My facility is using a negative pressure clave for peripheral and central lines. I am trying to understand why this would be beneficial, or is this just a left over that we have never updated?
The Clave has a negative displacement of up to 0.02cc. It actually decreases with repeated use. Most facilities use Clave on peripherals with saline only without any problems. There are also facilities that use them on central lines also saline only. The Clave however does not have a saline only claim. The MicroCLAVE has the FDA Saline-only claim and can be used on all lines without heparin. It is a neutral displacement connector. It offers you the Saline Flush needed for HIT prevention while having the best infection control profile availible. Contact your ICU Medical rep at http://www.icumed.com/PSR/mappage-hospital.asp
Is there any data about the occlusion rates with the Microclave? I haven't seen anything yet. Tom, do you have info to support impact of the Microclave on occlusion rates?
It was just just this past year that we received the 510(K) for saline flush only on MicroCLAVE. We are not complete on true clinical trials that as you know can take time. There are users of both MicroCLAVE and CLAVE that use saline flush only without occlusion issues. It has been well stated on this site that occlusions are multifactorial with the needleless connector being 1 part of the equation. MicroCLAVE is neutral with no reflux at the catheter end upon connection or disconnection. For further assistance contact your local rep for samples/support.
I was looking on the FDA website for the MicroClave 510K and I can't find anything. Can you please point me in the right direction. I am interested in the saline only flush.
I am also interested in seeing this 510K for the Microclave, not the original Clave, which is the only one I can find from the FDA. Also, can you post some documentation about the FDA supporting a "neutral claim" for the microclave. I am so confused between all these negative/neutral claims. Thank you.
The micro clave is not neutral and in actuality has more reflux than the clave . There is only one connector that has zero/neutral fluid displacement with connection or disconnection and that is the InVision-Plus Neutral IV connector by RyMed. All other connectors have reflux. With positive pressure connectors the reflux is with connection. In order to have a positive pressure upon disconnection and equal but opposit (negative pressure) must happen at connection. With connectors such as the clave the reflux occurs with disconnection. If there is a clamping secquence direction there is a reflux. Regardless of the slight of hand or the definition of neutral etc. the truth of the matter is there is only one connector that has no reflux at connection or disconnection. It is the InVision Plus. This i s the result of the design. For more information go to rymedtech.com.
I don't think that I can agree with you about the Microclave creating more reflux than the Clave. In our testing, we did compare many caps. The Microclae didn't have a greater reflux than the Clave.
We also tested against the Rymed product and found minimal difference between the Microclave and the Rymed product.
We are waiting for more info about studies on both about the decrease in occlusions. We need more information.
[quote=Cheryl Barrett]My facility is using a negative pressure clave for peripheral and central lines. I am trying to understand why this would be beneficial, or is this just a left over that we have never updated? [/quote]
My thought would be that it just hasn't been updated, since you wouldn't want anything that is a "negative" pressure. We have chosen the RyMed Invision-Plus Neutral for several reasons. Along with our Clinical Engineering and Infection Control Departments, we tested 11 products on the market and found the RyMed superior in the following ways: It was the ONLY one that was "clean" under blacklight after using a "bug glow" product provided by infection control team, it has one of the smallest priming volumes and dead spaces, it has zero displacement upon connection AND disconnection, it has a straight through pathway and has no special clamping technique to work properly. I wouldn't recommend anything that is "negative" with either connection or disconnection. This is easy to test with microbore tubing and colored water flushing well and connecting/disconnecting the syringe. Our tests showed the RyMed and the BioNector as the only ones that showed zero displacement. Good Luck with your choice. Laura
I amm sorry you do not believe me. It is true. The microclave is not neutral. In fact it has more reflux than other ICU products. As far as occlusion The RyMed has demonstrated occlusion reduction. Visit rymedtech.com and see Karen White Poster. While not published it has out performed other connectors in head to head trials. Low prining volume and straight fluid pathway with no dead space make flushing successful in completely cleaning the pathway. The InVision-Plus is the only connector with two independent microbial barriers. It is a new approach to protecting the fluid pathway and institutions such as Duke, and Vanderbilt have done extensive testing and found that this new design lowers infection rates and occlusion rates. It is extremely popular in the NEONate and Pediatric populations (low priming volume) and has been associated with zero CRBSI rates. Like the shift from needles to needleless, the new shift is from needleless to protected fluid pathway.
