as simple as it may seem....I'm curious to know what the frequency of cap changes are out there....no matter what cap...Do you change caps with tubing changes??blood draws? daily... weekly?
This is a huge interest of mine also. I know that the CDC guidelines states that injection caps should be changed at the same interval as changing the administration set. But if you follow the INS standards for changing primary intermittent tubing, then do you also change this cap at the same 24 hours? If you use an injection cap on primary continuous sets for the purpose of making tubing changes safer (not opening the line for air emboli, etc) then how do you change the injection cap? Lots of issues with this one. Lynn
This has been one of my concerns. I believe ireaching "target ZERO, it will necessitate some change to currenct guidelines . Many of the current protocols have developed as a result of inability to disinfect caps as well as inability to visualize flushing, reflux etc.. The MaxPlus Clear cap can be disinfected, and proper flushing can be visually confirmed. It can be flushed until clear and is designed to assist the nurse in maintaining best practice in protecting their lines. If the primary purpose of a needleless access cap is to protect that line from Infection/occlusions then why would we open every 24 hours. That would only be indicated if a cap was not doing it's "job" in protecting the line. The flat top permits disinfection and the clear housing of the MaxPlus Clear valve allows the IV team experts to assess for and moniter "Zero tolerance" to poor line maintenence. I have seen a significant improvement in practice with this valve. Dr. Jarvis was right, we just need to disinfect the lines, and see what we are doing with lines, it has made a huge difference in ease of educateing nurses to best practices of disinfecting, flushing and saline locking lines.
How long do you think it will it take for guidelines to change to reflect the new technology ? I'd like to see the MaxPlus Clear valve be considered part of the Line, keeping it closed and free of contamination rather than part of the tubing...it's just common sense.
First, it is important for you to understand that no set of guidelines or standards from any organization will address one brand of product alone.
Second, the purpose of the injection cap is not to protect the line from infection/occlusion as you stated. The purpose of injection caps was to facilitate intermittent infusions. I strongly believe it is a misuse of all needleless injection caps to place them in the line when there is a continuous infusion of fluids. There is no purpose of these caps when there is a continuous infusion because the set should only be disconnected once every 72 or 96 hours to change it. Adding a needleless connector in this set-up adds another luer connection, costs and makes it to easy to use a primary continuous set for intermittent use. When these sets are disconnected they become an intermittent set and require changing every 24 hours.
We know that all needleless connectors grow biofilm. So I do not think it should be considered as part of the line if you mean part of the catheter and never changed. Each time it is used introduces more bugs that grow more biofilm, so leaving it permanently attached is not the goal, in my opinion. Lynn
Our facility recently revised our policy to q 3 days (from q 6 days) to reflect the RNAO Best Practice Guidelines: "Recommendation 11.0Nurses will change all add-on devices at a minimum of every 72 hours. Level IV" (accessed at http://www.rnao.org/Storage/11/570_BPG_Reduce_Vascular_Access_Complications.pdf , page 36.) We do not routinely change our caps post-blood procurement- unless we are unable to clear our transparent caps of all visible blood. (There was much debate over the transition to q 3 days, as this necessitates increased hub manipulation & INS standards support a q7d change.)
The reality of the clinical setting is that connectors are being used on intravenous tubing. Many central venous catheters are multilumen and bifurcated extensions are popular with peripherals. Patient care has moved to intravenous route of administration. The MaxPlus that was mentioned is a positive pressure device. This classification of connectors has been shown to increase infection rates. Primarily because of the tortuous pathway required by the internal mechanism required to set up first the negative pressure at connection and then provide the positive pressure at disconnection. The Maxplus has a swabbable surface and has been shown to provide disinfection if the 3 second scrub is religiously followed.
However, minimizing surface contamination is only one piece of the puzzle. Dead space within the fluid pathway is an enormous problem and enhances bacterial colonization and biofilm formation. A wonderful well designed study by Guy Cook a biofilm expert can be viewed at Rymedtech.com. This study was not funded by any manufacturer and reviews many available connectors.
All connectors except the InVision-Plus Neutral connector have single barriers. They were designed to protect needlestick injury, be easy to use and with positive pressure reduce occlusion (caused by earlier connectors). Intraluminal fluid pathway protection has been shown to be necessary to prevent connector contamination. Straight fluid pathway, independent double microbial barrier, no dead space, and zero fluid displacement on connection or disconnection are required to impact the entire CR-BSI cascade.
Connectors are used. The selection process has been confusing. Understanding what design features impact outcome is vital. Marsha Ryder's presentation shows many internal workings of connectors. Swabability is only one piece of the puzzle.
Denise, You really need to acknowledge your relationship with Rymed esp. in light of your position in AVA. There is really NO truly neutral valve available at this time.
Jennifer Hopkins-Hyde this statement is blatantly false Zero fluid displacement IV connectors do exist. You should perform more professionally accurate and clinically appropriate due diligence on the entire field of needlefree technology before you make blanket assertions about any device over another. Where are your published studies or FDA 510(k) submitted documentation? Do not engage in what neither the ICU Medical nor Medegen Medical employee "RN" posts on this site care to do whether for the good of truth in manufacturer reporting or patient safety and outcome improvement.
