07/30/2013

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Improving Patient Outcomes

Through Accountable Care:

Catheter-Related

Bloodstream Infections

Russell Olmsted, MPH, CIC is a paid consultant of Ethicon, Inc.

This promotional educational activity is brought to you by Ethicon, Inc.

and is not certified for continuing medical education.

The third-party trademarks used herein are trademarks of their respective owners.

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Objectives

To discuss:

� Changing healthcare landscape & healthcare-associated

infections (HAIs)

� Evidence supporting the use of a CHG sponge dressing

per CDC Guideline recommendations

� Marketplace options and supporting efficacy data

� Aligning practices to organizational goals

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Changing Healthcare Landscape

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• Non payment of

Healthcare Acquired

Infections (HAIs) 1

• Value-based purchasing 2

• CMS readmission

penalties 3

• “Accountable Care” 4

• Reportable quality metrics 2,3,4

• Measured patient

outcomes 2,4

• Evidence-based medicine

practices/protocols

• Patient satisfaction

reporting 2,4

Reimbursement

Landscape

Regulatory

Requirements

Provider

Opportunities

• Improve patient

outcomes

• Lower/eliminate

readmissions

• Eliminate healthcare

acquired infections

• Increase patient

satisfaction

1 – Medicare Program: Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates; Payments for Graduate Medical Education in Certain Emergency Situations; Changes to Disclosure of

Physician Ownership in Hospitals and Physician Self-Referral Rules; Updates to the Long-Term Care Prospective Payment System; Updates to Prospective Payment System; Updates to Certain IPPS-Excluded Hospitals; and

Collection of Information Regarding Financial Relationship Between Hospitals; Final Rule, Federal Register, Volume 73, Volume 161, Tuesday, August, 19, 2008.2 – Medicare Program: Hospital Inpatient Value-Based Purchasing Program, Federal Register, Volume 76, Number 88, Friday, May 6, 2011.

3 - Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY2012 Rates; Hospitals’ FTE Resident Caps for Graduate

Medical Education Payment, Federal Register, Volume 76, Number 160, Thursday, August 18, 2011.4 – Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations, Federal Register, Volume 76, Number 212, Wednesday, November, 2, 2011.

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Hospital Acquired Infections: A Big Problem

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Top 4 Hospital Acquired Infections

by Annual Occurrence & Cost

Top 4 Hospital Acquired Infections

by Type

According to the CDC, HAIs accounted for an estimated

1.7 million infections and 99,000 deaths annually

Department of Health and Human Services, Action Plan to Prevent Healthcare-Associated Infections 06222009, Section 3 Introduction, pg 7, 8.

Infection

Type

Annual Number of

Infections

Total Annual Cost

to Hospitals

Bloodstream

Infections248,678 $5,779,774,076

SSI 290,485 $3,033,534,855

Urinary Tract

Infections561,667 $425,743,586

Pneumonia VAP 250,205 $6,273,139,760

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CMS: 10 Preventable Conditions

� Foreign object retained after surgery

� Air embolism

� Blood incompatibility

� Stage III and IV pressure ulcers

� Falls and trauma

� Manifestations of poor glycemic control

� Catheter-associated urinary tract infections

� Vascular catheter-associated infection

� Surgical site infection

� Deep vein thrombosis (DVT) / pulmonary embolism (PE)

http://www.cms.hhs.gov/HospitalAcqCond/06_Hospital-Aquired_Conditions.asp Accessed on April 17, 2009

As of Fiscal Year 2009 CMS is tracking the incidence

of selected infections including CRBSI

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2011 CDC Guidelines

� Intended to provide evidence-based

recommendations for preventing

intravascular

catheter-related infections

� 5 major areas of emphasis:

1. Education of healthcare professionals

2. Use maximal sterile precautions (MSP)

3. Use of > 0.5% CHG skin prep

4. Avoiding routine replacement of CV catheters as a

strategy to prevent infections

5. Use antiseptic/antibiotic impregnated catheters

and CHG impregnated sponge dressing

(If rate of infection not decreasing despite

adherence to above 4 strategies)

� Targets elimination of CRBSI

from all patient-care areas

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O’Grady NP, Alexander M, et al., Guidelines for the prevention of intravascular catheter-related infections. Centers for Disease Control and Prevention. MMWR Recomm Rep 2011 April 1.