I regret to inform you that MicroCLAVE is indeed classified as neutral and does not "has more reflux than other ICU products". Microclave has a deadspace of less than 0.04cc's. There are no coring issues with Clave products. Clave products are proven to reduce CR-BSI and with CLC2000 to maintain catheter patency. The Clave products also have flow rates greater than that of an 18 gauge catheter, thereby allowing them to be used in critical care/trauma situations. The Clave was the first with a dedicated sterile internal fluid pathway and remains unique with it's reverse slit septum/blunt cannula system. Clave has a proven 14 year history. I don't believe that this forum should be used by us manufacturer's to banter back and forth. I usually refrain from such and just answer or clarify clinicians queries.
I agree with you Tom that manufacturures shoud not use this forum for banter, but we have to jump in when other companies use buzzwords like "neutral pressure" to create a market for their product when these devices are in fact negative. All connectors are neutral if they are clamped before disconnection. As you know, the microclave uses the same 510K as the regular clave and is not approved for a saline only flush. This is because they are virtually the same product. The thinner housing on the microclave reduces it's deadspace by only 2 one hundredths of a mL (not enough to be clinically significant as 1 drop is 0.05mL) This is less than a half of a drop difference. Also, neither the clave or the microclave have passed the newest stringent 2005 FDA recommendations for microbial contamination. The mechanism of action for these two valves is the same. Also, what are you comparing the 14 year infection record of the clave to? If it is the national infection rate compared to the previous blunt cannula systems, the BSI rate with the clave has risen significantly due to the top that can not be thoroughly disinfected while swabbing. I am not plugging my own product here, but am stating facts. I appreciate you're passion in selling your products and respect you as a colleague, but we really need to stop selling confusion and stick to the facts.
You are incorrect on many points and with that you are creating the confusion. You did not state facts but opinion. MicroClave has a saline flush claim on the 510K it shares with Clave. The deadspace is different but not because of "thinner housing". The surface of the MicroClave can be disinfected. Our microbial challenge is with P. Ariginosa which is more stringent than what has been required. There are multiple independant studies that show that the Clave reduces infection and these are not just vs a blunt system. There has NOT been an increase in BSI with Clave. Again, this is banter between manufacturers.
The clave did not pass this test. The testing that you are referencing uses sterile syringes for each flush, which does not happen in the real world.
As to the microclave surface, it is identical to the clave surface, which can be visualized on this link after vigorous scrubbing with 70% ipa. Notice how it can not be cleaned effectively. http://www.maximusmedical.com/bloodstream_challenge_photos.htm
Also, how is the deadspace different? Look at a cross section of the clave and microclave to see they are virtually the identical on the inside. The microclave is simply a re-branded version of the clave. It is still negative displacement, has the same surface, fluidpath, and mechanism of action. The early marketing pieces for microclave didn't even call it "neutral." This was added later to compete with Rymed invision. The piece actually read "The most significant feature of the Microclave is the new streamlined design of the outer housing." There were no saline only or neutral displacement claims.
These are facts, supported by literature. I hope this clears up any confusion.
There is not such a thing like a neutral luer activated device.
Strong words, right?
Simply remember the good old 80!
Did we not disconnect our syringe during flushing? We found out the benefit from a positive pressure, so why would we use something else 20 years later?
By the way, if you claim that there is a change in your performance, you need the FDA approval. You changed from a negative pressure to a neutral pressure and the performance did not changed. And again, there is not one neutral LAD who will perform like the name says!
There are more studies nessessary, and the new SOLO from Bard performce perfect with a positive LAD and not with the MicroClave.
These needleless connectors are not "approved" by the FDA. They are cleared for market, which means that they have been compared to a predicate device (a similar device that is already on the US market) and that comparison shows "substantial equivalence." This is the hurdle that a device coming to market through the 510K process has to meet. There is no performance standard that a product has to meet.
Andre, The problem with positive pressure valves is the physics. In order to push something out of any valve on disconnection, there must be something to push out. So with a positive pressure valve, there is blood drawn into the valve upon connection of the syringe to the valve. Who knows how much blood (and possibly bacteria) is left inside the nooks and crannies of the valve upon disconnection? Some hospitals have experienced an increase in CRBSI when changing to a positive pressure valve (maragakas). That's why a TRULY neutral valve would be the home run!!
