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IDSA-SHEA Compendium Recommendation on Positive Pressure Needleless Connectors

Compendium of Strategies to Prevent Healthcare-Associated Infections in Acute Care Hospitals

"Supplemental Aritcle:  SHEA/IDSA Practice Recommendation, Strategies to Prevent CLABSI in Acute Care Hospitals, Page S26 states the following:

III. Approaches that should not be considered a routine part of CLABSI prevention

     3. Do not routinely use positive-pressure needleless connectors with mechanical valves before a thorough assessment of risks, benefits, and education regarding proper use (BII). 88-91

          a. Routine use of the currently marketed devices that are associated with an increased risk of CLABSI is not recommended.

I have been watching for

I have been watching for postings about this message and am surprised that no one has posted a comment about this. I am curious about your thought on this. If you currently use, one of these devices, what action, if any, do you see your facility taking? What factors would you include in a risk vs benefit analysis? What additional educational efforts do you plan? I don't wish to start a raging debate about the design of devices, but am very interested in your organizations approach to this. I think the timing of this is critical since the value-based purchasing intiative from CMS went into effect on Oct 1 and your hospitals will no longer be reimbursed for the treatment of hospital acquired catheter related bloodstream infection. 


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

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

Lynn Hadaway Associates, Inc.

126 Main Street, PO Box 10

Milner, GA 30257


Office Phone 770-358-7861

Lynn makes a great point. 

Lynn makes a great point.  For over 2 years in this forum many posters have discussed very passionately the clinical benefits of positive pressure devices and their beliefs in them without a preponderance of evidence to support their commitment to use, while many others have posted about an awareness of the unintended consequences of increased CRBSI that positive pressure devices can create.  Where is the discussion now?

Will these devices continue to be used in the face of this issuance and increasing medical liability?  What are clincians doing with them since they come packaged in the Bard and Arrow insertion kits?  Doesn't the new Maxplus device come in the Bard SOLO kit?  Is it time for hospitals and clinicians to start demanding safer product options in these kits instead of having no choice but to pay for the products that come in them?  It seems a choice should at least exist in lieu of something that has been deemed less safe.

If I'm a Premier hospital knowing that Premier endorsed the Compendium I might not be too excited about going against one of the recommendations.  If I'm United Healthcare I'm doing all I can to make sure these recommendations are strongly considered if not adopted in totality.  No ifs, ands, or buts.

For a list of endorsing organizations go here

When in the history of healthcare have so many academic, influential, federally-funded, industry and commercial organizations ever simultaneously endorsed such a sweeping set of recommendations to prevent HAI?  Are people choosing to ignore them?  Can anyone afford to?

I'm curious as well.  And,

I'm curious as well.  And, we don't use them. 

Mari Cordes, BS RN 

Nurse Educator IV Therapy
Fletcher Allen Health Care, Burlington VT
Educator, Bard Access Systems 

Mari Cordes, BS RNIII VA-BC
Vascular Access Department
University of Vermont Medical Center

The recommendations say

The recommendations say research and test for your self.   Each connector is different and has different features.Let’s see what the references used to make the “positive pressure” statements in this new strategy actually tell us:

88- Maragakis - Smartsite Plus, a positive pressure mechanical valve associated with increased BSI

89- Fields - Clave, a negative pressure mechanical valve and CLC2000, a positive pressure mechanical valve associated with increased BSI

90- Salgado - Smartsite, a negative pressure mechanical valve associated with increased BSI

91-  Rupp - Smartsite Plus, a positive pressure mechanical valve associated with increased BSI

What do all these needleless connectors have in common?  The answer is not positive pressure! What they have in common is they are all mechanical valves, meaning they have multiple moving parts which must actuate together to activate flow through the device. This means, just as Maragakis points out in ref 88, “The fluid path in MV devices has moving parts …internal corrugations that may serve as reservoirs and foster the growth of microbial contaminants.”  These mechanical valves also have access ports that have indentations which are difficult to disinfect.   Contamination can harbor in the crevices and intricate surface details and not be completely removed during swabbing. This contamination can be delivered  into the fluid path.

