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2011 Guidelines for the Prevention of Intravascular Catheter-Related Infections

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Replacement of Administration Sets

Recommendations

  1. In patients not receiving blood, blood products or fat emulsions, replace administration sets that are continuously used, including secondary sets and add-on devices, no more frequently than at 96-hour intervals, [177] but at least every 7 days [178–181]. Category IA
  2. No recommendation can be made regarding the frequency for replacing intermittently used administration sets. Unresolved issue
  3. No recommendation can be made regarding the frequency for replacing needles to access implantable ports. Unresolved issue
  4. Replace tubing used to administer blood, blood products, or fat emulsions (those combined with amino acids and glucose in a 3-in-1 admixture or infused separately) within 24 hours of initiating the infusion [182–185]. Category IB
  5. Replace tubing used to administer propofol infusions every 6 or 12 hours, when the vial is changed, per the manufacturer’s recommendation (FDA website Medwatch) [186]. Category IA
  6. No recommendation can be made regarding the length of time a needle used to access implanted ports can remain in place. Unresolved issue

Background

The optimal interval for routine replacement of IV administration sets has been examined in a number of well-controlled studies and meta-analyses. Data from these studies reveal that replacing administration sets no more frequently than 72–96 hours after initiation of use is safe and cost-effective [141, 177, 179–181]. More recent studies suggest that administration sets may be used safely for up to 7 days if used in conjunction with antiseptic catheters or if fluids that enhance microbial growth (e.g., parenteral nutrition or blood) have not been used [216, 345]. When a fluid that enhances microbial growth is infused (e.g., fat emulsions and blood products), more frequent changes of administration sets are indicated as these products have been identified as independent risk factors for CRBSI [182, 216, 346–350]. Little data exist regarding the length of time a needle used to access implanted ports can remain in place and the risk of CRBSI. While some centers have left them in place for several weeks without CRBSI, [351], this practice has not been adequately studied.

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Needleless Intravascular Catheter Systems

Recommendations

  1. Change the needleless components at least as frequently as the administration set. There is no benefit to changing these more frequently than every 72 hours. [39, 187–193]. Category II
  2. Change needleless connectors no more frequently than every 72 hours or according to manufacturers’ recommendations for the purpose of reducing infection rates [187, 189, 192, 193]. Category II
  3. Ensure that all components of the system are compatible to minimize leaks and breaks in the system [194]. Category II
  4. Minimize contamination risk by scrubbing the access port with an appropriate antiseptic (chlorhexidine, povidone iodine, an iodophor, or 70% alcohol) and accessing the port only with sterile devices [189, 192, 194–196]. Category IA
  5. Use a needleless system to access IV tubing. Category IC
  6. When needleless systems are used, a split septum valve may be preferred over some mechanical valves due to increased risk of infection with the mechanical valves [197–200]. Category II

Background

Stopcocks used for injection of medications, administration of IV infusions, and collection of blood samples represent a potential portal of entry for microorganisms into vascular access catheters and IV fluids. Whether such contamination is a substantial entry point of microorganisms that cause CRBSI has not been demonstrated. Nonetheless, stopcocks should be capped when not being used. In general, closed catheter access systems are associated with fewer CRBSIs than open systems and should be used preferentially [352].

"Piggyback" systems (secondary intermittent infusions delivered through a port on a primary infusion set) are used as an alternative to stopcocks. However, they also pose a risk for contamination of the intravascular fluid if the device entering the rubber membrane of an injection port is exposed to air or if it comes into direct contact with nonsterile tape used to fix the needle to the port. Modified piggyback systems have the potential to prevent contamination at these sites [353].

Attempts to reduce the incidence of sharps injuries and the resultant risk for transmission of bloodborne infections to healthcare personnel have led to the introduction and mandating of needleless infusion systems. There are several types of needleless connectors on the market.

The first type of needleless system connectors consisted of a split septum connector, which is accessed with a blunt cannula instead of a needle (external cannulae activated split septums). Because of the large amount of space in the connector to accommodate the cannula, when the cannula is removed it may result in the creation of negative pressure which may cause blood to be aspirated into the distal lumen, possibly increasing the risk of catheter occlusion or thrombosis. A luer-activated device, which incorporates a valve preventing the outflow of fluid through the connector, was designed to eliminate this problem. Some luer devices require a cap to be attached to the valve when not in use, which can be difficult to maintain aseptically, and therefore they may be prone to contamination.

Another type of second-generation needleless system addressed the occlusion issue by incorporating positive or neutral fluid displacement to either flush out aspirated blood or prevent its aspiration into infusion catheters.

