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The Impact of IV Connectors on Clinical Practice and Patient Outcomes

T oday a huge goal in the clinical setting is to eliminate hos-pital-acquired infections (HAI). Catheter related blood stream infection (CR-BSI) is an expensive and deadly

HAI. Statistics show that 500,000 CR-BSI occur nationally which calculates to 1370 per day, 57 per hour or almost 1 per minute. (Crinch & Maki, 2005) This really is not surprising when you consider that IV therapy has become the primary route for therapeutic regimens in the acute care setting with 96% of admit-ted patients having some type of vascular access device (VAD). In acute long term care settings the rate is closer to 100%.

There are two phases when a CR-BSI may occur. The first is with catheter insertion and continues through the following 48-72 hours. The second phase is care and maintenance and lasts until the catheter is removed. It is worth noting that the care

and maintenance phase is the complete responsibility of the primary nurse and yet there is very little intravenous therapy education provided in nursing schools and very little research available to guide practice.

It has only been during the past decade that contamination of the intraluminal fluid pathway has gained recognition as a cause of CR-BSI. (Safdar & Maki, 2004; Garland, Alex, Sevallius, Murphy, Good, Volberding, 2008) Prior to then, the focus was predominantly on extraluminal insertion site protection with the nursing focus dressing management. Meticulous dressing management is critical to success but CR-BSI elimination is impossible without proper intraluminal protection.

The primary CR-BSI causative agent is biofilm formation. Biofilm formation depends on the number of cells, the pres-ence of surface conditioning and the flow rate of the solution. (Donlan & Costerton, 2002) Staph epidermis, and Staph aureus have surface cell receptors which assist in fibrin, fibrinogen location enabling the microorganisms to successfully adhere. (Raad, 1998; Murga, Miller, Donlan, 2001) Therefore, contam-ination prevention strategies must be two-pronged – to prevent active and passive microorganism migration into the intralumi-nal fluid pathway and to prevent microorganism adhesion by

The Impact of IV Connectors on Clinical Practice and Patient OutcomesDenise Macklin, BSN

AbstractIt has only been during the past decade that contamination of the intraluminal fluid pathway has gained recognition as

a cause of CR-BSI. The IV connector is the gate keeper of the intraluminal fluid pathway. The care and maintenance of catheters is the complete responsibility of the primary nurse. The primary CR-BSI causative agent is biofilm formation. Biofilm formation depends on the number of cells, the presence of surface conditioning and the flow rate of the solution. Staph epidermis, and Staph aureus have surface cell receptors which assist in fibrin, fibrinogen location enabling the microorganisms to successfully adhere. Therefore, intraluminal contamination prevention strategies must be two-pronged - to prevent active and passive microorganism migration into the intaluminal fluid pathway and to prevent microorganism adhesion by minimizing fibrin build-up on the internal surface. The two care and maintenance procedures nurses use to protect the intraluminal pathway are swabbing the connector septum and flushing the connector after use. Individual-izing the care based on the patient has not been studied. Since every patient is unique, different catheters and connectors are used, and even the nurse’s experience and knowledge are different, achieving consistent positive outcomes using a one-size-fits-all approach has shown to have inconsistent outcomes. An overview of swabbing and flushing is discussed and then how IV connector design affects these practice and outcomes is reviewed. It is imperative to recognize what pro-cedures are performed for improved patient outcomes, versus what procedures are performed to overcome IV connector design features. If flushing and swabbing procedures are standardized to general time requirements alone and connector design is overlooked, it should be understood that outcomes may vary and this variance may not be related to inconsistent nursing adherence to IV connector related swabbing and flushing procedures.