The connector with a BSI rate below the national average often the “before” device is the Interlink.  Is it really positive pressure that created the issue? Lets be realistic folks… look at the Interlink closely, what features of this connector make it a device that is associated with a low BSI rate?  I know … it is because it is Split Septum! Yes that’s the answer to all our problems – Split Septum!  That is what all the manufacturers will say.  NOT SO!  Look at the Interlink and think, why is this device associated with a low BSI rate?  Okay, let’s start with the basics… The access port is skin colored – REMINDER TO SWAB! The access port is smooth and there are no nooks, crannies, or areas that harbor bacteria. Hey swabbing works on this device – that’s a nice feature! Oh inside – wow, there is only one part and it moves out of the way when accessed so the fluid can flow through it. And lastly it is clear – so you can see the fluid path and flush the device well.  So folks, it boils down to practice again – and some devices let best practices work while others do not!  Positive Pressure devices as you call them are not the culprit … mechanical valve devices with multiple moving parts and intricate and ornate access surfaces are! As the strategy document suggests, “Conduct a thorough assessment of risks, benefits, and education.  Routine use of currently marketed devices that are associated with an increase in CLABSI is not recommended.” It is easy to find the currently marketed devices that are associated with an increase in CLABSI, just look up the actual studies referenced in the strategy document and the actual products are listed in those studies.  References 88-91.

Best practices such as thorough swabbing with friction, complete and clear flush help prevent CLABSI’s. Some connectors allow these best practices to be performed better than others and this is what makes the difference.  
rivka livni
If devices can cause a

If devices can cause a higher infection rate, how would you explain the differences in blood stream infection rates between inpatients and outpatients population? It is well known that outpatients have a much lower infection rate yet they use the same devices and same catheters as inpatients.

Is it not clear that it has to do with staff practice rather then the device?

When I look at an inpatient hospital course, it is overwhelming to see the number of different staff who access their catheter, especially if the patient travels for different diagnostic procedures, OR visits and so on. So many nurses "forget" to change a cap everytime they change the IV tubings, "forget" to swab the cap with alcohol everytime before access.

Positive pressure, Negative pressure, Neutral or whatever, hospital acquire catheter related blood stream infection will decrease drastically only when the practice improves with better staffing of knowledgeble management and staff who really cares.

I do not think it is the device.

[quote=rivka livni] I do

[quote=rivka livni]

I do not think it is the device.


Curious posts and discussion relative to inpatient vs. outpatient and impact of devices, whether positive pressure devices affect CRBSI.

"When I drive in snow or wet conditions I skid and have poor handling and traction.  When I drive in dry or normal conditions I don't skid and have superb handling and traction.  However, I'm using the same car and same tires.  Therefore, neither my car nor my tires can be to blame and it must be something else.  It must be me, the driver."

I think this is a naive conclusion.

You are claiming that devices have no impact on the delivery of care.  I'd be careful here.  Admittedly when clinicians' practices are sub-optimal outcomes are affected.  But intimating that "forgetting to swab the cap" is or can be the lone determining cause of a CRBSI is asanine.  Pathogenesis of CRBSI is multi-variant.  Stating the converse, that simply swabbing a cap can prevent a CRBSI, turns your assertion on its head.  It is also not supported in the literature specific to your own example.

Menyhay, Maki ICHE 2006 Vol. 27 No. 1 clearly showed that 67% of 3 different connectors (Clearlink, Microclave and Posiflow) tested against an aggressive disinfection protocol still allowed microbial ingress and contamination.  Arguing that the devices are not at least somewhat to blame or aren't "the culprits" is one that is absolutely wrong and disproved by published evidence.

It is true that outcomes are affected by practices.  Practices and education should always be paramount in healthcare.  The Compendium reinforces this precept as a priority, and no physician or practicioner would argue the contrary.  But devices with sub-optimal design inhibit good practice and can negatively affect outcome.  The recommendation in the Compendium on CLABSI relative to positive pressure devices elucidates this.  I think you're walking a fine line of potential patient harm and medical liability to your institution if you continue to use them.

Consider the following:

What could likely be coming next is an FDA labeling modification on positive pressure devices to include known risks.

The value is in the data, not the clarity.

I often wonder about posters

I often wonder about posters who use aliases to hide thier identity and affiliations.  Would Whosthegenius mind identifying yourself?


Rich Lewis, RN

IV Assist, Inc.

