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Saharris
"Passive Disinfection"

I am seeing some of the new devices out there that provide a "cap" to injection/infusion ports on IV tubing. I am seeing nurses unscrew the cap, give the medication, and screw the same dried out cap back on. Anybody else seeing this? It seems the "visual confirmation" is replacing common sense on the need to really clean these IV connectors with some elbow grease. We know we need to scrub the skin before placing a PICC, why can't we get the same message across on the care and maintenance end?

kathykokotis
surprise

why would anyone be surprised by this event

both companies are teaching you never have to scrub again in their inservices and so we are raising an entire generation of non scrubbers.  Their posters do not mention a five minute wat time and stress the fact they are good for 96 hours which some think means they can be re-used.

I am biased as i work for Bard Access and was part of the acquistion team to purchase SiteScrub a competitiive product. 

Friction is still old school but actually works in 10-15 seconds

I am still trying to figure out how you use these caps in a code, ER, operating room, recovery room, and during an IV push.  Beats me how one waits five minutes each time. 

Kathy Kokotis

Bard Access Systems - I am biased

Dan Juckette
One of the strategies I use

One of the strategies I use is patient education. Empower the patient to stop anyone who does not scrub. Patients understand how long 5 minutes is, even when nurses don't. They know how long 15 seconds is and have a vested interest in staying alive. I ask them about scrubbing when I round on them to reinforce the idea that it is not OK to slack off on scrubbing.

Daniel Juckette RN, CCRN, VA-BC

G. Irwin
Passive disinfection

I agree with Kathy.  How do you manage to get the "right" number of minutes of cap on?  I really see that reapplying the old alcohol cap is a work=around that nurses will take, instead of applying a new one.  How do you monitor that?

Also, I haven't seen studies that indicate that 5 minutes is enough.  How do we know that 5 minutes is right?  Just asking.

Gwen Irwin 

CCorrig
SwabCap Passive Disinfection

SwabCap Passive Disinfection

 

Thanks for your questions on disinfection caps.  I'm the clinical manager for the SwabCap and SwabFlush products.  I am responsible for the inservicing and training for our customers.   I can not speak on behalf of other products on the market but our inservicing, training, labeling and product literature clearly teach that SwabCap is a single use device.   When SwabCap is removed, the clinician can immediately access the needleless connector (NC).  If successive accesses are required, for example, when using SAS technique, the NC should be cleaned using the hospitals scrub-the-hub protocol before access number 2 and 3.  After the last flush or lock, the NC is again capped.   When not in use, NCs are always capped.  This "closed system" approach ensures that NCs are always protected and bathed in alcohol so they never build-up bioburden which the nurse would need to remove using a time-consuming, variable scrub-the-hub technique.

 

The dramatic clinical, compliance and cost savings our customers are reporting in large multi-site clinical studies can be attributed to consistent, technique-free, high compliance disinfection and protection of their NC's.   These studies were presented at SHEA and AVA this year and will be published soon.  Scrub-the-hub approaches and devices do not offer protection from bioburden build-up between accesses, they do not provide extended alcohol exposure time and they do not allow for easy compliance measurement.   Scrub-the-hub approaches rely on nursing technique and nursing compliance which are highly variable and difficult to sustain.

 

SwabCap has a unique sealed design which keeps the alcohol in the system to continuously bathe the access surface and threads and keep out contaminates such as body fluids, liquids and airborne contaminates.   SwabFlush puts a SwabCap in the plunger of every flush syringe so the clinician has a cap every time they need it.  This minimizes the re-use potential since the next cap is literally already in their fingers.   It is also sterile packaged, of course, to minimize the potential for cross-contamination in pockets and patient rooms.

 

Our disinfection studies, case studies and posters can be found here  www.swabcap.com

 

Please contact me directly at 224 221 7956 if you have any questions or would like to learn more about SwabCap and SwabFlush.