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minimizing fibrin build-up on the internal surface. The protector of the VAD intraluminal fluid pathway is the

IV connector. Clinical practice depends completely on swab-bing the connector and flushing the connector and catheter to provide intraluminal protection. Yet in the practice setting these essential nursing practices may not be performed con-sistently. Patient diagnosis and co-morbidities affect both the response to infection and clotting cascade function. However, much of swabbing and flushing practice today is based on time alone; flush q8h, qshift, swab 5 sec, 15 sec, 30 sec, change con-nector q96h, q7d, or after blood draw. Individualizing the care based on the patient has not been studied. Since every patient is unique, different catheters and connectors are used, and even the nurse’s experience and knowledge are different, achieving consistent positive outcomes using a one-size-fits-all approach has shown to have inconsistent outcomes

There is a desire for evidence to use for clinical practice deci-sions. The rule of thumb is to use valid, up-to-date and available data. This can mean anything from community norm, in-vitro studies, case studies, case series to double blind randomized prospective controlled trials and meta analyses. Much of cur-rent IV practice lacks any formal scientific study and rigor. A common nursing weakness may be looking for evidence that supports what is being done instead of being open to changing practice as new information comes available. Another issue is the idea that some studies, such as in-vitro or case study are not credible research. While the strongest research is double blind randomized controlled study, it is not always available. These are expensive and often due to numerous issues difficult to de-sign. Therefore, when looking for evidence, it is important to review all studies available and then look at the study’s design, methods, ethics, statistical power, limitations and clinical ap-plicability not just the conclusion. All studies have limitations and should be stated in the manuscript, poster or oral presenta-tion. When looking at published guidelines, it is important to look at what data was used to formulate a particular guideline. Sometimes only one poorly designed published study with a small sample is referenced as a rationale for change in prac-tice. As new information becomes available, practitioners and administrators must be open to changing practice, have an ef-fective and efficient process to evaluate evidence, and evaluate any change that is made. It is especially important to communi-cate by poster, presentation and publication successful practice changes, so that over time there will be valid science on which to build IV practice.

Data reported over the past six years has suggested that con-nector design may be contributing to CR-BSI development. (Salgado, Chinnes, Paczesny, Cantey, 2007:Field, McFarlane, Cheng, Hughes, Jacobs, et.al. 2007: Jarvis, Murphy, Hall, Fogle, Karchmer, Harrington, et.al. 2009) Because swabbing and flushing practices are so critical and more than twenty IV connectors currently in clinical use in the U.S. market with new ones continuing to enter the market, it is important to un-derstand how IV connector septum design, activation design, and the fluid pathway design influence swabbing and flushing practices. This article will examine how IV connector design affects practice and outcomes.

IV Connector OverviewBy way of introduction, it is helpful to review some basics

(Figure 1a)• All IV connectors consist of a septum, a fluid pathway,

and a mechanism for activation and for returning the sep-tum to its original position with disconnection.

• The activation system determines septum/housing integrity and potential for fluid displacement.

• Priming volume is the amount of fluid needed to completely fill or “prime” the IV connector’s fluid pathway. There is a 10 fold difference in internal pathway volumes. (Maki, 2010)

• Dead space is understood as the residual fluid volume that is outside the main fluid pathway represented by pockets, cavi-ties or spaces that can not be effectively flushed. Dead space is a phenomenon of the law of physics that fluid follows the path of least resistance. With withdrawal the dead spaces are filled but then with flushing the dead space is bypassed.

• Interstitial space is space inside the connector, not part of the fluid pathway, that should never be filled, partially or fully, with fluid. Think of a building, the interstitial space is the leftover gaps between building walls. It is neither inside any room nor outside the building

• Categories of IV connectors based on purpose: Needle-free (NF) and Intraluminal Protection (IP).

NF IV connectors entered the market place between 1991 and 2002 in response to rising concern about accidental needle sticks. The purpose of these products is to provide safety for the healthcare worker by eliminating accidental needle stick injuries while still providing a simple connection similar to needles. Within the NF category there are two types of IV con-nectors based on when reflux occurs. First there are IV connec-tors that have blood reflux with disconnection known as Nega-tive Displacement. Included in this category are Clave®, (ICU Medical, San Clemente, CA) ClearLink®, (Baxter Healthcare Corp., Deerfield, IL), FloStar® (IntraVascular, Waukegan, IL), InterLink®, (Becton Dickinson, Sandy, UT), LifeShield® (Ab-bott Laboratories, Abbott Park, IL), MicroClave® (ICU Medi-cal), Q-Syte™ (Becton Dickinson), SafeLine® (B. Braun Med-ical Inc., Bethlehem, PA), SmartSite® (Carefusion, San Diego, CA), V-Link® (Baxter Healthcare).

