Infection Prevention Related to Disposable Leadwires · Cleaning Cleaning is critical to patient...

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Infection Prevention Related to Disposable Leadwires

May 27, 2015

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DisclosurePOTENTIAL CONFLICT OF INTEREST:

Jeff Wiser is an Employee of 3M Infection Prevention Division Laboratory


Jeff WiserTechnical Service Engineer

• Discuss the clinical and financial impact of HAIs today

• Describe how reusable EKG leadwires may contribute to the possible development of HAIs

• Identify measures to reduce the risk of cross-contamination potentially leading to HAIs due to reusable EKG wires

• Explain the benefits of disposable EKG leadwires in reducing the risk of cross-contamination

• Identify the steps involved in changing clinical practice to include the use of disposable EKG leadwires

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Learner Objectives


IntroductionPreventing infection is a fundamental responsibility for all healthcare team members

HAIs are associated with increased patient morbidity and mortality, and adversely affect hospital economics

Common environmental surfaces that come in direct contact with patients, which include reusable EKG leadwires, may facilitate cross-contamination of pathogens potentially resulting in HAIs

Healthcare facilities are changing to disposable leadwires to help reduce the risk of HAIs

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HAIs: Healthcare-Associated Infections

One out of every 20 hospitalized patients will contract an HAI

CDC estimates that HAIs account for approximately 1.7 million infections and 99,000 associated deaths annually in hospitals in the U.S.

1. CDC. Healthcare-associated infections (HAIs): the burden. http://www. cdc.gov/HAI/burden.html. 2. CDC. Estimating health care-associated infections and deaths in U.S. hospitals, 2002. http://www.cdc.gov/HAI/pdfs/hai/infections_deaths.pdf.

Accessed August 29, 2011. 7


Increase mortality by 10.1% vs. patient without HAIs

Increase patient’s hospital stay by 14.9 days

Account for more deaths in the US each year than AIDS, breast cancer and motor vehicle accidents combined

1. Pennsylvania Health Care Cost Containment Council. Hospital-acquired infections in Pennsylvania: calendar year 2006. 2. McCaughey B. Unnecessary Deaths:: The Human and Financial Costs of Hospital Infections. 3rd Edition. From Committee to Reduce Infection

Deaths: www.hospitalinfection.org/ridbooklet.pdf 8

HAIs: Clinical Realities


HAIs: Economic RealitiesEach suspected HAI adds excess

cost of $6767Each confirmed HAI adds an

additional $15,275 in excess healthcare costs

Medicare no longer pays additional costs required to treat several types of HAIs if condition not present upon admission

Adds $30 billion per year in additional healthcare costs

1. Pennsylvania Health Care Cost Containment Council. Hospital-acquired infections in Pennsylvania: calendar year 2006. 2. McCaughey B. Unnecessary deaths: the human and financial costs of hospital infections. Available at:

http://www.hospitalinfection.org/ridbooklet.pdf. 3. CMS. Press Releases: Medicare and Medicaid move aggressively to encourage greater patient safety in hospitals and reduce never events.

Accessed August 29, 2011. 9


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Pressure to Reduce HAIs

In the face of staggering statistics, healthcare facilities are under increasing pressure to reduce the number of HAIs from the government and insurance providers

Legislation mandating public reporting of hospital infection rates passed in 27 states

1. Legislation on healthcare-associated infections; updated December 11, 2008. Available at: http://www.hospitalinfection.org/legislation.shtml 10


BY 2008, APPROXIMATELY 70% OF ALLBACTERIA THAT CAUSED INFECTIONS INHOSPITALS WERE RESISTANT TO AT LEAST 1OF THE DRUGS MOST COMMONLY USEDFOR TREATMENT

Todar K. Bacterial resistance to antibiotics. In: Todar’s Online Textbook of Bacteriology.http://www.textbookofbacteriology.net


Infection Prevention

Studies of the effectiveness of room disinfection and protocols for cleaning have focused on high-touch objects:

• Bed rails

• Bed surface

• Supply cart

• Overbed table

• Intravenous pump

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Cleaning

Cleaning is critical to patient safety

No standards that define what “clean” means for environmental surfaces

CDC guidelines recommend hospitals “monitor” cleaning performance to ensure consistent cleaning and disinfection of surfaces in close proximity to patients

