Post on 19-Aug-2020
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
07/30/2013
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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.
07/30/2013
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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