Use of needleless connectors or mechanical valves appear to be effective in reducing connector colonization in some [196, 354, 355], but not all studies [356] when compared with stopcocks and caps. In one study [354], the incidence of CRBSI was reduced when the needleless connector was compared with standard stopcocks. Appropriate disinfectants must be used to prevent transmission of microbes through connectors [357]. Some studies have shown that disinfection of the devices with chlorhexidine/alcohol solutions appears to be most effective in reducing colonization [195, 196]. In addition, the time spent applying the disinfectant may be important. One study found that swiping the luer-activated device with 70% alcohol for only 3 to 5 seconds did not adequately disinfect the septal surface [358]. However, a number of outbreak investigations have reported increases in CRBSIs associated with a switch from external cannulae activated split septum needleless devices to mechanical valve devices [197, 198, 200, 359]. The reasons for these associations are not known and it is also not known if this is a device-specific or class association, particularly as physical and mechanical properties of needleless connectors vary from device to device. In addition, one investigation found CRBSIs increased with the switch from a luer-activated negative displacement mechanical valve to a luer-activated positive fluid displacement mechanical valve [199]. However in an observational study, a switch from a luer-activated negative displacement mechanical valve to a different luer-activated positive displacement mechanical valve as part of a bundled intervention resulted in a significant decrease in CRBSIs [201]. Potential explanations for outbreaks associated with these devices include difficulty encountered in adequate disinfection of the surface of the connector due to physical characteristics of the plastic housing diaphragm interface, fluid flow properties (laminar vs. turbulent), internal surface area, potential fluid dead space, inadequate flushing of the device due to poor visualization of the fluid flow pathway in opaque devices, and the presence of internal corrugations that could harbor organisms, particularly if the catheters are used to withdraw blood [199]. Some studies have shown that the increase in CRBSIs with the change to lueractivated devices may be related to improper cleaning and infection control practices such as infrequently changing the devices [192, 194]. Additionally, silver-coated connector valves have been FDA approved; however, there are no published randomized trials with this device and no recommendation can be made regarding its use. Likewise, an antiseptic-barrier cap for needleless connectors has been studied in a laboratory setting and appears to be effective in preventing the entry of microorganisms [360], but has not yet been studied in a clinical trial.

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Performance Improvement

Recommendation

Use hospital-specific or collaborative-based performance improvement initiatives in which multifaceted strategies are "bundled" together to improve compliance with evidence-based recommended practices [15, 69, 70, 201–205]. Category IB

Background

Clinical decision makers, healthcare payers, and patient safety advocates emphasize the importance of translating research findings into everyday practice. Rigorous evaluations of CRBSI preventive practices using study designs with high internal validity and including study populations that optimize external validity remain necessary. Once practices have been determined to be effective and economically efficient, the next step is to implement these evidence-based practices so they become part of routine clinical care. Unfortunately, implementation of evidence- based CRBSI preventive practices in U.S. hospitals has been suboptimal [361, 362]. In a national survey conducted in March 2005 of over 700 U.S. hospitals, approximately one quarter of U.S. hospitals indicated that either maximal sterile barrier precautions during central line insertion or chlorhexidine gluconate as site disinfectant, two practices widely recommended in the guidelines published in 2002 [363], were not being used routinely [364]. Approximately 15% of U.S. hospitals reported routinely changing CVCs to prevent infection despite evidence that this practice should no longer be used [362, 364].

Accordingly, investigators have attempted various approaches to better translate research findings and evidence-based recommendations into clinical practice. Numerous quality improvement studies have been published during the past several years that have used various methods, such as education of healthcare personnel, audit and feedback, organizational change, and clinical reminders [8–11, 69, 70, 202, 365–367]. The educational interventions primarily targeted hand hygiene, use of maximal sterile barriers during insertion, appropriate insertion site selection, proper site care using chlorhexidine gluconate, and prompt removal of unnecessary catheters. While a large number of before-and-after studies with a few using concurrent control groups [15, 70] have been published, no randomized, controlled trial evaluating a quality improvement strategy to prevent CRBSI has been reported [368]. The vast majority of before-and-after studies reported statistically significant decreases in CRBSI rates after a quality improvement strategy was implemented [368]. Additionally, both controlled trials also found statistically significant reductions of CRBSI in the intervention units compared with control units [15, 70].

Investigators have also employed multifaceted approaches in which several strategies are bundled together to improve compliance with evidence-based guidelines [15, 69, 70]. One such collaborative cohort study [69] of 108 ICUs in Michigan targeted clinicians’ use of five evidence-based practices: hand hygiene, maximum barrier precautions, chlorhexidine site disinfection, avoiding the femoral site, and promptly removing unnecessary central venous catheters. In addition to educating clinicians about CRBSI prevention, interventions used included: 1) a central venous catheter cart that contained all the necessary supplies; 2) a checklist to ensure adherence to proper practices; 3) stoppage of procedures in non-emergent situations, if evidence- based practices were not being followed; 4) prompt removal of unnecessary central catheters identified during daily patient rounds; 5) feedback to the clinical teams regarding the number of CRBSI episodes and overall rates; and 6) buy-in from the chief executive officers of the participating hospitals that chlorhexidine gluconate products/solutions would be stocked prior to study initiation. Using an interrupted time series analysis and multivariable regression, the investigators reported a statistically significant 66% decrease in CRBSI rates approximately 18 months after the intervention began [69] and sustained reductions over time [369]. Specific process and outcome measures for tracking and feedback (i.e rate of central line infections, proportion of central lines placed with all or individual bundle elements performed AND documented) should be identified in individual institutions based on areas that have been identified for performance improvement.

Finally, emphasis on the care and maintenance of catheters once they are in place should be a focus of performance improvement and quality assurance in all programs. A study to assess practice and staff knowledge of CVC post-insertion care and identify aspects of CVC care with potential for improvement revealed several areas of opportunity to improve post-insertion care [370]. Data were recorded on 151 CVCs in 106 patients giving a total of 721 catheter days. In all, 323 breaches in care were identified giving a failure rate of 44.8%, with significant differences between intensive care unit (ICU) and non-ICU wards. Dressings (not intact) and caps (incorrectly placed) were identified as the major lapses in CVC care with 158 and 156 breaches per 1000 catheter days, respectively. Interventions to improve reliability of care should focus on making the implementation of best practice easier to achieve.

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