1. CDC. Management of multidrug-resistant organisms in healthcare settings. http://www.cdc.gov/ncidod/dhqp/pdf/ar/MDROGuideline2006.pdf. 13


Effective CleaningHospitals often rely on visual

inspection as a cleaning monitor method

Visual inspection has been shown to be inadequate

More reliable, quantitative cleaning monitoring methods show cleaning is done effectively and completely

1. Boyce JM, Havill NL, Dumigan DG, Golebiewski M, Balogun O, Rizvani R. Monitoring the effectiveness of hospital cleaning practices by use of an adenosine triphosphate bioluminescence assay. Infection Control and Hospital Epidemiology. 2009;30(7):678-684.

Picture: http://www.gfcleaning.com/commercial.php14


Polling Question #1Who is responsible for cleaning the ECG leadwires in your facility?

A. Nursing StaffB. Environmental Services (EVS)C. Environmental Services (EVS) & Nursing StaffD. Not Sure


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Reusable EKG Leadwires

Reusable EKG leadwires can become contaminated during patient use

Leadwires are difficult to clean and often overlooked sources of resistant pathogens that could be dispersed to patients

1. Brown DQ. Disposable vs. reusable electrocardiography leads in development of and cross-contamination by resistant bacteria. Critical Care Nurse. 2011; 31(3): 62-68.

2. Picture: http://www.2ndwind.org/members/melissa_thompson.html Second Wind Lung Transplant Association, Inc. 16


The Risk for Cross-Contamination

Reusable items used for patient care that contact intact skin should be cleaned between use on patients

Several studies have demonstrated that even after cleaning reusable EKG leadwires, they can still harbor bacteria and potential pathogens

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Cleaned EKG Leadwires and Bacterial Growth

In a recent study, 320 cleaned reusable EKG leadwires were swabbed from:

• Critical Care Units

• Telemetry Unit

• Emergency Departments

• Operating Rooms

1. Albert NM, Hancock K, Murray T, Karafa M, Runner JC, Fowler SB, Nadeau CA, Rice KL, Krajewski S. Cleaned, ready-to-use, reusable electrocardiographic leadwires as a source of pathogenic microorganisms. American Journal of Critical Care. 2010; 19(6):e73-80. . 18


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Bacteria and Reusable LeadwiresBacteria cultured from swabbed cleaned reusable EKG leads:

• Staphylococcus epidermidis• Bacillus species• Staphylococcus hominis• Staphylococcus warneri• Staphylococcus haemolyticus• Micrococcus species • Corynebacterium species• Staphlococcus capitis• Acinetobacter lwoffii

• Staphylococcus simulans• Enterococcus faecium• Staphylococcus aureus• Staphylococcus auricularis• Enterococcus faecalis• Brevibacterium species • Staphylococcus lugdunensis• Streptococcus agalactiae• Enterococcus casseliflavus

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Comparison of the relative cross contamination risk of HAI with reusable monitoring equipment


Cross – contamination risk of reusable monitoring equipment:

Article AANA Journal –February 2001:

“The prevalence of visible and/or occult blood on anesthesia and monitoring equipment”

Perry SM, Monaghan P, The prevalence of visible and/or occult blood on anesthesia and monitoring equipmentAANA Journal/February 2001/Vol. 69, No.1 http://www.aana.com/newsandjournal/Documents/occultblood0201_p44-48.pdfPictures: http://kempkuties.blogspot.com/2009_01_01_archive.html http://1800cpap.com/disposable-pulse-oximeter-sensors.aspx?gclid=CKLb4cymmrwCFYEDOgodCEsAVw http://carlossamaniego.com/how-my-blood-pressure-dropps-30-points-in-15-minutes.html


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Facility 1 – equipment contaminated with blood:

8.8% BP Cuff

17.6% Pulse Ox

52.9% ECG Wires

Perry SM, Monaghan P, The prevalence of visible and/or occult blood on anesthesia and monitoring equipmentAANA Journal/February 2001/Vol. 69, No.1 http://www.aana.com/newsandjournal/Documents/occultblood0201_p44-48.pdf


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Facility 2 – equipment contaminated with blood:

22.7% BP Cuff

54.5% Pulse Ox

81.8% ECG Wires



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Both Facilities :

26.8% BP Cuff

19.6% Pulse Ox

64.3% ECG Wires



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1. Is there a threat of cross-contamination? 2. Which of these is the biggest threat?