It is quite surprising that there is so much misinformation. In fact there are two truly neutral connectors that have zero reflux with connection or disconnection - InVision-Plus Neutral and Bionector. All others have reflux with connection or disconnection. The positive pressure (connection) blame it on Newton. It is a law of physics that for every action there must be an equal opposite reaction. With non positive pressure connectors the reason for the reflux (disconnection) is the fluid pathway design. The reason the neutral devices have zero fluid movement is design. With the InVision Plus the fluid pathway is straight and has no deadspace. The microclave is not neutral. It is virtually neutral and states that in the literature. When choosing a connector until the InVision Plus all connectors were designed to do just that connect. Safely, needle free, and with ease. Now the demand is for connection and protection. Intraluminal fluid pathway protection. Single barrriers do not protect. Double, independent microbial barriers with zero reflux on connection or disconnection do. It is design not a plot. The 21st century is here and intraluminal fluid pathway protection is the new standard.
I have heard good things about the invision plus neutral valve, but we have not tried it. Do you know if the cost is similar to a positive pressure valve? Thanks, Amy
During insertion you check for blood return, this will be the first contact. Yes, physics, I agree. But everything stays and falls with bedside nursing. Maybe we should start and change the cap everytime we use the line....If you don't clean it like you should, it doesn't matter, you can have a 500$ cap, if nurses don't clean it, here is your infection. I don't have any experience with an increase of infection with positive LAD's.
I still believe, going back to physics, there is not such a thing like a neutral LAD! like you said, for every action is an interaction.
These people who are saying that the Microclave and Invision are neutral are trying to speak it into existance. The fact that these valves are negative displacement upon disconnection irrefutable. Also, these same people say that it is a bad thing for positive dispacement valves to have blood enter the catheter upon luer connection and that no blood should ever touch in inner lumen of the catheter. Blood enters the lumen when the catheter is inserted (ie. checking for flash back), and when a luer is attached to the valve, something is being infused, thus the blood that enetered upon connection is immediately evacuated from the valve and lumen. Negative and "neutral" valves leave blood in the lumen after the valve and catheter have been flushed. What happens when this blood sits stagnant in the catheter? Coagulation which leads to fibrin formation, occlusions, and increases the risk for blood stream infections due to biofilm buildup which serves as a wonderful growth media for bacteria.
Perhaps all needlefree connectors should be categorized as either positive or negative. the negative caps have positive outflows at connection and the negative inflows at the disconnection, without nurse intervention. a positive cap will exert negative inflow at its connection and positive outflow at disconnection. could it be that a positive cap may be a reverse negative cap since it has the same physical properties but they now occur at the opposite end of the activity when it maybe less critical as many argue that positive outlow at disconnection is preferred over a negative inflow at disconnection. Perhaps a cap with a small level of negative inflow does not have blood inflow at disconnection measurable at the 1/100 of cc level. but what if there was inflow at a disconnection which could be measured at 1/1000 of a cc or even at 1/10000 of cc? some might say that is virtually none. so if inflow at disconnection is labelled as virtually none even if there is some amount of measurable blood at 1/1000 or 1/10000 of cc range, is it still necessary for a nurse to intervene at a disconnection? just how much blood inflow could occur at 1/1000 or 1/10000 of cc level? this is a small but if it occurs at disconnection it makes a virtually zero cap only a less negative than others cap. is information available in writing that there is absolutely zero amount of negative inflow at disconnection and the amount stated does not include any rounding down of some measureable amount to zero even out to 5 or 6 decimal places? it may be that almost all needlefree connectors in the absence of nursing intervention provide a small but measurable amount of negative inflow.
REGARDING MIS INFORMATION, THE INVISION PLUS DEMONSTRATED IN THE STUDY THAT THE PERFORMANCE IS NEGATIVE. THE BIONECTOR IS IS ONE OF THE BETTER NEUTRAL LAD'S AND HAS LESS REFLUX THAN ALL THE OTHER "NEUTRAL" LAD'S BUT STILL IS A NEGATIVE CAP.
The Vygon Bionector and the RyMed Technologies InVision-Plus Neutral are the ONLY IV devices on the market that exhibit ZERO displacement upon connection or disconnection.
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.
I have found that when in doubt.... try it yourself and you will see if it does or does not have reflux. I have a sample of every valve out there and it is very easy for me to tyr it myself and then I have first hand experience in seeing yea or nay on reflux.
This recall may give us a better understanding of what system does what. I doubt it. the key here folks is focus your efforts on heparin and if need be heparin alternatives regardless of what system you use.
Talk to your pharmacist
Go to the Ameican Society of Hospital Pharmacists website and review their alternatives to heparin table.
