I definitely agree that such studies can be performed. Perhaps I did not state my position clearly. Studies comparing a needleless device of any kind to a stopcock system can not easily be generalized to practice in the US because this is not the way we practice. So while these studies can be done, you must understand the variables that prevent the application of the studies outcome to all clinical situations. A study that found a lower rate of infection with a needleless connector when compared to a stopcock system has very little, if any, application to practice in the US where stopcocks are not routinely used on most catheters.  

Lynn Hadaway, M.Ed., RN, BC, CRNI

www.hadawayassociates.com

Tom, you are correct about the stopcock/connector issue.

There seems to be confusion about why these two types of devices CAN be compared in experimental or observational studies. To those interested in this thread, please keep reading.

1) Two products do not have to have similar designs to be compared. (If you doubt this then consider the question: if this were true, i.e., items must be similar or almost identical, how would science ever conduct studies to validate the efficacy of new technology?)The investigator must also look at their purpose/intended use. And, in this example, the purpose of both the stopcock and any needleless connector is to permit intermittent access to an existing IV system. The duration of what is classifed as "intermittent" - which can be anything from a few minutes to many hours - is not usually the main point. The focus is on how effectively and safely the product achieves its clinical endpoint - delivery of fluid/drug without adverse event(s).

 2) The investigator must establish the baseline. If the current practice uses stopcocks (as is commonly seen in many non US health facilities) then THAT is the baseline for comparison.

Therefore, studies comparing needleless connectors to stopcocks are clinically relevant, appropriate, and worthy of our professional attention and analysis.

Thank you, Tom, for the opportunity to clarify this very important point.

 Marilyn Hanchett RN

A recent survey of nurses on their use and management of infusion tubing revealed some 1.    Hadaway L. Intermittent intravenous administration sets: Survey of current practices. Journal of American Association for Vascular Access. 2007;12(3):143-147.
danagerous practices.

One of siginifcant risk is the frequent disconnection of continuous fluids. Reasons given include allowing the patient to eat, ambulate, shower, etc. I consider this to be a risky practice. It dramatically alters the patient's progress toward their therapuetic goals, thus slowing their progress toward discharge. It tells me that busy nurses are taking the path of least resistance without thinking about the clinical outcomes. So disconnection of continuous infusions should not be the common practice. The only reason to disconnect for a few seconds would be to change the tubing at the 72 or 96 hour interval. Continuous fluids should not be disconnected on a regular basis and therefore there is no need for any needleless connector in the line. These frequent disconnections are not addressed in policy and procedure. Management of the continuous tubing is no better than management of intermttent tubing, therefore these tubings are contaminated because of no sterile cap on the end. I strongly believe that a large component of the issue of infection associated with needleless connectors is directly related to extremely poor management of infusion tubing. A huge deficient in the research literature is a complete absence of any studies on intermittent tubings. This is the reason for the INS standard stating that any intermittent tubing should be changed at 24 hours. When you frequently disconnect a continuous infusion tubing, you are making it an intermittent tubing and it then should be changed at 24 hours. Continuoous tubing means that it is not disconnected at all.

I do agree that an open stopcock is an open hub, and therefore you cannot draw any comparisons of infection rates of needleless connectors from studies that compared any needleless device to a stopcock.  

Lynn Hadaway, M.Ed., RN, BC, CRNI

www.hadawayassociates.com

The Bouza study, along with several others from Europe, have compared various needleless connectors to the standard stopcock. And those authors frequently refer to these as their "traditional open system". I heard Dr. Elliott from the UK give a presentation of this last summer and his work was published in a meta-analysis. Regardless of what you call it, you can not make any valid assessments of the infection rates when comparing 2 vastly different systems to each other. A needleless system must be compared to another needlelless system, not a stopcock. In the US, we knew that stopcocks seriously increase the risk of infection and that is why we stop routine use of them in the US, many years ago. So we can not make any generalizations about practice in this country based on studies using systems that are vastly different from ours.  

Lynn Hadaway, M.Ed., RN, BC, CRNI

www.hadawayassociates.com

The Bouze study compared using a Clave to the traditional open stopcocks which is the standard in Europe. This is absolutely not the same as comparing 2 types of needlelsss connectors. this is a huge difference! Lynn  

Lynn Hadaway, M.Ed., RN, BC, CRNI

www.hadawayassociates.com

Sorry Tom, but I disagree. I do not like to put needleless connectors in the line for a continuous infusion. There is no evidence that they prevent any infections when used in this manner. The other reason I have heard is to make it easier to change the tubing, however this does not work in the light of what CDC recommends - that these be changed at the same interval as the tubing itself. I believe these lines make it far too easy to randomly disconnect continuous infusions, thus altering therapeutic response to the fluids, and may increase the risk of tubing contamination because the tubing is not appropriately managed while disconnected. I recommend against using these devices for continuous fluids.  

Lynn Hadaway, M.Ed., RN, BC, CRNI

www.hadawayassociates.com