The RyMed InVision-Plus Neutral IV connector also exhibits neutral pressure and carries a registered trademark on the term "neutral." Neutral Displacement is defined in their patent language as -0.000mL/+0.002mL immediately upon connection, and + or - 0.000mL immediately upon connection. http://rymedtech.com/
Both of these devices exhibit zero fluid displacement because neither contain dead space within the fluid pathway. Both offer an internal fluid spike or cannula whose internal fluid path volume is not "displaced" by the luer slip during access, entry.
The MicroClave by ICU Medical calls itself "neutral" with the subsequent caveat, "This means that there is virtually no reflux of blood into the catheter lumen either when you connect or disconnect an administration device." http://icumedical.com/micro-clave-connector.asp This is because, while the MicroClave does offer a dedicated internal cannula, the silicone seal or "sleeve" encompassing the fluid cannula still allows for "dead" volume capture at the proximal tip of the seal. This dead space is displaced when compressed by a luer slip. The MicroClave claims the lowest dead space of any needlefree connector (0.04mL). This is true. However, in order for a device to offer truly NEUTRAL or zero displacement there must exist ZERO dead space. Curiously, the MicroClave "Neutral" exhibits more negative fluid displacement upon disconnection than that of the original Clave.
When one performs a structured, uniform fluid displacement evaluation on all connectors, these fluid displacement phenomena are clearly identifiable and can be quantitatively measured and consistently repeated. There should, in fact, exist THREE classifications of devices; those offering negative displacement upon disconnection requiring a clamping sequence, those with negative displacement upon connection (positive pressure valves) requiring no clamping sequence, and those with ZERO displacement at neither connection NOR disconnection where NO change to clamping practice is needed.
All blood reflux cannot be eliminated. The IV connectors only impact that of mechanical reflux, not physiological. When repetitive reflux episodes during routine catheter/IV connector access occur, the repetitive cycling of blood along the intraluminal surface of the catheter accelerates the deposition of protein, blood fibrin, necessarily accelerating the process of or potential for occlusion. If the SASH method is used, 4 additional cycles of blood reflux will occur with any device carrying negative displacement. With the SAS method 3 refluxive episodes occur. With a 4-drug administration this equates to 16 or 12 cycles of blood in and out of the tip of the catheter respectively. These repetitive reflux episodes can contribute to intraluminal thrombotic catheter occlusion potential and can be mitigated by flushing. However, if these repeated episodes of intraluminal blood movement could be minimized or eliminated, it stands to reason that occlusion potential could thus be mitigated. Reduced intraluminal thrombotic occlusions have been reported with zero displacement devices. Conversely, "positive pressure" connectors, those displacing upon connection, generally reflux more as a device category than their "negative displacement upon disconnection" predecessors. This largely is due to the internal valve mechanism needed to provide the fluid expulsion upon disconnection. Luer-slip access depresses the internal "valve" into the fluid chamber, causing inner volume displacement which then fills the chamber with fluid in order to then expel or "push" the fluid outward upon disconncetion. This is why NO clamping sequence can be employed with positive pressure devices because clamping exhibits the requisite fluid expulsion during luer-slip exit.
Also, only IV connectors that offer a dedicated internal fluid pathway with ZERO dead space, i.e. the Bionector and InVision-Plus Neutral, can be effectively flushed with 10mL saline-only flush. Dead space cannot be effectively flushed or cleared. So the argument that since all devices allow blood penetration, passage through the connector during aspiration therefore ALL carry the same fibrin build-up and biofilm potential is invalid. RyMed publishes a blood clearing report at http://rymedtech.com/html/resources.htm and it shows 0.00 residual hemoglobin after only a 5mL normal saline flush. RyMed also posts an independent study correlating device priming volume as a predictor of biofilm formation. The Vygon did not appear in the study but the InVision-Plus Neutral was logarithmically superior. http://www.rymedtech.com/assets/SHEA_Clinical_Poster_LRG_0407.pdf The Clave's blood clearing report is published at http://icumedical.com/Docs-Clave/M1-1053-clave-blood.pdf and shows a residual blood volume of 28% in the wash post-flush. The study demonstrates that minimal residual hemoglobin was found in subsequent second, third or fourth flush-washes. Therefore, the deduction can be made clearly that the residual hemoglobin resides "dead" somewhere in the fluid path or system. No blood clearing reports are published online for the MicroClave. Such reports for the Bionector are not published online. However, Vygon does cite three "Laboratory Reports" relative to its device's testing. Of all the IV connector manufacturers posting information online, RyMed offers the most comprehensive, unbiased, educational information available. http://rymedtech.com/html/neutral_notes.htm
Fact. Rymed Invision causes blood reflux upon luer disconnection.
Also, you're ignoring a huge question. Why do nurses access valves in the first place? They do this to aspirate blood, deliver medication, and flush with saline. This makes your spin on positive displacement as (reflux on connection) an insignificant point. The blood that will enter the catheter upon connection is no different than when a nurse is checking for flashback on the placement of the line. I know you're trying to sell some Invision valves, but telling clinicians there is no clamping protocol for your negative displacement device could be putting patients at a higher risk for occlusion, infection, and possibly worse if that valve was to accidentally come off of a central line of an unconcious patient in the icu.
It's JUDITH, not Jennifer and I work for neither ICU Medical or Medegen. I work for the patients trying to find safety and quality care as well as engineers trying to develop a truly neutral valve - nigh impossible. My studies spanning 8 plus years indicate that there is NO TRULY NEUTRAL VALVE - for that matter even a needle on insertion has reflux; some are close, but they all have blood reflux on connection OR disconnection. A truly neutral valve would be a home run IF we nurses always swabbed on connection.