Heparin will only be shipped weekly by APP. quantities may be limited. I have hospitals that are out of heparin or their pharmacists are wisely conserving the heparin
Did you all now get my point. This stated Monday. You have not experienced what I think is coming. Let's hope I am just Chicken Little today and that the heparin sky is not falling or the lack thereof heparin. I have four hospitals in two days out of heparin. I hope that I will be wrong and there will not be a shortage and that I am over analyzing this supply/demand issue and the recall.
I agree and I did the same and I will publish what I found.
Sometime the clinicians just get insulted by Vendors and there selling strategy, but there are good reps too.
However, best way to find out what is the right cap for you. Get a clear picc from BD, get all the caps you can get and place and flush and disconnect. You will be surprised!
Its surprising that anyone would say they are surprised there is so much misinformation out there. Everyone knows marketing takes directed but limited data and manipulates it to create enough doubt in customers minds to slow or reverse falling market share if you have it, and to try and gain market share, if you don't.
Even with many stated claims, the facts are becoming more well known by clinicians about all needlefree caps. The microclave is a smaller version of clave and has less inflow at disconnection mainly because it has less outflow at connection due to smaller dead space. If lab data is taken out to 1/10000 of an ml amount, the microclave still has negative inflows. Its an improvement over clave negative cap, but still negative.
By definition, a negative cap will outflow at connection and inflow at disconnection. If invison cap has a range that goes up to +0.002 ml of outflow at connection, this is in the true definition of a negative cap. If we apply Newton's Laws of physics, with a range up to 2/1000 of an ml outlow at connection then there must be a similar inflow at disconnection. With inflow at connection just like the negative microclave and bionector caps, the invision cap is in the same negative inflow at disconnection category as microclave and bionector.
Lab data which has not been rounded at any decimal place, for the microclave, invision and bionector caps will show outflows at connection and inflows at disconnection at the 1/10000 level. These results should not be rounded to zero just because the test was at a selected 1/1000 level and not at the 1/10000 level. For a cap to be truly negative it should have .0000000000 ad infinitum of inflow at disconnection and none of the current caps do that. And if you have fluid outlow at connection at the 1/10000 of an ml amount, then you must have the same 1/10000 of an ml inflow at disconnection. This meets the true definition of a negative cap and this makes the so called neutral caps, simply improved versions of more negative caps.
These discussions are all interesting but are belaboring many engineering and design issues. The bottom line is the clinical outcomes with each of these products. Which ones produce the most patent catheter lumens and the least amount of catheter related bloodstream infection? The answer to these questions is absolutely unknown. I have read many comments about positive displacement devices causing more infection. This has not been proven in a randomized controlled clinical trial. We have at least 4 observational studies of facilities using Brand X with a documented rate of BSI, then switching to Brand Y and documenting a dramatic increase in BSI, then switching back to Brand X and tracking a decline in BSI. These studies are pointing out a problem but they do not show strong evidence that Brand Y is the cause. There is no consistency among the products being used. The Johns Hopkins report was about a switch from a negative luer-activated to a positive luer activated valve. MUSC switched from a split septum to a negative luer activated. An Australian hospital report switched from a split septum to both a negative and positive luer activated. Nebraska Med Ctr switched from a split septum to a positive luer activated. These studies do not show that one single product design is the problem.
All of this discussion about the amount of displacement is useless if we still have problems with BSI and occlusion in the very real patients we take care of each day. Sorry but I had to voice my frustration over all of these messages debating one product over another.
what appear to be mundane details about certain products is often belabored here. while the experts know about it many viewers do not have access to this information. It puts more focus on vendor claims. having an opportunity to hear the story from both sides provides more information on products. While some see quid pro quo, most nursing consultants try very hard not to be unduly influenced by vendors in exchange for support of new products. they really dont know what data they may not be seeing. Its the way it is when using products reviewed by fda and any unfavorable study data is not required to be published.
The reason I am convinced that a truly neutral valve would be a homerun is procedure. With each valve, there is a procedure - always swab, but do you clamp or not? Some hospitals have more than one valve in the house - positive and negative displacement valves - each with a totally different procedure - clamp or not. If you clamp a negative displacement valve before disconnect, you may leave the valve open, other valves need to be clamped. Do most nurses know what they are supposed to do? I believe in the KISS procedure - SWAB, SWAB, SWAB a valve that can be clamped or not. A truly neutral valve would go a long way in improving these outcomes; then we would just have to teach nurses IV Therapy 101 - back to basics - swab before administration, then let's see what would happen to CRBSI and occlusions, but let's find a truly neutral vlave and there is none.
