Tag Archives: clinical study

Jun 6, 2018

New study finds disinfecting caps help reduced PLABSI rates by 81%

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The Journal of the Association for Vascular AccessAll intravenous catheters represent a potential entry site for bacteria and the beginning of a bloodstream infection. Central lines have been vigilantly protected for many years now, even though peripheral IV lines are much more common. In fact, 200 million patients have PIVs placed each year compared to only 5 million central lines placed annually. Historically PIV lines, due to shorter wear times and placement locations have been deemed less risky. Yet, PIVs deserve to be protected just as vigilantly since any BSI, whether peripheral line-associated bloodstream infections (PLABSI) or central line-associated bloodstream infection (CLABSI), is a major concern.

While historically PIVs have not received as much attention, a team of researchers at Mercy Hospital in St. Louis, MO set out to change that. They reduced PLABSIs by 81% during their study intervention period. That is a decrease from 0.57 to 0.11 per 1000 patient days (p<0.01). The study looked at the impact a comprehensive PIV maintenance bundle could have on reducing peripheral line-associated bloodstream infections.

They developed the bundle based on the Centers for Disease Control and Prevention, Infusion Nurses Society and Society for Healthcare Epidemiology of America compendium guidelines. It included multiple components such as assessing and removing PIV catheters at the first sign of phlebitis and monitoring and changing the dressing if nonocclusive or if blood was present. Mercy Hospital had also been successfully using disinfecting caps on central lines for five years and added 3M™ Curos™ Disinfecting Cap for Needleless Connectors to the PIV catheter maintenance bundle as a preventative method. In addition, they added 3M™ Curos™ Tips Disinfecting Cap Strip for Male Luers to all disconnected IV tubing, to replace inconsistent methods of managing the intermittent tubing that had previously been used.

During the study, compliance with disinfecting cap use increased across the board:

• 89 percent compliance with disinfecting caps on PIV lines
• 84 percent compliance with disinfecting tips on disconnect IV tubing
• 94 percent compliance with disinfecting caps on central lines (up from 84 percent before intervention period)

These high compliance rates indicate that PIV maintenance bundles are easy to integrate into existing workflows and do not add extra effort to a nurse’s busy day. The findings of this study also support that a bundled approach is effective for reducing infection and can help lead a cultural shift in the healthcare community that elevates PIV standards to the level of central lines.

The results Mercy achieved by implementing PIV maintenance bundles can be replicated at other facilities. If you are interested in doing more to prevent PLABSIs, talk with your 3M representative and ask how your partner can help evaluate your current PIV bundle.

Aug 3, 2017

Health care hygiene compliance: Not just for hands anymore?

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It’s time to add ‘and stethoscope hygiene’ to ‘practice hand hygiene’ signs

Stethoscope blog

Changing habits is hard. We can see the data, understand the science and even participate in a training session, yet we go back to doing it like we always did.

That is precisely what researchers observed and documented in a recently published quality improvement project on stethoscope hygiene. In the July issue of the American Journal of Infection Control from the Association for Professionals in Infection Control and Epidemiology (APIC), researchers found that healthcare providers rarely perform stethoscope hygiene between patient encounters, despite its importance for infection prevention. The authors call for the inclusion of stethoscope hygiene in all hand hygiene initiatives.

Infection prevention is a complex undertaking, and stethoscope hygiene is an important component. Here are a few simple tips from 3M™ Littmann® stethoscopes along with some hand hygiene essentials.

Stethoscope blog chart

Barriers to change may exist at several levels. Maybe there is a level of disbelief that stethoscopes get as contaminated as hands, despite what research shows. Maybe wiping stethoscopes is perceived as inconvenient or there’s concern that sanitizers and wipes will damage the stethoscope (Tip: All Littmann stethoscopes feature next-generation tubing with improved resistance to alcohol). Whatever the obstacles, let’s challenge ourselves to identify and overcome them. It’s essential to patient safety.

At 3M, we are committed to a future without preventable infections. As with hand hygiene, cleaning stethoscopes between patients should be expected in all health care settings and supported by leadership and clinicians alike. The future of infection prevention and superior patient care will be built upon a culture of compliance. Be a stethoscope hygiene champion in your facility!