You are selling neutral in practice in that the nurse does not have to remember to clamp or not, but at this point in time, there is always blood movement in or out of the valve on connection or disconnection.
Always remember to question the Kool-Aid you are given with any product....
I have done the displacement studies myself and have seen first hand the reflux in the Rymed cap. The registered trademark for "neutral" does not mean the device is approved as neutal, it just mean that an application was submitted to trademark that name. I have just been to the FDA website and according to the searchable database for 510K submissions Invison Plus is a heparin-lock device. Bionector is the only device where neutral was submitted through the FDA. At the end of the day it is just best to test these things yourself.
we reference the manufacturer's guidelines for the frequency of our cap changes. Per those guidelines we change every 72 hours. We also change for withdrawal occlusions. Sometimes a cap change allows free blood flow.
This contradicts itself. If a cap has displacement at connection of up to +0.002 of ml how can there be a valid claim made of a cap having zero displacement at connection and disconnection when its reported as having as much as +0.002 of an ml displaced at connection. The definition of a negative cap is positive fluid outflow at connection and negative fluid inflow at disconnection.
when has any manufacturer of any intravenous products including needlefree caps ever indicated that it is not a function of their product, or the responsibility of their product to try and protect the line from infection or occlusion whenever their product is used?
It is the goal of healthcare professionals worldwide to be dedicated to protecting their patients through the application of evidence-based practices and products only.
Clinicians need to beware of the slick product marketing undertaken by manufacturers and their paid "clinicians" who are keenly adept at cherry-picking only what makes their products look good, misrepresenting others and likewise ignoring a full understanding, acknowledgement and presentation of all devices, features, their function and performance.
I have found only a few companies, unfortunately, in the LAD category that are truly concerned with patient safety and tell the whole story (or at least as much as they know) about their products and only 1 that seems to know the most about the true function of all products. Perhaps you should be a little more unbiased and patient safety driven in your research, Andre.
Significant potential harm is being done to patients by clinical and corporate-sponsored misrepresentation and intellectual dishonesty bordering on negligence.
There is an evolving body of worldwide evidence that does not support the use of positive displacement devices on patients because of the obstructions in the fluid path caused by pistons/plungers that deform upon luer activation, trap blood or meds, and act as BSI hazards due to biofilm formation.
I would direct all readers of this post to the following recent warning issued for positive displacement devices:
Positive displacement, needle-free intravascular connector valves PDF Version
Also see
Linda Michal RN, Sue Schilling RN, Nancy Hutchinson RN, MSN, CIC, and Brian Jacobs, MD. The Impact of Single Valve and Positive Pressure Valve Connectors on Occlusions in Children with Central Venous Catheters. Cincinnati Childrens MC. Posters and abstracts presented at AVA 2006. (I believe)
Field, McFarlane, Cheng et al. Incidence of CRBSI Among Patients With a Needleless, Mechanical Valve-Based INtravenous Connector in an Australian H-O Unit. ICHE May 2007, 28:5.
This is the kind of data that should be shared, discussed, and further investigated.
The value (and clarity) is in the data. These aren't precious gems; they're human beings who can die at the bedside.
We as a practice community invest a significant amount of time debating (including here) what is or is not "neutral." Certain manufacturers - and we all know who they are - have even attempted to use this issue as their primary marketing/sales tool. But is it valid? Is it, in fact, a significant issue? Does "neutral" even actually exist?
As one of many product specifications, it is (probably) worth noting. But is it for example as clinically significant as access site disinfection (a major clinical challenge)? Cap change frequency (a real conundrum!)? Flushing frequency (wide practice variation, just about everywhere you look!)? Other variables? We simply do not know.
The concept of "neutral" may or may not be important. We do know, from what has been published so far, that there are both positive and negative results with all sorts of needleless connectors. In the face of such diverse and often conflicting information, we are compelled - as one or more individuals have indicated here - to rely on the science, our own analysis and application to specific clinical populations/needs - rather than on sell sheets and marketing spin.
Is "neutral" really significant? Hmmm . . .
Well, in the absence of clear and compelling evidence I can only say: I'm from Missouri; you have to show me!
I care about my patients and my research is independent from any company, not everyone can say that........anyway, I am sure companies who like to use corn syrup instead of NS are very concernd about their patients, oh, I forgot, this is a 40 billion $ business. Give me a break! I am ok beeing insulted once, do it not twice!
Please identify yourself and clarify your response. I, for one, do not understand what you mean. Corn syrup? Personal insults? Who are you and what are you talking about?
Good post, Marilyn. I agree, and reposted my response from another forum topic.
I would also like to add that I've been following the bashing and insulting on this forum over the past few months, and would like to see it stop. I'd prefer to have each professional take responsibility for their own practice and contribute to this forum in a positive manner, instead of repeatedly hurling *&!! at each other. Agreeing to disagree is productive. Bringing uncontrolled emotional responses into a professional forum is not. Before posting anything, visualize yourself actually verbalizing your comments face to face with the person you are communicating with. If a lot of comments I've seen on this forum actually happened face to face, I think a few folks would have lost their jobs.