Clamping or not clamping has nothing to do with "leaving a valve open." This does nothing to strengthen the argument for using a "neutral" valve. You can use a negative or positive valve ( I excluded saying neutral because this does not exist) as long as the flushing and clamping protocol is consistant and standardized in the hospital. Positive flushing techniques need to be performed by nurses with negative valves. This step is eliminated with positive valves. Does every nurse use this flushing method on their negaitve valves? Probably not, so why wouldn't you err on the side of caution and use a positive device that does this for you? It would seem this would offer the best opportunity to keep the line clear of retrograde blood after disconnection.
Clamping an extension set which has a negative displacement cap while performing a positive pressure disconnection should not cause most negative cap valves to stick in the open position. If before disconnection you close an extension set clamp which has a positive pressure cap on it before the cap can discharge positive pressure bolus, when disconnecting syringe, it's the positive pressure cap valves which may stick in the open position.
Cheryl,
The Clave has a negative displacement of up to 0.02cc. It actually decreases with repeated use. Most facilities use Clave on peripherals with saline only without any problems. There are also facilities that use them on central lines also saline only. The Clave however does not have a saline only claim. The MicroCLAVE has the FDA Saline-only claim and can be used on all lines without heparin. It is a neutral displacement connector. It offers you the Saline Flush needed for HIT prevention while having the best infection control profile availible. Contact your ICU Medical rep at http://www.icumed.com/PSR/mappage-hospital.asp
Hope this helps.
-Tom Billings, RN
Is there any data about the occlusion rates with the Microclave? I haven't seen anything yet. Tom, do you have info to support impact of the Microclave on occlusion rates?
Gwen Irwin
Austin, Texas
Gwen,
It was just just this past year that we received the 510(K) for saline flush only on MicroCLAVE. We are not complete on true clinical trials that as you know can take time. There are users of both MicroCLAVE and CLAVE that use saline flush only without occlusion issues. It has been well stated on this site that occlusions are multifactorial with the needleless connector being 1 part of the equation. MicroCLAVE is neutral with no reflux at the catheter end upon connection or disconnection. For further assistance contact your local rep for samples/support.
-Tom
Hi Tom,
I was looking on the FDA website for the MicroClave 510K and I can't find anything. Can you please point me in the right direction. I am interested in the saline only flush.
Thank you.
Hi,
Here is a link to one of the MicroCLAVE product sheets.
http://www.icumed.com/Docs-MicroClave/M1-1113.pdf
If you contact me directly or your local ICU Medical Product Specialist we can get you a copy of the 510K. Find your local rep here...
http://www.icumed.com/PSR/mappage-hospital.asp
Hope this helps,
-Tom
Tom,
I am also interested in seeing this 510K for the Microclave, not the original Clave, which is the only one I can find from the FDA. Also, can you post some documentation about the FDA supporting a "neutral claim" for the microclave. I am so confused between all these negative/neutral claims. Thank you.
The micro clave is not neutral and in actuality has more reflux than the clave . There is only one connector that has zero/neutral fluid displacement with connection or disconnection and that is the InVision-Plus Neutral IV connector by RyMed. All other connectors have reflux. With positive pressure connectors the reflux is with connection. In order to have a positive pressure upon disconnection and equal but opposit (negative pressure) must happen at connection. With connectors such as the clave the reflux occurs with disconnection. If there is a clamping secquence direction there is a reflux. Regardless of the slight of hand or the definition of neutral etc. the truth of the matter is there is only one connector that has no reflux at connection or disconnection. It is the InVision Plus. This i s the result of the design. For more information go to rymedtech.com.
Denise
Denise,
I don't think that I can agree with you about the Microclave creating more reflux than the Clave. In our testing, we did compare many caps. The Microclae didn't have a greater reflux than the Clave.
We also tested against the Rymed product and found minimal difference between the Microclave and the Rymed product.
We are waiting for more info about studies on both about the decrease in occlusions. We need more information.
