CLABSI and Needleless Connectors - TSICP Texas Society of ...

Prevention of Central Line-associated Bloodstream 

Infections and the Role of Needleless Connectors 

TSICP Annual Meeting 

Austin, Texas 

March 23, 2012 

William R. Jarvis, M.D. 

Jason and Jarvis Associates, LLC 

www.jasonandjarvis.com

Objectives 

• To discuss the CDC Draft IV Guideline 

recommendations. 

• To discuss the SHEA Compendium IV 


• To discuss the data that led to these 


• To discuss the impact of implementing 

these recommendations.

Hierarchy of Medical Evidence 

http://library.downstate.edu/ebm/2500.htm 

3

CDC HICPAC 

2011 IV 

Guideline 

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

CDC Guidelines for the Prevention of Intravascular 

Catheter-Related Infections, 2011 

Major areas of emphasis include: 

1. Education and training healthcare personnel who insert and maintain catheters; 

2. Using maximal sterile barrier precautions during central venous catheter insertion (CVC); 

3. Using a >0.5% chlorhexidine (CHG) preparation with alcohol for skin antisepsis; 

4. Avoiding routine replacement of CVCs as a strategy to prevent infection; 

5. Using antiseptic/antibiotic impregnated short-term CVCs and chlorhexidine impregnated 

sponge dressings, if the rate of infection is not decreasing despite adherence to other 

strategies (i.e., education and training, maximum barrier precautions, and >0.5% CHG 

preparations with alcohol for skin antisepsis); and 

6. Performance improvement by implementing bundled strategies, and documenting and 

reporting rates of compliance with all components of the bundle as benchmarks for quality 

assurance and performance improvement. 

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

CDC Guidelines for the Prevention of Intravascular 

Catheter-Related Infections, 2011 

Guideline Categorization Scheme: 

1. Category IA. Strongly recommended for implementation and strongly supported 

by well-designed experimental, clinical, or epidemiologic studies. 

2. Category IB. Strongly recommended for implementation and supported by some 

experimental, clinical, or epidemiologic studies and a strong theoretical rationale; 

or an accepted practice (e.g., aseptic technique) supported by limited evidence. 

3. Category IC. Required by state or federal regulations, rules, or standards. 

4. Category II. Suggested for implementation and supported by suggestive clinical 

or epidemiologic studies or a theoretical rationale. 

5. Unresolved issue. Represents an unresolved issue for which evidence is 

insufficient or no consensus regarding efficacy exists. 


CDC IV Guideline: What’s Added 

1. Use hospital-specific or collaborative-based performance 

improvement initiatives in which multifaceted strategies are 

"bundled" together to improve compliance with evidencebased 

recommended practices. Category 1B 

2. Use ultrasound guidance to place central venous catheters to 

reduce the number of cannulation attempts and mechanical 

complications [if this technology is available]. Category 1B 

3. When needleless systems are used, the split septum valve is 

preferred over the mechanical valve due to increased risk of 

infection. Category II 


CDC IV Guideline: What’s Added 

4. Do not routinely use anticoagulant therapy to reduce the risk of catheterrelated 

infection in general patient populations. Category II 

5. Use a 2% CHG wash daily to reduce CRBSI. Category II 

6. During axillary or femoral artery catheter insertion, maximal sterile 

barriers precautions should be used. Category II 

7. Replace arterial catheters only when there is a clinical indication. Category 

II 

8. Remove the arterial catheter as soon as it is no longer needed. Category II 


CDC IV Guideline: What’s Been Upgraded 

1. Use a chlorhexidine-impregnated sponge dressing for temporary short-term 

catheters in patients > 2 months of age, if the CR-BSI rate is decreasing despite 

adherence to basic prevention measures, including education and training, 

appropriate use of chlorhexidine for skin antisepsis, and MSB. Category 1B 

(changed from unresolved issue to Category 1B) 

2. Use a CHG/silver sulfadiazine or minocycline/rifampin-impregnated CVC in 

patients whose catheter is expected to remain in place >5 days if, after 

successful implementation of a comprehensive strategy to reduce rates of 

CLA-BSI, the CLA-BSI rate is not decreasing. The comprehensive strategy 

should include at least the following three components: educating persons who 

insert and maintain catheters, use of maximal sterile barrier precautions, and a 

2% CHG preparation with alcohol for skin antisepsis during CVC insertion. 