Within this group different activation methods are used. The first is the non-universal split-septum (SS) design marketed in the early 1990s by Hospira Lifeshield® and Becton Dickinson Interlink®. These needleless IV connectors require additional components and adapters to access the IV connector. (Figure 1) The SS design has a pre-slit septum that permits activation via a disposable cannula. A variation of the pre-slit septum design

Figure 1. SS Connector Cutaway

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is offered by Becton Dickinson’s Q-Syte™ in which the inser-tion of a slip tip syringe or male luer permits activation. With the SS system the activator pushes the sides of the split septum down and inward and into the fluid pathway. The entire inside of these IV connectors is the fluid pathway. Priming volume is large (smaller for Q-Syte™ than Interlink®). Dead space con-sists of all the area above the disposable cannula or the syringe/IV set slip tip as well as any other areas outside the direct fluid path. Blood reflux (Fluid displacement) with disconnection is a function of the total volume profile of the disposable cannula or syringe slip tip within the fluid pathway. Upon disconnec-tion the reflux volume equals the cannula/slip tip displacement volume. Due to the syringe or IV administration set slip tip size in relation to connector internal volume, the blood reflux asso-ciated with disconnection is greater with the smaller Q-Syte™ than InterLink®.

The second NF group has a septum that is accessed direct-ly by a syringe slip tip or an IV set male-luer slip tip. These are often referred to as needleless mechanical valves (NMV). Included in this group are Clave®, ClearLink®, MicroClave®, SmartSite®, and V-Link™. They are activated when the slip tip compresses the septum allowing the slip tip to enter the fluid pathway. These connector designs have gaps around the sep-tum with different septum surface designs and septum materi-als, moving parts within the fluid pathway, differing priming volumes, and dead space volumes. With connection the slip tip moves the IV connector valve system approximately 0.280 inches. With disconnection, the connector fluid pathway de-sign snaps the septum back and results in the negative fluid displacement volume. ICU Medical’s Clave® and MicroClave® use a reverse split-septum design. With this design an internal cannula moves outward through the septum into the slip tip with connection. The Clave® and MicroClave® (claiming to be neutral but with larger reflux than Clave®) exhibit a smaller negative fluid displacement than other negative reflux connec-tors. (Figure 2) The volume is lower because they have only a small dead space pocket above the internal fluid cannula, virtu-ally a straight-through pathway, and no moving parts within the fluid pathway. All NF connectors have a single o-ring, seal or single barrier for fluid pathway protection.

During the 1990s intraluminal thrombotic catheter occlu-sion rates rose secondary to the early generation SS and NMV connector designs due to the blood reflux upon disconnec-tion. To combat thrombotic occlusion the third type of needle-less IV connector designs; first identified as positive-pressure they are now referred to as a positive-pressure mechanical valve (PPMV) and entered the market place in the late 1990s.

These include: CLC 2000® (ICUMedical), Flowlink® (Baxter Healthcare), MaxPlus® (Maximus, Ontario, Canada) Posiflow® (Becton Dickinson), SmartSite Plus® (Carefusion) UltraSite® (B.Braun Medical Inc.). PPMV include a new feature that was designed to minimize occlusion. It was believed that by moving the reflux episode to connection and providing a final push with disconnection that the blood would clear from the catheter tip and eliminate catheter-related occlusions. Like other NF con-nectors, the intraluminal fluid pathway is protected by some type of single barrier. Because for every action there must be an opposite but equal reaction, inside PPMV connectors is a mechanism that compresses forming a negative pressure with activation (reflux occurs) and then decompresses and returns to its original shape (causing a final push) with disconnection. The required internal pressure producing mechanism results in a pathway design that is more tortuous and has increased dead space volume. (Figure 3) Since reflux was not eliminated, fi-brin build-up in these dead spaces continued. PPMV have been reported to be associated with increased CR-BSI. (Maragakis, Bradley, Song, Beers, Miller, Cosgrove, 2006; Rupp, Sholtz, Jourdan, Marion, Tyner, Fey, 2007: Jarvis 2009)