***********************
Neutral, almost neutral, not neutral, negative, better negative......I don't think it's helpful to spend a lot of energy determining value in relation to the terminology used to describe needleless access devices. We could spend a lot of time and energy debating the FDA, marketing and labeling, while the two most important considerations REALLY are:
1. How the LAD really functions - know how the device is designed, and how it works. Study them/read the studies. Take them apart. Compare them using tubing. Yes, neutral displacement may not be completely neutral. And positive displacement connectors may still have backflow into the catheter after the positive bolus has left the catheter and gone into the patient's bloodstream. So then what does it all mean.......?
2. How the connector impacts your quality data - occlusion and infection rates especially. Before you do that, though - you'd better have clear baseline data of your current status before implementing a new LAD, including audit data of staff nursing behavior. The LAD is one part of a complete IV system, with several human beings on the patient end of it.
Mari Cordes, BS RN
Nurse Educator IV Therapy
Fletcher Allen Health Care, Burlington VT
Mari Cordes, BS RNIII VA-BC
Vascular Access Department
University of Vermont Medical Center
In my opinion, the bottom line is that there are no guidelines from the FDA about what characteristics or criteria is required to be considered a neutral or positive or negative needleless connector. No organization has set any ground rules for how displacement is measured, how much is required to be considered positive, or what actually defines neutral. Until we have some more guidelines such as this, it becomes a marketing tool.
Wow, dare I add to this thread! Simply put, as a clinician I want as little blood as possible entering the distal end of the catheter unless I specifically want to withdraw blood. For this reason I really like the Rymed valve. In my experience it works well while keeping it very user friendly for the floor nurse who may not have(but should) the expertise of many of those who post on this site. I have no disclosures other than I think nursing is the most noble of professions and our postings here should reflect the same.
I'm curious, Stephen - I've never seen a Rymed connector in action. We've compared many different connectors as far as reflux goes. Have you used them long enough to gather any QA data about catheter occlusions and infection rates?
How does the amount of backflow compare with a Microclave?
Thanks in advance,
Mari
Mari Cordes, BS RN
Nurse Educator IV Therapy
Fletcher Allen Health Care, Burlington VT
Mari Cordes, BS RNIII VA-BC
Vascular Access Department
University of Vermont Medical Center
For 470 PICCs with Invision caps 3 occlusions, infection rate 0.4%. We used biopatch and Maximim sterile barrier precautions. It was interesting to note we trialed 3 new catheters during this time and I anticipated an increase in complications but there were none. I attribute this to the valves ease of use in regards to a clamping sequence with the floor nurses. The gaps in the microclaves luer connection were unacceptable to our team and we did not use them. There is a very slight reflux with the Rymed(almost imperceptable) but it does not seem to affect PICC occlusion from a clinical standpoint. We also pressure injected the valves with CT and did not have any problems. Hope this was helpful!
Well, as simple as you thought your question was, you can see it is not a simple issue.
all of the issues discussed show that this is a multi-faceted and complex problem and solution. Look at the data out there disputing complex vs simple fluid paths, swabability, reflux etc. Bottom line to me is that you need to work with the factors you can control, swab the heck out of your caps, change them in accordance to manufacturers guidelines which is a gray area since they usually state per your P&P so develop one that you have positive outcomes with. But the number one way to prevent reflux of any kind is to quit depending on a device or a valve to do it for us just flush using positive pressure and clamp prior to bottoming out the syringe and disconnecting and be sure your clamp is at the lowest possible point on your extension.
I still think the simplest cap is one that has nothing impeding the fluid path or making the device open except a cannula or luer connection and one we can actually see into to check for clearing blood and lipids.
Use of InVision Injection caps for 14 months with good results
We've been using InVision for over a year and we have seen our infection rate plumet to near zero. We don't have total control of our lines from insertion because they come from many hospitals in Oregon but we still have an incredibly low rate of infection. We still have zero infections from all PICC lines we have placed here. We use a 2 minute chlorhexidine scrub for insertion. We change the caps every 7 days or with each dressing change with biopatch. We do not change them after blood draws which means less direct line communication and potential contamination. We require glove use with all line entry. We change caps prior to blood cultures for good measure but have not seen a huge amount of contamination prior to doing that. The caps are slightly negative but we know that because they hold 0.02 mL and the amount of reflux seems to be directly related to the priming volume. We do flush while clamping the last 0.5 mL but we don't worry when agency staff come in and flush whatever way the facility they were used to does. We see about 4 varieties of caps come in from other facilities and ALL have been seen with blood residue in them if they are clear and each time I am glad we use a cap that has no crevices on the inside or the outside. There is a simple straw inside of the double microbial barrier so no moveable parts unless you call the top of a vial a moveable part. The nurses love the easy touch free packaging too. The caps have been shown to be disinfected with a 3-5 sec. alcohol scrub and dry and that is what we do. We change intermittent tubing every 72 hours which is controversal due to INS/CDC but our infection rates are fine. I chose this cap due to swabability, lowest dead space, low reflux, infection rate in another hospital using it (zero for over 3 years), total clearing of blood with 4 mL, and examination and literature study of almost all other caps on the market. We do not use heparin except for deaccess of an implanted port and for dialysis catheters. We flush all lines with 10 mL BID and we check blood return with each flush. We flush 20 mL after labs. We have never seen any coring. Hope this answers all the comments from my point of view.
Lynn Hadaway, M.Ed., RN, CRNI
Lynn Hadaway Associates, Inc.
PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
Hi Lynn,
This has been one of my concerns. I believe ireaching "target ZERO, it will necessitate some change to currenct guidelines . Many of the current protocols have developed as a result of inability to disinfect caps as well as inability to visualize flushing, reflux etc.. The MaxPlus Clear cap can be disinfected, and proper flushing can be visually confirmed. It can be flushed until clear and is designed to assist the nurse in maintaining best practice in protecting their lines. If the primary purpose of a needleless access cap is to protect that line from Infection/occlusions then why would we open every 24 hours. That would only be indicated if a cap was not doing it's "job" in protecting the line. The flat top permits disinfection and the clear housing of the MaxPlus Clear valve allows the IV team experts to assess for and moniter "Zero tolerance" to poor line maintenence. I have seen a significant improvement in practice with this valve. Dr. Jarvis was right, we just need to disinfect the lines, and see what we are doing with lines, it has made a huge difference in ease of educateing nurses to best practices of disinfecting, flushing and saline locking lines.
How long do you think it will it take for guidelines to change to reflect the new technology ? I'd like to see the MaxPlus Clear valve be considered part of the Line, keeping it closed and free of contamination rather than part of the tubing...it's just common sense.
Thanks,
Chonna Bartholomew, RN BS
First, it is important for you to understand that no set of guidelines or standards from any organization will address one brand of product alone.
Second, the purpose of the injection cap is not to protect the line from infection/occlusion as you stated. The purpose of injection caps was to facilitate intermittent infusions. I strongly believe it is a misuse of all needleless injection caps to place them in the line when there is a continuous infusion of fluids. There is no purpose of these caps when there is a continuous infusion because the set should only be disconnected once every 72 or 96 hours to change it. Adding a needleless connector in this set-up adds another luer connection, costs and makes it to easy to use a primary continuous set for intermittent use. When these sets are disconnected they become an intermittent set and require changing every 24 hours.
We know that all needleless connectors grow biofilm. So I do not think it should be considered as part of the line if you mean part of the catheter and never changed. Each time it is used introduces more bugs that grow more biofilm, so leaving it permanently attached is not the goal, in my opinion. Lynn
Lynn Hadaway, M.Ed., RN, BC, CRNI
www.hadawayassociates.com
Lynn Hadaway, M.Ed., RN, CRNI
Lynn Hadaway Associates, Inc.
PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
We recently changed the procedure at our Health System to every three days and after blood infusions. We wanted after blood draws, but lost out.
Thanks,
Julie
Our policy for Home infusion is Weekly, after each blood draw(because blood can stay in the crevices of the cap) and Prn.
Daphne Broadhurst
Desjardins Pharmacy
Ottawa, Canada
The reality of the clinical setting is that connectors are being used on intravenous tubing. Many central venous catheters are multilumen and bifurcated extensions are popular with peripherals. Patient care has moved to intravenous route of administration. The MaxPlus that was mentioned is a positive pressure device. This classification of connectors has been shown to increase infection rates. Primarily because of the tortuous pathway required by the internal mechanism required to set up first the negative pressure at connection and then provide the positive pressure at disconnection. The Maxplus has a swabbable surface and has been shown to provide disinfection if the 3 second scrub is religiously followed.
However, minimizing surface contamination is only one piece of the puzzle. Dead space within the fluid pathway is an enormous problem and enhances bacterial colonization and biofilm formation. A wonderful well designed study by Guy Cook a biofilm expert can be viewed at Rymedtech.com. This study was not funded by any manufacturer and reviews many available connectors.
All connectors except the InVision-Plus Neutral connector have single barriers. They were designed to protect needlestick injury, be easy to use and with positive pressure reduce occlusion (caused by earlier connectors). Intraluminal fluid pathway protection has been shown to be necessary to prevent connector contamination. Straight fluid pathway, independent double microbial barrier, no dead space, and zero fluid displacement on connection or disconnection are required to impact the entire CR-BSI cascade.
Connectors are used. The selection process has been confusing. Understanding what design features impact outcome is vital. Marsha Ryder's presentation shows many internal workings of connectors. Swabability is only one piece of the puzzle.
Denise
Jennifer Hopkins-Hyde this statement is blatantly false Zero fluid displacement IV connectors do exist. You should perform more professionally accurate and clinically appropriate due diligence on the entire field of needlefree technology before you make blanket assertions about any device over another. Where are your published studies or FDA 510(k) submitted documentation? Do not engage in what neither the ICU Medical nor Medegen Medical employee "RN" posts on this site care to do whether for the good of truth in manufacturer reporting or patient safety and outcome improvement.
The Vygon Bionector was introduced in the early, mid-1990s and is the first needle-free IV connector to exhibit "neutral" pressure. http://www.vygonusa.com/bionector-needleless-access.htm
The RyMed InVision-Plus Neutral IV connector also exhibits neutral pressure and carries a registered trademark on the term "neutral." Neutral Displacement is defined in their patent language as -0.000mL/+0.002mL immediately upon connection, and + or - 0.000mL immediately upon connection. http://rymedtech.com/
Both of these devices exhibit zero fluid displacement because neither contain dead space within the fluid pathway. Both offer an internal fluid spike or cannula whose internal fluid path volume is not "displaced" by the luer slip during access, entry.