Category IA (changed from a Category 1B to a 1A) 



3. Minimize contamination risk by scrubbing the access port with an appropriate 

antiseptic (CHG, povidone iodine, an iodophor, or 70% alcohol) and accessing the 

port only with sterile devices. Category IA (upgraded from a Category 1B to a 

1A) 

4. Replace dressings used on short-term CVC sites every 2 days for transparent 

dressings, except in those pediatric patients in which the risk for dislodging the 

catheter may outweigh the benefit of changing the dressing. Category IB 

(changed from 11 to 1B) 

5. Use a fistula or graft in patients with chronic renal failure instead of a CVC for 

permanent access for dialysis. Category IA (changed from a 1B to a 1A) 

6. When adherence to aseptic technique cannot be ensured (i.e., catheters inserted 

during a medical emergency), replace the catheter as soon as possible, i.e., within 

48 hours. Category 1B (changed from a II to 1B) 



7. Use povidone iodine antiseptic ointment or 

bacitracin/gramicidin/polymyxin B ointment at the hemodialysis 

catheter exit site after catheter insertion and at the end of each dialysis 

session only if this ointment does not interact with the material of the 

hemodialysis catheter per manufacturer's recommendation. Category IB 

(changed from a Category II to 1B) 

8. Use a sutureless securement device to reduce the risk of infection for 

intravascular catheter. Category II (changed from unresolved issue to 

Category II) 

9. Use prophylactic antimicrobial lock solution in patients with long-term 

catheters who have a history of multiple CR-BSI despite optimal 

maximal adherence to aseptic technique. Category II (changed from 

“do not use” to “use”; both Category II) 


Strategies to Prevent Central Line-Associated Bloodstream 

Infections (CLA-BSIs) in Acute Care Hospitals. 

Marschall J, et al. Infect Control Hosp Epidemiology 2008;29:S22-30.

SHEA Recommended Basic and Special 

Approaches for the Prevention of CLA-BSIs 

Basic Practices 

Catheter Checklist B- II 

Hand Hygiene B- II 

Insertion site-Femoral A- I 

Cart Kit B- II 

Maximal Barrier Precautions A- I 

Chlorhexidine (CHG) Skin Prep A- I 

Special Approaches 

CHG Baths (ICU patients) B- II 

Impregnated Catheters A- I 

BioPatch Disk B- I 

Antimicrobial Locks A- I 

Marschall J, et al. ICHE 2008;29:S22-30. 

Catheter 

Insertion 

Bundle 

Catheter 

Maintenance 

Bundle

Enhancing Patient Safety Through 

Implementing These 

Recommendations

Microbial Source of CLA-BSI 

EXTRALUMINAL COLONIZATION INTRALUMINAL COLONIZATION 

Vein 

Skin 

Extraluminal biofilm is the major 

source of CLA-BSI within the first week 

of catheterization in short-term 

catheters. 

Extraluminal biofilm is the major 

source of tunnel infections in long-term 

catheters. 

Hub 

Skin 

1. Ryder, MA. Catheter-Related Infections: It's All About Biofilm. Topics in Advanced Practice Nursing 

eJournal. 2005;5(3) ©2005 Medscape. Posted 08/18/2005 . http://www.medscape.com/viewarticle/508109. 

Catheter 

Intraluminal biofilm is the major source 

of CLA-BSI after 1 week in both shortand 

long-term catheters.

Skin Organisms 

Endogenous 

Skin flora 

Extrinsic 

HCW hands 

Contaminated disinfectant 

1 

2 

Fibrin Sheath, 

Thrombus 

Contaminated 

Catheter Hub 

Endogenous 

Skin flora 

Extrinsic 

HCW hands 

Skin 

Vein 

1. Safdar N, Maki DG. The pathogenesis of catheter-related bloodstream infection 

with noncuffed short-term central venous catheters. Int Care Med. 2004;30:62-67. 