 

Best Regards,

Cindy Corrigan, RN

Senior Manager, Clinical Services

Excelsior Medical

 

 

Dan Juckette
One needs to ask the

One needs to ask the question, is someone who will re-use an obviously single use disposable item going to be contientous in scrubbing for 15 seconds? My audits have shown that people who are non-compliant with either method tend to be non-compliant with them all. My data is derived from patient reporting, followed up with peer reporting and observation. Our facilities use SiteScrub, Curos and SwabCap. I have no financial interest in any of them and advocate for them all. Patient reporting of non-compliance and peer pressure seem to have the best outcomes for changing behaviors. Technological solutions will mitigate practice lapses when people make mistakes but cannot mitigate bad practice. It is up to bedside caregivers to identify and stop bad practice. Sometimes naming names is the only way to get bad practice to end.

Daniel Juckette RN, CCRN, VA-BC

lynncrni
First let me say that I am a

First let me say that I am a consultant for Excelsior Medical. With that information, you can make your own judgement about any bias in my reply. There are now in vitro studies showing that 15 sec scrubs do not produce a clean NC and that there are some organisms that still pass through. Please note that the CDC nor the INS stated a specific time for cleaning an NC due to the fact that there have been no clinical studies showing any actual clinical reduction in CRBSI. All data comes from in vitro studies. These caps are designed to remain on the NC between uses to protect it from organisms, body fluids and skin oils, and other environmental debris. This only makes sense to me. None of the manufacturers of these caps state that they can be reused, therefore the nurses practicing below the standard of care must be re-educated. If this does not change their practices, then you need to do more assessment of why they are doing it. I would bet it is because the facility has not provided access to these caps in a convenient manner. Reusing it is much easier that walking to the storage bin to retrieve an new one. That is a systems problem, not a product problem. Also, the product data says that it is effective within 5 to 15 minutes, however they are not intended for immediate removal after this period. They are intended to be left in place until it is time to use the catheter for a subsequent infusion, usually several hours later. Please see the statement in the INS standards of practice that we know that NC and catheter hubs are a known source of catheter contamination. It only makes sense to close this system as much as possible and prevent accummulation of junk on the NC connection surface that nurses are not or cannot remove with a manual scrub. Lynn

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

Lynn Hadaway Associates, Inc.

PO Box 10

Milner, GA 30257

Website http://www.hadawayassociates.com

Office Phone 770-358-7861

Natalie F.
 The sad truth is that these

 The sad truth is that these products WILL reduce infections since the current state of clinicians wiping caps is abysmal.  I understand the need for education but I've seen all types of nurses skip this basic step.  I say bring'em on.

plsysinc
Passive Disinfection

Some thought needs to be given to any passive disinfection caps.  First, you are correct that they need to be replaced with a new cap after each use.  However, one issue that has been tossed around is the need for swabbing and do these caps replace that need.  Passive disinfection is the method used by these add-ons.  I am not sure how many of us have much experience with soaking as a disinfection method.  I am an old nurse and back in the 60's and even the 70's soaking instruments was relatively common.  The procedure for this disinfection method was to scrub the item to be soaked before placing it in the solution.  So keeping this in mind, when the cap is removed the surface is prepped but after you have used the port and before you ably the NEW cap, I would think that you should scrub the hub.  This is obviously the opposite of what nurses are used to.  But placing a sterile product on a dirty surface should at least give us some pause. The issue of scrubbing the hub is going to continue to be a big one.  We can not see micro-organisms with the naked eye.  Habits, like handwashing, have proven to be difficult to achieve stirict adherence in clinical practice.  No matter what the solution, it is my opinion that nursing practice must be part of the equation.  The AVA save that line program is one attempt to get the word out.  Remember, these habits are probably not built in nursing school. 

Denise Macklin

 

Christine Arme
Passive Disinfection Caps

Great discussion!  My disclosure - I work for Ivera Medical, manufacturer of the Curos Port Protector (the Green cap).

There is controversy regarding disinfections caps.  This forum is a classic example.  I would expect no less as this is NEW technology - a complete paradigm shift.  But let's not get so far into the woods that we lose site of the big picture.  We are talking about keeping needleless connectors disinfected and covered when not in use.  We are talking about minimizing risk in a current situation that has a lot of risk.

