Part 2: Insertion Bundle & Maintenance Bundle

1. The Bundle Concept

The concept of a “bundle” — a structured set of evidence-based interventions that, when implemented together and reliably, produce significantly better outcomes than when any element is used individually — was pioneered by a major healthcare improvement organization for CLABSI prevention and has become a cornerstone of patient safety worldwide.¹²

The fundamental principle is all-or-none compliance: partial implementation of bundle elements yields suboptimal results. Studies consistently demonstrate that achieving high (>95%) compliance with all bundle elements simultaneously produces the greatest CLABSI reduction, while compliance with most-but-not-all elements results in significantly less improvement. In the landmark Michigan collaborative, compliance with all five insertion bundle elements rose from 30% at baseline to 96% at 3 months, accompanied by a 66% reduction in CLABSI rates.²

2. The Central Line Insertion Bundle

2.1 Overview

The evidence-based insertion bundle consists of five components, each supported by strong evidence (Category IA or IB recommendations):¹²³

2.2 Hand Hygiene

Recommendation: Perform hand hygiene before and after palpating catheter insertion sites, before and after inserting, replacing, accessing, repairing, or dressing an intravascular catheter, and before donning sterile gloves for catheter insertion.³⁴

Evidence and Rationale:

• Hand hygiene is the single most important measure for preventing healthcare-associated infections, including CLABSI
• Acceptable agents include alcohol-based hand rub (ABHR; 60–95% ethanol or isopropanol) or antimicrobial soap and water (if hands are visibly soiled)
• ABHR is preferred when hands are not visibly soiled because of superior antimicrobial efficacy, speed of action, and better skin tolerance
• Hands must also be cleaned after removal of gloves, as gloves do not provide complete protection against hand contamination
• Hand hygiene compliance should be monitored as part of unit-level infection prevention programs, with a target of >90% compliance³⁴

Implementation Considerations:

• ABHR dispensers should be placed at the point of care (within arm’s reach of the catheter insertion area)
• Central line insertion checklists should include a hand hygiene verification step
• The observer (nurse or trained monitor) should confirm hand hygiene before allowing the procedure to proceed

2.3 Maximal Sterile Barrier Precautions

Recommendation: Use maximal sterile barrier precautions — including cap, mask, sterile gown, sterile gloves, and a large sterile full-body drape — during the insertion of central venous catheters, PICCs, and guidewire exchanges.³⁵

Evidence and Rationale:

A landmark randomized controlled trial demonstrated that maximal sterile barriers reduced catheter colonization and CLABSI by approximately sixfold compared with standard precautions (sterile gloves and a small drape only). The absolute risk reduction was 3.5 CLABSI per 1,000 catheter-days. Despite higher initial supply cost, the reduced infection rate translated into significant net cost savings.⁵

Implementation Considerations:

• All personnel present during the procedure (operators, assistants, observers) should wear cap and mask
• The large drape should be sufficiently sized to cover the patient from head to toe and extend over the sides of the bed to maintain a sterile field
• Commercially available central line insertion kits containing all maximal sterile barrier components are recommended to simplify compliance
• Ultrasound probe covers (sterile) are required when using ultrasound guidance during sterile insertion

2.4 Chlorhexidine Skin Antisepsis

Recommendation: Prepare the insertion site with >0.5% chlorhexidine preparation in alcohol (standard preparation: 2% chlorhexidine gluconate in 70% isopropyl alcohol) before central venous catheter insertion and during dressing changes. If there is a contraindication to chlorhexidine, tincture of iodine, an iodophor (povidone-iodine), or 70% alcohol may be used as alternatives.³⁶

Evidence and Rationale:

A meta-analysis of eight randomized controlled trials comparing chlorhexidine-based preparations to povidone-iodine for catheter site antisepsis demonstrated a 49% reduction in CLABSI with chlorhexidine (relative risk 0.51, 95% CI 0.27–0.97).⁶ The combination of chlorhexidine with alcohol provides both rapid bactericidal activity (from alcohol) and sustained residual activity (from chlorhexidine that binds to the stratum corneum).³

Application Technique:

1. Apply chlorhexidine-alcohol solution using a back-and-forth friction scrub
2. Cover an area of at least 20 cm (approximately 8 inches) in diameter centered on the insertion site
3. Continue scrubbing for a minimum of 30 seconds
4. Allow the antiseptic to dry completely before insertion — minimum dry time is approximately 2 minutes for chlorhexidine-alcohol preparations
5. Do not blot or fan dry — allow to air dry to permit full antimicrobial activity
6. Do not apply the antiseptic solution and then wipe it off before it dries

Contraindications and Special Considerations:

2.5 Optimal Catheter Site Selection

Recommendation: In adult patients, use the subclavian site rather than the jugular or femoral sites for nontunneled central venous catheters to minimize infection risk, when not contraindicated. Avoid the femoral site in adult patients whenever possible.³⁷

Evidence by Insertion Site:

Key Evidence:

