Needle free valve connectors NFCs and the risk of bloodstream infections Commentary from a clinical perspective
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Slide 1 :
Needle free valve connectors (NFCs) and the risk of bloodstream infections -Commentary from a clinical perspective Arne Simon MD, PhDChildren‘s Hospital Medical Center University of Bonn Adenauerallee 119, 53113 Bonn, Germany
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Simon A, Trautmann M: Needle free valve connectors 2 This presentation refers to the original publication Simon A, Trautmann M. [Needleless connection valves--commentary from a clinical perspective][Article in German] Dtsch Med Wochenschr. 2008 Feb;133(5):206-8 Michael Trautmann is the Director of the Institute of Hospital Hygiene, Klinikum Stuttgart, Germany. Both authors are full members of the Commission of Hospital Hygiene and Prevention of Infection at the Robert Koch-Institute, Berlin, Germany.
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Simon A, Trautmann M: Needle free valve connectors 3 Benefits of NCV use NCVs reduce the risk of bleeding and air embolism in case of an accidental disconnection of the iv. system. NCVs reduce the risk of health care associated needle stick injuries because they enable the health care providers to inject medications safely without any needle. NCVs alleviate the workflows of iv. system changes and the disinfection of the catheter hub; both procedures represent important critical control points in the prevention of catheter-associated bloodstream infections (BSI). NCVs allow the no touch application of iv. medications through any injection port (three way cocks). Zero-volume NCVs prevent the negeative pressure at the catheter tip when a syringe at the injection port is disconnected. These systems supersede flushing with NaCl 0.9%/heparine solutions.
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Simon A, Trautmann M: Needle free valve connectors 4 Drawbacks of NCV use The use of certain NCVs has been related to a significant increase in catheter-associated BSI [1, 2, 3, 4, 5, 6]. NCVs may cause mechanical problems and may increase the frequency of disconnections, when the are not used appropriately (by thoroughly educated personnel). 1. Danzig LE, Short LJ, Collins K, et al. Bloodstream infections associated with a needleless intravenous infusion system in patients receiving home infusion therapy. Jama 1995;273:1862-4 2. Field K, McFarlane C, Cheng AC, et al. Incidence of catheter-related bloodstream infection among patients with a needleless, mechanical valve-based intravenous connector in an Australian hematology-oncology unit. Infect Control Hosp Epidemiol 2007;28:610-3 3. Kellerman S, Shay DK, Howard J, et al. Bloodstream infections in home infusion patients: the influence of race and needleless intravascular access devices. J Pediatr 1996;129:711-7 4. Maragakis LL, Bradley KL, Song X, et al. Increased catheter-related bloodstream infection rates after the introduction of a new mechanical valve intravenous access port. Infect Control Hosp Epidemiol 2006;27:67-70 5. McDonald LC, Banerjee SN and Jarvis WR. Line-associated bloodstream infections in pediatric intensive-care-unit patients associated with a needleless device and intermittent intravenous therapy. Infect Control Hosp Epidemiol 1998;19:772-7 6. Rupp ME, Sholtz LA, Jourdan DR, et al. Outbreak of bloodstream infection temporally associated with the use of an intravascular needleless valve. Clin Infect Dis 2007;44:1408-14
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Simon A, Trautmann M: Needle free valve connectors 5 Example of a zero-volume NCV Bionecteur™ is a product of VYGON International
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Simon A, Trautmann M: Needle free valve connectors 6 Internal design issues of NVCs Like other conventional injection ports, the outer surface of an NCV may be contaminated during any manipulation (health care personnel) or after contact to the patient‘s skin. Appropriately used NVCs may display the advantage, that it is easier to disinfect the outer membrane of the NCV in comparison to conventional open Luer-Lock- three way cocks. One important issue in NCV design is the necessity to completely avoid any deposition of residual small volumes of blood or other media (e.g. parenteral nutrition solutions, iv. lipids) inside of the NCV during continuous use or after injection. Even the smallest residue may harbor bacteria and form a critical matrix for bacterial colonization, proliferation and subsequent catheter-associated infection. Thus, the internal design of the NCV is of paramount interest.