� “strongly recommended for

implementation and supported by

some experimental, clinical, or

epidemiologic studies and a strong

theoretical rationale”

� CHG impregnated sponge dressings

are the only form of CHG dressing

recommended in new CDC guidelines– “No recommendation is made for other

types of chlorhexidine dressings (Unresolved Issue)”

CHG impregnated sponge dressings

received a Category 1B

recommendation for reducing

the risk of CLABSIs

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CDC Recommendations Regarding the Use of

Chlorhexidine-Impregnated Dressings

� Use a chlorhexidine-impregnated sponge dressing for temporary short-term catheters

in patients >2 months of age if the CLABSI rate is not decreasing despite adherence to

basic prevention measures, including education and training, appropriate use of

chlorhexidine for skin antisepsis, and MS. Category 1B

� Chlorhexidine impregnated dressings have been used to reduce the risk of CRBSI.

In the largest multicenter randomized controlled trial published to date comparing

chlorhexidine impregnated sponge dressings vs standard dressings in ICU patients,

rates of CRBSIs were reduced even when background rates of infection were low.

(References: Timsit, Garland, Ho, Levy)

� No recommendation is made for other types of chlorhexidine dressings.

Unresolved issue

http://www.cdc.gov/hicpac/pdf/guidelines/bsi-guidelines-2011.pdf

CHLORHEXIDINE-IMPREGNATED DRESSINGS

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CHG Impregnated Sponge Dressing

� CDC Category 1B Recommendation is based on the review of 4

clinical studies exclusive to BIOPATCH® Protective Disk with CHG:– Timsit et al.

– Ho et al.

– Levy et al.

– Garland et al.

� These studies are based on the clinical use of BIOPATCH® and

demonstrate statistically significant reduction of CLABSI rates

� All references cited by the CDC in support of the Category 1B

recommendation were BIOPATCH® clinical studies

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BIOPATCH® Protective Disk with CHG

Hierarchy of Medical Evidence

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Chlorhexidine-Impregnated Sponges and Less Frequent Dressing

Changes for Prevention of Catheter-Related Infections in Critically Ill

Adults: A Randomized Controlled Trial

This randomized clinical trial assessed the superiority of BIOPATCH® Disk regarding rate

of major CRIs (clinical sepsis with or without bloodstream infection) and noninferiority

(less than 3% colonization-rate increase) of 7-day vs. 3-day dressing changes.

� 1,636 patients from 7 intensive care units in 3 university and 2 general hospitals

� Patients required an arterial catheter, CVC, or both for >48 hours

� 1,727 of the total 3,778 lines enrolled in this study were arterial catheters

� Median duration of catheter insertion was 6 days

� Chlorhexidine gluconate-impregnated sponge or standard dressing (control) was used

for the patients

� Scheduled change of unsoiled adherent dressings was every 3 or 7 days, with immediate

change of any soiled or leaking dressings

Timsit J. et al., JAMA. 2009; 301:1231-1241.

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BIOPATCH® Protective Disk with CHG – The Only Evidence-

based Catheter Dressing for CRBSI Reduction

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Timsit JAMAChlorhexidine-Impregnated Sponges and Less Frequent Dressing Changes for

Prevention of Catheter-Related Infections in Critically Ill Adults.

Harnage JAVAAchieving Zero Catheter Related Blood Stream Infections:15 Months Success in a

Community Based Medical Center.

Garcia AJICAdding a Chlorhexidine Patch to the IHI Bundle: Goal Zero in Reducing Central Line-

Associated Bacteremia

Ruschulte Annals Hematology Antiinfective wound dressing reduces catheter-related infections in oncological patients.

Banton JAVA Impact on catheter-related bloodstream infections with the use of the Biopatch dressing

Maki

40th InterscienceConference on

AntimicrobialAgents and

Chemotherapy

September 2006- The Efficacy of a Chlorhexidine-Impregnated Sponge (Biopatch)

for the Prevention of Intravascular Catheter-Related Infection-A Prospective, Randomized,

Controlled, Multicenter Study.

Fauerbach AJICContinuing Evolution of Multidisciplinary Approach to Prevention of Central Line-

Associated Bacteremias.

Chambers Journal of Hospital InfectionReduction of exit-site infections of tunneled intravascular catheters among neutropenic

patients by sustained-release chlorhexidine dressings: results from a prospective

randomized controlled trial.

Huang, et al. Journal of Pediatric SurgeryStrategies for the Prevention of central venous catheter infections: an American Pediatric

Surgical Association Outcomes and Clinical Trials Committee systematic review

Keyserling NAVAN 1994 -Pilot Study of a Chlorhexidine Disc Catheter Dressing In A Neonatal Unit.

Perencevich JAMAPreventing Catheter-Related Bloodstream Infections Thinking Outside the Checklist.

