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Needleless Connector Devices a

Needleless Connector Devices a

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Article
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Within the past 20 years there has been an explosion of devices designed to allow connection of multiple intravenous sets and catheter hubs without the use of needles. Currently, the number of devices, their internal and external designs, and their functions can be quite confusing. There is a lack of clear definitions and terminology universally ac...

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... connectors can be categorized by the com- plexity of their internal mechanisms and by how they function (Table 1). ...

Citations

... Failure to adequately engage the Luer lock system in these connectors has been reported to prevent connector activation and fluid flow. [1][2][3][4] An NC is a device that allows for safe needleless connection to VADs while reducing the risks of extraluminal infection, air embolism with centrally inserted devices, and needlestick injuries among health care workers. 1,2,5,6 These devices come in numerous designs, which include positive, negative, and neutral fluid displacement abilities, using mechanical or pressure-sensitive valves. ...
... [1][2][3][4] An NC is a device that allows for safe needleless connection to VADs while reducing the risks of extraluminal infection, air embolism with centrally inserted devices, and needlestick injuries among health care workers. 1,2,5,6 These devices come in numerous designs, which include positive, negative, and neutral fluid displacement abilities, using mechanical or pressure-sensitive valves. 7 Advances in NC design have reduced a number of undesirable design features, such as dead space, interstitial spaces, opaque housings, significant reflux volumes, priming volumes, and fluid displacement. ...
... 7 Advances in NC design have reduced a number of undesirable design features, such as dead space, interstitial spaces, opaque housings, significant reflux volumes, priming volumes, and fluid displacement. 1,2,5,6 The potential for bacterial colonization of NCs and subsequent associated catheter-related infection has also been a major concern. 8 Clinical standards for the use of NCs in infusion therapy have recently been published. ...
Article
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Needleless connectors are used widely across all types of vascular access devices and provide safe, needleless administration of intravenous fluids and medications. An analysis of patients from an outpatient parenteral antimicrobial therapy program is presented in which elastomeric pumps had failed to flow due to incomplete tightening of Luer lock needleless connections. An alert was issued to community nursing staff responsible for daily elastomeric pump changes to ensure that needleless connectors were properly checked for full tightening. The frequency of failure of flow events before and after the alert was reviewed. Force and torque profiles required to activate the internal mechanism of connectors were measured in the 4 most frequently used needleless connectors in the outpatient parenteral antimicrobial therapy program. The degree of torque and force required to activate the different needleless connectors varied and was identified as a factor contributing to inadequate connection with the elastomeric pump and consequent failure of flow. Repeated feedback to nursing staff over the study period about the force and torque required for needleless connector flow activation resulted in a highly significant decrease in the rate of failure of flow events per elastomeric pump from a rate of 0.0147 events per elastomeric pump per year in the last 3 months of 2018 to 0.0003 in the first 6 months of 2020 (difference = 0.0144 [CI, 0.0097–0.02]; P < .0001).
... 20,22 In particular, the pressure-activated anti-reflux NFC, which is one of the latest generation NCFs, can improve patient safety and prevent blood reflux and subsequent intraluminal catheter occlusion. [23][24][25][26] The device incorporates a patented bidirectional silicone valve to help prevent backflow of blood by physically absorbing and compensating for pressure changes that usually cause blood to flow back into the catheter lumen. ...
Article
Objectives To evaluate the effectiveness of needle-free connectors to maintain Central Venous Catheter—CVC patency. Background Loss of patency is a common complication associated with CVC. For patients, this can be stressful and painful, and can result in a delay in infusion therapy. Pressure-activated anti-reflux needle-free connectors are one of the most modern devices; however, no studies have compared this connector with the open-system three-way stopcock in terms of the incidence of CVC occlusion. Methods This study is a prospective before and after intervention study. From March to August 2018, an observation phase was conducted with the three-way stopcock as the standard central venous catheter hub and closure system (phase 1). After implementation of needle-free connectors (phase 2), post-intervention observations were made from September 2019 to January 2020 (phase 3). Results Of 199 CVCs analyzed, 41.2% (40/97) occluded in at least one lumen in the first phase, and 13.7% (14/102) occluded after introducing the technological device, absolute risk reduction 27.5% (95% confidence interval 15.6%–39.4%). The lumens supported by needle-free connectors showed a higher probability of maintaining patency compared with three-way stopcocks. No differences were observed in the rate of infection. Conclusions Pressure-activated anti-reflux needle-free connectors are effective and safe devices suitable for the management of vascular access in cardiac patient care. Staff training, even on apparently simple devices, is essential to avoid the risk of infection.