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Simon A, Trautmann M: Needle free valve connectors 7 In vitro studies of NCV contamination In vitro studies investigating certain NCVs have confirmed that – after appropriate disinfection of the outer membrane of the NFC – a contamination of the outer surface of the syringe injection site does not result in a contamination of the injected fluid: Q-Syte™; Becton Dickinson, Sandy, UT, USA  Bionecteur™ (VYGON GmbH & Co.KG, Aachen)  1. Adams D, Karpanen T, Worthington T, Lambert P and Elliott TS. Infection risk associated with a closed luer access device. J Hosp Infect 2006;62:353-7 2. Trautmann M, Moosbauer S, Schmitz FJ and Lepper PM. Experimental study on the safety of a new connecting device. Am J Infect Control 2004;32:296-300 Widmer et al.  questioned the procedure of disinfection in the study published by Adams et al.  applying individual swabs containing 70% (v/v) isopropylalcohol to the compression seal and rotating five times through 360o (residence time 2 min). This complicated and time consuming procedure is impractical. In addition, adverse effects of any blood contamination of the NCV, which is often observed in clinical use, has not been investigated in this study. 3. Widmer A, Bolliger D. Infection risk associated with a closed luer access device. J Hosp Infect 2006;63:479; author reply 479-80
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Simon A, Trautmann M: Needle free valve connectors 8 In vitro studies of NCV contamination Trautmann and coworkers.  performed a series of in vitro experiments investigating the microbiological safety of the connecting device after artificial contamination in the laboratory setting and during routine clinical use. They studied whether the bacterial contamination of the outer membrane of the Bionecteur™ resulted in the injection of bacteria into the adjacent iv. line. In these experiments, very high bacterial inocula were used to simulate a ‘worst-case scenario’. The 70% (v/v) isopropyl alcohol disinfection of the outer membrane was performed by spraying three times from a distance of 15cm with a residence time of 3 x 15 seconds. This easy mode of disinfection definitely prevented the transmission of bacteria through the NCV, the sterile injection solutions were not contaminated. The authors concluded, that the Bionecteur™ is a safe NCV system provided, the health care personnel follows the instructions for disinfection properly before each connection or blood sampling procedure. 1. Trautmann M, Moosbauer S, Schmitz FJ and Lepper PM. Experimental study on the safety of a new connecting device. Am J Infect Control 2004;32:296-300
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Simon A, Trautmann M: Needle free valve connectors 9 Metaanalysis of clinical studies? In 2006 Niehl-Weise and coworkers.  published a metaanalysis of 4 randomized studies comparing clinical results between NCVs and conventional Luer-Lock connections. They described a trend for lower hub contamination and catheter-related infection rates in the NVC group, without statistical significance. Some studies did not describe the method of disinfection of the NCV membrane [1, 2]. The NCV time of use was 3 days (2 studies) and 6 days (1 study). The authors concluded, that from the perspective of infection prevention there is not enough evidence to recommend the routine use of NCVs in catheter care. Considering the heterogenic patient populations and standards of catheter care as well as the missing data considering the disinfection procedures, these results are of questionable clinical relevance. 1. Casey AL, Lambert PA and Elliott TS. Is there evidence for recommending needleless closed catheter access systems in guidelines? J Hosp Infect 2006;64:405-6 2. Do AN, Ray BJ, Banerjee SN, et al. Bloodstream infection associated with needleless device use and the importance of infection-control practices in the home health care setting. J Infect Dis 1999;179:442-8 3. Niel-Weise BS, Daha TJ and van den Broek PJ. Is there evidence for recommending needleless closed catheter access systems in guidelines? A systematic review of randomized controlled trials. J Hosp Infect 2006;62:406-13
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Simon A, Trautmann M: Needle free valve connectors 10 What to consider before implementing a new NCV The manufacturer should provide the treatment team with concise in vitro data confirming the microbiological safety of the system. The method of disinfection in these studies should be practicable and not too time consuming. The internal design of the NCV should exclude the deposition of small blood or infusion solution volumes inside the NCV during any use. The NC should be a zero volume system, avoiding the aspiration of small blood volumes into the catheter tip after disconnection. It is of paramount importance to educate the health care personnel in the correct use of the NCV. Incorrect use of a NCV with proven safety may result in mechanical complications and outbreaks of catheter-related infections . In pediatric units, syringes should never be used as ‚toys’, since a non supervised child playing with a syringe may accidentally inject air injection into the iv. catheter. 1. Cookson ST, Ihrig M, O'Mara EM, et al. Increased bloodstream infection rates in surgical patients associated with variation from recommended use and care following implementation of a needleless device.Infect Control Hosp Epidemiol 1998;19:23-7
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Simon A, Trautmann M: Needle free valve connectors 11 Conclusions Needle-less connection valves (NCVs) for infusion systems, blood drawing- or i.v. injection ports may offer significant benefits to the patient and the attending nurses and physicians. On the other hand, a number of recent reports have described a relationship between an increased incidence density of catheter-associated infections and the introduction of certain NCVs in clinical practice. Thus, the safety of the device in terms of an effective and feasible disinfection protocol for the outer membrane and absence of unintended bacterial deposits inside the device should have been confirmed with appropriate in vitro investigations. In addition, the introduction into clinical practice should be preceded by educational efforts (who to use the NCV correctly) and supervised by continuously performed surveillance for catheter-associated infections. Taking these prerequisites into account, NCVs may increase the safety and feasibility of intravenous therapy using central venous catheters in high-risk patients.
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