.1 .2

P < .001

No. Bone Marrow

Transplant Patients 67 187

No. developing invasive

Aspergillus infection 12 (18%) 9 (5%)

P < .01 +Portable HEPA unit in each room. Rhame et al, Am J Med (1984)

Construction

PERCENTAGE OF LEUKEMIA PATIENTS

ACQUIRING

NOSOCOMIAL ASPERGILLOSIS

No HEPA No HEPA;

Antibiotics

HEPA Overflow to

nonHEPA

(6/12)

(12/28)

(0/26)

(13/45)

Oren, I, et.al. 2001

HOSPITAL RENOVATION

The Problem

HOSPITAL RENOVATION

The Problem - 1

• 1998-99: costs of new hospital construction up 28.5%

• In 1998, 75% of new construction was renovation of existant facilities or creation of new contiguous facilities

• OPD facility construction up 17%

McKee (1998), Croswell, Modern Healthcare (1999)

HOSPITAL RENOVATION

The Problem - 2

• Construction, renovation or demolition generates vast quantities of dust which contains huge numbers of aerosolized filamentous fungi, such as Aspergillus, and sometimes as other potential pathogens, such as Legionella. Moreover, construction can impair air handling systems or contaminate potable water with these pathogens.

NOSOCOMIAL INFECTION CONTACT

Enteric GNB Pseudomonads S. aureus / MRSA Coag-neg Staph Enterococcus HBV RSV Rotaviruses RSV SARS virus Mites Lice

M. tuberculosis

Aspergillus,

other fungi VZV

Influenza virus

SARS virus

Legionella

Pseudomonads

HCW CARRIERS

S. aureus / MRSA

Coag-neg Staph

Gr A Streptococci

Acinetobacter

Proteus mirabilis

Citrobacter

Salmonella

HBV, HSV, HIV

ASPERGILLUS FUMIGATUS

VanCutsem, et. al. 1984

• Most common cause of invasive

and non-invasive aspergillosis

• Causes >50% of invasive

aspergillosis

• Capable of growth up to 55°C

(131°F)

EPIDEMIOLOGY

• A. fumigatus is a ubiquitous organism whose primary ecological niche is felt to be decomposing vegetable matter.

• Ambient levels in outside air is considerable

– Typical 1-15 spores/m3 with significant day to day variability.

– May reach tremendous levels near compost heaps and hay barns (106 spores/m3).

HOSPITAL RENOVATION

The Problem - 3

• Hospitals and clinics are filled with

patients who are immunocompromised

and highly vulnerable to devastating

invasive infection with these newly

unleashed pathogens

Aspergillus - Vulnerable Patient

Exposure

Invasive Pulmonary Aspergillosis Fungal Research Trust

Invasive Aspergillosis - Pulmonary Infarction Fungal Research Trust

Pegues, D. et. al. Clin Infect Diseases, 2002 34:412-6

Lutz, et. al., Clin Infect Dis 37: 786-793, 2003

6 ASPERGILLUS SSI TRACED TO

PROCEDURES IN 12-DAY PERIOD

INVASIVE ASPERGILLOSIS

• Caused by extremely common mold.

• Spread through air easily.

• Can be difficult to diagnose in severely immunosuppressed patients.

• Mortality over 50%.

Prevention of Exposure is Key

PATIENTS AT RISK • Bone marrow transplant patients

• Hematology and oncology patients who develop severe and prolonged neutropenia

• Solid organ transplant patients (intestinal > lung > liver > heart > kidney)

• Patients who receive prolonged high-dose corticosteroids (~1 mg/kg >1 week)

Recirculating

Portable HEPA

Filtration Device

THE VALUE OF ASPERGILLUS-FREE AIR IN THE

CARE OF BONE MARROW TRANSPLANT PATIENTS

Control Period without

HEPA-Filtration

HEPA Air

Filtration+

Mean CFU/M3 Aspergillus

fumigatus 2.1 .2

P < .001

No. Bone Marrow

Transplant Patients 67 187

No. developing invasive

Aspergillus infection 12 (18%) 9 (5%)

P < .01 +Portable HEPA unit in each room. Rhame et al, Am J Med (1984)

Construction

PERCENTAGE OF LEUKEMIA PATIENTS

ACQUIRING

NOSOCOMIAL ASPERGILLOSIS

No HEPA No HEPA;

Antibiotics

HEPA Overflow to

nonHEPA

(6/12)

(12/28)

(0/26)

(13/45)

Oren, I, et.al. 2001

WHAT HAPPENS TO

PATIENTS WHO LEAVE THE

PROTECTED WARD?