A major multicenter randomized trial (the 3SITES trial) comparing subclavian, internal jugular, and femoral catheterization in adult ICU patients found:⁷

• Subclavian site was associated with the lowest risk of catheter-related bloodstream infection and symptomatic deep vein thrombosis
• Femoral site had the highest risk of catheter colonization (hazard ratio 1.35 compared with subclavian) and overall catheter-related complications
• Internal jugular site had intermediate infection risk
• Subclavian site had the highest risk of pneumothorax (1.5% vs 0.1% for internal jugular)
• The investigators concluded that the subclavian site should be preferred when not contraindicated

Site Selection by Clinical Scenario:

Ultrasound Guidance:

Real-time ultrasound guidance for internal jugular vein catheterization is strongly recommended (Category IB) and should be considered standard of care. Ultrasound guidance reduces the number of insertion attempts, time to cannulation, mechanical complications (arterial puncture, hematoma), and failed insertions. Meta-analytic evidence demonstrates significant reductions in all of these outcomes.³⁸ While ultrasound guidance for subclavian and femoral access is also supported by growing evidence, the strongest data are for internal jugular cannulation.

2.6 Daily Review of Line Necessity and Prompt Removal

Recommendation: Assess the need for continued central venous access daily, and promptly remove any central line that is no longer essential. There is no indication for routine replacement of central lines at fixed time intervals to prevent infection.³⁹

Evidence and Rationale:

• Each additional day of central line dwell increases CLABSI risk
• Up to 30% of central line-days in ICUs may be unnecessary (lines left in place without active indications)
• Randomized trials of scheduled catheter exchange at fixed intervals (e.g., every 7 days) versus as-needed replacement showed no reduction in CLABSI with routine exchange and an increased risk of mechanical complications; thus routine scheduled replacement is not recommended³
• Daily “line necessity” discussions during multidisciplinary rounds — asking “Does this patient still need a central line?” — reduce unnecessary catheter-days by 20–30% and contribute to CLABSI rate reduction⁹

Implementation Strategies:

• Include central line necessity as a standard item on daily ICU rounding checklists
• Empower bedside nurses to prompt physicians/APPs regarding line necessity
• Use electronic health record clinical decision support (daily prompts or reminders) to flag central lines without active indications
• Establish automatic stop orders or mandatory reassessment orders for central lines
• Consider transition to peripheral IV access or midline catheter when central access is no longer strictly required

3. The Central Line Maintenance Bundle

The maintenance bundle addresses ongoing catheter care after insertion and targets the intraluminal colonization pathway — the predominant mechanism of CLABSI for catheters that have been in place for more than 10–14 days.¹¹⁰¹¹

3.1 Hand Hygiene Before and After Accessing the Line

Recommendation: Perform hand hygiene with alcohol-based hand rub or antimicrobial soap and water before and after every access of the central line, including medication administration, blood draws, tubing changes, dressing changes, and any other manipulation.³⁴

This is the same standard as for insertion and applies to every encounter with the catheter system. Compliance must be monitored and maintained at >90%.

3.2 Scrub the Hub

Recommendation: Disinfect catheter hubs, needleless connectors, and injection ports immediately before each access using an appropriate antiseptic agent with vigorous mechanical friction (scrubbing) for a minimum of 15 seconds (some organizations recommend 15–30 seconds). Allow to dry before accessing.³¹⁰¹¹

Acceptable Agents for Hub Disinfection:

Critical Technique Elements:

• Use a new antiseptic wipe or swab for each access
• Apply vigorous mechanical friction (the physical scrubbing action is as important as the antiseptic agent)
• Scrub all surfaces of the hub/connector — top, sides, and threads
• Allow to dry for at least 5–15 seconds before accessing (varies by institutional protocol)
• Access the line immediately after disinfection; if the connector has been contaminated (e.g., dropped, touched non-aseptically), repeat disinfection

Passive Disinfection Caps:

Passive disinfection caps (also called port protectors) contain 70% isopropyl alcohol and are designed to be applied to needleless connectors between accesses, providing continuous antisepsis of the connector surface. Evidence from multiple before-and-after studies and some randomized trials demonstrates:¹⁰¹²

• 40–60% reduction in CLABSI rates with routine use of passive disinfection caps
• Improved standardization of hub disinfection (eliminates variability in scrub time and technique)
• Particularly effective in settings where manual scrub-the-hub compliance is suboptimal
• Should be applied immediately after access and replaced after each use

3.3 Daily Chlorhexidine Gluconate (CHG) Bathing

Recommendation: Bathe ICU patients with ≥2% chlorhexidine gluconate-impregnated cloths daily to reduce skin bioburden and CLABSI risk. This practice is recommended as a supplemental strategy and is most strongly supported in adult ICU settings.¹¹¹³¹⁴

Evidence:

The REDUCE MRSA trial — a large, multicenter cluster-randomized trial involving 74 ICUs and over 74,000 patients — demonstrated that daily CHG bathing (combined with universal MRSA nasal decolonization with mupirocin) reduced:¹⁴