At some point, I'm sure there were similar discussions on seat belts in automobiles.  Do they really work?  Are they fool proof?  Will people use them?  Will they create a false sense of security?  And the questions go on.  Over time the use of seat belts has proven to save lives.  It is a law to wear a seat belt.  Today, automobile manufacturers are required to install annoying audible alarms to ensure the use of this safety tool because otherwise compliance is low.  Yes, compliance is low even though it is the right thing to do and a law.  Sound familiar?

Disinfection caps are the "auditable" alarm in a similar situation.

Let's talk about needleless connectors.  Their current market design allows the NC access point to be exposed to the hospital room environment including the floor, bed linens, arm pits, etc.  Therefore, it is imperative that a proper disinfection process be performed before every access because bio burden is there.  It is well known this does not happen.  Sadly, even the over achievers who do it right 99 times and miss once, they allow risk of infecting the patient.  It begs the question, does it make sense that a critical access point that leads directly to the bloodstream be allowed this exposure?

Disinfection caps not only disinfect (per the FDAs definition of disinfection which all disinfection caps had to demonstrate in order to come to market and no alcohol pad or scrub assist product has ever had to prove), they also remain in place to keep that critical access point clean and covered in between use while rolling around on the floor, bed linens and arm pits. This makes sense.  It eliminates bio burden build up opportunity. It reduces risk.  This is your paradigm shift.  Always clean vs. always dirty.

Is soaking better than friction for disinfection?  Soaking is an approved method for disinfection and a body of evidence for disinfection caps is building.  Clinical data takes time but is becoming readily available and is demonstrating a reduction in CLABSI and CBCs as outcomes.  Disinfection caps (or soaking) take the critical "failure point" of current practice, VARIANCE, out of the equation.  It does not matter which clinician luer locks the cap on, it disinfects the same way every time.  Being visibly auditable is how you achieve sustainability, another challenge with current practice.  If you can see it, you can manage it.

Is it possible a clinician may defy instructions, labeling and in-servicing directions and reuse a cap?  Yes.  There are those who have found creative ways to drive without a seat belt too.  We are dealing with the human race so creativity and compliance will always be a factor.  Convenient product access encourages proper use and compliance.  We have seen this demonstrated successfully with Curos on a Strip.

There are those who believe nurses should "do their job" and scrub the hub.  I think it's important to point out the landscape of their job has changed drastically over the years and while the unending "scrub the hub" battle lingers on the lives we are putting at risk are our patients.  New technology to minimize risk is here.  It is working.  I suggest you try it.  And, yes, I am biased - disclosure stated above.  :)

Christine Arme

VP of Clinical Integration

Ivera Medical

www.iveramed.com

Christine Arme

Saharris
Passive disinfection

With all due respect new technology does not equate to a paradigm shift. The shift occurs when it is proven that
the new technology is better than the current accepted practice. I am concerned that these devices actually lower the bar for nurses, the message being given is "you don't do it right now so here is something so you don't have to do it". What message is being given to the critical care nurse who has multiple IV pushes to give, with multiple blood draws? Hey just wait 5 minutes to " bathe the threads in alcohol"
As a clinician who is accessing and inserting vascular access devices every day I find your arguements sophomoric at best. Always clean vs. Always dirty? I am a believer in treating all access ports as always dirty until I, the clinician who is about to use the line, clean it. I believe the danger of these devices again is that they will lead to nurses believing that an object (the swabcap or the curos) will replace the nurses responsibility to clean the access site. Education does work and hospitals have achieved fantastic results without this technology, but it is a continual process. How many facilities spend zero dollars on educating nurses about standards of IV practice and yet will jump on this with a promise which is yet to be proven of an easy fix. Showing the FDA the thread is disinfected is a far cry from getting an indication for reducing CRBSI.
I am a huge fan of technology, but I really prefer technology that enhances good clinical behaviors.