Contaminated 

Infusate 

Extrinsic 

Fluid 

Medication 

Intrinsic 

Manufacturer 

1 = 60% 

2 = 12% 

3 =

SHEA Recommended Basic and Special 

Approaches for the Prevention of CLA-BSIs 

Basic Practices 

Catheter Checklist B- II 

Hand Hygiene B- II 

Insertion site-Femoral A- I 

Cart Kit B- II 

Maximal Barrier Precautions A- I 

Chlorhexidine (CHG) Skin Prep A- I 

Special Approaches 

CHG Baths (ICU patients) B- II 

Impregnated Catheters A- I 

BioPatch Disk B- I 

Antimicrobial Locks A- I 

Marschall J., et al. ICHE 008;29:S22-30. 

Catheter 

Insertion 

Bundle 

Catheter 

Maintenance 

Bundle

Evidence-Based Measures to Decrease 

the Risk of Infection During Insertion of 

the Intravascular Catheter: INSERTION 

BUNDLE 

• Insert a catheter only when clinically essential. 

• Use a catheter insertion check-list. 

• Use a catheter insertion cart or kit. 

• Hand hygiene. 

• Chlorhexidine-alcohol skin antisepsis. 

• Maximum barrier precautions. 

• Select the correct catheter and insert in the correct 

location (Vessel Preservation; avoid femoral).

Basic 

Practices: 

Use a 

Checklist1 Checklist1 1.Marschall J. et al., Strategies 

to prevent Central Line 

Associated Bloodstream 

Infections in Acute Care 

Hospitals. Infect Control 

Hospital Epidemiol 

2008;29:S22-30

Basic Practices: Use Catheter Cart or Kit 

1 

1. Marschall J. et al., Strategies to prevent Central Line Associated Bloodstream Infections in 

Acute Care Hospitals. ICHE 2008;29:S22-30.

Effect of Hand Hygiene on Resistant 

Organisms* 

Year Author Setting Impact on organisms 

1982 Maki adult ICU decreased 

1984 Massanari adult ICU decreased 

1990 Simmons adult ICU no effect 

1992 Doebbeling adult ICU decreased with one versus 

another hand hygiene 

product 

1994 Webster NICU MRSA eliminated 

1999 Pittet Hospital-wide MRSA decreased 

2009 Rupp Adult ICU No effect 

ICU = intensive care unit; NICU = neonatal ICU 

MRSA = methicillin-resistant Staphylococcus aureus 

*All interventions included multifaceted intervention programs; 

Most quasi-experimental or observational, not randomized trials. 

No randomized trial of hand hygiene vs. no hand hygiene has 

been conducted.

24 

Basic Practices: 

Use CHG Skin Prep 1 

• Apply 30 seconds with friction 

• Allow 30 seconds to dry 

1. Marschall J. et al., Strategies to prevent Central Line Associated Bloodstream Infections in Acute Care 

Hospitals. Infect Control Hospital Epidemiol 2008;29:S22-30

Effect of Maximal Barrier Precautions 

during Insertion on CVC Infections 

Raad et al, Infect Control Hosp Epidemiol, 1994 

p=0.03 

p=0.01

Evidence-Based Measures to Decrease the 

Risk of Infection During Maintenance of the 

Intravascular Catheter 

• Minimize catheter site skin bioburden 

(BioPatch). 

• Device selection (Catheter and connector) 

• Aseptic manipulation of catheter 

connectors--Scrub the hub (15-30 secs)! 

• Antibiotic/antiseptic lock 

• Antimicrobial/antiseptic-impregnated- 

catheters

Microbiology of the Skin 

• 80% of the resident bacteria exist 

within the first 5 layers of the 

stratum corneum 

• 20% are found in biofilms 

within hair follicles and sebaceous 

glands 

• Complete recolonization of the 

epidermis can occur within 18 

hours of antiseptic application 

Ryder, MA. Catheter-Related Infections: It's All About Biofilm. Topics in 

Advanced Practice Nursing eJournal. 2005;5(3) 

Posted 08/18/2005 . http://www.medscape.com/viewarticle/508109. 

©ETHICON, Inc 2005

29 

Skin Microbial Density 

Catheter Entry Site Matters 

• Skin surface microbial 

density varies at different 

body sites and between 

genders 

• Normal microbial colony 

counts at the antecubital 

space are 10-20 CFU 

per cm 2 

ANTECUBITAL SPACE 

1. Ryder M. Evidence-based practice in the management of vascular access 

devices for home parenteral nutrition therapy.JPEN. 2006;30(1):S82-93. 