 

Aug 2, 2016

3M™ Skin and Nasal Antiseptic effectively reduces S. aureus in the nares.

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S. aureus, nasal decolonization

Photo credit: Centers for Disease Control and Prevention

How can you, as a health care provider select an effective skin antiseptic product?

How can you help reduce the risk of surgical site infection for each of your patients?

And how can you do all this in a cost-effective way?

We know that surgical skin prepping is a critical step in reducing the risk of surgical site infection – but it may not be enough. There is rising concern that surgical site infections can be caused by bacteria in the nares of surgical patients and colonization with Staphylococcus aureus (S. aureus) is a well-documented risk factor. By reducing S. aureus in the nares before surgery, we can help reduce the risk of surgical site infection and other complications.

This is why we at 3M have developed an innovative product to reduce bacteria in the nares – 3M™ Skin and Nasal Antiseptic, (Povidone-Iodine Solution 5% w/w [0.5 available iodine] USP) Patient Preoperative Skin Preparation. Our product contains a 5% povidone-iodine solution that was specially formulated for use in the nose. A simple one-time application prior to surgery is sufficient to effectively reduce bacteria in your patients’ nares.

Here is what I think you may ask: “Why not just use a standard 10% povidone-iodine solution? It would be inexpensive and it even contains double the amount of iodine.” Good question, but in this case, more is not always better!

Even though off-the-shelf 10% povidone-iodine solution has been used for decades as an effective surgical skin prep, it may not be the product you should consider as a first choice for prepping of the nares. The unique environment of the nose with its constant build-up of mucus tends to wash out a standard povidone-iodine solution. This may make it difficult for you to achieve an effective and long-lasting reduction of bacteria in the nares of your patients.

The special formulation of 3M™ Skin and Nasal Antiseptic combines 5% povidone-iodine with a film-forming polymer that helps povidone-iodine adhere to the inner lining of the nose and, you guessed it, prevents it from being flushed out. The solution is also formulated to be pH-balanced. This makes it is less irritating and improves your patients’ comfort and acceptability.

But how can you be assured that our product works in the clinical setting; that our nasal antiseptic swabs are more effective than standard povidone-iodine?

A prospective randomized controlled clinical trial in 429 total joint arthroplasty patients was conducted to answer this question (Rezapoor et al., 2015). The patients were randomized into 1 of 3 groups, each receiving a different treatment to evaluate its efficacy in reducing S. aureus in the nares:

1) Off-the-shelf 10% povidone-iodine solution

2) 3M™ Skin and Nasal Antiseptic

3) Saline solution (control)

Baseline cultures were obtained and the nares were swabbed for culture again at 4 and 24 hours after treatment to determine the remaining S. aureus.

Our 5% povidone-iodine vs. 10% povidone-iodine study achieved the results we had expected – 3M™ Skin and Nasal Antiseptic was significantly more effective (p=0.003) at reducing S. aureus in the nares over the 4 hour time interval than standard 10% povidone-iodine solution. Standard povidone-iodine was similar in efficacy to the saline control.

The study results are visualized in the graph below.

Negative Nasal S. Aureus Cultures Post Treatment

These results at 4 hours demonstrate that 3M™ Skin and Nasal Antiseptic reduces S. aureus significantly better than standard 10% povidone-iodine solution to provide the assurance you need that by choosing 3M™ Skin and Nasal Antiseptic, you use the best products for your patients.

Here are some additional benefits of the 3M™ Skin and Nasal Antiseptic you may want to consider when selecting an antiseptic for the nares:

  • The broad-spectrum, fast-acting povidone-iodine antiseptic fits easily into your preoperative process
  • The film-forming formula was designed to work within one hour and maintain at least 12 hours of persistence (3M Study 05-011100)
  • It is effective against antibiotic resistant strains of S. aureus (in vitro*) (3M Study 05-010944)
  • No resistance has been shown (in vitro*) (3M Study 05-011322)
  • Compliance is not an issue because you as the caregiver apply the solution to the patient’s nares
  • The one-time application an hour before surgery makes the procedure very quick and easy
  • Surgical site infections are associated with increased health care cost, so using an effective product to reduce nasal carriage of bacteria may be a cost-effective addition to your preoperative protocol

So, in summary, the 3M™ Skin and Nasal Antiseptic is the only 5% povidone-iodine product that has been shown in a clinical study to be significantly more effective in reducing S. aureus in the nares than standard 10% povidone-iodine. Due to the adherent polymer, the 5% povidone-iodine remains in the nares for a longer period, which explains the better efficacy of this product. This confirms what I had mentioned in the beginning – that more is not always better.