The MicroClave by ICU Medical calls itself "neutral" with the subsequent caveat, "This means that there is virtually no reflux of blood into the catheter lumen either when you connect or disconnect an administration device." http://icumedical.com/micro-clave-connector.asp This is because, while the MicroClave does offer a dedicated internal cannula, the silicone seal or "sleeve" encompassing the fluid cannula still allows for "dead" volume capture at the proximal tip of the seal. This dead space is displaced when compressed by a luer slip. The MicroClave claims the lowest dead space of any needlefree connector (0.04mL). This is true. However, in order for a device to offer truly NEUTRAL or zero displacement there must exist ZERO dead space. Curiously, the MicroClave "Neutral" exhibits more negative fluid displacement upon disconnection than that of the original Clave.
When one performs a structured, uniform fluid displacement evaluation on all connectors, these fluid displacement phenomena are clearly identifiable and can be quantitatively measured and consistently repeated. There should, in fact, exist THREE classifications of devices; those offering negative displacement upon disconnection requiring a clamping sequence, those with negative displacement upon connection (positive pressure valves) requiring no clamping sequence, and those with ZERO displacement at neither connection NOR disconnection where NO change to clamping practice is needed.
All blood reflux cannot be eliminated. The IV connectors only impact that of mechanical reflux, not physiological. When repetitive reflux episodes during routine catheter/IV connector access occur, the repetitive cycling of blood along the intraluminal surface of the catheter accelerates the deposition of protein, blood fibrin, necessarily accelerating the process of or potential for occlusion. If the SASH method is used, 4 additional cycles of blood reflux will occur with any device carrying negative displacement. With the SAS method 3 refluxive episodes occur. With a 4-drug administration this equates to 16 or 12 cycles of blood in and out of the tip of the catheter respectively. These repetitive reflux episodes can contribute to intraluminal thrombotic catheter occlusion potential and can be mitigated by flushing. However, if these repeated episodes of intraluminal blood movement could be minimized or eliminated, it stands to reason that occlusion potential could thus be mitigated. Reduced intraluminal thrombotic occlusions have been reported with zero displacement devices. Conversely, "positive pressure" connectors, those displacing upon connection, generally reflux more as a device category than their "negative displacement upon disconnection" predecessors. This largely is due to the internal valve mechanism needed to provide the fluid expulsion upon disconnection. Luer-slip access depresses the internal "valve" into the fluid chamber, causing inner volume displacement which then fills the chamber with fluid in order to then expel or "push" the fluid outward upon disconncetion. This is why NO clamping sequence can be employed with positive pressure devices because clamping exhibits the requisite fluid expulsion during luer-slip exit.
Also, only IV connectors that offer a dedicated internal fluid pathway with ZERO dead space, i.e. the Bionector and InVision-Plus Neutral, can be effectively flushed with 10mL saline-only flush. Dead space cannot be effectively flushed or cleared. So the argument that since all devices allow blood penetration, passage through the connector during aspiration therefore ALL carry the same fibrin build-up and biofilm potential is invalid. RyMed publishes a blood clearing report at http://rymedtech.com/html/resources.htm and it shows 0.00 residual hemoglobin after only a 5mL normal saline flush. RyMed also posts an independent study correlating device priming volume as a predictor of biofilm formation. The Vygon did not appear in the study but the InVision-Plus Neutral was logarithmically superior. http://www.rymedtech.com/assets/SHEA_Clinical_Poster_LRG_0407.pdf The Clave's blood clearing report is published at http://icumedical.com/Docs-Clave/M1-1053-clave-blood.pdf and shows a residual blood volume of 28% in the wash post-flush. The study demonstrates that minimal residual hemoglobin was found in subsequent second, third or fourth flush-washes. Therefore, the deduction can be made clearly that the residual hemoglobin resides "dead" somewhere in the fluid path or system. No blood clearing reports are published online for the MicroClave. Such reports for the Bionector are not published online. However, Vygon does cite three "Laboratory Reports" relative to its device's testing. Of all the IV connector manufacturers posting information online, RyMed offers the most comprehensive, unbiased, educational information available. http://rymedtech.com/html/neutral_notes.htm
Clearthemud,
Fact. Rymed Invision causes blood reflux upon luer disconnection.
Also, you're ignoring a huge question. Why do nurses access valves in the first place? They do this to aspirate blood, deliver medication, and flush with saline. This makes your spin on positive displacement as (reflux on connection) an insignificant point. The blood that will enter the catheter upon connection is no different than when a nurse is checking for flashback on the placement of the line. I know you're trying to sell some Invision valves, but telling clinicians there is no clamping protocol for your negative displacement device could be putting patients at a higher risk for occlusion, infection, and possibly worse if that valve was to accidentally come off of a central line of an unconcious patient in the icu.
Brian Colby
Maximus Medical
It's JUDITH, not Jennifer and I work for neither ICU Medical or Medegen. I work for the patients trying to find safety and quality care as well as engineers trying to develop a truly neutral valve - nigh impossible. My studies spanning 8 plus years indicate that there is NO TRULY NEUTRAL VALVE - for that matter even a needle on insertion has reflux; some are close, but they all have blood reflux on connection OR disconnection. A truly neutral valve would be a home run IF we nurses always swabbed on connection.
You are selling neutral in practice in that the nurse does not have to remember to clamp or not, but at this point in time, there is always blood movement in or out of the valve on connection or disconnection.
Always remember to question the Kool-Aid you are given with any product....
JUDITH HOPKINS-HYDE, RN
we reference the manufacturer's guidelines for the frequency of our cap changes. Per those guidelines we change every 72 hours. We also change for withdrawal occlusions. Sometimes a cap change allows free blood flow.
We change ours every 3 days with our tubing changes.