Photo contributed by Marcia Ryder PhD MS RN 

10-20 cfu/cm 2

30 

Skin Microbial Density 

Catheter Entry Site Matters 

� Skin surface microbial 

density is highest on the 

skin at the femoral, jugular, 

and subclavian sites 

�� Normal microbial colony 

counts at the subclavicular 

space are 103-104 CFU per 

cm2 SUBCLAVICULAR 

SPACE 

1. Ryder M. Evidence-based practice in the management of vascular 

access devices for home parenteral nutrition therapy.JPEN. 

2006;30(1):S82-93 

Photo contributed by Marcia Ryder, PhD, MS, RN 

103-4 cfu/cm2 103-4 cfu/cm2

Timsit’s 

Randomized 

Controlled 

Trial:

Results 

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

Meta-analysis of CA-BSI Rates with 

Tennenberg 

Maki 

Hannan 

Bach 

Heard 

Collin 

Ciresi 

Pemberton 

Ramsay 

Trazzera 

George 

Summary 

Antiseptic Catheters 

0.0 0.5 1.0 2.0 3.0 

Odds Ratio 

OR 0.56, 95% CI (0.37-0.84) 

(Veenstra, Saint, Saha, et al. JAMA 1999)

Prevention: Impact of Coated Catheters 

Meta-analysis of published studies 

N° of studies 0.03 0.1 0.3 1.0 RR (95% CI) NNT 

18 colonization 0.60 (0.49-0.74) 8 

16 bloodstream infections 0.64 (0.46-0.88) 55 

6 >1 week 0.35 (0.16-0.67) 28 

9

Does the BioPatch Enhance CVC-BSI 

Prevention in Patients with Impregnated 

Catheters? 

• Study design: Prospective, randomized, open, controlled study in 

cancer chemotherapy patients requiring central venous catheters 

(CVC) for >5 days between January 2004 and January 2006. All 

patients had a chlorhexidine and silver sulfadiazine-impregnated 

triple lumen CVC. Randomized to CHG-sponge vs. standard 

dressing. Independent observation of site. 

• Results: 601 patients with 9,731 CVC-days. Mean CVC duration: 

16.6 days (treatment) vs. 15.8 days (control). Mean neutropenia: 

7.5 days (treatment) vs. 6.9 days (control). CVC-related infections: 

34/301 (11.3%) in control vs. 19/300 (6.3%) in CHG-sponge group 

(p=0.016, RR=0.54). CVC-related infections significantly reduced at 

internal jugular vein-inserted CVCs (P=0.018). 

• Summary: The use of the CHG-sponge (BioPatch) reduced CVCrelated 

infections by 44% even when CHG-silver impregnated 

catheters were used. 

Reschulte H et al. Ann Hematol 2009;88;267-72.

Types of Needleless Connectors 

Negative Pressure Positive Pressure Neutral Pressure

Increased Bloodstream Infection (BSI) 

Rates Associated with Needleless 

Author SS Used SS-BSI 

Rate* 

Connectors 

MV Used MV-BSI 

Rate* 

Pvalue 

Salgado 1 Interlink 1.79 Smartsite 5.41

How May the Mechanical Valves Lead to BSIs? 

• Location: Wake Forest University School of Medicine. 

• Study Design: Quantitative cultures of blood from ICU patients 

drawn through MV ND from December 12, 2004 to January 21, 2005 

(initial syringe pull back of morning blood draw). 

• Results: 

– 226 “discards” obtained from 83 patients. 

– 39/226 (17%; range 8% to 50%, by unit) culture positive. 

– Colony forming units (CFU/ml): median=0.3, range 0.1->100. 

– Pathogens: 25 CNS, 5 yeast, 2 S. aureus, 2 each Serratia or 

Enterococcus spp., 1 each S. maltophilia or Acinetobacter spp.; 

31% would be considered pathogens in a blood culture. 

– 31% of nurses did not disinfect the MV before accessing system. 

Karchmer TB et al. SHEA 2005, Abstract #307

Disinfection of Needleless Catheter Connectors 

• Study design: In vitro study. 

– 3 luer-activated valved connectors (Clearlink [Baxter 

Healthcare], PosiFlow [Becton-Dickinson], and Micro 

CLAVE [ICU Medical]) were studied. 

– One device as control, the rest inoculated by 

immersing the membranous surface in a suspension 

of E. faecalis containing >10 8 colony forming units 

(CFUs) per ml. Septum allowed to dry for 24 hours 

(final inoculum 10 5 CFU/ml). 