Gwen Irwin
Austin, Texas
[quote=Cheryl Barrett]My facility is using a negative pressure clave for peripheral and central lines. I am trying to understand why this would be beneficial, or is this just a left over that we have never updated? [/quote]
My thought would be that it just hasn't been updated, since you wouldn't want anything that is a "negative" pressure. We have chosen the RyMed Invision-Plus Neutral for several reasons. Along with our Clinical Engineering and Infection Control Departments, we tested 11 products on the market and found the RyMed superior in the following ways: It was the ONLY one that was "clean" under blacklight after using a "bug glow" product provided by infection control team, it has one of the smallest priming volumes and dead spaces, it has zero displacement upon connection AND disconnection, it has a straight through pathway and has no special clamping technique to work properly. I wouldn't recommend anything that is "negative" with either connection or disconnection. This is easy to test with microbore tubing and colored water flushing well and connecting/disconnecting the syringe. Our tests showed the RyMed and the BioNector as the only ones that showed zero displacement. Good Luck with your choice. Laura
I amm sorry you do not believe me. It is true. The microclave is not neutral. In fact it has more reflux than other ICU products. As far as occlusion The RyMed has demonstrated occlusion reduction. Visit rymedtech.com and see Karen White Poster. While not published it has out performed other connectors in head to head trials. Low prining volume and straight fluid pathway with no dead space make flushing successful in completely cleaning the pathway. The InVision-Plus is the only connector with two independent microbial barriers. It is a new approach to protecting the fluid pathway and institutions such as Duke, and Vanderbilt have done extensive testing and found that this new design lowers infection rates and occlusion rates. It is extremely popular in the NEONate and Pediatric populations (low priming volume) and has been associated with zero CRBSI rates. Like the shift from needles to needleless, the new shift is from needleless to protected fluid pathway.
Denise
I regret to inform you that MicroCLAVE is indeed classified as neutral and does not "has more reflux than other ICU products". Microclave has a deadspace of less than 0.04cc's. There are no coring issues with Clave products. Clave products are proven to reduce CR-BSI and with CLC2000 to maintain catheter patency. The Clave products also have flow rates greater than that of an 18 gauge catheter, thereby allowing them to be used in critical care/trauma situations. The Clave was the first with a dedicated sterile internal fluid pathway and remains unique with it's reverse slit septum/blunt cannula system. Clave has a proven 14 year history. I don't believe that this forum should be used by us manufacturer's to banter back and forth. I usually refrain from such and just answer or clarify clinicians queries.
Respectfullu,
Tom Billings, RN
Product Specialist, ICU Medical, Inc
[email protected]
I agree with you Tom that manufacturures shoud not use this forum for banter, but we have to jump in when other companies use buzzwords like "neutral pressure" to create a market for their product when these devices are in fact negative. All connectors are neutral if they are clamped before disconnection. As you know, the microclave uses the same 510K as the regular clave and is not approved for a saline only flush. This is because they are virtually the same product. The thinner housing on the microclave reduces it's deadspace by only 2 one hundredths of a mL (not enough to be clinically significant as 1 drop is 0.05mL) This is less than a half of a drop difference. Also, neither the clave or the microclave have passed the newest stringent 2005 FDA recommendations for microbial contamination. The mechanism of action for these two valves is the same. Also, what are you comparing the 14 year infection record of the clave to? If it is the national infection rate compared to the previous blunt cannula systems, the BSI rate with the clave has risen significantly due to the top that can not be thoroughly disinfected while swabbing. I am not plugging my own product here, but am stating facts. I appreciate you're passion in selling your products and respect you as a colleague, but we really need to stop selling confusion and stick to the facts.
Brian Colby
Brian,
You are incorrect on many points and with that you are creating the confusion. You did not state facts but opinion. MicroClave has a saline flush claim on the 510K it shares with Clave. The deadspace is different but not because of "thinner housing". The surface of the MicroClave can be disinfected. Our microbial challenge is with P. Ariginosa which is more stringent than what has been required. There are multiple independant studies that show that the Clave reduces infection and these are not just vs a blunt system. There has NOT been an increase in BSI with Clave. Again, this is banter between manufacturers.
Tom Billings, RN
Tom,
Please post a link to this saline only 510K. does not exist.
The FDA passed new recommendations in 2005 as to how these devices should be tested. This link summarizes these changes. http://www.maximusmedical.com/pdf/antimicrobial_comparison.pdf
The clave did not pass this test. The testing that you are referencing uses sterile syringes for each flush, which does not happen in the real world.