... Categories have been created for marketing purposes such as negative, positive, neutral, and antireflux to categorize each NC. 2,3 The question remains how much reflux is acceptable for NCs labeled for each category. The labels do not always seem to match the NC performance (Table 1) nor the current definitions (Table 2), yet no agency or governing body has created quantitative guidelines to categorize or classify NCs. ...
... The labels do not always seem to match the NC performance (Table 1) nor the current definitions (Table 2), yet no agency or governing body has created quantitative guidelines to categorize or classify NCs. 2,4 Favorable traits identified in NCs are those that have no blood reflux and have no clamping sequence. [5][6][7][8] The optimal design of a NC remains unclear and unresolved. ...
... Understanding the appropriate connect-disconnect-clamping sequence is essential to using the device effectively. 2,6 Purpose ...
Article
Background: Manufacturers designed needleless connectors (NCs) to reduce needlestick injuries and exposures to bloodborne pathogens. All NCs displace fluid, and most do not control fluid movement through the device. The observed bidirectional fluid movement and reflux may not be consistent with how the manufacturer of the device describes NC. Reflux may lead to a significant patient safety risk as it relates to intraluminal thrombotic occlusion and infection. Methods: The in vitro observational study 1 (OS1) systematically tested bidirectional flow control; the ability prevented retrograde fluid from flowing into the infusion system. Researchers tested 13 commonly used NCs. The observational study 2 (OS2) measured the amount of displaced fluid in each NC paired grouping during connection and disconnection of a Luer locking device. Results: OS1: Eleven NCs failed bidirectional flow control, and 2 passed bidirectional flow control. OS2: All 13 NCs had varying amounts of fluid displacement or reflux. The measured volume of reflux for NCs during disconnection was 0.17 μL to 114.65 μL. The measured volume of reflux for NCs during connection was 11.73 μL to 34.43 μL. Conclusion: NC labeling does not appear to correspond with manufacturer claims. Neutral displacement does not appear to be present in the NCs used in this observational study. To properly instruct health care professionals about using the various NCs available, it is imperative to know the accurate bidirectional control, reflux cycle, and volume of reflux beyond the manufacturer's performance claims. Precise information may assist the clinician in reducing intraluminal blood exposure of vascular access devices.
... The male Luer tip completely covers the opening and thus prevents any fluid extravasations into the interstitial space. [9,10] The current evidence supports the preferential use of split septum connectors over mechanical valves in critical care setting. However, to substantiate these facts, large prospective randomized clinical trials were necessary to effectively support the merits of needleless connectors. ...
... [11] Observations of another study revealed that infection rates had come down remarkably as nurses gained experience and also overcame the challenges of using the closed access system, i.e., needleless system. [9] We adopted a similar approach for proper implementation of the study design and components as well as to rule out any bias. Therefore, before the beginning of the study, all staff nurses working in the ICU were trained regarding the precise care of central line and prevention of Central line-Associated Bloodstream Infections (CLABIs). ...
Abstract Background: Use of Central Venous Catheters (CVC) can be associated with increased incidence of Catheter‑Related Bloodstream Infections (CRBSIs). The present study assessed the impact of open versus closed catheter access system of CVC on infection prevention in critically sick patients admitted in the Intensive Care Unit (ICU). Materials and Methods: After obtaining ethical clearance and consent of relatives of the patients admitted in ICU of our institute, the present study was carried out as a randomized, prospective, double‑blind trial with parallel group design (of 200 patients in each group). In study group (Group I), closed catheter access system (Luer access split septum) was used, while open access (three‑way) system was used in the control group. Among clinical parameters, if any patient developed fever, his/her blood, urine, and tracheal secretions were sent for culture and sensitivity. Collected data were analyzed using descriptive and inferential statistics. Results: Demographic profile was similar in both the groups. Significant clinical and statistical differences were observed in blood culture values (χ2 = 58.30, df = 1, p < 0.001) as well as Total Leukocyte Counts (TLC) on day 1, 4, and 8 (F2,260 = 80.61, p < 0.001). However, no statistically significant (t390 = 0.90, p = 0.367) difference was found in the duration of hospital stay among patients in both the groups despite significant differences in various clinical parameter. Conclusion: Luer access split septum connectors along with appropriate training of the nursing personals decrease CRBSI. Keywords: Bacteremia, catheter‑related infections, central venous catheters, intensive care units
... A multitude of NFCs are available commercially but most share common design features relating to the access port. In almost all cases, access to the catheter is activated through the insertion of a male Luer connector (from a fluid giving set or syringe) which causes the deformation of a silicone septum and therein provides access to the catheter line [25][26][27]. Three of the more common approaches are highlighted in Figure 2. ...