Perry SM, Monaghan P, The prevalence of visible and/or occult blood on anesthesia and monitoring equipmentAANA Journal/February 2001/Vol. 69, No.1 http://www.aana.com/newsandjournal/Documents/occultblood0201_p44-48.pdfPictures: http://kempkuties.blogspot.com/2009_01_01_archive.html http://1800cpap.com/disposable-pulse-oximeter-sensors.aspx?gclid=CKLb4cymmrwCFYEDOgodCEsAVw http://carlossamaniego.com/how-my-blood-pressure-dropps-30-points-in-15-minutes.html


Poll Question #2

How does your facility reprocess the reusable ECG leadwires?

a. Send them to your Sterile Processing Dept.

b. Wipe them with disinfectant wipes

c. Immerse in ultrasonic bath

d. ETO sterilization (or other sterilization method)

e. Other cleaning process


The risk of cross-contamination of antimicrobial resistant bacterial infection with reusable ECG wires


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In order for there to be a risk of cross-contamination, two conditions must be met:

1. Antibiotic Resistant Bacteria must be present on the presenting source – ECG Wires

2. There must be a pathway from source of bacteria to patient

- Pathway would necessarily include opportunity to enter open wounds or mucous membranes

Brown D, Disposable vs Reusable Electrocardiography Leads in Development of and Cross‐contamination by Resistant Bacteria Critical Care Nurse June 2012


Antibiotic Resistant Bacteria must be present on the presenting source – ECG Wires?


Are antibiotic resistant bacteria and other pathogens present on reusable ECG leads?

Culture results vary based on where and how the cultures were obtained.

Picture: Brown D, Disposable vs Reusable Electrocardiography Leads in Development of and Cross‐contamination by Resistant Bacteria Critical Care Nurse June 2012 © 3M 2015 All Rights Reserved.

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Swab Cultures


Culture Method: Swab Multi Center

Multicenter Study Of Bacteria On Reused Clean ECG Leadwires (Poster Presentation NTI 2011):

Swab done on 320 clean, but not currently in use, electrocardiography leadwires

Culture swab moistened with one drop sterile saline.

Study does not state which areas of ECG leads themselves were swabbed.

Albert NM, Hancock K, Murray T, Karafa M, Runner JC, Fowler SB, Nadeau CA, Rice KL, Krajewski S. Cleaned, ready-to-use, reusable electrocardiographic leadwires as a source of pathogenic microorganisms. American Journal of Critical Care. 2010; 19(6):e73-80. .

Crawford J, Doherty, L Practical Aspects of ECG Recording ISBN978‐1‐907830‐30‐3 pages 146‐147 Picture: http://www.copanusa.com/products/aerobic/


Culture Method: Swab Multi Center

Results:

Of 226 cultures from 201 leadwires

62.8% were positive for bacterial growth,

37.8% were potentially pathogenic organisms posing risk of infection

<20% of ECG Leads grew antibiotic resistant bacteria

Albert NM, Hancock K, Murray T, Karafa M, Runner JC, Fowler SB, Nadeau CA, Rice KL, Krajewski S. Cleaned, ready-to-use, reusable electrocardiographic leadwires as a source of pathogenic microorganisms. American Journal of Critical Care. 2010; 19(6):e73-80. . Picture: http://www.copanusa.com/products/aerobic/


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Culture Method: Swab Duke University

Duke university Poster Presentation NTI 2011:

“Swabs were done before and 5 minutes after cleaning with sodium hypochlorite wipes”

Telemetry systems in 30 medical units and 29 surgical units were tested.

Areshamwala, A; Duke University Hospital, Durham, NC - Poster Presentation NTI 2011 published in AJCC AMERICAN JOURNAL OF CRITICAL CARE, May 2011, Volume 20, No. 3 Picture: http://www.copanusa.com/products/aerobic/



Results:

69% grew organisms before the intervention and 24% grew organisms after the intervention.