As to the microclave surface, it is identical to the clave surface, which can be visualized on this link after vigorous scrubbing with 70% ipa. Notice how it can not be cleaned effectively. http://www.maximusmedical.com/bloodstream_challenge_photos.htm
Also, how is the deadspace different? Look at a cross section of the clave and microclave to see they are virtually the identical on the inside. The microclave is simply a re-branded version of the clave. It is still negative displacement, has the same surface, fluidpath, and mechanism of action. The early marketing pieces for microclave didn't even call it "neutral." This was added later to compete with Rymed invision. The piece actually read "The most significant feature of the Microclave is the new streamlined design of the outer housing." There were no saline only or neutral displacement claims.
These are facts, supported by literature. I hope this clears up any confusion.
Brian Colby
There is not such a thing like a neutral luer activated device.
Strong words, right?
Simply remember the good old 80!
Did we not disconnect our syringe during flushing? We found out the benefit from a positive pressure, so why would we use something else 20 years later?
By the way, if you claim that there is a change in your performance, you need the FDA approval. You changed from a negative pressure to a neutral pressure and the performance did not changed. And again, there is not one neutral LAD who will perform like the name says!
There are more studies nessessary, and the new SOLO from Bard performce perfect with a positive LAD and not with the MicroClave.
I am open for further discussions...
here is my eamail
[email protected]
Andre
These needleless connectors are not "approved" by the FDA. They are cleared for market, which means that they have been compared to a predicate device (a similar device that is already on the US market) and that comparison shows "substantial equivalence." This is the hurdle that a device coming to market through the 510K process has to meet. There is no performance standard that a product has to meet.
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
It is quite surprising that there is so much misinformation. In fact there are two truly neutral connectors that have zero reflux with connection or disconnection - InVision-Plus Neutral and Bionector. All others have reflux with connection or disconnection. The positive pressure (connection) blame it on Newton. It is a law of physics that for every action there must be an equal opposite reaction. With non positive pressure connectors the reason for the reflux (disconnection) is the fluid pathway design. The reason the neutral devices have zero fluid movement is design. With the InVision Plus the fluid pathway is straight and has no deadspace. The microclave is not neutral. It is virtually neutral and states that in the literature. When choosing a connector until the InVision Plus all connectors were designed to do just that connect. Safely, needle free, and with ease. Now the demand is for connection and protection. Intraluminal fluid pathway protection. Single barrriers do not protect. Double, independent microbial barriers with zero reflux on connection or disconnection do. It is design not a plot. The 21st century is here and intraluminal fluid pathway protection is the new standard.
Denise
Denise,
I have heard good things about the invision plus neutral valve, but we have not tried it. Do you know if the cost is similar to a positive pressure valve? Thanks, Amy
During insertion you check for blood return, this will be the first contact. Yes, physics, I agree. But everything stays and falls with bedside nursing. Maybe we should start and change the cap everytime we use the line....If you don't clean it like you should, it doesn't matter, you can have a 500$ cap, if nurses don't clean it, here is your infection. I don't have any experience with an increase of infection with positive LAD's.
I still believe, going back to physics, there is not such a thing like a neutral LAD! like you said, for every action is an interaction.
PLSYSINC,
REGARDING MIS INFORMATION, THE INVISION PLUS DEMONSTRATED IN THE STUDY THAT THE PERFORMANCE IS NEGATIVE. THE BIONECTOR IS IS ONE OF THE BETTER NEUTRAL LAD'S AND HAS LESS REFLUX THAN ALL THE OTHER "NEUTRAL" LAD'S BUT STILL IS A NEGATIVE CAP.
ANDRE SCHOTTE
ANDRE,
The Vygon Bionector and the RyMed Technologies InVision-Plus Neutral are the ONLY IV devices on the market that exhibit ZERO displacement upon connection or disconnection.
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
Hi everyone,
I have found that when in doubt.... try it yourself and you will see if it does or does not have reflux. I have a sample of every valve out there and it is very easy for me to tyr it myself and then I have first hand experience in seeing yea or nay on reflux.
Cheryl Kelley RN BSN, VA-BC
Kathy Kokotis
Bard Access Systems
It is all about heparin and the heparin recall
This recall may give us a better understanding of what system does what. I doubt it. the key here folks is focus your efforts on heparin and if need be heparin alternatives regardless of what system you use.
Talk to your pharmacist
Go to the Ameican Society of Hospital Pharmacists website and review their alternatives to heparin table.
Heparin will only be shipped weekly by APP. quantities may be limited. I have hospitals that are out of heparin or their pharmacists are wisely conserving the heparin
Did you all now get my point. This stated Monday. You have not experienced what I think is coming. Let's hope I am just Chicken Little today and that the heparin sky is not falling or the lack thereof heparin. I have four hospitals in two days out of heparin. I hope that I will be wrong and there will not be a shortage and that I am over analyzing this supply/demand issue and the recall.
kathy
Kathy Kokotis
Bard Access Systems
Cherryl,
Thanks, finally.....