Construction Phase No. Air Samples No. Positive (%) IPA Rate

(per 1,000)

A (Indoor)

1 (3.7)

B (Indoor) 24 4 (16.7) 0.24*

* P < 0.001

Adapted from Raad et al, Infect Control Hosp Epidemiol, 2002

EPIDEMIOLOGY OF ASPERGILLOSIS

OUTBREAKS: 1972-2003

Cause of outbreak No. studies Total no.

patients

Mean no./

Outbreak

Adjacent outdoor

construction

4 48 12

Indoor renovation 12 78 6.5

Ventilation system contamination 5 69 14

Contaminated insulation 3 23 7.5

Contaminated dressings 2 7 4

Other 5 40 8

Total 31 265 8.5

NOSOCOMIAL OUTBREAKS ASSOCIATED

WITH EXTERNAL CONSTRUCTION

Organism

No. of studies

Aspergillus species 14

Legionella species 2

Acinetobacter baumanii 1

Nocardia asteroides 1

Histoplasma capsulatum 2*

HOSPITAL

RENOVATION

The Solution

HOSPITAL RENOVATION

The Fundamental Issues in Patient

Protection

1. Isolate (shield ) the patient

2. Isolate the work area

3. Take nothing for granted, achieving maximal patient

safety is complex, takes a great deal of coordination

among many stakeholders and requires a well-oiled

systems approach, with well-defined responsibilities

and accountability.

HOSPITAL RENOVATION

Programmatic Essentials • Baseline institutional compliance + familiarity with AIA guidelines

• Comprehensive written Construction and Renovation P&P, with:

– Defined authority and responsibilities:

• To initiate construction or renovation

• For daily implementation of P&Ps

• For closure or relocation patient-care units

• Infection control risk assessment (ICRA)

Dust Generating Risk

(A - D)

Patient Area Risk

(Minimal – High)

Infection Control

Precautions

Level (I - IV)

Pre-Construction IC Risk Assessment

UWHC Policy 13.16

HOSPITAL RENOVATION

Pre-Construction IC

Authorization

UWHC Policy 13.16

Nurse manager – notified of project and risk, signature required before work can begin

Infection Control Practitioner – Initial check of worksite precautions; signature required before work can begin.

Work crew – Maintenance of day to day containment of worksite; completion of Daily Worksite Checklist by supervisor required.

Level II, III, IV

Level III, IV

HOSPITAL RENOVATION

– ICRA, monthly review by ICC

– Relocate high-risk patients and units

– Procedures for HVAC/air handling, dust and debris, and water control

– Contractor and institutional responsibilities and accountability

– Education of HCWs and contractors – Transport and disposal of waste materials

– Monitoring of compliance with P&Ps, criteria for halting work,

check-off list desireable

– Traffic patterns for patients, HCWs and construction workers

– Emergency preparedness (ie, water leaks, HVAC failure,

– Air or water environmental sampling

• Implementation (and revision) of the program on an ongoing basis

TRAINING STICKER

A small sticker (about 2" diameter) which we give to contractors to affix to their hardhats after

they have completed Safety/Infection Control Training. It enables us to see, at a glance, who has

been trained at the worksite.

HOSPITAL RENOVATION

– Education of HCWs and contractors

– Transport and disposal of waste materials

– N95 masks for high-risk patients leaving protected unit – Emergency preparedness (ie, water leaks, HVAC failure,

HOSPITAL RENOVATION

– Education of HCWs and contractors

– Transport and disposal of waste materials

– N95 masks for high-risk patients leaving protected unit

– Emergency preparedness (ie, water leaks, HVAC failure,

HOSPITAL RENOVATION Procedures

for HVAC/Air Handling, Dust Abatement- 1

• Barrier systems:

– Fire-rated plastic sheeting, sealed at ceiling height

Rigid,dust-proof, fire-resistant rigid walls, with caulked seams, entry vestibule, gasketed door frames

– Sealed windows in patient-care units, assure HEPAs functional and not leaking, rooms + units of high-risk patients positive-pressure, inlet air filters functional, signage

• Negative-pressure work area:

– Outlet air to building exterior or HEPA-filtered if recirculated, scavenging HEPA filters in work areas, no disruption of hospital HVAC/air flow patterns, monitor pressures/air flow patterns frequently, avoid overloading air ducts

– Designated worker traffic routes, waste egress

• Planning for disruption of utility services

• Worker risk assessment and education

• Heightened surveillance for related infection

When is a HEPA filter

a HEPA filter?

– Sealed windows in patient-care units, assure HEPAs functional and not leaking, rooms + units of high-risk patients positive-pressure,

inlet air filters functional, signage • Negative-pressure work area:

CONSTRUCTION SIGNAGE

Vent to

outside

Filter and

Recirculat

Filtered exhaust

may be ducted:

• Directly to outside of building

• Outside via exhaust duct

• Into areas surrounding construction site

OUTSIDE EXHAUST

– Sealed windows in patient-care units, assure HEPAs functional and not leaking, rooms + units of high-risk patients positive-pressure,

inlet air filters functional, signage • Negative-pressure work area:

– Outlet air to building exterior or HEPA-filtered if recirculated,

scavenging HEPA filters in work areas, no disruption of hospital HVAC/air flow patterns, monitor pressures/air flow patterns frequently, avoid overloading air ducts

Recirculating

HEPA for

Dilution

Ventilation

– Sealed windows in patient-care units, assure HEPAs functional and not leaking, rooms + units of high-risk patients positive-pressure, inlet air filters functional

– Outlet air to building exterior or HEPA-filtered if recirculated, scavenging HEPA filters in work areas, no disruption of hospital

HVAC/air flow patterns, monitor pressures/air flow patterns frequently, avoid overloading air ducts

EXHAUST DUCT

Exhaust grilles

(e.g., bathrooms)

EXHAUST INTO DUCT

AVOID OVERPRESSURIZING

EXHAUST DUCTS

ONLY UWHC HVAC

personnel permitted to

access ducts.