... Removing blood from the NFC is a critical concern and there has been an increasing shift from opaque NFC structures to more transparent polymers that can enable visual inspection of the internal working of the hub. The movement of blood within the catheter and its propensity to travel (reflux) to the needle free hub upon the insertion and disconnection of the external Luer is however dependent on the design of the NFC hub [25,26]. A variety of engineering features have been implemented in recent years as a means of improving the performance of such devices in terms of haemocompatibility and in reducing the potential for CRBSI. ...
... Removing blood from the NFC is a critical concern and there has been an increasing shift from opaque NFC structures to more transparent polymers that can enable visual inspection of the internal working of the hub. The movement of blood within the catheter and its propensity to travel (reflux) to the needle free hub upon the insertion and disconnection of the external Luer is however dependent on the design of the NFC hub [25,26]. ...
Article
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Catheter related blood stream infection is an ever present hazard for those patients requiring venous access and particularly for those requiring long term medication. The implementation of more rigorous care bundles and greater adherence to aseptic techniques have yielded substantial reductions in infection rates but the latter is still far from acceptable and continues to place a heavy burden on patients and healthcare providers. While advances in engineering design and the arrival of functional materials hold considerable promise for the development of a new generation of catheters, many challenges remain. The aim of this review is to identify the issues that presently impact catheter performance and provide a critical evaluation of the design considerations that are emerging in the pursuit of these new catheter systems.
... Despite optimal flushing and locking techniques, there are external influences that displace the internal locking volume causing blood to reflux into the catheter. Body or muscle movements, intrathoracic pressure changes caused by coughing or vomiting, arm abduction or adduction, application of blood pressure cuff, catheter mechanical changes of clamping and unclamping, syringe plunger rebound in certain syringes after flushing and connection and disconnection of syringes or needle free connectors, all cause pressure changes within a catheter that may pull blood into the catheter tip (Goossens 2015;Hadaway and Richardson 2010). Neutral or antireflux needle free connector technology should theoretically prevent blood reflux from occurring; however, it is suggested by Hadaway and Richardson (2010) that up to 0.02 mL of blood can still be drawn into the catheter tip depending on theneedle free connector design and clamping sequence followed by clinicians (Hadaway and Richardson 2010). ...
... Body or muscle movements, intrathoracic pressure changes caused by coughing or vomiting, arm abduction or adduction, application of blood pressure cuff, catheter mechanical changes of clamping and unclamping, syringe plunger rebound in certain syringes after flushing and connection and disconnection of syringes or needle free connectors, all cause pressure changes within a catheter that may pull blood into the catheter tip (Goossens 2015;Hadaway and Richardson 2010). Neutral or antireflux needle free connector technology should theoretically prevent blood reflux from occurring; however, it is suggested by Hadaway and Richardson (2010) that up to 0.02 mL of blood can still be drawn into the catheter tip depending on theneedle free connector design and clamping sequence followed by clinicians (Hadaway and Richardson 2010). Unwanted reflux volumes have also been demonstrated by other researchers (Elli et al. 2016;Hull et al. 2018). ...
... Body or muscle movements, intrathoracic pressure changes caused by coughing or vomiting, arm abduction or adduction, application of blood pressure cuff, catheter mechanical changes of clamping and unclamping, syringe plunger rebound in certain syringes after flushing and connection and disconnection of syringes or needle free connectors, all cause pressure changes within a catheter that may pull blood into the catheter tip (Goossens 2015;Hadaway and Richardson 2010). Neutral or antireflux needle free connector technology should theoretically prevent blood reflux from occurring; however, it is suggested by Hadaway and Richardson (2010) that up to 0.02 mL of blood can still be drawn into the catheter tip depending on theneedle free connector design and clamping sequence followed by clinicians (Hadaway and Richardson 2010). Unwanted reflux volumes have also been demonstrated by other researchers (Elli et al. 2016;Hull et al. 2018). ...
Chapter
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Peripheral and central vascular access devices are a fundamental and essential part of healthcare delivery, used extensively in hospital and community settings to meet the challenging and complex IV therapy requirements of the modern-day patient. For vascular access devices (VAD) to be a safe and effective tool for the administration of IV therapy, they must be reliable. Reliability in this context refers to optimal catheter function, demonstrated by the ease of flushing and aspirating, combined with an absence of associated complications. Proficient care and maintenance of these devices by healthcare professionals requires a high degree of knowledge, skill and understanding. In this section, we explore the details of flushing by examining how, why, when and with what solution vascular devices are to be flushed.