The newest generation of IV connector the Intraluminal Protection (IP) category entered the market place in May 2004. The IP purpose is patient safety by providing intraluminal fluid pathway protection with the goal of both reduced CR-BSI and occlusion incidence. This category includes InVision-Plus® with Neutral Advantage® technology (RyMed technologies, Franklin TN). The IP category concentrates on design features that will minimize bacterial migration into the fluid pathway, will minimize fibrin adhesion, and will support clinical swab-bing and flushing procedures.

In comparison to NF connectors, the IP design eliminates dead space by the incorporation of a double microbial barrier. The double microbial barrier’s inner component consists of a silicone boot valve that encompasses the fluid spike. Dur-ing assembly, the hydrophobic polyisoprene septum, acting as

Figure 2. NMV Connector Cutaway

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Figure 3. PPMV Connector Cutaway

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the second outer microbial barrier component, is situated on top of the boot valve. These two components are under a full compression state inside the housing against the fluid spike so that the dead space is effectively “squeezed” from the area surrounding the tip of the fluid spike providing a measure of “active compression” when in the closed or passive state. The compressed nature of the double microbial barrier on the flu-id spike accounts for the signature tight septum seal integrity when not connected to an administration device and signature connection during activation. The smooth outer septum made of a hydrophobic material, now tightly sealed within the hous-ing body, allows for effective surface disinfection swabbing. The fluid pathway is straight, with no dead space, and has a low 0.027 mL priming volume. With the absence of dead space there is zero reflux with connection or disconnection. The dou-ble barrier system provides fail safe protection to the intralumi-nal fluid pathway when not activated.

Septum Disinfection Septum disinfection is the front line action to prevent micro-

bial migration into the fluid pathway. Joint Commission Patient Safety Guidelines require specific focus on septum disinfection. The CDC recommends cleaning with 70% alcohol, chlorhexi-dine (CHG), providone iodine, or an iodophor prior to each access. Alcohol biocide activity occurs while wet. It dehydrates the cell surface causing cell destruction. Products combining chlorhexidine and alcohol require drying for biocide activity. CHG must enter the cell and disrupt the cell contents to cause cell death. Since all CHG products contain alcohol, it is dif-ficult to determine which antiseptic is the primary disinfecting agent. In addition, the binding of CHG to protein which results in persistence when applied to skin does not occur when CHG is applied to inanimate objects.

The IV connector must be swabbed before each access. This results in three separate swabbing procedures with each IV push medication or blood draw. It is not uncommon for nurses to repeatedly enter a patient’s IV connector throughout a shift. While it is understood that friction is required, exactly what is the best way to swab has not been studied. Length of time is the only factor that has been slightly studied. Lengthy 15-30 second swabbing procedures (singing Happy Birthday once or twice) may be difficult to achieve consistently at the bedside in the rapid-paced acute care setting and may not be successful. The only published swabbing study uses 15 seconds but does not

use any other time increment but did find that at this time frame both alcohol and alcohol/CHG disinfectants were effective.

Connector Design and SwabbingWhen not in use IV connector surfaces are easily contami-

nated. It logically follows that if these devices are not properly disinfected prior to access with a blunt cannula (SS), syringe/ IV male-luer slip tip (NMV, PPMV) the tip will effectively “push” surface bacteria into the fluid pathway. Research has confirmed that complete disinfection of some IV connectors septum’s surfaces is difficult and in fact may not be achievable at high rates in the clinical setting (Menyhay & Maki 2006; Arduino, Bland, Danzig, McAllister, Aquero, 1997). This un-derscores the need for the connector to have design features that will support swabbing practices. These features focus on septum material and septum smoothness and seal integrity. The septum should be made of hydrophobic material and be smooth without irregularities to prevent bacteria from sticking. The septum seal should be tight when not activated.