I agree and I did the same and I will publish what I found.
Sometime the clinicians just get insulted by Vendors and there selling strategy, but there are good reps too.
However, best way to find out what is the right cap for you. Get a clear picc from BD, get all the caps you can get and place and flush and disconnect. You will be surprised!
Andre Schotte
Its surprising that anyone would say they are surprised there is so much misinformation out there. Everyone knows marketing takes directed but limited data and manipulates it to create enough doubt in customers minds to slow or reverse falling market share if you have it, and to try and gain market share, if you don't.
Even with many stated claims, the facts are becoming more well known by clinicians about all needlefree caps. The microclave is a smaller version of clave and has less inflow at disconnection mainly because it has less outflow at connection due to smaller dead space. If lab data is taken out to 1/10000 of an ml amount, the microclave still has negative inflows. Its an improvement over clave negative cap, but still negative.
By definition, a negative cap will outflow at connection and inflow at disconnection. If invison cap has a range that goes up to +0.002 ml of outflow at connection, this is in the true definition of a negative cap. If we apply Newton's Laws of physics, with a range up to 2/1000 of an ml outlow at connection then there must be a similar inflow at disconnection. With inflow at connection just like the negative microclave and bionector caps, the invision cap is in the same negative inflow at disconnection category as microclave and bionector.
Lab data which has not been rounded at any decimal place, for the microclave, invision and bionector caps will show outflows at connection and inflows at disconnection at the 1/10000 level. These results should not be rounded to zero just because the test was at a selected 1/1000 level and not at the 1/10000 level. For a cap to be truly negative it should have .0000000000 ad infinitum of inflow at disconnection and none of the current caps do that. And if you have fluid outlow at connection at the 1/10000 of an ml amount, then you must have the same 1/10000 of an ml inflow at disconnection. This meets the true definition of a negative cap and this makes the so called neutral caps, simply improved versions of more negative caps.
These discussions are all interesting but are belaboring many engineering and design issues. The bottom line is the clinical outcomes with each of these products. Which ones produce the most patent catheter lumens and the least amount of catheter related bloodstream infection? The answer to these questions is absolutely unknown. I have read many comments about positive displacement devices causing more infection. This has not been proven in a randomized controlled clinical trial. We have at least 4 observational studies of facilities using Brand X with a documented rate of BSI, then switching to Brand Y and documenting a dramatic increase in BSI, then switching back to Brand X and tracking a decline in BSI. These studies are pointing out a problem but they do not show strong evidence that Brand Y is the cause. There is no consistency among the products being used. The Johns Hopkins report was about a switch from a negative luer-activated to a positive luer activated valve. MUSC switched from a split septum to a negative luer activated. An Australian hospital report switched from a split septum to both a negative and positive luer activated. Nebraska Med Ctr switched from a split septum to a positive luer activated. These studies do not show that one single product design is the problem.
All of this discussion about the amount of displacement is useless if we still have problems with BSI and occlusion in the very real patients we take care of each day. Sorry but I had to voice my frustration over all of these messages debating one product over another.
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
what appear to be mundane details about certain products is often belabored here. while the experts know about it many viewers do not have access to this information. It puts more focus on vendor claims. having an opportunity to hear the story from both sides provides more information on products. While some see quid pro quo, most nursing consultants try very hard not to be unduly influenced by vendors in exchange for support of new products. they really dont know what data they may not be seeing. Its the way it is when using products reviewed by fda and any unfavorable study data is not required to be published.
The reason I am convinced that a truly neutral valve would be a homerun is procedure. With each valve, there is a procedure - always swab, but do you clamp or not? Some hospitals have more than one valve in the house - positive and negative displacement valves - each with a totally different procedure - clamp or not. If you clamp a negative displacement valve before disconnect, you may leave the valve open, other valves need to be clamped. Do most nurses know what they are supposed to do? I believe in the KISS procedure - SWAB, SWAB, SWAB a valve that can be clamped or not. A truly neutral valve would go a long way in improving these outcomes; then we would just have to teach nurses IV Therapy 101 - back to basics - swab before administration, then let's see what would happen to CRBSI and occlusions, but let's find a truly neutral vlave and there is none.
Judy
Brian Colby
Maximus Medical