... 17,18 Reflux of blood into the terminal end of a catheter is a cause of catheter occlusion. 19 Patient movements, muscle flexing, and coughing all cause pressure changes and reflux within the catheter. As the catheter is manipulated, blood is intermittently pulled back into the catheter. ...
... As the catheter is manipulated, blood is intermittently pulled back into the catheter. 19,20 These deposits of blood on the catheter may be cleared, somewhat, with saline flushing. [21][22][23] When catheter lumen flushing is inadequate or blood protein deposits completely or partially block the terminal end of the catheter, these occlusions to the terminal end of the catheter may prevent blood sampling and the infusion of fluids. ...
Article
Full-text available
Background Continual improvement is a necessary part of hospital culture. This occurs by identifying opportunities for improvement that influence efficiency while saving money. Methodology An investigation of intravenous device-related practices was performed by the nurses of the intravenous access team, pharmacy, and hospital operations at Hartford Hospital using Lean Six Sigma methodology. Central venous access device occlusion and tissue plasminogen activator variability was identified. Using observation, measurement of performance, and root cause analysis, the hospital's practices, policies, and equipment were evaluated for the process of occlusion management. The team utilized a Six Sigma strategy employing the elements define, measure, analyze, improve, and control, which is a disciplined, data-driven methodology that focuses on eliminating defects (waste). Interventions initiated based on the assessment performed by the team using the define, measure, analyze, improve, and control approach included replacement of negative displacement needleless connectors with antireflux needleless connectors and specialty team assessment before tissue plasminogen activator use. Results Over the course of the 26-month study, Hartford Hospital experienced a 69% total reduction in tissue plasminogen activator use representing a total 26-month savings of $107,315. Other cost savings were reflected in areas of flushing, flushing disposables, and in a decrease in needleless connector consumption. Central line-associated bloodstream rates fell 36% following the intervention as an unexpected secondary gain, resulting in further savings related to treating this nonreimbursable hospital-acquired condition. Conclusions This study examined the influence of using Lean Thinking and Six Sigma methodology as a tool in saving hospital money, resulting in better patient outcomes.
... N eedle-free connectors, which attach to catheter hubs, were initially introduced into clinical practice to reduce the risk of needlestick injuries (Loveday et al, 2014). Needle-free connectors have been categorised by manufacturers according to the type of fluid displacement that occurs on disconnection of a male luer (Hadaway and Richardson, 2010). Negative-displacement devices will allow blood reflux into the catheter lumen, necessitating a positive-pressure technique to avoid occlusions. ...
Article
Background: needle-free connectors are widely used in clinical practice. The aim of this study was to identify any differences between microbial ingress into six different connectors (three neutral-displacement, one negative-displacement and two anti-reflux connectors). Methods: each connector underwent a 7-day clinical simulation involving repeated microbial contamination of the connector's injection ports with Staphylococcus aureus followed by decontamination and then saline flushes through each connector. The simulation was designed to be a surrogate marker for the potential risk of contamination in clinical practice. Results: increasing numbers of S. aureus were detected in the flushes over the 7 days of sampling despite adherence to a rigorous decontamination programme. Significant differences in the number of S. aureus recovered from the saline flush of some types of connectors were also detected. Two different durations (5- and 15-second) of decontamination of the injection ports with 70% isopropyl alcohol (IPA) wipes were also investigated. There was no significant difference between the median number of S. aureus recovered in the saline flushes following a 5-second (165.5, 95% CI=93-260) or a 15-second decontamination regimen (75, 10–190). Conclusions: The findings suggest that there may be differences in the risk of internal microbial contamination with different types of connectors and that even 15 seconds of decontamination may not fully eradicate microorganisms from the injection ports of some devices.
... Study objectives were to (i) theoretically estimate amount of blood reflux volume in microliters (μL) permitted by each NFC based on exact component measurements, and (ii) experimentally measure amount of fluid movement or reflux. The 14 NFCs are represented in each of the four current marketing categories of NFC (13 *As defined in publications as positive pressure mechanical valve with reflux occurring on connection with a final fluid push at disconnection clearing blood from catheter tip, described as a compression/decompression mechanism creating positive (disconnection) and negative pressure (on activation) resulting in fluid displacement fluctuations (2,16). ...