With the NF compression system, gaps around the septum can be seen with the naked eye. Gaps around the septum or surface irregularities provide areas for micro-organisms to re-side and which can not be effectively cleaned with swabbing. For example the Clave®/MicroClave® outer septum seal is pas-sive, loose-fitting, and not tightly closed. (Figure 4) The pre-piercing of the septum, as well as a circular gap around the septum silicone seal are evident upon visual inspection. The Ultrasite’s® surface is irregular. (Figure 5) Applying a ”bugglo” solution to symbolize micro-organisms and shining a fluores-cent light on the septum can increase visibility of these areas. Since silicone is not a smooth surface, a silicone septum will glow the brightest. (Figure 6) The fluorescent light shows that swabbing may not eradicate bacteria located in gaps and sur-face irregularities. (Figure 7) The most telling demonstration is seen after swabbing and followed by syringe connection/dis-connection. The fluorescent light will show color all along the syringe slip tip demonstrating how bacteria is pushed into the system. (Figure 8)

Single study outcomes that have not been replicated with different products should be considered product specific and generalizing to all products may not achieve the same results. For example: Seymour (2000) and Bouza (2003) showed the ability of the Clave® to become contaminated and remain con-taminated both inside and outside of the fluid pathway after

Figure 4 Loose-Fitting Septum

Figure 5 Irregular-Septum Surface

Figure 6 Before Swab

Figure 7 After 3-Second Alcohol Swab

Figure 8 After Connection

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disinfection. Sixty-seven percent of MicroClave®, Clearlink® and PosiFlow™ tested showed microbial transmission across the membrane even with aggressive surface disinfection (Me-nyhay, 2006). These studies used specific connectors and show that with these connectors even with extended swabbing may not yield successful disinfection. However, these studies did not study all connectors and findings should not be generalized. The MaxPlus® connector for example includes a unique smooth, tight fitting septum design to enhance swabbing efforts. The manufacture recommendations include a 3 second swab.

In contrast to NF connectors, the IP connector design in-cludes a smooth hydrophobic septum that is under pressure. (Figure 9) These features support successful swabbing actions. (Figure 10,11,12) It has been shown in independent labora-tory testing that by swabbing the InVision-Plus® IV connector septum with only three clockwise/counterclockwise rotations using 70% isopropyl alcohol, up to 99.99% of septum bacte-ria were eliminated (Nelson Laboratories, 2007). Cleaning the InVision-Plus® with alcohol using a motion like “juicing an orange” is included in a catheter care and maintenance bundle reported to result in zero CR-BSI. (Harnage, 2007). In an in-vi-tro connector comparison study used a technique driven down-ward thumb pressure and a three rotation swab procedure on MaxPlus Clear®, Q-Syte™, MicroClave®, Lifeshield™TKO™ Clave®, and InVision- Plus® Neutral with Advantage™ inocu-lated septums with five clinically common organisms (105) in a clinical replicating scenario (swab, withdraw blood for patency, swab, flush with saline) repeated every 6 hours over four days, showed the connector with the least intraluminal CFU counts > 15, (a CFU count known to cause bloodstream infections) was the InVision-Plus® (0.00 – 0.10) with the others MaxPlus®

Clear 0.10-0.25, TKO™Clave® 0.25-1.70, MicroClave® 0.00-1.90 and Q-Syte™ 2.10-9.70. (Figure 13)

Careful review of swabbing studies is paramount. The swab-bing procedure should be supported by IV connector design rather than the IV connector design requiring nurses to perform labor-intensive practices that may not achieve septum antisep-sis. It has become widely accepted that nurses are simply not swabbing or not swabbing long enough. A negative clinical out-come should not automatically be blamed on the nurse. When faced with time constraints, these long swabbing times may not be adhered to. Minimally, understanding septum design should drive swabbing time. Consideration should be given to connec-tors that have in-vitro studies with well designed methodolo-gies that show successful swabbing practice and outcome. To assure septum disinfection and consistent compliance, septum design should allow for short swabbing time to achieve surface disinfection. Long complicated swabbing procedures make consistent practice in the clinical environment difficult. Addi-tional research is needed to understand surface disinfection in clinical practice.

