My organization is trying to make a decision on the MaxPlus Clear product. Can someone tell me if this is considered a mechanical valve? I have been told by B Braun that there is no such thing as a positive displacement valve that is not mechanical. Is this true? Can someone please email me with the answer at [email protected]. Thank you so much.
Yes, MaxPlus is a mechanical valve activated by a luer from a syringe or male tip of an IV tubing. The B Braun rep is correct. All positive displacement needleless connectors are mechanical valves.
Lynn Hadaway, M.Ed., RN, BC, CRNI
www.hadawayassociates.com
Lynn Hadaway, M.Ed., RN, NPD-BC, CRNI
Lynn Hadaway Associates, Inc.
PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
Try flushing it according to manufacturer protocol. (Read the directions) Also, Marcia Ryder's study had nothing to do with the MicroClave. It was done with the original Clave. And as Hospira and ICU Medical will tell you, the Clave and Microclave are significantly different products. (Even though the Microclave has no 510K from the FDA that substantiate their new claims) Their Marketing team should all get promotions for taking an old obsolete product such as the Clave and slapping a label with new claims on it such as "neutral", "saline flush", and "power injectable." Other companies went through the ringer with the FDA to get these claims validated, but not the microclave. Its like painting your car different color and expecting it to go faster.
The evolution of the term “mechanical valve” with reference to needleless access devices needs to be understood for what it truly is; a marketing strategy by a large manufacturer in an attempt to reposition their product by differentiating it from their competition in order to gain market share and your business.
If you actually research the terminology “mechanical valve” you will notice that in the field of medicine this terminology is associated with cardiology as in “mechanical heart valve” and was not a term used in the practice of vascular access until it was introduced to Vascular Access, Infusion Nursing and Infection Control professionals in 2005. Prior to this time researchers utilized the following terminology in their original articles and abstracts to describe these devices: Closed Luer Access Device, Needleless Connectors, Needleless IV Infusion System, Needleless Catheter Connectors, Needleless Intravenous Port, and Needleless Valve Ports. CDC documents call these devices needleless intravascular devices and the FDA refers to them as needleless devices. At the Society of Healthcare Epidemiology of America conference which took place April 11, 2005 a well known and highly paid consultant to a leading needleless access device manufacturer made the following statement, “There has been a problem that they have recently recognized related to increase in bloodstream infections associated with the introduction of luer access or mechanical valve devices,” referencing a study conducted by Barry Farr and Carrie Hall at the University of Virginia. After this initial introduction the terminology “mechanical valve” was utilized by this same individual at multiple industry conferences throughout 2005-2007. The fact is the original study used to introduce the terminology mechanical valve did not use that terminology, Carrie Hall’s University of Virginia abstract called it a “needleless IV infusion system.”
The first time the term “mechanical valve” was used in a publication to describe a needleless access device was in June 2005 in an abstract authored by the same well known and highly paid consultant. After this the term “mechanical valve” became more prevalently used in the area of vascular access with no one really understanding where it came from or what it meant. In his speeches this consultant identified the risk factors associated with “mechanical valves;” intricate access surfaces which are difficult to clean, gaps around plunger which cannot be accessed for disinfection can harbor bacteria and contaminate the fluid path, opaque housing hides incomplete flushing and internal mechanisms which obscure the fluid path making it impossible to visually confirm complete flushing. These risk factors are features of specific devices, not features of all “mechanical valves” however they were positioned as features of all “mechanical valves” in order to gain more opportunity for the device that was being positioned as a split septum device and not mechanical. The irony as outlined below is that by definition, the device the consultant was promoting is also a mechanical valve.
In engineering, a mechanical valve is a device that manually or automatically regulates the flow of fluid in machines, piping, and other systems. In medicine a valve has been described as a membranous structure in a hollow organ or passage, as in an artery or vein folds or closes to prevent the return flow of the body fluid passing through it. Devices that regulate the flow of gases, liquids, or loose materials through tubing or through apertures by opening, closing, or obstructing ports or passageways have also been defined as valves.