As you can see, by choosing the 3M™ Skin and Nasal Antiseptic as part of a comprehensive preoperative protocol, you can help to safely and effectively reduce the risk of surgical site infections in your patients – and all in a budget-conscious manner!

References:

Rezapoor M, Nicholson T, Patel R, et al. Do iodine-based solutions differ in their effectiveness for decolonizing intranasal Staphylococcus aureus? Presented at the MSIS Annual Meeting, Cleveland, OH, August 2015.

3M Study 05-011100

3M Study 05-010944

3M Study 05-011322

*The clinical significance of in vitro data is unknown

Jul 25, 2016

Researchers add to wealth of evidence supporting 3M™ Bair Hugger™ patient safety

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The 3M™ Bair Hugger™ patient warming system has warmed more than 200 million patients since its launch in 1987, and that number grows by nearly 50,000 patients each day. One reason for the Bair Hugger system’s success is an impressive history of safety and effectiveness.

So when a competitor makes outlandish claims that fly in the face of 28 years of clinical use and a wealth of scientific research (over 170 studies and more than 60 randomized controlled clinical trials document the clinical benefits, efficacy and safety of forced-air warming), we will rely on science to set the record straight.

Researchers John P. Abraham, Ph.D., Professor of Thermal Sciences at the University of St. Thomas, and Jennifer A. Wagner, Ph.D., Prism Environmental Health and Safety Solutions, recently released the results of a study, which found that the Bair Hugger system did not disrupt clean operating room airflow and did not move air from the the floor to the surgical site.  The Bair Hugger Warming System is a safe, effective method to warm your surgical patients. Take a few minutes to review the study overview below. The videos also do an excellent job of depicting the results, and can be viewed here.

Operation Room Air Flow Study with 3M™ Bair Hugger™ Warming System in Simulated Hip Replacement Surgery

John P. Abraham, Ph. D., University of St. Thomas and Jennifer A. Wagner, Ph. D., Prism Environmental Health and Safety Solutions

The Bair Hugger Warming System provides a safe and effective way to maintain normal body temperature during surgery.  When used properly the Bair Hugger Warming System lowers the risk of hypothermia and improves patient recovery and surgery outcomes (i.e. reduces risk of surgical site infection, blood loss and transfusion requirement, prolonged recovery, and fatal heart attack).  A scientific research project was undertaken to assess whether the Bair Hugger System disturbed the clean-air flow in an operating room in the vicinity of a sterile surgical site.  The investigation showed that the Bair Hugger Warming System did not disrupt the normal airflow patterns of an operating room, and did not move air from the floor to the surgical site in a simulated hip replacement procedure.

The investigation had three separate components. One part of the investigation incorporated advanced mathematical calculations based upon the fundamental laws of physics to track the paths of airflow in the operating room. The calculations demonstrated that the air from the Bair Hugger System avoided the surgical site. The air flow that emerged from the Bair Hugger System traveled away from the surgical table and migrated toward the room exhaust vents along with the air beneath the operating table – not toward the surgical site.

A second part of the investigation involved experiments performed in an operating room with flow visualization studies that purposely injected visible fog into multiple locations in the room: 1) behind the anesthesia screen where the Bair Hugger air would exit near the patient’s head; 2) underneath the surgical table; and 3) next to the surgical table, near the surgical team, and near the surgical site. This investigation found that downward clean moving air from ceiling supply ducts in an operating room inhibited air from other sources from intruding into the surgical region. The downward flow of clean air worked irrespective of whether the Bair Hugger Warming System was used or not.