(Not in itself a CRBSI reduction “study” but does support CRBSI reduction and Timsit paper

which did include Biopatch

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CDC Recommendations Regarding

Catheter Insertion Site Visualization

� Monitor the catheter sites visually when changing the

dressing or by palpation through an intact dressing on a

regular basis, depending on the clinical situation of the

individual patient. If patients have tenderness at the

insertion site, fever without obvious source, or other

manifestations suggesting local or bloodstream infection,

the dressing should be removed to allow thorough

examination of the site. Category IB

http://www.cdc.gov/hicpac/pdf/guidelines/bsi-guidelines-2011.pdf

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CDC Debate:

CHG Dressing vs. CHG Sponge Dressing

Department of Health and Human Services, Centers for Disease Control and Prevention, Guideline for the Prevention of Intravascular Catheter-Related Bloodstream Infections. Final Issue Review, May 17, 2010. Available at http://www.cdc.gov/hicpac/pdf/BSI_guideline_IssuesMay17final.pdf, Accessed September 26, 2012.

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CDC Unresolved Issues. Represents an Unresolved Issue for Which

Evidence is Insufficient or no Consensus Regarding Efficacy Exists

� No recommendation is made for other types of chlorhexidine dressings

� No recommendation is made regarding replacement of peripheral catheters

in adults only when clinically indicated

� No recommendation can be made regarding attempts to salvage an umbilical

catheter by administering antibiotic treatment through the catheter

� No recommendation can be made regarding the frequency for replacing

intermittently used administration sets

� No recommendation can be made regarding the frequency for replacing

needles to access implantable ports

� No recommendation can be made regarding the length of time a needle used

to access implanted ports can remain in place

http://www.cdc.gov/hicpac/pdf/guidelines/bsi-guidelines-2011.pdf

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In Vitro Comparative Analysis of a Chlorhexidine Gluconate (CHG)

Sponge Dressing and a CHG-containing Hydrogel Dressing

CHG TRANSFER

� CHG is transferred only where there is direct contact between the

device and the skin, because CHG binds tightly to the skin1 and

does not migrate across it. This is demonstrated in tests of CHG

transfer to porcine skin (Figure 1).2

� The BIOPATCH® Protective Disk with CHG design enables placement

around the catheter and complete contact with the surrounding

skin. In contrast, when the TegadermTM CHG dressing was placed

over the catheter, “tenting” occurred and the skin immediately

surrounding the insertion site and underneath the catheter was not

in contact with the dressing.

1. Jackson MM. Topical antiseptics in healthcare. Clin Lab Sci. 2005;18(3):160-169.

2. Westergom C. Ex Vivo Comparative Analysis of Chlorhexidine Gluconate (CHG) Coverage on Porcine Skin. Ethicon, Inc., Somerville, NJ, 2008.

3. CHG Transfer Onto Porcine Skin: 2x2” pieces of porcine skin were cleaned, dried and placed on top of PBS saturated c-fold towels. Catheters were inserted through a 10 mm biopsy punch and dressed according to either product’s directions for use. Samples were incubated at 30°C for 24 hours. The skin was removed, stained with Sodium Hypobromite solution and photographed. Data on file. Ethicon, Inc.

Figure 1 (A,B):3 CHG is transferred from BIOPATCH® circumferentially around the insertion site.

Figure 1 (C,D):3 CHG is transferred from TegadermTM CHG only where there is direct contact between the

hydrogel pad and skin and not under the catheter or where tenting occurred.

BIOPATCH® TegadermTM CHG

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BIOPATCH® Protective Disk with CHG vs 3M™

Tegaderm™ CHG Dressing

BIOPATCH® 3M™ Tegaderm™

Proven to reduce CRBSIs1 � No Data

Continuous CHG release correlated to

positive clinical outcomes � No Data

360˚ contact on skin surface � Not Possible

Does not stick to catheter hub or skin � No Data

Cited in CDC Guidelines and SHEA /

IDSA Practice Recommendations2,3 � No

FDA – Cleared indication to reduce

CRBSIs local infections and skin

colonization � No

1. Biopatch IFU

2. Marscall, Mermel, etal, Strategies to prevent Central Line. Associated Bloodstream Infections in Acute Care Hospitals infection Control and Hospital EPI Oct. 08 Vol. 29, Supp1.

3. 2011 CDC Guidelines

CR Approved 4-24-09

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Labeling Comparison: Two Chlorhexidine

Gluconate Sponge Dressings

� BIOPATCH® is the only CHG

sponge clinically-proven carrying

an FDA-cleared indication for the

prevention of CRBSIs

� GuardIVa’s packaging states:

This dressing is not clinically

tested for its activity to reduce

local infections, CRBSI and skin

colonization of microorganisms

commonly related to CRBSI.