FlushingWhile flushing is primary to CR-BSI reduction activity, little

is understood about how and when it should be done. When oc-clusion occurs, the default position is that the nurse has not been flushing. But with flushing as with swabbing, the patient, the practice and the connector impact success. Fibrin build-up on the catheter wall can result in occlusion and CR-BSI. Research shows occlusion occurs in 3-36% of patients (Ociepa, Malo-ney, Urasinski, Sawicki, 2010; Bucki, Tomaszewska, Karpe, Stoksik, Sonta-Jakimczyk, Szczepanski, 2008; Dal, Guerretta, Mazzufero, Rasero, 2009; Dillon, Jones, Bagnall-Reeb, Buck-ley, Wiener, Haase, 2004; Kuhle, Koloshuk, Marzinotto, Bau-man, Massicotte, Andrew et.al., 2003). Fibrin deposition on the intraluminal surfaces of the IV connector fluid pathway and catheter increases the risk of coagulase-negative staphylococci infection (Van Rooden, Schippers, Guiot, Barge, Hovens, van-derMeer, et.al. 2008). Thrombosis has been shown to enhance the risk of infection (Jacobs 2003).

To address these risks, flushing is the only practice available for cleaning fibrin and residual medications from the intralu-minal fluid pathway. Syringe size for flushing was increased to 10 mL in the 1990s to lessen potential silicone catheter damage associated with flushing. The push-pause flushing method was also introduced. It was hypothesized that this method would en-

Figure 9 Tight-Fitting Smooth Septum

Figure 10 Before Swab

Figure 11 After Swabbing

Figure 12 After Connection

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hance fluid turbulence and the “scrubbing” action of the flush. No research is available to support this practice. It is known, however, that turbulent flow enhances bacterial adhesion and that a steady flush minimizes this adhesion (Donlan 2002).

Final heparin flush with CVCs is still used in some institutions with VADs. However, heparin is associated with a serious complication - hepa-rin induced thrombocytopenia (HIT). Numer-ous medications are incompatible with heparin and must be completely flushed before Heparin is instilled. (Table 1) Heparin is also a protein and when used as a final locking flush is a food source for intraluminal biofilms. The decision on when to flush a catheter that is not being ac-cessed for medication administration or blood sampling is based on time - qshift, q12h, q8h, once a day etc.

No research exists that focuses flushing on pa-tient need yet many patients are at high risk for occlusion. (table 2) For instance, it is understood that catheter reflux can occur with negative intra-thoracic pressure. Tracheostomy suctioning, and ventilators are associated with increased negative intrathoracic pressure. Improved outcomes may occur if VADs are routinely flushed after suction-ing. Ventilator patients may need more frequent flushing. Another complication is in trauma pa-tients who are in a hypercoagulation state. Yet flushing routines for these patients are the same as for an oncology patient admitted for low platelet counts (unable to form a clot). Occlusion rates are often not formally monitored. Capture of this data when it does occur is often related to the usage of alteplase (Cathflo, Genentech, San Francisco, CA). This tracking mechanism only documents total occlusion and even then does not track any patient-related data.

Table 1 Diagnoses Associated with High Risk for Occlusion

Acute Spinal Cord Injury Advanced Age Major Trauma Gynecologic MalignanciesBrain Tumor Lung CancerBone Marrow Transplant Sickle Cell Anemia Acute Pancreatitis Engorgement of the Upper Trunk Vessels Resulting From Compression of theRenal Failure SVC by an Extrinsic Mass Diabetes Catheter Tip Location in Subclavian Vein Malposition of the Catheter SurgeryDehydration Chronic Obstructive Pulmonary Disease High Platelet Levels Catheters Placed via the Left Subclavian VeinHistory of Deep Vein ThrombosisOral Contraceptive UsePregnancySmoking

