Our CVL policy recently changed to direct connect for contnous infusions per INS Standards. Several of our nurses in ICU moonlight with a Vascular company that is contracted to insert PICCs in our hospital and that company's policy is to always us a cap for connections, even continous infusions....and told me that is what the manufacturer recommendations are. So I contacted 2 big CVL companies and asked for those recommendations. Both have responded; in writing; that "a needleless connector should be used on any lumen of a device that is not being utliized for power injection or CVP reading". We are always told to "follow manufacturer instructions", so what to do?
This is what one company sent me:
It is true INS put out a statement that direct connect is ideal for continuous infusions. There is no evidence that the practice reduces infection or has real purpose. I have searched the for answers from the CDC, AVA, NIH, and INS. There is no research information available to support this practice.
Here are some of the drawbacks:
- Central line (PICC, CVL) catheter hub breakage. Hospitals that have tried this practice report an increase of catheter hub breakage because nurses have to use hemostats to remove the IV tubing. When a catheter hub breaks the entire line has to be pulled and replaced. When this happens the chance of infection from another stick is present. If the catheter is exchanged over a wire there is also a chance of infection.
- Contaminated hubs were the other drawback. A needleless connector or valve is engrained into all nurses heads to scrub the hub for 15-20 seconds. It has been observed by infection control that the same practice of scrubbing the catheter hub is not done. Nurses are in a rush to get that open catheter hooked up to tubing and do not scrub the end for the reccomeneded amount of time or at all.
- Central line catheter companies do not recommend this practice. It is in their IFUs to utilize a needleless connector on the end of all lumens unless the lumen is being used for CVP monitoring.
Thanks for your input!!
Since I have been a loud voice against the practice of using needleless connectors inside a continuous infusion set, I will respond with my thoughts on these issues. I have not seen the statements from the manufacturers you are referring to, however these statements sound like CYA and are not evidence based practice. The INS Standards state, "The need for a needleless connector placed between the VAD hub and the administration set used for continuous fluid infusion is unknown." Then goes to discuss the main reason for a needleless connector is to prevent accidental needlestick injuries by eliminating needles - no other reason to use them at all!. Plus there is some evidence that rapid fluid flow rate is negatively affected by the presence of the NC.
Before the introduction of NCs the admin set was always directly connected to the VAD hub. There is no evidence for or against the use of NC when discussing infection rates - none! So we do not know if they are a positive or negative aspect. BUT there is plenty of evidence that NC lead to intraluminal contamination, also stated and supported in the INS Standards. So no claims at all can be made regarding infection risk in a continuous infusion system with or without the NC.
Look at the instructions from the NC companies. Indications are for connection for INTERMITTENT infusion. I don't think they say anything about their use for continuous infusion. I think the NC instructions takes precedence over the catheter company statements. If this was sent to you in a letter, it means that this statement has not been reviewed by the FDA. If this statement had been sent to the FDA for review it would be added to the catheter instructions for use. That may be happening and just not had time to work through the system yet - don't know for sure. But those statements seriously lack evidence to support them
It does not make sense to me to have multiple luer locking connections when 1 connection will work. Hub cracking can happen just as easily when the NC is used because the actual hub should still be cleaned when the NC is removed. Hub cracking is related to not allowing the disinfectant solution to thoroughly dry, and it happens reqardless of what device is being attached.
The absence of evidence showing the safety of this practice and the large amount of evidence showing the NC as a significant source of intraluminal contamination still says to me that they should be eliminated whenever possible. And it is possible to eliminate their use with continuous infusions.
Finally the presence of the NC inside the continuous set promotes the bad practice of random disconnection of the infusion for any number of reasons. This means the patient is not receiving the prescribed fluids/meds while disconnected and this could have negative aspects for their overall outcomes. What is being done with the disconnected set and how is the reconnection confirmed to be the correct fluids and the correct patient? There are absolutely no studies that have looked at this issue either. All studies on IV administration sets have been conducted with the set attached to the catheter hub and never disconnected until the designated time to change it - over the years these studies have supported increasing this time from 24 h, to 48, h, to 72 h and now we are at 96 h. But these sets in the studies are never disconnected! Without the presence of the NC, this danger practice of disconnection would decrease.
So there are many aspects to think about. And I still would go with NO NC for a continuous infusion.
Lynn
Lynn Hadaway, M.Ed., RN, NPD-BC, CRNI
Lynn Hadaway Associates, Inc.
PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
I don't think it's really appropriate to impose an increased risk of harm to the patient as a way of encouraging better practice, that's akin to saying that a hub scrub should be developed where if the nurse scrubs for only 9 seconds instead of 10 it injects bacteria into the line, to punish them for only scrubbing 9 seconds.