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In Vitro Comparative Analysis of

2 Chlorhexidine Gluconate Sponge Dressings

DIFFERENT INDICATIONS

� Unlike the BIOPATCH® Protective

Disk with CHG, the GuardIVa™ is

indicated only as an absorbent,

hemostatic protective dressing

and is not indicated to reduce

infection.

� According to the GuardIVa™

package insert, the CHG is added

to the dressing as a preservative

to prevent bacterial growth

within the dressing itself1 rather

than on the skin beneath it.

GuardIVaTM [package insert]. Dublin: HemCon Medical Techologies, Europe Ltd.

• Chorhexidine gluconate (CHG) is added to the dressing as a preservative to inhibit

the growth of microoganisms within the dressing.

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BIOPATCH® Protective Disk with CHG vs Silver:

Clinical Evidence

® ® ®™

1. Maki DG, Mermel L, Genthner D, Hua S, Chiacchierini RP.An evaluation of BIOPATCH Antimicrobial dressing compared to routine standard of care in the prevention of

catheter-related bloodstream infection. Johnson & Johnson Wound management, a Division of ETHICON, INC. 200. Data on file

2. Madeo M, martin CR, Turner C, Kirkby V, Thompson DR. Intensive and Critical Care Nursing (1998) 14,187-191.

3. Crawford AG Fuhr JP. Rao B. Infection Control and Hospital Epidemiology, 2004;25:668-674

®

Registered trademarks of their respective owners.

Only BIOPATCH® Dressing is clinically proven to reduce catheter-related bloodstream infections (CRBSI) and location infections.1

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Hospitals implement policies and practices aimed

at reducing the risk of central line-associated bloodstream

infections that meet regulatory requirements and

are aligned with evidence-based standards

The Joint Commission: Comprehensive Accreditation Manual for Hospitals: TheOfficial Handbook. Oak Brook, IL: Joint Commission Resources, 2011

Joint CommissionNational Patient Safety Goal #7

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Elimination of CRBSIs From All Patient-care Areas:

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Readmission

Rates

Readmission

Rates

Readmission

Rates

Extended Use

Peripheral IV

Lines

Extended Use

Peripheral IV

Lines

Extended Use

Peripheral IV

Lines

Surgical DrainsSurgical DrainsSurgical DrainsHome InfusionHome InfusionHome Infusion

Arterial LinesArterial LinesArterial Lines

Staff Compliance

=Kits

Staff Compliance

=Kits

Staff Compliance

=Kits

CVC Lines &

PICC Lines

CVC Lines &

PICC Lines

CVC Lines &

PICC Lines

1 – Medicare Program: Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates; Payments for Graduate Medical Education in Certain Emergency Situations; Changes to

Disclosure of Physician Ownership in Hospitals and Physician Self-Referral Rules; Updates to the Long-Term Care Prospective Payment System; Updates to Prospective Payment System; Updates to Certain IPPS-

Excluded Hospitals; and Collection of Information Regarding Financial Relationship Between Hospitals; Final Rule, Federal Register, Volume 73, Volume 161, Tuesday, August, 19, 2008.2 – Medicare Program: Hospital Inpatient Value-Based Purchasing Program, Federal Register, Volume 76, Number 88, Friday, May 6, 2011.

3 - Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY2012 Rates; Hospitals’ FTE Resident Caps for

Graduate Medical Education Payment, Federal Register, Volume 76, Number 160, Thursday, August 18, 2011.4 – Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations, Federal Register, Volume 76, Number 212, Wednesday, November, 2, 2011.

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PointPrevalence

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Secure catheter with at

least 1.25cm for proper

placement of BIOPATCH®

BIOPATCH® must have complete contact with skin for maximum efficacy.

Correct positioning of catheter also allows sufficient room for cleaning of

insertion site and under catheter hub to help keep patients infection-free.

What is hubbing?Why insert catheter to the hub?

– Bleeding

– Pistoning

What is the problem with hubbing?

Vascular Access is a team effort

In many cases, responsibility ends at insertion

Proper Placement of

BIOPATCH® Protective Disk

with CHG

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Conclusion

� We are moving into an era of zero tolerance and reduced

reimbursement for healthcare-associated infections

� Both mandatory reporting and decreased CMS and insurance

reimbursement for selected HAIs, including CLA-BSIs, has increased

administrative attention on prevention of these infections

� Economic data show that preventing CLA-BSIs is much less expensive

than treating CLA-BSIs

� Given the evidence, the economics, and the impact on patient safety,

it make sense to implement all evidence-based measures, including

use of the BIOPATCH® Protective Disk with CHG, to prevent CLA-BSIs

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4©Ethicon, Inc. 2012 BP-324-12