AIR SAMPLING DURING CONSTRUCTION: SOLID

ORGAN TRANSPLANT UNIT

AIR SAMPLING DURING CONSTRUCTION:

PEDIATRIC HEMATOLOGY-ONCOLOGY UNIT

for HVAC/Air Handling, Dust and Debris Control - 2

• Remediation after water contamination:

– Define full extent of contamination, assess interstitial spaces,

underneath carpeting, behind cabinets…moisture meters

helpful

– Seal area, maintain negative-pressure…mobile HEPAs

– Decontaminate with chlorine-based mist or diluted bleach vs

1:9 copper-8-quinolinate fungicide

– Remove contaminated materials ASAP, <24 hrs

– Vacuum sealings with HEPA vacuum cleaner

HOSPITAL

RENOVATION

Take-home Message

HOSPITAL

RENOVATION

Take Home Message

• Get involved early in renovation planning.

• Train facility Plant Engineering workers and outside contractors.

• Establish routes for workers/ trash removal to minimize impact on patient care areas.

• Do not begin work until risk assessment complete and authorization obtained.

HOSPITAL RENOVATION

Take Home Message

• Establish and maintain negative pressure at worksite.

• Visquene or durable barriers, taped at edges; may

need to extend through interstitial.

– May need input from Safety Officer

• Barriers/neg pressure must remain until all dust generating work is complete, walls and ceilings closed, sanding done, area cleaned.

HOSPITAL RENOVATION

Take Home Message

• Filter worksite air if recirculated

• Lightly spray down carpets before removal.

• Bag or cover trash before leaving worksite. Wipe down carts if visibly soiled.

• May need recirculating HEPAs in adjoining patient areas.

•Hand Hygiene

•Continuous subglottic suctioning

•Silver-coated endotracheal tubes

•Prevention of nosocomial Legionella infection

CONTROL OF NOSOCOMIAL

LEGIONELLOSIS AT THE UNIVERSITY OF

WISCONSIN HOSPITAL AND CLINICS

• In 1987 we had 2 cases of nosocomial

Legionella pneumonias over 4 months,

sent our water out for Legionella

culturing and it was negative

• In 1987 we had a case of nosocomial Legionella pneumonias over 4 months, sent our water out for sampling and it was negative

• In 1993 we had another small cluster (2 cases) and did large-volume sampling and PFEP subtyping of 8 nosocomial isolates since 1985 ourselves.

Maki, Marx and Stolz. ICAAC 2007

• In 1993 we had another small cluster (2 cases) and did large-volume sampling and PFEP subtyping of 8 nosocomial isolates since 1985

ourselves: 39% of water samples were +, with very low numbers of organisms(<100 cfu/L), all 8 isolates over 11 years were clonal with our water strains.

• In 1993 we had another small cluster (2 cases) and did large-volume sampling and PFEP subtyping of 8 nosocomial isolates since 1985 ourselves: 39% of water samples were +, with very low numbers of organisms(<100 cfu/L), all 8 isolates over 11 years were clonal with our

water strains. We attempted pulse hyperchlorination.

COPPER-SILVER IONIZATION

• In 1993 we had a small cluster (2 cases) and did large-volume sampling and PFEP subtyping of 8 nosocomial isolates since 1985 ourselves: 39% of water samples were +, with very low numbers of organisms(<100 cfu/L), all 8 isolates over 11 years were clonal with our water strains. We attempted pulse hyperchlorination.

• In 1995, we implemented continuous silver-copper ionization of our hospital water:

1985-1995 ~210,000 admissions 10 cases nLD

• In 1993 we had a small cluster (2 cases) and did large-volume sampling and PFEP subtyping of 8 nosocomial isolates since 1985 ourselves: 39% of water samples were +, with very low numbers of organisms(<100 cfu/L), all 8 isolates over 11 years were clonal with our water strains. We attempted pulse hyperchlorination.

• In 1995, we implemented continuous silver-copper ionization of our hospital water:

1985-1995 ~210,000 admissions 10 cases nLD 1995-2012 ~325,000 admissions 0 cases nLD

PREVENTION OF

•Hand Hygiene

•Continuous subglottic suctioning

•Silver-coated endotracheal tubes

•Surveillance of VAP with feedback and benchmarking

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