Clinical Ninja
I am in a continuous state

I am in a continuous state of disbelief surrounding the various "experts" that are constantly negating the true benefits of positive pressure connectors. I am a seasoned clinician, researcher, and have been following this topic for many years. Each and every hospital that I have worked at has had nothing but positive results from utilizing positive pressure devices. Currently, my facility uses a positive pressure device (not a mechanical valve) which features a flat surface that can be cleaned without any contamination of the hub. Also, the housing is clear which permits for visual observation of the fluid path. For several years we have been using this particular device with amazing results (both decreased Infection and Occlussion rates). It kills me to see all of the Nurses, Physicians, and Infection Control Practitioners who are frequently "blinded" by the various conartist researchers who are paid off by the sponsors that they consult for. Don't get me started, as I can easily divulge information about these "experts" that will quickly change your opinions about their credibility. These various "conartist" strategies recommend not using positive pressure mechanical valaves, and also don't clarify the specifics surrounding the different products in comparison. Rather, they choose to "lump" everything into a "positive pressure" category. The devices out there are all very different, and I love to see the "conartist experts" flipping their ideas on a monthly basis...confusing everyone within the industry who relies on their un-scientific studies and self-publicity.

I am in the process of creating a beautiful spreadsheet, including  Jarvis, Maki, Hadaway, name just a few. This information included will contain ($$ paid by sponsors, their position on various technologies...and how it changes depending on the direction of the economy, as well as their direct quotations from various conferences...and how they frequently contradict themselves).

Just think of me as the "Barbara Walters" of medical device experts. More to come on "20/20" of the medical device discussions. 

Thank you rivka livni and

Thank you rivka livni and for sure thank you Clinical Ninja.

I think in all these comments we can see who is a clinician and who likes to sell his opinion.

There was a time when this homepage was created to help nurses/clinicians with experience to make a difference at the bedside.

Now we have this market share fight and for some reason there is not a lot of ethic in there.

Demanding safer products is very nice but who is protecting the patient from the "non-safe" company, sales person and educator?

Let's face it and I love to repeat myself: The luer activated device is just one part in the whole bundle. You need professional equipment to do a profesisonal job. Bedside nursing is a very important part, if they don't do there job we still get our infection and IT DOSEN'T MATTER WHAT LAD WE HAVE AT THAT POINT.

However, it is important to find out what works best for your hospital, your nurses and your patient population. I look at all these statistics and presentations how bad my positive LAD is and wonder that my infection rate is only 0.2%. Why is that?

Now some say I get paid to say that, some think my clinical research was not done right, some simply don't like the fact that someone found out what the truth is.

"I am a clinician and that's what I found"......proofe I am wrong if you can and give other nurses the chance to make a difference for there patients and not for your market shares!!


rivka livni
To "whosthegenius": Your car

To "whosthegenius": Your car driving analogy is poor. If I understand what your say in your analogy - it is actually the weather condition that is to blame, not the driver, or the car.

Same as if the same catheter with the same device one in outpatient with no infections one with inpatient with infection the difference must be the nature of practice between them, or should I say "the weather around them".  Inpatient with multilple access by multiple practitieners with different knowledge of practice.... do you see where I am going?

I will admit however that when a poorly designed product has been approved for the  market, and we as practieners don't know about it's poor design, I would expect that the governing body (FDA?) or whoever, should alert us about it.

As a practicing PICC nurse who makes decisions about a new product for our hospital, when I meet a new rep from any company, the first thing I say to them is "I do not want to hear from you how bad a product your competitor sell, tell me about YOUR product ONLY". If they start to bad mouth another product, I send them on their way and will not listen to anything else they want to say.

Clinical Ninja
Rivka are right

Rivka are right on! Great comments surrounding the importance of decision making by clinicians. Also, I too am flabergasted regarding the fact that 95% of the current Medical Device companies (or their consultants...Jarvis (not to mention names), have not a clue what the latest FDA microbial ingress is all about).

I am a frequent visitor of INS, AVA, APIC, SHEA conferences, and love to debate these topics with vendors and presentation "experts." I especially loved visiting a vendor who was demonstrating the impossible notion of "neutral pressure" using a fluid that was tinted red. Being the lover that I am, I tasted the red solution which ended up being Karo corn syrup. Wow...what a concept! I truly hope that my blood is as sweet as Karo.

Peace Out!

Clinical Ninja

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