According to these definitions, all needleless access devices, whether defined as split septum, internal cannula activated, or luer activated, etc., are mechanical valves.
The first published statement with in the industry of vascular access that describes a mechanical valve as it relates to vascular access is “MV devices have intricate access surfaces that are more difficult to disinfect and the fluid path in the MV devices has moving parts, and at least 1 of the MV devices has internal corrugations that may service as reservoirs and foster growth of microbial contaminants.” This description by Maragakis is very clear and leads one to believe that mechanical valves have:
·Intricate access surface details which are difficult to disinfect
·Fluid flow path that has more than 1 moving parts and/or internal corrugations
Clever marketing by large manufacturers has done nothing but create confusion for clinicians who use these products daily. Those manufacturers with the deepest pockets are capable of adding new terminology into a market to reposition their own product as good and all others as bad.
The categories used to describe a specific needleless access connector vary from manufacturer to manufacturer. These recently construed categories should not be used to base product decisions. The specific deficits of needleless access devices that have been associated with increased bloodstream infections are clearly identified in the research articles published by Maragakis, Field, Salgado, and Rupp. Simply put it is not the type of device which makes the device problematic, but rather if the device has inherent in its design the specific deficits identified by these authors. These deficits are listed below:
·“MV devices have intricate access surfaces that are more difficult to disinfect than simpler split septum models. The fluid path in the MV devices has moving parts and at least 1 of the MV devices has internal corrugations that may serve as reservoirs and foster growth of microbial contaminates. Some of the devices have been noted by healthcare personnel to have incomplete flushing of blood from the fluid channel, and some are opaque, so that this would not be readily apparent to the user.”
·“risk of colonization of the connector device may be higher for MV devices because of the potential difficulty in sterilizing the gap between the valve and the hub.”
·“our findings … suggest that the mechanical valve system could be more difficult to disinfect because of the complicated nature of the multi part device.”
·“Upon close inspection of the valve, one can observe a shallow depression and a rim between the diaphragm and the plastic housing. It is possible that microbes and debris could collect in this area, which would be relatively resistant to cleansing or disinfection. The internal mechanism of the valve contains moving parts which introduces irregularities in the fluid flow and may promote stagnation and create potential reservoirs for microbial growth. Also, the plastic housing is opaque, which prohibits visual inspection of the connector valve. Therefore, it is possible that blood or infusion products could collect within the valve and because of its opaque nature, go unnoticed by healthcare workers.”
At the same industry conference one year later, another infection control professional presented a study and the term “advanced luer activated device (ALAD)” describing a device with features which assisted his facility in reducing needlestick injuries and also resulted in a decrease in bloodstream infections. This professional identified several features of the ALAD which were associated with a reducing the risk for a patient to develop a bloodstream infection; a smooth, flat access surface with minimal crevices for easy and complete disinfection, no interstitial space where bacteria could grow, an advanced seal design which reduces the risk of bacterial ingress and a positive fluid pulse which reduces the risk of occlusions.
This ALAD is the MaxPlus, which at that time was being manufactured under a private label for another manufacturer. According to broad generic definition the MaxPlus as well as all needleless access connectors could be categorized as mechanical valves, but when compared to the mechanical valve description as outlined by Maragakis, the MaxPlus does not have the deficits described. The MaxPlus does have the product features which were used to define the term “Advanced Luer Activated Device” as presented in abstract form at the 2006 SHEA conference. MaxPlus exhibits several specific features that virtually no other device offers. These specific features are associated with a reduction in occlusions and bloodstream infections.
The previous posts omitted information by stating that all positive displacement connectors are mechanical valves. There are positive, negative, neutral and split septum devices which all according to the actual definition of mechanical valve, would be considered mechanical. With regard to other studies and industry consultants to wish you choose to seek information, be prudent to consider the source of this information, their corporate affiliations, and if any biases are present in the data. Consider if the study is controlled, double blind and random or anecdotal. In laboratory studies, understand if the research design includes inherent biases which would intentionally make one product outperform another. An example of unbiased research is the September 2008 ECRI Report on needleless connectors.