Stephen Harris RN, CRNI, VA-BC
Chief Clinical Officer
Carolina Vascular Wellness

Natalie F.
 In a perfect world ALL

 In a perfect world ALL nurses would wipe the cap thouroughly and then let it dry.  In the inperfect world we live in, these caps WILL improve the standard of care for access because no one will ever have 100% swabbing compliance.  I understand the point that equipment should not replace good clinical practice but in this case that's wishful thinking.  I say bring on any product that makes compliance easier, whether it's these caps, better PICCs or improved site dressings.

lynncrni
Great discussion. I would

Great discussion. I would like to add one other way to look at these devices. My disclosures - Excelsior Medical (SwabCap), plus BD, Baxter, B Braun manufacturers of multiple needleless connectors. I do believe that these caps make a lot of sense but I do not think of them as "disinfection" caps, rather I consider them to be in a generic category called "protection" caps as they protect the NC from all types of environmental debris (organisms, lint, spilled fluids, body oils, sweat, etc) in between uses. I am very curious about the FDA's definition of "disinfection" as it does not appear to be applied the same as when that word is used for other devices. For more than 30 years now, the Spauling scheme has been applied to disinfection and disinfectants. This divides items into critical (devices used in sterile areas such as the bloodstream), semicritical (devices used on mucous membranes such as endotracheal equipment), and noncritical (devices used only on intact skin such as BP cuffs). NCs do not fit into any of these categores. The NC leads to the bloodstream but is not actually placed in the bloodstream. All disinfection literature is written about devices that are cleaned and disinfected after being used on a patient, but not while it is attached to the patient. All NCs would require disinfection while it is attached to the catheter hub. There are 3 levels of disinfection - high, medium and low with different chemicals that are associated with each level. Phenolic compounds, quatennary ammonium, bleach, and other very caustic chemicals are the agents that will achieve high levels of disinfection. None of these agents would be possible to use on any brand of NC. Alcohol is listed as a low level disinfectant and is only recommended for small areas and this literature uses the exampe of a medication vial rubber stopper. Contact time is also discussed in the literature which includes the application and drying time. With this information, alcohol appears to be the best disinfectant agent but it provides a low level of disinfection, thus the nurse would never render the NC surface free of all organisms. Therefore it makes sense for the NC surface to be in contact with alcohol for a much longer period of time. My point is that a simple alcohol pad regardless of how it is applied can never reach a consistent and satisfactory level of disinfection for these NC surfaces. To me, this means that protection between uses is critical rather than having to worry about extreme variations in nursing practice, the space between the moving center post and outer wall of the NC where it is impossible to clean, the configuration of the connection surface of the NC, etc. Lynn

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

Lynn Hadaway Associates, Inc.

PO Box 10

Milner, GA 30257

Website http://www.hadawayassociates.com

Office Phone 770-358-7861

Dan Juckette
To me, when you have both

To me, when you have both tools that allow you to really scrub a connector and tools that prevent the connector from getting "dirty" to begin with, iand you don't use them you are saying " I don't want my patients to be too safe". Really! You could stock a years supply of every one of these products on the market for the cost of one IV related BSI. Nothing is error-proof but I will take cheap and convenient anytime.