– Accessed by sterile syringe containing 3ml of sterile 

tryptocase soy broth and flushed with broth. 

– Vigorous 3-5 second swabbing. 

Menyhay and Maki ICHE 2006;27:23-27.

Menyhay and Maki ICHE 2006;27:23-27.

Disinfection of Mechanical Valves 

• Study design: 300 MVs (4 types from 3 manufacturers) were 

tested. Each septum inoculated with 105 CFUs/ml of S. 

epidermidis, S. aureus, P. aeruginosa, and/or C. albicans. 

Membranous septum disinfected for 15 seconds with friction, 

using 70% alcohol or 3.15% chlorhexidine/70% alcohol 

(Chlorascrub ). 0.9% non-bacteriostatic saline flush solutions 

were collected downstream and quantitatively cultured. 

• Results: Disinfection of the membranous septum for 15 

seconds with friction, using either 70% alcohol alone or 

3.15% chlorhexidine/70% alcohol (Chlorascrub ) was 

equally effective in preventing the transfer from the 

membranous septum downstream in the process of 

accessing the ports. 

Kaler W et al. JAVA 2007;12:140-142.

Letter to Infection Control Practitioners Regarding Positive Displacement Needleless Connectors: 

Dear Infection Control Professional: The Food and Drug Administration is requiring nine companies to conduct a 

postmarket surveillance study on positive displacement needleless connectors to assess whether they may be 

associated with a higher rate of device-associated bloodstream infections (BSI) than other types of needleless 

connectors, and to assess the factors that may contribute to a possible increased risk. 

Summary of the Problem: 

FDA has become aware of information that raises concerns about the safety of positive displacement needleless 

connectors. These devices are intended for use as an accessory to an intravascular administration set to allow 

delivery of a wide range of fluids to a patient's vascular system through a cannula inserted into a vein or artery. 

Needleless connectors may also be referred to as “valves” or “accesses.” “Positive displacement” refers to the 

positive pressure of fluid movement from a reservoir into the lumen of the catheter upon disconnection of an 

administration set or syringe. 

FDA has received three reports of death associated with BSI and positive displacement needleless connectors. Infection 

control authorities are also concerned about positive displacement connectors and the device’s association with BSI. 

……..Because there is presently insufficient information to determine if positive displacement connectors increase the 

risk of BSI compared with other needleless connectors, FDA is requiring the companies to conduct postmarket 

surveillance studies to provide an assessment of the risk associated with positive displacement needleless 

connectors. 

The Postmarket Studies> 

Manufacturers must answer the following two public health questions about positive displacement needleless connectors 

with their postmarket surveillance studies: 

1. What is the rate of bloodstream infections for subjects receiving your positive displacement connector for central line 

access and is it statistically non-inferior to the rates seen in subjects receiving other needleless connectors (e.g. 

negative, neutral, or split-septum connectors) for central line access, given comparable patient populations? 

2. Are there patient demographics, comorbidities/severity of illness, or device cleaning practices for which placement of 

your positive displacement connector for central line access increases subjects’ risk of bloodstream infections 

compared with other needleless connectors? 

These studies may take up to three years to complete. At the end of the study period, FDA will assess whether regulatory 

or other actions need to be taken. 

References: 

Field K, McFarlane C, Cheng AC, Hughes AJ, Jacobs E, Styles K, Low J, Stow P, Campbell P, Athan E. Infect Control Hosp Epidemiol. 2007 May;28(5):610-3.; Jarvis WR, Murphy C, Hall KK, Fogle PJ, Karchmer 

TB, Harrington G, Salgado C, Giannetta ET, Cameron C, Sherertz RJ. Clin Infect Dis. 2009 Dec 15;49(12):1821-7; Maragakis LL, Bradley KL, Song X, Beers C, Miller MR, Cosgrove SE, Perl TM. 

InfectControl Hosp Epidemiol. 2006 Jan;27(1):67-70; Rupp ME, Sholtz LA, Jourdan DR, Marion ND, Tyner LK, Fe; PD, Iwen PC, Anderson JR. Clin Infect Dis. 2007 Jun 1;44(11):1408-14; Salgado CD, 

Chinnes L, Paczesny TH, Cantey JR. Infect Control Hosp Epidemiol. 2007 Jun;28(6):684-8.