To Janet Steves,
I still believe in change and we know change is good. In the past we flushed our lines/LAD's with 10ml and thought we are fine. Now finally we can see what is actually going on inside and we start to blame the LAD? If we change to new equipment/devices/technology, we have to change our behavior as well. That is the great thing in the medical field.
I don't know how many clear LAD's you flushed in the past from other companies...
The Microclave is one of the best NEGATIVE LAD's on the market, I agree with Marcia.
Andre
lme PICC Team Clinical Leader
I am currently using the MaxPlus clear in my practice and love it! I disagree with J Stevens from Sarasota. You most certainly can totally clear this device with using the push/pause technique while flushing. And the beauty of it, is you can see if you're leaving residual behind. Unlike the Micrclave, that you don't know if you're flushing effectively. The MaxPlus Clear is flush at the top and if you're familiar with the "glo studies" that have been done in comparison with other needleless connectors, the MP Clear is far superior. I used this cap before they developed the clear for 5 years with no problems. I was forced to change to the Microclave because of a contractual issue, and had nothing but problems. We are using the MaxPlus clear now and have definitly reduced the number of problems we were having when using the Microclave.
lme PICC Team Clinical Leader
Is anyone having trouble with the Microclave?
One way to simplify connectors is to look at the goal of the original design. This yields two distinct systems - Needle free and Intraluminal Protection. Needle free was designed to eliminate needles in an effort to protect nurses from HIV. In 2004 needlefree became the OSHA standard. The newest system is intraluminal protection. This system was designed to protect the patient by protecting the intraluminal fluid pathway. Between 1990 and 2004 connector design was tweaked to lessen occlusions the main catheter event related to their use. Two types of needlefree connectors - split septum and luer access have reflux with disconnection. Clamping sequence and flushing were added to nursing care and maintenance regimens to attempt to lessen this. There is no research to date that demeonstrates either the practice or the results of these actions. The positive push designs again tweaked the needle free design to add a "cleaning" push with disconnection. The mechanical valve terminology was added to further define the internal mechanism required to provide both the negative reflux with connection (sets up the negative pressure) and the resulting positive push with disconnection. With the increase in IV route of administration usage by 2005 it was noted at a SHEA conference that these mecahnical valve (positive push) connectors were associated with increased CR-BSI rates. These findings have continued with the culmination of the SHEA/ISDA compendium release in october 2008 stating that this type of device should not be used without a risk assessment and should not be selected as a CR-BSI reduction strategy. This is after numerous prestigious MDs and hospitals reported similar findings as initially reported. Add the positive push increase in CR-BSI return to original connector and the rates return to the previous level.
The intraluminal protection systems are not a tweak of the original needle free design but a bottoms up design where each component was designed to protect the fluid pathway. Still a connector, it has features that promote disinfection, minimize active and passive migration of micro-organisms and minimize adhesion of fibrin so that micro-organisms can not attach to the surface. This design enables nursing to swab successfully and flush successfully with no clamping sequence. The nursing outcome is ease of use not just easy to connect to.
Having been involed with connectors for three years it seems extremely interesting that many nurses are so attached to their connector system. When making a selection for any product it is important to decide what is your goal. Improved patient outcomes is our goal. Products should promote positive patient outcomes, and support nursing care. When studies and recommendations are reported we all should be open to the results. Often we discount success stories because we do not agree with them. The great thing about technology is that it is there to support our actions. Yes they make money, yes they have marketing departments, but every once in a while technology makes a breakthrough. Like the Prius hybrid or panty hose - They come up with a different way of solving a problem. Not a tweak but a new way. These transformational designs can be rapidly accepted in the commercial world - look at the IPOD- but often in the clinical world nurses want to keep what they are familar with. My best suggestion is keep an open mind and look at each new device that comes on the market with an open mind and focus always on patient outcomes. Some early adopter nurses have had outstanding results bundling all technology focused specifically on CR-BSI reduction and nursing practice such as Sophie Harnage and Brenda Coulet. There are others who have not reported their activities. It is my hope that we in the nursing community will publish our findings regardless of the limitations of the design. Whether a pump, a syringe, a connector it is manufacturing that makes the innovative leaps that have improved our ability to provide wonderful care.