Conclusions of the study were that a standardized cleaning strategy may result in decreased HAIs

Areshamwala, A; Duke University Hospital, Durham, NC - Poster Presentation NTI 2011 published in AJCC AMERICAN JOURNAL OF CRITICAL CARE, May 2011, Volume 20, No. 3 Picture: http://www.copanusa.com/products/aerobic/


• Is this behavior sustainable?

• At best 24% of leads carry bacteria - Falls far short of a zero – tolerance objective for HAI

• Can ECG leads be cleaned 100% - 100% of the time?

Areshamwala, A; Duke University Hospital, Durham, NC - Poster Presentation NTI 2011 published in AJCC AMERICAN JOURNAL OF CRITICAL CARE, May 2011, Volume 20, No. 3 http://en.wikipedia.org/wiki/Hawthorne_effect Picture: http://www.copanusa.com/products/aerobic/



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Culture Method: Swab University of Wisconsin-Madison School of Medicine

50 randomly selected leads to determine the presence of methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin resistant Enterococcus (VRE), fluoroquinolone resistant gram negative bacilli (FQRGNB), and Clostridium difficile.


Safdar N, et al. Telemetry leads as reservoir for nosocomial pathogens Int J Infect Control 2012, v8:i2 doi: 10.3396/ijic.v8i2.012.12Picture: http://www.med.wisc.edu/


Culture Swabs were used on leads, then vortexed in 0.9% saline solution and solution was placed on different agars.

Results:

2% of leads positive for MRSA

6% positive for VRE

No FQRGNB or C diff were detected on any of the leads.

One lead storage container was also found to be positive

for VRE.

Multiple other organisms were recovered from the leads

Safdar N, et al. Telemetry leads as reservoir for nosocomial pathogens Int J Infect Control 2012, v8:i2 doi: 10.3396/ijic.v8i2.012.12Picture: http://www.copanusa.com/products/aerobic/ © 3M 2015 All Rights Reserved.


“In an earlier study, published in abstract form from our institution that examined telemetry leads as reservoirs of resistant bacteria, Maki et al. found that out of 50 leads cultured, nine were positive for VRE (18%), and four for S. aureus (8%). Gram-negative bacteria, such as Pseudomonas species (4), Acinetobacter species (3), and Serratia species (1) were also recovered.”

“At our institution, this data provided the impetus to switch to disposable leads.”

Maki DG, Brookmeyer P. A survey of EKG telemetry harnesses as a reservoir of resistant nosocomial pathogens. Abstract no. K-746 Paper presented at: Intersci Conf AntimicrobAgentsChemother 2003; Chicago, IL. Picture: http://www.copanusa.com/products/aerobic/

Safdar N, et al. Telemetry leads as reservoir for nosocomial pathogens Int J Infect Control 2012, v8:i2 doi: 10.3396/ijic.v8i2.012.12


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Poll Question #3

Does your facility monitor the cleaning process for the reusable ECG leadwires?

a. Yes, via visual inspection

b. Yes, via rapid cleanliness monitoring (e.g. ATP)

c. Not Sure

d. No


Alternate Culture Methods


Culture Saturating with NSS and Incubating in Tryptic Soy Broth University of Wisconsin-Madison

Earlier study, University of Wisconsin-Madison School of Medicine –Maki, Brookmeyer

ECG Leads were cultured by sweeping down the entire length of each lead, including connector with a sterile 4X4cm gauze pad pre-moistened with sterile saline.

Gauze was then dropped into tryptic soy broth (TSB), incubated for 18-24 hours, then subcultured onto different agars.

Maki DG, Brookmeyer PR. A survey of EKG telemetry harnesses as a reservoir of resistant nosocomial pathogens. In: Abstracts ofthe Interscience Conference on Antimicrobial Agents and Chemotherapy.Washington, DC: American Society for Microbiology; 2003. Abstract K‐746.