Companies FDA is Requiring to Perform 

Positive Displacement Needleless 

Connector Post-market Surveillance Study 

• Amsino International, Inc.: Cortez Needle Free IV Connector. 

• Baxter Healthcare Corporation: IV/Catheter Extension Set with NAC 

Plus Needleless Access Connector and NAC Plus Needleless Access 

Connector. 

• Becton Dickinson Infusion Therapy Systems Inc.: BD posiflowTM Positive Displacement Valve. 

• B. Braun Medical Inc.: Ultrasite Valve. 

• Cardinal Health 200, LLC: IVAC Needle Free Administration Sets. 

• Carefusion 303, Inc.: SmartSite Needle Free Valve Administration Sets. 

• Critical Device Corporation: NIMA Needleless Injection site Master 

Adapter with PosiFlow Positive Displacement Feature, and IV Sets. 

• ICU Medical, Inc: CLC 2000, CLC2000 Catheter Patency Device, and 

TEGO. 

• Medegen Medical Manufacturing Services/System: Maxplus/MaxPlus 

Tru-Swab Positive Displacement Connector.

Current SHEA or CDC Recommendations 

Regarding Neeleless Connectors 

SHEA: Do not routinely use positive-pressure 

needleless connectors with mechanical valves before a 

thorough assessment of risks, benefits, and education 

regarding proper use (B-II). 

Marschall J. et al., Infect Control Hosp Epidemiology 2008;29:S22-30. 

CDC: When needleless systems are used, a split septum 

valve may be preferred over a mechanical valve due to 

increased risk of infection with some mechanical 

valves. Category II 

http://wwwn.cdc.gov/publiccomments/comments/guidelinesfor-the-prevention-of-intravascular-catheter-related-infections.aspx

49 

Not All CHG-Containing Devices Are Created 

Equal

3M Tegaderm CHG Data 

Publications (N=2) 

• 1. Olson C, et al. Clinical Performance of a New Transparent Chlorhexidine Gluconate 

Central Venous Catheter Dressing (Ease of Use Study). JAVA 2008;13:14-20. The primary 

objective was to evaluate the overall satisfaction with the securement at the end of the study 

participation. The secondary objectives were to evaluate the overall satisfaction with the 

dressing. Results: There was no statistically significant difference between TegadermTM CHG 

and the non-antimicrobial dressing in dressing wear time, number of dressing changes, ease of 

application, ease of applying correctly and ease of removal. Only at the end of study evaluation, 

were the clinician’s satisfaction with securement and overall satisfaction with dressing 

significantly better with TegadermTM CHG. 

• 2. Eyberg C, et al. A Controlled Randomized Prospective Comparative Pilot Study to 

Evaluate the Ease of Use of a Transparent CHG Gel Dressing vs. a CHG Disk in Healthy 

Volunteers. JAVA 2008;13:112-117. Assessment of the ease of application and performance 

factors of TegadermTM CHG vs. BIOPATCH® in healthy volunteers (N=12). Each clinician 

(total of 12 clinicians) applied and removed one TegadermTM CHG and one BIOPATCH® on 

one simulated PICC and one simulated IJ site. 

Abstracts ( N=15) 

The majority (N=13) assessed nurse satisfaction with performance of the product, absorption of the product, cost, or in vitro antimicrobial 

activity. Only two even mention any CVC-BSI rates; both are small before/after studies at small hospitals. In one, the product introduction was 

because of a elevated CVC-BSI rate and they introduced a wide variety of measures (including changing from a positive to neutral pressure 

mechanical valve and expanding the PICC team [Pappas et al]). In the other (Reilly et al), a small before/after study was done over about 17 

months. The CVC-BSI rate decreased initially after introduction of the CHG dressing, but the rate was increasing toward 2 (the prior baseline 

rate) per 1,000 CVC-days at the end of the period reported with the dressing.