Table 2 Drugs Physically Incompatible with Heparin

Alteplase (Activase)AmikacinAmiodarone (Cordarone)Amphotericin BAmpicillin SodiumAmsacrineAtracurium BesylateAtropinen SulphateCephalothin SodiumChlorpromazineCimetidine (concentrated based)Ciprofloxacin (Cipro)ClarithromycinDacarbazine (DTIC)Daunorubicin HCLDiazepam (Valium)DiltiazemDobutamine HCLDoxorubicin (Adriamycin)DoxycyclineDroperidol (Inapsin)ErgotamineErythromycin FilgrastimFlecainideGatifloxacinGentamicinHaloperidol (Haldol)HyaluronidaseHydrocortisone (concentration

based)Hydromorphone

Idarubicin (Idamycin)Isosorbide DinitrateKanamycinLabetalolLevofloxacinLevorphanolMeperidine HCLMethotrimeprazine (Levoprome)MexilitineMidazolamMitoxantrone HCLMorphineNetilmicinPenicillin G (concentration based)PentazocinePhenytoin (Dilantin)Polymyxin BPromazine HCLPromethazinePropafenoneQuinidine GluconateStreptomycin SulphateTeniposideTobramycin (Nebcin)TramadolTriflupromazineTrifupromazine (Vesprin)VancomycinVinblastineWarfarin (concentration based)

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Another practice commonly identified as “flush bags” is be-ing used in some clinical settings. This practice is a variation of the primary/secondary infusion system. The change is the flush bag rate of infusion. In the original setup, the primary fluid infused at 75 mL to 125 mL or more continuously and the secondary medications were infused periodically. With the flush bag scenario, there is no continuous fluid prescribed, so a keep-vein-open (KVO) is hung as the primary infusion. The KVO rates may be as low as 10 mL/hr in the adult population. Over time such low rates, combined with physiologic reflux episodes associated with elevated blood pressure, pain, and anxiety can result in partially/totally occluded catheters. This is especially problematic when combined with a patient in a hypercoagulation state.

Flushing and Connector DesignHow does the evidence on flushing bear upon connector de-

sign? With the recent insights about bacteria’s affinity for fibrin, it is now understood that repeated connector wall coating sec-ondary to blood sampling, blood withdrawal for patency, as well as, blood reflux episodes associated with connection/disconnec-tion provide the surface conditioning necessary for bacterial ad-hesion which is a requirement for biofilm colonization.

Connector dead space is filled the first time blood is with-drawn to check for patency and proper vein placement. The more tortuous the fluid pathway, the greater the dead space the more fibrin build-up can occur. A study including a large sampling of IV connectors by Bacterin International, Inc.,Belgrade, MT (Cook, Meyer, Luchsinger, 2007) was performed by dripping a staph epidermis 105 solution through 12 different IV connectors. The study then examined each IV connector fluid pathway at 24, 48 and 72 hours for biofilm development. The study conclusion was that the larger the priming volume or dead space within the IV connector fluid pathway, the more biofilm was present. In addition the study noted that biofilm was present as early as 24 hours. The IP connector, which had the smallest priming volume and no dead space, was 93.0% - 99.9% more effective

in reducing biofilm formation than all the other needle-free IV connector systems tested. (Figure 14) Edminston also inoculates connector intraluminal fluid pathway and reports that increased intraluminal fluid pathway volume corresponds to higher organ-ism growth rates. (Edminston & Markina 2010)

The SHEA/ISDA compendium, published October 2008, recommends approaches to avoid as a routine part of CR-BSI prevention. These recommendations include; Do not routinely use PPMV before completing a thorough assessment of risks, benefits, and education regarding proper use. and the guide-lines recommend against routine use of currently marketed devices that are associated with an increased risk of CR-BSI (Marschall, Mermel, Classen, Arias, Podgorny, Anderson, et.al. 2008). These guidelines should assist in helping to reduce CR-BSI and intaluminal thrombic occlusions.