Daniel Juckette RN, CCRN, VA-BC

lynncrni
None of the manufacturers of

None of the manufacturers of these protective caps have instructions to put it on, then wait 5 minutes to use the NC. This information has been altered for competitive purposes and is factually wrong. Their studies as required by the FDA show that the "disinfection" occurs within the 5 to 15 minutes, depending on the specific brand. These caps are not intended to be put on, left for this short period and then removed. I answered this question from the floor at the recent AVA conference. The cap is put on after the NC is used. It remains on until it is time to use the NC again, which could be 4, 6, 8, 12, or 24 hours. It is removed and discarded and the NC connection surface will be clean so the connection of the first saline syringe can be made. After aspiration and flushing, then discoonection of this syringe there could easily be blood tinged fluid left on the NC surface, therefore it should be cleaned with a new alcohol pad before the connection of the IV set or syringe with the medication. Once the IV set has rolled around in the bed with the patient for 30-60 minutes, the IV set is disconnected after the med has infused and the NC surface is cleaned again with a new alcohol pad before connecting the second saline syringe. If heparin is used, it should be cleaned again with a new alcohol pad. So these caps are not intended to totally replace the need for cleaning the NC surface. They do provide a barrier to overcome the well-documented problems with NCs. Many sets of standards and guidelines (CDC, SHEA, INS) clearly state that NCs are a significant source of contamination and risk for BSI. Also read the published literature which identifies numerous problems such as device design externally and internally, the lack of appropriate cleaning, the lack of knowledge about these devices among the personnel using them, etc. Nurses do not bear the sole responsibility for this problem, however there have been several published reports of surveys - nurses self-reporting on their practices with NCs. Those reports document that 31%, 3%, 4% and 5% state they never clean the NC before use. Then there is the question of inadequate cleaning. Then there is the question of what is "adequate" cleaning. These caps only provide a means to prevent exposure to all of the huge amount of fluids and other environmental debris that comes into contact with them. Lynn

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

Lynn Hadaway Associates, Inc.

PO Box 10

Milner, GA 30257

Website http://www.hadawayassociates.com

Office Phone 770-358-7861

kathykokotis
caps

First off i need to know what enviromental airborne organisms cause a great deal of CLA-BSI or CR-BSI so I need to know what the cap is protecting the patient from organism wise?  The majority of organisms are killed with alcohol a quick disinfectant that takes 10 seconds according to Simmons and 15 seconds according to Kaler.  By the way that is with friction of course.  Skin organisims are the number one cause of CLA-BSI and CR-BSI so friction works with alcohol.  The key concept to a cap is nurse's are too lazy to scrub and too inept to actually scrub the hub.  So since the nurse's will not do their job let's give them something that might do part of their job for them.

Second the promotion of this product on the actual poster says scrubbing is not needed.  I find scrubbing is not needed to be not true when one does an IV push and access's a line at least three times.  Scrubbing is still needed but the poster says scrubbing is not needed so it leads to a very confusing message to say the least to the provider.  You must still scrub prior to access as one can contaminate a hub with staph aureus in-between an access (i.e. IV push)

Third the caps must be on for 5-15 minutes and I do not know how that is at all possiible during a code, anesthesia, recovery room, multiple IV pushes in any department including the ICU and the emergency department.  5-15 minutes is a long time to wait to use a line so one must still use scrubbing.  But the cap poster says scrubbing is no longer needed.

Last where is the marking on these caps to know if it is not a re-used cap or has been even on there for five-fifteen minutes?  There is no way to tell to telk how long the cap has been in place and you have to once again trust staff that they put a new cap on.  No one even trust their staff these days to scrub it seems so how do you trust they put a new cap on?

so here is the bottom line:  you still have to teach scrubbing......................................................regardless

you have to teach scrubbing in-between multiple accesses

you have to teach scrubbing of the catheter HUB/stopcock when you change needleless caps and no one better argue with me on this one

you have to teach scrubbing if a cap is damp or visibly soiled according to the 510K for all caps.  that is the first time one takes the cap off.  The second access and third and fourth involve scrub in-between.

The CDC 2011 states SCRUB the ACCESS SITES and the AVA program for SAVE the line still states vigorous SCRUB. 

So my opinion is if you use these caps stop telling your staff to stop scrubbing because they have the caps.  I do not care if you use the caps just do not throw away your alcohol swabs or discourage the use of an alcohol swab or continue to believe your nurse's are too lazy or inept to scrub a hub.

I am biased as I work for Bard and we have SiteScrub.  Lynn Hadaway is biased because she works for Excelsior Med which has SwabCap. 

My bias is I still believe scrubbing an access site is still necessary regardless of what product one uses including the old fashioned alcohol swabs.  Try however to use sterile swabs due to the impact of spores.

Kathy Kokotis RN BS MBA

Bard Access Systems

 

 

 

Apoorvasnv
Gist

While this subject can be very touchy for most people, my opinion is that there has to be a middle or common ground that we all can find.

 

 

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