FDA-Approved Indications 

BioPatch® Protective Disk with 

CHG Indications for Use 

Biopatch containing Chlorhexidine Gluconate is 

intended for use as a hydrophilic wound dressing that is 

used to absorb exudates and to cover a wound caused 

by the use of vascular and non-vascular percutaneous 

medical devices such as: IV catheters, central venous 

lines, arterial catheters, dialysis catheters, peripherally 

inserted coronary catheters, mid-line catheters, drains, 

chest tubes, externally placed orthopedic pins and 

epidural catheters. It is also intended to 

reduce local infections, catheterrelated 

bloodstream infections 

(CRBSI), and skin colonization of 

microorganisms commonly 

related to CRBSI, in patients with 

central venous or arterial 

catheters. 

3M Tegaderm 

CHG Dressing 

Indications for Use 

3M Tegaderm CHG dressings 

Chlorhexidine Gluconate I.V. 

Securement Dressing), can be 

used to cover and 

protect catheter sites 

and to secure 

devices to skin. Common 

applications include IV catheters, 

other intravascular catheter 

percutaneous devices.

In Vitro Comparative Analysis of a Chlorhexidine Gluconate (CHG) Sponge Dressing and a CHGcontaining 

Hydrogel Dressing 

BIOPATCH ® Tegaderm TM CHG 

CHG TRANSFER 

1. CHG is transferred only where there is direct contact between the device 

and the skin, because CHG binds tightly to the skin 1 and does not migrate 

across it. This is demonstrated in tests of CHG transfer to porcine skin 

(Figure 1). 2 

3. 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. 

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

Figure 1 (C,D): 3 CHG is transferred from Tegaderm TM CHG only where there is direct contact between the hydrogel pad and skin and not 

under the catheter or where tenting occurred. 

References: 

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. 

52

In Vitro Comparative Analysis of a Chlorhexidine Gluconate (CHG) Sponge Dressing and a CHGcontaining 

Hydrogel Dressing 

FLUID MANAGEMENT 

1. BIOPATCH ® Protective Disk with CHG absorbs fluids rapidly, which helps 

avoid the potential for skin maceration. In vitro studies demonstrate that 

BIOPATCH ® fully absorbs blood within 0.5 seconds (Figure 2; A, B). 1 In 

contrast, Tegaderm TM CHG gel pad did not fully absorb blood even after 2 

hours. This may be due to the high water content of the gel itself (70% to 

90%), 1 which limits its absorption of fluids. Tegaderm TM CHG only partially 

absorbs blood after 2 hours (Figure 3; C). 1 

2. Given the fact that under normal conditions blood clots within 4 to 8 

minutes, 1 minutes, this slow absorption may lead to blood clots and proteinaceous 

1 this slow absorption may lead to blood clots and proteinaceous 

materials remaining on the skin beneath the TegadermTM CHG dressing. 

3. Incomplete absorption of blood or bodily fluids can create an environment 

conducive to bacterial growth (Figure 4). 2 

BIOPATCH ® fully absorbs blood within 0.5 seconds (Figure 2, A and B). Blood is only partially absorbed into 

the Tegaderm TM CHG gel pad even after 2 hours (Figure 3, A-C). 3 

References: 

1. Gonzalez S. Differences In Absorption Between Biopatch® And TegadermTM CHG Part II: Rate of absorption of different fluids. Ethicon, October, 2010. Data on file. Ethicon, Inc. 

2. Maki DG, Ringer M. Evaluation of dressing regimens for prevention of infection with peripheral intravenous catheters. Gauze, a transparent polyurethane dressing, and an iodophor-transparent dressing. JAMA. 

1987;258(17):2396-2403. 

3. BIOPATCH® vs. TegadermTM CHG Absorption pictures: Drops of citrated porcine blood were dropped onto the foam side of Biopatch® or the gel side of TegadermTM CHG using an 18 gauge needle. The time for 

blood absorption was recorded. Data on file. Ethicon, Inc. 

53

GUARDIVa TM COMPARISON 

In Vitro Comparative Analysis of 2 Chlorhexidine Gluconate Sponge Dressings 

KEY DIFFERENCE BETWEEN PRODUCTS 

These two CHG-impregnated 

sponge dressings may have a 

similar outward appearance, but 

their materials of construction and 

delivery characteristics are very 

different, and BIOPATCH ® is the 

only product clinically-proven with 

FDA-cleared indication for the 

prevention of CR-BSIs. 