• MRSA-positive clinical cultures by 37%
• All-cause bloodstream infections by 44%
• CLABSI specifically (as a secondary outcome) by a significant margin

Additional supporting evidence:

Application Protocol:

1. Use no-rinse 2% CHG-impregnated disposable cloths (preferred over liquid CHG soap for standardization and ease of use)
2. Bathe the patient daily from the neck down, covering all major skin surfaces (chest, abdomen, back, arms, legs, axillae, inguinal areas)
3. Do not apply to the face, open wounds, mucous membranes, or eyes
4. Allow to air dry — do not rinse off
5. Replace traditional soap-and-water bathing with CHG bathing for daily hygiene in ICU patients
6. Continue daily CHG bathing for the duration of central line placement

Contraindications and Precautions:

3.4 Dressing Management

Recommendation: Use either sterile gauze or a sterile transparent semipermeable dressing to cover the catheter insertion site. Replace dressings when they become damp, loosened, visibly soiled, or at scheduled intervals (every 2 days for gauze dressings; every 5–7 days for transparent semipermeable dressings). Replace the dressing whenever the catheter site is inspected or the site is palpated through the dressing.³¹¹

Dressing Types:

CHG-Impregnated Dressings:

Chlorhexidine-impregnated transparent dressings (e.g., CHG-containing gel pads integrated into transparent dressings) provide sustained local antisepsis at the catheter insertion site. Major trial evidence includes:¹⁶¹⁷

CHG-impregnated dressings are recommended as a supplemental strategy when CLABSI rates remain above institutional goals despite high compliance with the standard insertion and maintenance bundle.¹¹

Dressing Change Procedure:

1. Perform hand hygiene
2. Don clean gloves to remove the old dressing
3. Inspect the insertion site for signs of infection (erythema, tenderness, purulence, induration)
4. Remove gloves and perform hand hygiene
5. Don sterile gloves
6. Clean the site with >0.5% chlorhexidine in alcohol using a back-and-forth friction scrub; allow to dry completely
7. Apply a new sterile dressing; ensure complete adherence to the skin without wrinkles or gaps
8. Date and initial the new dressing
9. Document site assessment findings

3.5 Needleless Connector Management

Recommendation: Access intravascular catheters only with sterile devices. Minimize the number of catheter accesses. Disinfect needleless connectors before each access. Replace needleless connectors at least every 72 hours or per manufacturer instructions, and immediately replace if contaminated, damaged, or if residual blood or debris is present.³¹⁰¹¹

Needleless Connector Types:

Connector Selection Considerations:

• No single connector type has been definitively proven superior for CLABSI prevention in large randomized trials
• The ease of disinfection (smooth, flat septum surfaces) may be more important than the specific displacement mechanism
• Complex internal valve mechanisms with crevices may harbor organisms and be more difficult to disinfect
• Institutional standardization of a single connector type is recommended to simplify training and maintenance¹⁰

3.6 Administration Set Change Intervals

Recommendation: Replace administration sets (IV tubing) at intervals based on the type of infusion, not on a calendar schedule unrelated to infusate type.³¹¹

3.7 Catheter Securement

Recommendation: Use a sutureless securement device to reduce the risk of infection at the insertion site. If sutures are used, ensure aseptic placement and monitor for suture-site inflammation.³¹¹

Evidence:

• Sutureless securement devices (adhesive anchoring devices, subcutaneous stabilization devices) eliminate skin punctures from sutures, reducing a potential portal of entry for organisms
• Meta-analyses suggest a modest reduction in catheter-related infections with sutureless securement compared with suture fixation
• Sutureless devices also reduce needlestick injury risk for clinicians¹¹

4. Insertion Bundle Compliance Monitoring

4.1 The Central Line Insertion Checklist

A standardized insertion checklist should be used for every central line insertion. The checklist serves as both a cognitive aid and a compliance monitoring tool. A trained observer (typically the bedside nurse) reviews the checklist in real time and is empowered to stop the procedure if any bundle element is violated.²¹⁸

Essential Checklist Elements:

4.2 Nurse Empowerment to Stop the Procedure

A critical element of the insertion bundle is the empowerment of the bedside nurse (or trained observer) to halt the procedure if a break in sterile technique is observed or if any required bundle element is omitted. This practice was a cornerstone of the landmark statewide collaborative that achieved dramatic CLABSI reductions. Institutional culture must explicitly support this empowerment through:²¹⁸

• Written institutional policies affirming the authority of any team member to stop a procedure for safety concerns
• Administrative backing from unit leadership and physician champions
• Non-punitive reporting systems for near-misses and bundle violations
• Regular feedback sessions reinforcing that stopping the procedure for safety is expected and valued

5. Central Line Insertion Cart (Supply Standardization)

A dedicated central line insertion cart (or pre-assembled kit) containing all supplies needed for a bundle-compliant insertion reduces omission of bundle elements and streamlines the procedure.²¹⁸

Recommended Cart/Kit Contents:

6. Summary: Bundle Components and Evidence Strength

Insertion Bundle

Maintenance Bundle