The purpose of a needless connector is twofold; it reduces the risk of needlestick as opposed to needle access connectors, but more importantly they reduce infection risk since it's well established that a closed, smooth surface is more effective at preventing entry of bacteria into the system and is more conducive to thorough antisepsis than an open female hub. Contrary to your statements, this is actually an FDA approved claim by NC manufacturers, BD Maxzero for instance lists this benefit in both their FDA application as well as FDA approved marketing materials. This is generally accepted to be common knowledge in the Infection Prevention community as well. Once contaminated, an open female hub is essentially impossible to clean to any reasonable standard, this is the main reason why needleless connectors are used and have been widely used since the early 90's.
While risk of contamination is lower when there is minimal manipulation of the connection, it's not accurate to suggest that there is never a legitmate reason to disconnect a continuous infusion, whether it be the need to change tubing, add-on sets, or to protect phsyical harm to a patient such as when you find them out of bed on the other side from their IV pump and about to yank out their line at an angle that would most likley require an emergent trip to vascular surgery. The instances where the tubing is connected should be minimal and there should be a high threshhold to when it's appropriate to disconnect, but it's not accurate to claim there is never a legitimate reason to do so.
Regarding your claim that in the studies on administration set duration never included administration sets that were ever disconnected for any reason, that is not correct. All of the studies done in clinical settings utilized routine clinical practices, not a single one of them included any additional restriction on temporary disconnections of the sets. This confusion seems to originate with differing definitions used by the researchers and yourself and the INS. The studies excluded "intermittent infusions", which referred to infusions that were intermittently infusing not intermittently connected, mainly referring to administration sets that were intermittently infusing antibiotics.
I agree with emphasizing the importance of leaving a closed system closed, however I don't agree that to try and encourage nurses to leave the system closed we should increase the risk of opening the system.
Adamantly disagree with the study you referenced. That study has numerous questions and is not accepted by the IP community that I work with. There are far too many other resources stating NC as an infection risk including SHEA and CDC. So everyone will need to read the evidence and decide for themselves. Lynn
Lynn Hadaway, M.Ed., RN, NPD-BC, CRNI
Lynn Hadaway Associates, Inc.
PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
I'm not sure what "that study" is that you're referring to, but neither SHEA for the CDC has ever recommended using an open female hub as the connection point for administration sets or other access of an IV device.
There's plenty of evidence that the connection point can become contaminated, which is why it's important that the connection piont be conducive to proper cleaning, but there is no evidence that NCs are more prone to contamination than an open female hub. There has been evidence that certain types of NCs, namely positive displacement NCs with a mechanical valve, pose a higher infection risk than other NCs, but not that they pose a higher infection risk than an open female hub. Saying that because some NCs pose a higher infection risk than other NCs we should just stop using them all together is like saying that because some hub scrubbing techniques are less effective than others that we should stop scrubbing hubs all together.
As you've pointed out, one of the purposes of an NC, along with being conducive to good asepsis, is to prevent needlesticks, this is because the alternative to an NC is a needle-access connector, no connector at all doesn't seem to be supported by an sort of existing rationale.
"That study" is the one you mentiolned earlier. I, along with many others, have had serious issues with it since it was released. Here is the SHEA document I am referring to:
1.Marschall JMD, Mermel LADOS, Fakih MMDMPH, et al. Strategies to Prevent Central Line–Associated Bloodstream Infections in Acute Care Hospitals: 2014 Update. Infection Control and Hospital Epidemiology. 2014;35(7):753-771.
This document is a collaboration between SHEA, IDSA, TJC and others. Here is the exact quote:
Unresolved issues
1. Routine use of needleless connectors as a CLABSI prevention strategy before an assessment of risks, benefits, and education regarding proper use.
a. Multiple devices are currently available, but the optimal design for preventing infections is unreolved. The original purpose of needleless connectors was to prevent needlestick injuries during intermittent use. No data regarding their use with continuous infusions are available."
Absence of data causes me to determine that they should not be used for continuous infusions. You, obviously, have decided otherwise based on the absence of data.
Lynn Hadaway, M.Ed., RN, NPD-BC, CRNI
Lynn Hadaway Associates, Inc.
PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
It's not really just me who has come to the conclusion that a contaminated solid surface can be more effectively cleaned than a bottomless hole, it's every available source other than yourself. A few examples: http://journals.sagepub.com/doi/abs/10.1177/1757177416657164
https://www.americannursetoday.com/preventing-catheter-related-bloodstre... http://www.icumed.com/products/infusion-therapy/needlefree-iv-connectors...
If we assume contamination can occur evenly accross the surface of the connector, then only being able to clean 50% or less of that surface means we're only reduce the bacterial load by about 50%, which is far less than approx 99% reduction that occurs with the easily cleanable smooth surface of a connector.
Everyone is entitled to their opinion.
Lynn Hadaway, M.Ed., RN, NPD-BC, CRNI
Lynn Hadaway Associates, Inc.
PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
I'm not sure that seeing 50% as being less than 99% is really an "opinion". You are correct that this recommendation is an opinion based recommendation, and there is nothing wrong with formulating a recommendation based on rationale and related evidence when no direct evidence exists, but with that comes an obligation to defend that rationale. I'm still not even clear if the recommendation is based on the idea that it is more safe or because it's less safe so it then discourages disconnecting.