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Results:

This study placed the percentage of leads positive for one or more antibiotic resistant bacteria: 73%


Safdar N, et al. Telemetry leads as reservoir for nosocomial pathogens Int J Infect Control 2012, v8:i2 doi: 10.3396/ijic.v8i2.012.12Picture: http://www.culturemediasupplies.com/CM164.html



Dr. Brookmeyer, also from the university of Wisconsin, added data to this study. The final results of the combined studies placed the percentage of leads that carried antibiotic resistant bacteria at 77%


Safdar N, et al. Telemetry leads as reservoir for nosocomial pathogens Int J Infect Control 2012, v8:i2 doi: 10.3396/ijic.v8i2.012.12Picture: http://www.culturemediasupplies.com/CM164.html


• 50 cultures of leadwires in an ICU

• Leads cleaned and cultured prior to patient use.

• Snaps at the ends were dipped in sterile cup broth and then cultured using a sterile container containing tryptic soy broth.

• Incubated for 24 hours then spread on blood agar and MacConkey medium


Ghandi H, Sharma S, Gilski D, Beveridge R, Patel P. Investigating Electrocardiography Lead Wires as a Reservoir For Antibiotic‐Resistant Pathogens Circulation2008;117(21):e454. http://download.ebooks6.com/download.php?id=7967 Picture: http://www.culturemediasupplies.com/CM164.html

Culture Method: Submersion Tryptic Soy Broth Advocate Lutheran General Hospital Park Ridge, IL

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Culture Method: Submersion Tryptic Soy Broth Advocate Lutheran General Hospital Park Ridge, IL

Conclusions:

“ECG lead wires are reservoir source of multi-drug resistant organisms in intensive care unit setting.

Failure to effectively decontaminate ECG lead wire may result in an invasive infection by multi-drug resistant organisms

Disposable ECG lead wires may reduce the risk of transmission of hospital infections and improve patient safety”


Ghandi H, Sharma S, Gilski D, Beveridge R, Patel P. Investigating Electrocardiography Lead Wires as a Reservoir For Antibiotic‐Resistant Pathogens Circulation 2008;117(21):e454. http://download.ebooks6.com/download.php?id=7967 Picture: http://www.culturemediasupplies.com/CM164.html

2013 Asia and Indonesia – Culture Method: Submersion 0.89% NaCl with added neutralizer and transfer to blood agar

• 408 cleaned bed side ECG lead wires were sampled

• 43 portable ECG devices ECG lead wires

• 4 intensive care units (ICUs) and 1 post-anesthesia care unit (PACU)

• More than half of examined ECG lead wires (n=232; 51.4%) were contaminated with significant bacteria and risk pathogens.

“Manually cleaned ECG lead wires may serve as a vector for transmission of nosocomial pathogens. The current reprocessing technique for ECG lead wires needs to be improved.”


Lestari et al.: Microbial contamination of manually reprocessed, ready to use ECG lead wire in intensive care units GMS Hygiene and Infection Control 2013, Vol. 8(1), ISSN 2196-5226 Picture: http://en.wikipedia.org/wiki/File:Agarplate_redbloodcells_edit.jpg

Implications of Differing Culture Methods


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Swab cultures may be less effective than immersion due to ECG Manufacturers’ specifications for cleaningManufacturers’ specifications for cleaning ECG

leadwires prohibit soaking or spraying, do not mention sterilization or autoclaving, and restrict the options to wiping the wires with antibacterial wipes

Areas that are reachable by culture swabs are the same areas that are reachable by antibacterial wipes.


American National Standards Institute/ Association for the Advancement of Medical Instrumentation. AAMI Standards and Recommended Practices ES60601-1-2005. Arlington, VA: Association for the Advancement of Medical Instrumentation; 2005: section 4.3.1.Picture: Brown D, Disposable vs Reusable Electrocardiography Leads in Development of and Cross‐contamination by Resistant Bacteria Critical Care Nurse June 2012

Cleveland Clinic Disposable Leadwire Study• Compared infection rates of patients receiving disposable vs.

Reusable leadwires

• Single facility in 11 matched ICUs

• Analysis included patients with ICU stays longer than 48 hours

• Only 2578 of the 7240 subjects were included in the analysis with 50% (1289) of them being disposable.

• Infection rates dropped due to a bundle implementation (which included the disposable leadwires) from 0.9/100 patient days to 0.15/100 patient days.