The third part of the investigation included a review of the scientific literature. The best scientific work did not show any causal link between the use of a Bair Hugger Warming System and surgical site infections. Even contrary research, which was largely funded by a competitive company, failed to show any causal link. More than 170 clinical studies have utilized the Bair Hugger system, and studies have demonstrated forced-air warming’s clinical effectiveness. Studies have demonstrated perioperative temperature management with forced-air warming actually reduces the risk of surgical site infections, surgical bleeding3-5 and risk of heart attack6.

The findings of the three components of this investigation mutually reinforce one another. All of these studies showed that the Bair Hugger Warming System is safe when used according to manufacturer directions, providing an effective way to maintain patient temperature.

References:

1. Kurz, A. Sessler, DI. Lenhardt, R. Perioperative Normothermia to Reduce the Incidence of Surgical Wound Infection and Shorten Hospitalization. N Engl J Med. 1996;334:1209-15.

 2. Mahoney, CB. Odom, J. Maintaining intraoperative normothermia: A meta-analysis of outcomes with costs. AANA Journal. 1999;67(2):155-164.

 3. Rajagopalan, S. Mascha, E. Na, J. et. al. The Effects of Mild Perioperative Hypothermia on Blood Loss and Transfusion Requirement. Anesthesiology. Jan 2008;108(1):71-77.

 4. Schmeid H, Kurz A, Sessler DI, Kozek S, Reiter A. Mild hypothermia increases blood loss and transfusion requirements during total hip arthroplasty. Lancet 1996:347(8997):289–92.

 5. Winkler M, Akça O, Birkenberg B, et al. Aggressive warming reduces blood loss during hip arthroplasty. Anesth Analg 2000;91(4):978–84.

 6. Frank SM, Fleisher LA, Breslow MJ, et al. Perioperative maintenance of normothermia reduces the incidence of morbid cardiac events: a randomized clinical trial. JAMA 1997;277:1127–34.

 

Jul 8, 2016

Ask for evidence when determining forced-air patient warming fact from fiction

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Since 1987, the 3M™ Bair Hugger™ patient warming system has maintained a commitment to excellence by focusing on three guiding principles:

  1. Educating clinicians on the benefits of maintaining normothermia and emerging trends/science in the field of temperature management.
  2. Improving our products to continuously reflect customer needs and remain an industry leader in technology advancement.
  3. Supporting key research to advance the science of normothermia maintenance.

These principles are as relevant—if not more so—in today’s healthcare environment, where patient outcomes and clinical value lead the decision-making process. Medical devices are no longer products you sell to doctors or nurses based on “features” alone; they are tools that must contribute to better outcomes while providing an economic benefit worthy of investment.

The patient warming industry is a microcosm of the larger healthcare environment. Competition is growing and new technologies are attempting to gain a foothold in a crowded market. It’s virtually impossible for clinicians to distinguish between fact and fiction as they are bombarded with clever sales tactics and products claiming equal performance at lower cost.

Clinical Evidence is Key

To truly separate clinically supported warming technologies from “me too” imitators, clinicians should demand the clinical evidence supporting a manufacturer’s claims of performance, safety and overall value.

3M’s commitment to the science of temperature management has never been more evident. Recently, the company announced the publication of a robust research compendium highlighting the safety and effectiveness of the Bair Hugger patient warming system. The compilation of over 200 study summaries includes more than 60 randomized controlled trials and covers a wide range of surgeries – including hip, knee, cardiac and abdominal procedures – and reinforces the sheer volume of extensive research supporting the clinical use of the Bair Hugger system.

The compendium features summaries of publications in which the Bair Hugger system was either the subject of (or used during) a clinical research study or investigation. Also included are review articles, case studies and letters to the editor, which introduce relevant information or real-world user experience with the Bair Hugger system.

The compendium was assembled utilizing multiple search engines and five databases, including Medline, Embase, Biosis, Elsevier Biobase and Chemical Abstracts. Many of the included studies measure the performance of the Bair Hugger system against competing technologies, ranging from convection warming to resistive polymer technologies.

To download a digital copy of the Bair Hugger System Research Compendium, Click here.

Download a copy of the 3M Bair Hugger patient warming system research compendium