54


DIFFERENT FOAM CHARACTERISTICS 

The outside appearance of 

GuardIVaTM is very similar to 

that of BIOPATCH ® Protective 

Disk with CHG. However, on 

closer inspection, they are 

clearly different. 1 

References: 

1. SEM: Electron micrographs at 50 times magnification using a JEOL JSM-5900LV SEM. Data on file. Ethicon, Inc. 

55

GUARDIVa TM COMPARISON 


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

of microoganisms within the dressing. 

References: 

1. GuardIVa TM [package insert]. Dublin: HemCon Medical Techologies, Europe Ltd. 

DIFFERENT INDICATIONS 

1. Unlike the BIOPATCH ® Protective 

Disk with CHG, the GuardIVa TM is 

indicated only as an absorbent, 

hemostatic protective dressing and 

is not indicated to prevent 

infection. 

2. According to the GuardIVa TM 

package insert, the CHG is added 

to the dressing as a preservative 

to prevent bacterial growth within 

the dressing itself 1 rather than on 

the skin beneath it. 

56

Interventions That Prove That 

Implementation of Evidence-Based 

CVC-BSI Prevention Measures Can 

Prevent Infections, Save Lives, and 

Save Money

Keystone Project 

• Study design: Intervention cohort study in 

108 Michigan Intensive care units (ICUs) over 

18 months. Comparison of CVC-BSI rates 

before, during, and after intervention. 

• Results: 103 ICUs. 1,981 months of ICU 

data and 375,757 catheter-days. 

Median CVC-BSI Rates per 1,000 CVC-days 

Baseline 3 Months IRR 16-18 Months IRR 

2.7 0 0.62 1.4 0.34 

Conclusion: An evidence-based intervention resulted in 

a large and sustainable decrease (up to 66%) in CVC-BSI 

rates that was maintained for 18 months. 

Pronovost P. et al NEJM 2006;355:2725-32

Michigan’s Keystone Project-Can Results Be Sustained? 

Pronovost P et al., BMJ. 2010;340:c309.

The Majority of CR-BSIs Occur 

Central Venous Venous CRBSIs 

Outside of the ICU 

Annual Central Venous CRBSIs 

(n=250,000) 1,2 

70% 

30% 

Non-ICU 

Patients 

ICU Patients 

A significant opportunity exists to reduce CR- 

BSI incidence in non-ICU settings. 

1. Mermel L, Farr B, Sheretz R. Guidelines for the management of intravascular catheter-related infections. 

Clinical Infectious Diseases. 2001;32:1249-1272. 

2. Centers for Disease Control and Prevention. Guidelines for the prevention of intravascular catheterrelated 

infections. Morbidity Mortality Weekly Report. 2002;51:1-29. 

1 Mermel, 2000 and CDC 2002

Impact Of Dedicated IV Device-Care Teams 

Study No. Patients IV-Related P-Value 

Sepsis 

• Concurrent but non-randomized: 

Nehe, Ward Care 391 26.2% 

JAMA (1980) TPN Team 284 1.3%

CLA-BSI Prevention Insertion and Maintenance 

Bundles 

Insertion Bundle 

Catheter checklist 

Hand hygiene 

Insertion site-Femoral 

Cart kit 

Maximal barrier precautions 

Chlorhexidine (CHG) skin prep 

Maintenance Bundle 

Select the safest needleless connector 

Scrub the hub (>15 secs with CHG-alcohol or alcohol) 

Antiseptic or antimicrobial-impregnated catheters 

CHG-impregnated sponge (BioPatch) 

Antimicrobial or antiseptic locks 

CHG Baths (ICU patients) 

Prevention Possibility: 70%-100%

Conclusions 

•CVC-Related BSIs are a major cause of patient morbidity and mortality. 

•Prevention of CVC-Related BSIs requires a multi-factorial approach, 

including: 

•Implementation of SHEA and CDC CVC-BSI Prevention Guideline 

Recommendations (2009/2010) 

•Implementing new prevention evidence. 

•Implementation of insertion and maintenance bundles. 

•Educating staff; Insuring adequate and properly trained staff 

•Insuring that policy = practice (clinician accountability) 

•Monitoring CVC insertion and maintenance processes and CVC-related 

BSI rates (outcomes). 

•A comprehensive CVC-related BSI prevention program can dramatically 

reduce infection rates and improve patient safety. 

•A rate of ZERO CVC-BSIs in ICU patients is a reality and should be our 

goal.

Thank You!

CLABSI and Needleless Connectors - TSICP Texas Society of ...

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