Denise Macklin
Denise, c'mon. Enough of this. Your logic does not hold true.
An old device + a new "name" does NOT = a new device or new technology.
Suggesting that it does implies that the rest of us are unable to discern the reality and that renaming is somehow the equivalent of reinventing.
Well, come to think ot it, perhaps that might be true - sort of - in Hollywood or in politics, where spin is an aceptable method of communication, but certainly NOT here. All this does is confuse the issue. We do not need any more confusion about needleless connectors.
Please, my friend, no more thinly veiled infomercials.
Marilyn
I find a personal attack unprofessional in this format. I was not doing an infomercial and to the best of my investigation I stand by what I wrote. Intraluminal protection is not spin.
Denise Macklin
Here we go again, full circle! Manufacturers and marketers coming up with clever terminology to differentiate their product! If an Intraluminal Protection System is new technology designed to protect the internal lumen of the catheter, than why is there not a new FDA 510K supporting this new technology and claim. My review of the FDA website reveals a 1999 clearance date for this so called new technology.
If you are interested in peer reviewed published studies, take a look at an article recently published in “Pediatrics,” Volume 121, Number 5, May 2008 titled “Systematic Intervention to Reduce Central Line-Associated Bloodstream Infection Rates in a Pediatric Cardiac Intensive Care Unit,” which reports how interventions, including the MaxPlus, assisted a pediatric cardiac intensive care unit (CICU) reduce central-line associated bloodstream infection (CLABSI) rates from 7.8/1000 catheter days to 2.3/1000 catheter days.
During a pre-intervention period the CICU implemented a central venous line insertion bundle including assessment of venous patency, proper hand hygiene and maximal sterile barrier precautions including CHG skin antisepsis and a CHG eluting disk. CLABSI rates decreased from 7.8 to 4.7/1000 catheter days.
During the full intervention period, the CICU converted their needleless connector system “to a device that has a flat access surface and contains a positive-displacement valve (MaxPlus needleless connector).” CLABSI rates in the CICU decreased an additional 50%, from 4.7/1000 catheter days to 2.3/1000 catheter days. There were 15 fewer CLABSI's in the 9 month full intervention period than the 9 month pre-intervention period. The authors estimate this initiative prevented approximately 20 CLABSI’s per year and saved their facility between $236,000.00 and $782,000.00.
A previous post brings up the SHEA/IDSA compendium. There is an article in the February 2009 issue of “ICT” which discusses the SHEA/IDSA compendium from a clinician’s perspective. This clinician reviewed the referenced studies and discovered that not one of them associated the feature of positive displacement with increased catheter related bloodstream infection (CRBSI) rates. The authors of the four studies used as references in the SHEA-IDSA recommendation clearly state the features of “mechanical valves” they believe are associated with an increase in CRBSI and they are:
As a previous post suggests, “keep an open mind and focus on patient outcomes.” In addition, do your own research when you are evaluating devices and look at the strength and source of the evidence when making decisions. For example, evidence from an article published in a peer reviewed acclaimed medical journal authored by multiple MD’s and Clinical Nurses and researched in collaboration with Harvard School of Medicine at one of the nations leading Children’s Hospitals should carry a stronger evidence rating than that of a single author study conducted at a small community hospital.