... Negative displacement NFCs allow fluid displacement into the catheter lumen during disconnection from a male luer syringe or IV tubing. This displacement occurs when fluid (blood) is mechanically pulled away from the patient and into the catheter or NFC lumen based on pressure changes (9,13). Because blood is pulled toward the NFC through the catheter upon disconnection, protocol states the catheter be clamped prior to luer-lock disconnection (2,6,14). ...
... In this study, we chose to measure the fluid movement for each category of connector around the plunger (6,26). This space between the plunger and outer housing creates a reservoir where fluid is gathered; when the NFC is disconnected from a syringe or IV tubing, fluid movement occurs and is pushed outward, toward the patient (13). This design is created to overcome potential blood reflux that occurs upon disconnection, but does not prevent fluid displacement associated with connection (13). ...
Article
Full-text available
Methods: In this study, 14 NFC brands representing each of the four market-categories of NFCs were selected for evaluation of fluid movement occurring during connection and disconnection of a syringe. Study objectives were to 1)theoretically estimate amount of blood reflux volume in microliters (μL) permitted by each NFC based on exact component measurements, and 2) experimentally measure NFC volume of fluid movement for disconnection reflux of negative, neutral and anti-reflux NFC and fluid movement for connection reflux of positive displacement NFC. Results: The results demonstrated fluid movement/reflux volumes of 9.73 μL to 50.34 μL for negative displacement, 3.60 μL to 10.80 μL for neutral displacement, and 0.02 μL to 1.73 μL for pressure-activated anti-reflux NFC. Separate experiment was performed measuring connection reflux of 18.23 μL to 38.83 μL for positive displacement NFC connectors. Conclusions: This study revealed significant differences in reflux volumes for fluid displacement based on NFC design. While more research is needed on effects of blood reflux in catheters and NFCs, results highlight the need to consider NFCs based on performance of individual connector designs, rather than manufacturer designation of positive, negative and neutral marketing categories for NFCs without anti-reflux mechanisms.
... Blood reflux is considered a cause of catheter occlusion (Hadaway & Richardson, 2010). Layers of blood cells develop inside the lumen and on the tip of the catheter as blood refluxes during initiation and disconnection of infusions, NCs, or syringes (Elli, Abbruzzese, Cannizzo, & Lucchini, 2016;Hadaway & Richardson, 2010). ...
... Blood reflux is considered a cause of catheter occlusion (Hadaway & Richardson, 2010). Layers of blood cells develop inside the lumen and on the tip of the catheter as blood refluxes during initiation and disconnection of infusions, NCs, or syringes (Elli, Abbruzzese, Cannizzo, & Lucchini, 2016;Hadaway & Richardson, 2010). Reflux also occurs with body movements such as muscle flexing or coughing that cause pressure changes within the bloodstream. ...
... IV medication or solution administration was performed by cleaning the rubber port with an alcohol wipe and advancing a needle through the rubber port. The process of pushing the needle through a rubber port scraped the bacteria off the needle before it entered the port, similar to the action with the split septum needleless device where a blunt connector is pushed through the septum (Hadaway & Richardson, 2010;Salgado, Chinnes, Paczesny, & Cantey, 2007;Seymour, Dhallu, Moss, Tebbs, & Elliot, 2000). While this was an effective method of M o u r e a u , N L P h D b y P r i o r P u b l i c a t i o n P a g e | 272 ...
Thesis
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Abstract Background: This thesis is a collection of original authored published works under the theme of Vessel Health and Preservation for patients receiving intravenous therapies. The key concepts of assessment and selection, insertion, management and evaluation with overarching education are covered within the thesis. The seven publications represent the research and form the body of the thesis including three systematic reviews, one retrospective cohort analysis, two prospective quasi-experimental cohort studies, and one multi-centre quasi-experimental study. Methods: A substantial exegesis follows each publication using a systematic framework of evidence for how content of each publication is embodied within the overarching theme of Vessel Health and Preservation. Results: This thesis provides an exegetical description of how each of the seven publications are reported within the key concepts relevant to the Vessel Health and Preservation theme, precedents of practice and research, and researcher’s practice. Conclusion: The theme of Vessel Health and Preservation was comprehensively reviewed with the results of each publications contributing to the evidence and overall goal of vein preservation. The body of work and the contributions to the theme of Vessel Health and Preservation represent an original contribution to nursing knowledge in vascular access for assessment and selection, insertion, management, evaluation and clinical education, for the promotion of patient safety. https://www120.secure.griffith.edu.au/rch/file/e6aea329-fae8-4c41-aa3f-6b4f80298977/1/Moureau_2017_01Thesis.pdf