Another factor to consider is whether there is any advantage to having a clear connector housing. The clear housing is a de-sign feature that is supposed to show flushing success. Howev-er, this feature is only for gross contamination. The naked eye cannot see microscopic fibrin or bacterial residual. The pres-ence of biofilm is determined by electron microscopy. A clear housing may offer a false sense of security that the connector is clean. Remember, often our hands look clean but are they? An in-vitro study performed on the InVision-Plus® reported successful fluid pathway cleaning 99.96% little as 1.0 mL of normal saline and 100% with as little as 4 mL of microscopic hemoglobin residual. (Nelson Laboratories, 2009)

Efforts to overcome blood reflux (negative fluid displace-ment) associated with IV connectors have fallen on the nurse in the form of clamping sequence procedures. With SS and NMV designs, it is necessary to apply pressure to the syringe plunger, close the clamp and then disconnect. With access the syringe must first be attached, pressure applied to the syringe plunger and then the clamp opened. If this procedure is not followed and the clamp is opened first, the blood reflux prevented at dis-connection will now occur. When PPMV became available, the clamping sequence was reversed. To allow for the final outward push, the syringe must be disconnected first and then the clamp closed. This is the opposite from the SS and NMV disconnection procedure. (Figure 15) On IV administration set y-site injection ports clamping is not available so reflux can not be prevented. Since many settings have both types of IV connectors within the same facility, it is now necessary for nurses to be able to visu-ally identify SS, NMV and PPMV in order to provide the cor-rect disconnection sequence. One study showed that 100% of nurses sampled did not know the type of IV connector they were using nor that there were different disconnection requirements (Chernecky, Casalla, Jarvis, Macklin, Rosenkoetter, 2009). The IP design does not require a clamping sequence, simplifying nursing practices and can be flushed with saline only.

ConclusionWhen developing a catheter care and maintenance bundle

with the goal of reducing complications, it is important to understand the new CR-BSI landscape. It requires intralu-minal protection as well as extraluminal site management. IV connector design affects outcome (Jarvis 2009, Maki 2010).

Figure 14 Growth of S. Epidermidis after 48 Hours

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Early generation designed SS, NMV, PPMV connectors while providing healthcare workers protection by minimizing acci-dental needle stick injury require additional nursing effort to achieve outcome success. These designs may also require ad-ditional add-on products to improve success. The new IP ap-proach, in comparison, provides design features that focus on reduction of patient complications and success of clinical prac-tice. It is most important to recognize that the full burden of positive outcomes is not totally dependent on nursing practice. Even with pristine practice, with some IV connector designs it may be impossible to achieve consistent positive outcomes.

It is imperative to recognize what procedures are performed for improved patient outcomes, versus what procedures are performed to overcome IV connector design features. It is es-sential to identify the IV connectors used in a specific clinical setting and develop a protocol that is IV connector appropri-ate. Less confusion and better compliance can occur when a single IV connector is used for all catheters both peripheral and central. (Jarvis 2009) Specific connector designs features have been shown to facilitate swabbing and flushing and improve outcomes. They include:• Smooth, tight fitting septum • Low intraluminal fluid pathway volume• Straight fluid pathway

• No dead space• No reflux with connection or disconnection • Fail-safe back-up systems as suggested by leading infection

control experts To ensure consistent outcomes, flushing and swabbing pro-

cedures should also be clinically studied so that they can be in-dividualized to the patient’s specific condition. If procedures are standardized to general time requirements and connector design is overlooked, it should be understood that outcomes may vary and this variance may not be related to inconsistent nursing adherence to IV connector related swabbing and flushing procedures.

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Figure 15 NF & IP Connector Maintenance IV/Vascular Access

Negative Positive Zero Fluid Pressure (NF) Pressure(NF) Displacement(IP)

Bionector® CLC2000® InVision-Plus® Clave® Flowlink® with Neutral ClearLink® MaxPlus™ Advantage™ FloStar™ Posiflow™ Technology InterLink® SmartSite Plus® LifeShield® UltraSite® MicroClave® Q-Syte™ SafeLine® SmartSite® V-Link®

Disconnect Disconnect Disconnect Care: Care: Care:

Flush Flush Flush

Keep pressure Remove syringe Clamping on syringe, from injection sequence not Close the Clamp port required

Remove syringe Clamp Clamp when from injection not in use port for patient safety

Authors: C. Chernecky PhD, RN, AOCN, FAAN (Medical College of Georgia)

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