Kelly Cole
The ire and discord that arises when discussing connectors is just amazing. The data continues to come to print that intraluminal contamination is a problem. One that really has not been quantified until recently. In the past extraluminal protection was the focus. I think it is widely accepted that both pathways are a problem. A connector is the gate keeper and the practitioner is the care taker. When making a selection for a gate keeper or a procedure for the practitioner it is important to look at both. Evidence that makes it to print is at least 2 years old and really evidence achieved in each institutuion is vital. Nurses are slow to publish. In addition nursing practice is most often case study. However, when someone like Sophie Harnage's bundle goes three years CR-BSI free it is notable. When an institution like MD Anderson reports 10 fold reduction (poster) it is notable. A product that comes to market takes years to be developed. A product or a manufacturer is not the enemy. Positive Push connectors were designed to solve the occlusion problem. A different septum design was made to improve disinfection. That is what engineers and inventors do. They look at a problem and try to solve the problem. Intraluminal Protection systems, look at the problem from the patient side and each part of the gatekeeper and attempt to develop a way of impededing bacterial contamination, migration, and adherence. I am not sure why this is such a radical idea. That is what inventors all do. I have been in IV therapy for 27 years as a specialty. But I was practicing when butterflys entered the market. They had many drawbacks but they offered improved patient care. I saw the entry of Tunneled, Implanted PICC etc. into the market. Really, the evolution of IV therapy to the center of care is nothing less than amazing. I have been committed to this specialty and the expansion of practice throughout my career. When new systems come to the market place whether they be a Prius, an IPOD, or a intraluminal protection system, a transformation occurs and the enire market place leaps forward. Even now, manufacturers are working on new products to help us. While a few are early adopters, most are not. When looking at your practice, become knowledgeable about what it is you want and need. Many of us lend our expertise to manufacturers. We understand nursing and the clinical setting. Truly, these relationships have proven to be vital to improved design and improved practice. However, to infer that consulting means that we somehow become brain dead or marketing mouth pieces is not fair. In actuality really just the opposite occurs. To insinuate that when I take the time to speak on this list serve that I am somehow not speaking independently from my own investigation is insulting. I have offered my best and most up to date thoughts. I am part of this group as an independent nurse, researcher, author and yes some of the time a consultant.
Denise Macklin
Very nice written for someone who is not acting the way he is writing.
I learned very fast that as soon as you touch the “cap” business you will be attacked by most of the people.
Why is that? Why are nurses attached to there cap?
I learned my lesson at INS, verbally and physically! Of course I got frustrated but Kathy Kokotis (thank you) took care of me and I learned that is all about market share! The old caps loose, the new caps win and some simply have no share at all and are desperate.
To understand their action and acting, you have to understand the business.
Let’s make it simple and return what we learned in Savannah!
Do not trust every study, do not trust every Vendor, do not trust every Manufacturer and do not trust every “independent” part time educator.
Who can we trust?
We should do our own studies, collect our own data and compare that to the Manufacturer.
Be a real independent Picc nurse!!
And please don't say personal attacks are unprofessional, we did not start this!!!Andre
Denise, you cannot claim to be an independent, objective and unbiased voice for the profession when you are a paid company spokesperson. And, Denise, you are being paid. Please be sure to disclose your company affiliation in your future posts so that everyone is fully informed. That is the professional thing to do.
Marilyn Hanchett RN
I agree............here we go again. This was the longest discussion last year, wasn't it?
Gwen Irwin
Mark my words he next wave is the hub and I am already seeing it. There are five new devices to scrub the so called hub now. Abbott Hospira just launched "Effective", PFM has "Site Scrub", Excelsior Med, Ivera, and a new one coming from a venture firm in Utah. Keep posted the talk of caps is going to be old news.
biased kokotis (Bard Acess Systems)
I don't disagree that some of these interventions may add a layer of protection or swabbing convenience to otherwise sub-par IV connectors and/or swabbing practices. But I think that the marketplace - patients, clinicians, hospitals & payors - is entitled to a stronger base of evidence and at least a modium of discourse on the potential for unintended consequences caused by new interventions and practice changes in lieu of haphazard advocacy and adoption by the experts.
For the nurses that don't swab with a cheapie alcahol wipe now, what is the incentive for them to start using a significantly more expensive product in these scrub caps? it doesn't cause them to be less lazy. How about the hospital spends the money on more education staff or accountability programs that will actually make a difference. This is just a ploy by companies to make more money on products that already exist. Just like the Clave and Microclave. Just because the company that makes and sells the product tells you its new and improved, doesn't mean that it is. Increase compliance with aseptic technique, and the BSI trend will decrease. Don't throw money at a made up problem and expect the real problem to get better. The problem they are solving with these new scrub caps is "how do we make more money?" Also, please don't trust the studies that the company pays to produce!