Cleveland Clinic Disposable Leadwire Study

Overall infection rates did not differ

• Between ECG-LW groups,

• Between groups in matched ICUs,

• Between groups by infection type, or

• When only patients with ICU stays longer than 48 hours were considered (2578 cases).


Nancy M. Albert, et al: Infection Rates in Intensive Care Units by Electrocardiographic Lead Wire Type: Disposable vs ReusableAm J Crit Care 2014;23:460-468 doi: 10.4037/ajcc2014362

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Cleveland Clinic Disposable Leadwire StudyConcerns:

• Large drop in infection rate reduces the power if the study to detect differences

• Cardiovascular ICUs (3260 of 7240 subjects) reusable leadwires cleaned in ultrasonic bath

• Disposable leadwires were used in the ICU only and not hospital wide.

• Organism could have been inoculated in a different department.

© 3M 2015 All Rights Reserved.Picture: http://www.ultrasonicleaning.com/can-i-use-solvents-with-ultrasonic-cleaner/

Cleveland Clinic Disposable Leadwire Study

Positive lesson:

• Clean leadwires, like clean surfaces yield less cross contamination.

• But…. Leadwires are not routinely effectively cleaned.


Picture:http://www.google.com/imgres?q=cleaning+in+the+hospital&hl=en&sa=X&rlz=1W1SNNT_enUS386US387&biw=1249&bih=494&tbm=isch&prmd=imvns&tbnid=Yx1aOW3tVbIAeM:&imgrefurl=http://www.hospitalmanagement.net/contractors/cleaning/sodexo2/sodexo23.html&docid=Ph-0dYsDiTiJUM&imgurl=http://www.hospitalmanagement.net/contractor_images/sodexo2/3-hospital-cleaner.jpg&w=400&h=400&ei=eynFTor4He6gsQLK7tycCw&zoom=1&iact=rc&dur=313&sig=111351457906012736789&page=2&tbnh=128&tbnw=148&start=13&ndsp=13&ved=1t:429,r:7,s:13&tx=84&ty=49

Conclusions of these studies• Different hospitals produce different leadwire cleaning

results• Different units produce different leadwire cleaning

results• Different methods of culture produce different results –

More aggressive forms of cultures produce higher antibiotic resistant bacteria results.

• Studies have in common that reusable ECG leads pose a significant risk of antibiotic resistant bacterial cross-contamination.


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Benefits of Disposable EKG Leadwires

1. Combatting cross-contamination: EKG leadwires are difficult to clean

2. Cost: The additional costs associated with HAIs allow the case to be made for disposable items be cost effective

1. Brown DQ. Disposable vs. reusable electrocardiography leads in development of and cross-contamination by resistant bacteria. Critical Care Nurse. 2011; 31(3): 62-68. 55


Poll Question #4

In your opinion, how much of a cross contamination risk are reusable leadwires?

a. A significant risk

b. Some risk

c. Slight risk

d. No risk

e. Not sure


Evaluation and Implementation

Evaluation and implementing disposable products can be complex with variables that must be considered

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Evaluation of Disposable Products

In evaluating disposable product, determine the highest risk of cross-contamination:1. Most direct contact to patients2. How many patients one

reusable product touches in its lifetime

3. How many times the product touches one patient

4. Effectiveness of recommended cleaning practice

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Cost and Benefits

By preparing a cost justification using costs and benefits, the selection process and conversion can be more comfortable:

• Implementation cost

• Usage cost ( per patient)

• Cost of current cleaning practices

• Potential reduction of HAIs

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Changing Clinical Practice

Armed with evidence that EKG leadwires harbor infectious organisms, replacing reusable leadwires could reduce the risk for cross-contamination

Eliminating reusable leadwires is a natural progression in the standardization of disposable equipment

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SummaryHealthcare-associated infections are an important health

risk to hospitalized patientsHospitals and other healthcare facilities are under

increasing pressure to reduce the risk of HAIs and their associated costs, while maintaining a high quality of patient care

The use of disposable EKG leadwires can assist in reducing the risk of infection from cross-contamination

Today, healthcare facilities must be proactive about implementing measures that reduce cross-contamination between patients and help minimize the risk for HAIs

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Questions?


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