Needle free connectors, port protectors and infection risk today. Giancarlo Scoppettuolo A. Gemelli University Hospital Foundation, Rome

Transcription

1 Needle free connectors, port protectors and infection risk today Giancarlo Scoppettuolo A. Gemelli University Hospital Foundation, Rome 1

2 Pathogenesis of CRBSI and Prevention of extra and intraluminal colonization CHG Skin Preparation (applied before catheter insertion and with every dressing change) CHG Eluting Disk (applied after catheter insertion and with every dressing change) Swabable Needlefree Connector Intraluminal colonization Extraluminal colonization Modified, Courtesy of R. Garcia, MD 2

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4 Needlefree connectors and HCWs safety Following the issue of a safety alert by the US Food and Drug Administration (FDA) in 1992, needle-free devices (NFDs) have been used in place of hypodermic needles to access vascular access devices. The use of hypodermic needles was associated with a risk of intravenous catheter-related needlestick injuries and, as NFDs appeared to reduce this risk, their use was recommended. 4

5 Needleless System: a device that provides an alternative to needle for various procedures to reduce the risk of injury involving contaminate sharps Needleless Systems include: IV medication systems that administer medication or fluids through a cathether port using non-needle connections Jet injection systems that deliver medication beneath the skin or through a muscle 5

6 o Needlefree connectors: needlestick injuries prevention o Prevention of occlusion (negative, neutral or positive displacement) o Needlefree connectors and risk of infection (negative, neutral or positive displacemente, swabability, active or passive disinfection ) 6

7 NFC CLASSIFICATION NFC COMPLEXITY OF INTERNAL MECHANISM HOW THEY FUNCTION SIMPLE (LAMINAR FLOW) NEGATIVE, NEUTRAL OR POSITIVE DISPLACEMENT COMPLEX (TURBOLENT FLOW) Hadaway,

8 «Simple» Needle free Connectors Simple devices have no internal mechanism and include devices with an external split septum. One design requires the use of a blunt plastic cannula attached to the administration set or syringe and inserted through the prepierced septum of the needleless connector. A second design eliminates the blunt plastic cannula and allows the male luer end of an administration set or syringe to be inserted into the prepierced septum. Neither of these designs has any internal moving pieces, allowing the fluid to flow straight through the device lumen. Hadaway,

9 «Complex» Needle free connectors Complex needleless connectors contain some type of internal mechanism The internal mechanism in this group of needleless connectors must be capable of allowing fluid to flow in both directions for infusion and aspiration. Complex NFDs require the membrane to be depressed with the syringe tip that opens up the fluid pathway, thus allowing fluid to pass through the middle or around the membrane. These devices can also have a split-septum and are categorised as mechanical valve split-septum devices. If the fluid flows through the middle of the centerpiece, the mechanical valve will have a negative displacement, whereas if the fluid flows between the outer housing and the movable centerpiece the fluid displacement will be positive 9 Hadaway, 2010

10 Another way to categorise: how they function Negative displacement: meaning that blood will be pulled back into the catheter lumen. Negative fluid displacement occurs while the administration set is attached, as in the case of an empty fluid container allowed to remain connected, and upon disconnection of the administration set, syringe, or blunt cannula. With split-septum systems, blood is pulled back into the catheter lumen as the blunt cannula or male luer end of the administration set is withdrawn from the septum. With mechanical valves, blood is pulled into the catheter lumen by the movement of the valve mechanism. Blood allowed to reside inside the lumen will lead to partial or complete lumen occlusion. Therefore, this category of devices mandates the use of flushing and clamping techniques to overcome this blood reflux. Hadaway,

11 11 Hadaway, 2010 Luer access Split Septum With negative displacement

12 Split septum opened by blunt cannula 12 Hadaway, 2010

13 Luer activated mechanical valve with negative displacement (The fluid flows through the middle of the centrepiece) 13 Hadaway, 2010

14 Another way to categorise: how they function Positive fluid displacement: it occurs upon disconnection of the administration set or syringe from the device. These valves have a reservoir for holding a small amount of fluid. Upon disconnection, this fluid is pushed out to the catheter lumen to overcome the reflux of blood that has occurred. Blood can still move into the catheter lumen, but the displacement mechanism prevents it from residing in the catheter lumen after disconnection While the administration set is attached to this device, the valve remains open. The positive displacement occurs only upon administration set or syringe disconnection. Consequently, an empty fluid container allowed to remain connected will allow blood to reflux into the catheter. 14 Hadaway, 2010

15 Luer activated mechanical valve with positive displacement (The fluid flows between the outer housing and the movable centerpiece) 15 Hadaway, 2010

16 Another way to categorise: how they function Neutral displacement: the device prevents blood reflux upon connection and disconnection. There can be a very small amount of blood reflux (eg, up to 0.02 ml), and some have purported that this indicates it is not neutral. The terms negative, positive, and neutral displacement are marketing terms, and there are no documents from any regulatory organizations providing guidance on the use of these terms. 16 Hadaway, 2010

17 Luer activated mechanical valve with neutral displacement 17 Hadaway, 2010

18 Needle free connectors Negative displacement 18

19 NFC - negative displacement Q-Site (BD) 19

20 Needle free connectors Neutral displacement 20

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22 22 NeutraClear (CAIR)

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25 Needle free connectors «Very» Neutral displacement (anti-reflux valve) 25

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28 Needle free connectors Positive displacement 28

29 29 UltraSite (Bbraun)

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31 31 NFC with Anti reflux valve

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33 33 NFC with Anti reflux valve

34 EXTERNAL DESIGN AND CONNECTION SURFACE Amount of grooves and gaps Roughness or smouthness of the septum Clear or opaque 34

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39 39 CDC GUIDELINES, 2011

40 40 SHEA/IDSA GUIDELINES, 2014

41 41 INS GUIDELINES, 2016

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43 The real problem of Needle free connectors Poor compliance to disinfection practices: a significant safety issue! Contamination introduced directly through the catheter hub (intraluminal contamination) is associated with poor aseptic compliance Contamination caused by lack or inadequate aseptic technique is preventable Compliance regarding scrubbing the hub is central to patient safety and all health professionals require continued education to ensure that a consistent and robust approach to asepsis is maintained (Kelly, 2017) This is really a safety issue, if we consider that Needle free devices constitute more than 80% of access devices. HOW TO DISINFECT: UNRESOLVED ISSUE 43

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47 NFC Active disinfection It requires compliance by HCWs! Time of friction and disinfectant: unresolved issues in guidelines Passive disinfection Port protectors 47

48 ACTIVE DISINFECTION Centers for Disease Control, EPIC3 and the Infusion Nurses Society recommend to minimize intraluminal contamination risk disinfecting hub or needle free connectors by scrubbing with an appropriate disinfectant (70% alcohol, chlorhexidine, povidone iodine, and iodophors) prior to any access 48

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57 The present and the future of NFC PASSIVE DISINFECTION USING PORT PROTECTORS. 57

58 58 Port Protectors

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77 77 INS 2016 : port protectors

78 Conclusions 78 Needle free connectors are widely used in clinical practice on the hub of vascular catheters They are totally effective in preventing needlestick injuries for healthcare workers Their effect on the prevention of occlusion depends on their displacement mechanism They influence the risk of intraluminal contamination because of poor compliance to disinfection practices and probably because active disinfection practices are not fully standardized The most effective and standardized disinfection for needle free connectors is passive disinfection using port protectors containing disinfecting agents

79 Thank you for your attention!