Do Needleless Connector Manufacturer Claims on Bidirectional Flow and Reflux Equate to In Vitro Quantification of Fluid Movement?

Abstract

Highlights Abstract 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.

Assessment of Reflux From Needleless Connectors: Blinded Comparison of Category Designation to Benchtop Function Using a Venous Simulator

“…Similarly, the current results are generally in good agreement with a previous study by Elli et al22 The previous work tested 4 of the 13 NCs from the current study, with only the positive displacement MaxZero differing by more than approximately 1 μL relative to the current results. The current results are also in excellent agreement with those recently presented in a similar study 23…”

CLE3AR Study

“… 11 , 16 – 20 In addition, their bidirectional fluid control design helps minimize end-user error because they do not require a specific clamping sequence to flush the catheter. 11 , 16 , 18 …”

“…11,[16][17][18][19][20] In addition, their bidirectional fluid control design helps minimize end-user error because they do not require a specific clamping sequence to flush the catheter. 11,16,18 Faced with the ongoing concerns over occlusion-related complications, Hartford Hospital launched a Lean Six Sigma (LSS) quality program to identify and address sources of waste, process variability, and defects that negatively impacted patient safety and outcomes. Using the Lean thinking principles (efficiency, effectiveness, and economics), the Hartford team was able to significantly reduce overall tPA and needleless connector consumption within the first 26 months of launching the program.…”

“…Antireflux needleless connectors have been shown to do this most effectively 11,16–20 . In addition, their bidirectional fluid control design helps minimize end-user error because they do not require a specific clamping sequence to flush the catheter 11,16,18 …”

Home infusion pharmacy quality improvement for central venous access devices using anti-reflux needleless connectors to reduce occlusions, emergency room visits, and alteplase costs

“…Thrombolytic use in patients with a peripherally inserted central catheter (PICC) is associated with a 3-fold higher risk of infection (adjusted odds ratio, 3.59). 5 Since unintentional blood reflux within the catheter is the primary cause of these occlusions, and use of anti-reflux needleless connectors with bidirectional flow control has been demonstrated to result in the least amount of blood reflux, 6 in the study described here we sought to determine if implementation of anti-reflux needleless connectors could reduce occlusions and associated cost. 3,7 A literature review failed to identify any research comparing types of needleless connectors in relation to the incidence of occlusion and costs associated with thrombolytic use in the home infusion setting.…”