Jose Delp RN BSN
Clinical coordinator IV Team
Upper Chesapeake Health
Jose Delp RN BSN
CliClinical Nurse Manager IV Team
Upper Chesapeake Health
Every 3 day's and/or with every tubing change
After blood draws if they are done with cap
prn if contamination is visible
when has any manufacturer of any intravenous products including needlefree caps ever indicated that it is not a function of their product, or the responsibility of their product to try and protect the line from infection or occlusion whenever their product is used?
I have to disagree here as well. I know Rymed will not like my answer again, sorry guys and clearthemud.
At this time we don't have a TRUE neutral LAD ( Luer Activated Device).
I agree and will give the credit that the Clave and the InVision are the better negative LAD's but not neutral ( but close).
So, I know it is about definition. Think about it, you can be pregnant or not pregnant. There is not such a thing like a little bit pregnant.
Anyway, we change every 3 day's with tubing change and with our dressing change and prn.
Andre
It is the goal of healthcare professionals worldwide to be dedicated to protecting their patients through the application of evidence-based practices and products only.
Clinicians need to beware of the slick product marketing undertaken by manufacturers and their paid "clinicians" who are keenly adept at cherry-picking only what makes their products look good, misrepresenting others and likewise ignoring a full understanding, acknowledgement and presentation of all devices, features, their function and performance.
I have found only a few companies, unfortunately, in the LAD category that are truly concerned with patient safety and tell the whole story (or at least as much as they know) about their products and only 1 that seems to know the most about the true function of all products. Perhaps you should be a little more unbiased and patient safety driven in your research, Andre.
Significant potential harm is being done to patients by clinical and corporate-sponsored misrepresentation and intellectual dishonesty bordering on negligence.
There is an evolving body of worldwide evidence that does not support the use of positive displacement devices on patients because of the obstructions in the fluid path caused by pistons/plungers that deform upon luer activation, trap blood or meds, and act as BSI hazards due to biofilm formation.
I would direct all readers of this post to the following recent warning issued for positive displacement devices:
http://www.va.gov/NCPS/alerts.html
PDF Version
Also see
Linda Michal RN, Sue Schilling RN, Nancy Hutchinson RN, MSN, CIC, and Brian Jacobs, MD. The Impact of Single Valve and Positive Pressure Valve Connectors on Occlusions in Children with Central Venous Catheters. Cincinnati Childrens MC. Posters and abstracts presented at AVA 2006. (I believe)
Field, McFarlane, Cheng et al. Incidence of CRBSI Among Patients With a Needleless, Mechanical Valve-Based INtravenous Connector in an Australian H-O Unit. ICHE May 2007, 28:5.
This is the kind of data that should be shared, discussed, and further investigated.
The value (and clarity) is in the data. These aren't precious gems; they're human beings who can die at the bedside.
We as a practice community invest a significant amount of time debating (including here) what is or is not "neutral." Certain manufacturers - and we all know who they are - have even attempted to use this issue as their primary marketing/sales tool. But is it valid? Is it, in fact, a significant issue? Does "neutral" even actually exist?
As one of many product specifications, it is (probably) worth noting. But is it for example as clinically significant as access site disinfection (a major clinical challenge)? Cap change frequency (a real conundrum!)? Flushing frequency (wide practice variation, just about everywhere you look!)? Other variables? We simply do not know.
The concept of "neutral" may or may not be important. We do know, from what has been published so far, that there are both positive and negative results with all sorts of needleless connectors. In the face of such diverse and often conflicting information, we are compelled - as one or more individuals have indicated here - to rely on the science, our own analysis and application to specific clinical populations/needs - rather than on sell sheets and marketing spin.
Is "neutral" really significant? Hmmm . . .
Well, in the absence of clear and compelling evidence I can only say: I'm from Missouri; you have to show me!
Marilyn Hanchett RN
I care about my patients and my research is independent from any company, not everyone can say that........anyway, I am sure companies who like to use corn syrup instead of NS are very concernd about their patients, oh, I forgot, this is a 40 billion $ business. Give me a break! I am ok beeing insulted once, do it not twice!
Andre
Please identify yourself and clarify your response. I, for one, do not understand what you mean. Corn syrup? Personal insults? Who are you and what are you talking about?
Marilyn Hanchett RN
Good post, Marilyn. I agree, and reposted my response from another forum topic.
I would also like to add that I've been following the bashing and insulting on this forum over the past few months, and would like to see it stop. I'd prefer to have each professional take responsibility for their own practice and contribute to this forum in a positive manner, instead of repeatedly hurling *&!! at each other. Agreeing to disagree is productive. Bringing uncontrolled emotional responses into a professional forum is not. Before posting anything, visualize yourself actually verbalizing your comments face to face with the person you are communicating with. If a lot of comments I've seen on this forum actually happened face to face, I think a few folks would have lost their jobs.
***********************
Neutral, almost neutral, not neutral, negative, better negative......I don't think it's helpful to spend a lot of energy determining value in relation to the terminology used to describe needleless access devices. We could spend a lot of time and energy debating the FDA, marketing and labeling, while the two most important considerations REALLY are:
1. How the LAD really functions - know how the device is designed, and how it works. Study them/read the studies. Take them apart. Compare them using tubing. Yes, neutral displacement may not be completely neutral. And positive displacement connectors may still have backflow into the catheter after the positive bolus has left the catheter and gone into the patient's bloodstream. So then what does it all mean.......?
2. How the connector impacts your quality data - occlusion and infection rates especially. Before you do that, though - you'd better have clear baseline data of your current status before implementing a new LAD, including audit data of staff nursing behavior. The LAD is one part of a complete IV system, with several human beings on the patient end of it.
Mari Cordes, BS RN
Mari Cordes, BS RNIII VA-BC
Vascular Access Department
University of Vermont Medical Center
In my opinion, the bottom line is that there are no guidelines from the FDA about what characteristics or criteria is required to be considered a neutral or positive or negative needleless connector. No organization has set any ground rules for how displacement is measured, how much is required to be considered positive, or what actually defines neutral. Until we have some more guidelines such as this, it becomes a marketing tool.
Lynn Hadaway, M.Ed., RN, BC, CRNI
www.hadawayassociates.com
Lynn Hadaway, M.Ed., RN, CRNI
Lynn Hadaway Associates, Inc.
PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
Wow, dare I add to this thread! Simply put, as a clinician I want as little blood as possible entering the distal end of the catheter unless I specifically want to withdraw blood. For this reason I really like the Rymed valve. In my experience it works well while keeping it very user friendly for the floor nurse who may not have(but should) the expertise of many of those who post on this site. I have no disclosures other than I think nursing is the most noble of professions and our postings here should reflect the same.
Stephen Harris RN, CRNI
Stephen Harris RN, CRNI, VA-BC
Chief Clinical Officer
Carolina Vascular Wellness
I'm curious, Stephen - I've never seen a Rymed connector in action. We've compared many different connectors as far as reflux goes. Have you used them long enough to gather any QA data about catheter occlusions and infection rates?
How does the amount of backflow compare with a Microclave?
Thanks in advance,
Mari
Mari Cordes, BS RN
Mari Cordes, BS RNIII VA-BC
Vascular Access Department
University of Vermont Medical Center
Stephen Harris RN, CRNI
For 470 PICCs with Invision caps 3 occlusions, infection rate 0.4%. We used biopatch and Maximim sterile barrier precautions. It was interesting to note we trialed 3 new catheters during this time and I anticipated an increase in complications but there were none. I attribute this to the valves ease of use in regards to a clamping sequence with the floor nurses. The gaps in the microclaves luer connection were unacceptable to our team and we did not use them. There is a very slight reflux with the Rymed(almost imperceptable) but it does not seem to affect PICC occlusion from a clinical standpoint. We also pressure injected the valves with CT and did not have any problems. Hope this was helpful!
Stephen Harris RN, CRNI, VA-BC
Chief Clinical Officer
Carolina Vascular Wellness
Yes, thank you Stephen. When you refer to the gaps in the microclave's luer connection, what do you mean?
Mari Cordes, BS RN
Mari Cordes, BS RNIII VA-BC
Vascular Access Department
University of Vermont Medical Center
Well, as simple as you thought your question was, you can see it is not a simple issue.
all of the issues discussed show that this is a multi-faceted and complex problem and solution. Look at the data out there disputing complex vs simple fluid paths, swabability, reflux etc. Bottom line to me is that you need to work with the factors you can control, swab the heck out of your caps, change them in accordance to manufacturers guidelines which is a gray area since they usually state per your P&P so develop one that you have positive outcomes with. But the number one way to prevent reflux of any kind is to quit depending on a device or a valve to do it for us just flush using positive pressure and clamp prior to bottoming out the syringe and disconnecting and be sure your clamp is at the lowest possible point on your extension.
I still think the simplest cap is one that has nothing impeding the fluid path or making the device open except a cannula or luer connection and one we can actually see into to check for clearing blood and lipids.
We've been using InVision for over a year and we have seen our infection rate plumet to near zero. We don't have total control of our lines from insertion because they come from many hospitals in Oregon but we still have an incredibly low rate of infection. We still have zero infections from all PICC lines we have placed here. We use a 2 minute chlorhexidine scrub for insertion. We change the caps every 7 days or with each dressing change with biopatch. We do not change them after blood draws which means less direct line communication and potential contamination. We require glove use with all line entry. We change caps prior to blood cultures for good measure but have not seen a huge amount of contamination prior to doing that. The caps are slightly negative but we know that because they hold 0.02 mL and the amount of reflux seems to be directly related to the priming volume. We do flush while clamping the last 0.5 mL but we don't worry when agency staff come in and flush whatever way the facility they were used to does. We see about 4 varieties of caps come in from other facilities and ALL have been seen with blood residue in them if they are clear and each time I am glad we use a cap that has no crevices on the inside or the outside. There is a simple straw inside of the double microbial barrier so no moveable parts unless you call the top of a vial a moveable part. The nurses love the easy touch free packaging too. The caps have been shown to be disinfected with a 3-5 sec. alcohol scrub and dry and that is what we do. We change intermittent tubing every 72 hours which is controversal due to INS/CDC but our infection rates are fine. I chose this cap due to swabability, lowest dead space, low reflux, infection rate in another hospital using it (zero for over 3 years), total clearing of blood with 4 mL, and examination and literature study of almost all other caps on the market. We do not use heparin except for deaccess of an implanted port and for dialysis catheters. We flush all lines with 10 mL BID and we check blood return with each flush. We flush 20 mL after labs. We have never seen any coring. Hope this answers all the comments from my point of view.
Michelle Todd, CRNI--Head PICC Nurse, Vibra Specialty Hospital of Portland [email protected]