Among the many types of infections being targeted by reduction efforts, catheter-related bloodstream infections (CRBSIs) have become a particular focus for organizations such as the Association for Professionals in Infection Control & Epidemiology (APIC), Centers for Disease Control and Prevention (CDC), Centers for Medicaid and Medicare Services (CMS), and the Department of Health and Human Services (HHS).

Russell N. Olmsted

Russell N. Olmsted, MPH, CIC, 2011 APIC president, commented, "According to Dr. Thomas Frieden, director of the Centers for Disease Control & Prevention (CDC), this site of healthcare-associated infection (HAI) is included as one of the Winnable Battles aimed at improving the lives of citizens of the U.S.¹ The current Winnable Battles have been chosen based on the magnitude of the health problems and our ability to make significant progress in improving outcomes. A high proportion (up to 70%) of catheter-related BSIs, especially those from an indwelling central line, can be prevented."

Prevention of CRBSIs is also aligned with initiatives by HHS leadership and its agencies such as CDC/Healthcare Infection Control Practices Advisory Committee (HICPAC), which recently released updated "Guidelines on Prevention of Intravascular Catheter-Related Infections,"² Olmsted added.

"Additionally, prevention of CRBSIs is in line with incentives that are incorporated into CMS’s value-based purchasing, and APIC’s recently launched ‘I believe in zero central line-associated bloodstream infections (CLABSIs)’ campaign, conducted in collaboration with the Infusion Nurses Society (INS), the Association for Vascular Access (AVA) and Bard Access Systems³," said Olmsted. "Prevention of CLABSI is also supported by a substantial body of scientific evidence which is reflected in the HICPAC and 2011 Guidelines from INS."

"It is a travesty that an alarming number of patients are harmed by preventable hospital-acquired infections, including catheter-related blood stream infections (CRBSIs)," remarked Dan Sirota, vice president of Cook Medical’s Interventional Radiology Strategic Business Unit. "On any given day, about 1 in every 20 patients is adversely affected by care in the hospital. Of those medical errors, each year approximately 78,000 patients acquire a central line-associated blood stream infection, according to a 2011 CDC report, a significant burden to patients and the U.S. healthcare system. Even more staggering than the numbers is that most of these infections are preventable."

"While some medical centers have taken the initiative to prevent infections with checklists and improved hygiene practices, it is inexcusable to overlook the fact that these current measures are not enough, and lives are being lost," continued Sirota. "The government is demanding a reduction in hospital-acquired conditions. The Partnership for Patients is aimed at improving quality, affordability and safety of health care of Americans. The hope is to reduce hospital-acquired conditions by 40 percent by 2013."

Patrick J. Parks

In addition, "there’s a genuine concern in reducing healthcare costs," emphasized Dr. Parks. "If these patients don’t die from an infection, which is frankly the majority of these patients, then they’ll go on to have an extended hospital stay. So there’s definitely morbidity for the patient – they become infected, they have to take antibiotics, they require supportive care, they generally are in the hospital about 12 to 14 days longer than the average patient. It’s a desire to reduce that morbidity and reduce the cost as well."

Kathy Warye

Kathy Warye, vice president, infection prevention, BD, cited statistics from the CDC that estimate there are more than 80,000 HA-BSIs (healthcare-associated bloodstream infections) occurring in U.S. ICU patients each year, costing up to $29 billion annually. "In addition, CMS and major insurance carriers have discontinued increased payment for HA-BSIs. Because of these costs, taking strides to reduce the risk of CRBSIs is in the best interests of hospitals and patients alike."

Healthcare Purchasing News spoke with several leading experts about the implications of CDC’s 2011 "Guidelines for the Prevention of Intravascular Catheter-Related infections" and some of the new recommendations, the first such update since 2002.

"Infection preventionists in collaboration with direct care providers will be using this updated CDC Guideline to assess how well their current policies and practices align with evidence-based recommendations," said Olmsted. "IPs will also be assessing data they collect from surveillance for CLABSIs to identify opportunities for improvement – or, in the case of several facilities across the U.S. – to sustain the significant reductions in rates of CLABSI that they and the care providers have realized. This Guideline also provides newer evidence and may lead to use of this evidence, including products or technology, for improving safety and quality of care."

The CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC) have also begun to integrate a new methodology for guideline development that should ultimately lead to more frequent updates to guidelines as new evidence emerges.

"I think what we also have seen is there’s a recognition that coming out with new guidelines every ten years isn’t quite 21st century enough," Dr. Parks contended. "So they’ve decided to have a new method of assessing and evaluating information that is probably going to be much closer to real time."

William Jarvis

William Jarvis, M.D., president, Jason & Jarvis Associates, and former director, Office of Extramural Research, National Center for Infectious Disease, Centers for Disease Control and Prevention, pointed out that the various recommendations included in the 2011 "Guidelines for the Prevention of Intravascular Catheter-Related Infections" are rated as Categories IA, IB or IC–the highest recommendations. Category II are for those recommendations that are supported by suggestive clinical or epidemiologic studies or a theoretical rationale, but still require additional evidence. Then, there are a number of unresolved issues. "In the introductory section they point out that all Category Is, whether they be ‘A’, ‘B’, or ‘C’ should be fully implemented. That hopefully will be helpful because I know in the past a lot of times hospitals would just pick out the IAs and implement them, rather than now the IA, IB and IC [are strongly recommended]."

"The second thing is, they rightly point out that performance improvement initiatives using bundles of practices are to be encouraged," he continued. "I think they recognize in this document that both insertion bundles and maintenance bundles are really important in preventing CLA-BSIs. The insertion bundle really targets extraluminal colonization, or the outside of the catheter becoming colonized and causing infection, and the maintenance bundle is targeted at intraluminal colonization, keeping it from becoming colonized on the inside."

"The insertion bundle is really important, especially in the early days, the first 7 days of catheterization," Dr. Jarvis stressed. "If you have catheters in for a very short period of time that may be all you need. But then most of our patients have catheters in for much longer than that, and the insertion bundle’s impact starts to diminish a bit and the manipulation of the connector and the stop cock and the IV line becomes more and more important as time goes on. So the maintenance bundle is really aiming at that."

The use of "checklists" to standardize procedures at the bedside, similar to those used in the airline industry are gaining foothold, fueled by numerous success stories from hospitals throughout the country that are using them to make real progress in reducing a variety of HAIs.

"Once these kinds of checklists have been incorporated, what we’re seeing is a dramatic drop in the infection rate as a consequence of including checklists," explained Dr. Parks. "They’re also called bundles, where you put together a series of what’s perceived to be best practices, and if you carry these out sequentially and do this in a uniform fashion you can reduce the risk of infection, and that’s what we’re seeing."

"Another thing [CDC] recommends is the importance of having a cart or kit that has everything [that is needed]," said Dr. Jarvis. "Even if you have a checklist and it mentions chlorhexidine skin prep, if the CHG skin prep is not [included in the materials you have], then you’re going to do one of two things, you’re either going to use something else or break sterile technique. So a kit that has all of those things in it, so the clinician doesn’t have to try and remember it all, because oftentimes the person that’s actually inserting the catheter may not be that conversive in it. Those of us in infection control spend our lives thinking about this stuff but the bedside nurse or physician doesn’t, they have many other things they’re worried about."

Dr. Jarvis described a number of studies that have proven the value of bundles including the well-publicized Keystone project headed by Dr. Peter Pronovost involving 103 hospitals in Michigan. "You’ve got a paper out of Hopkins in the surgical ICU, where they went from 11.4 to 0 CLA-BSIs in surgical patients. Now there’s two different children’s hospital [cooperatives] with multiple hospitals showing a decrease in PICU CLA-BSIs."

"We should really be having mandates from the government for insertion and maintenance bundles, at least in our ICU patients," Dr. Jarvis contended. "There are more and more studies coming out showing the value of the insertion and maintenance bundles, it’s not clear to me why we’re waiting for having the government mandate it, at least in the ICUs, where approximately 30 percent of BSIs occur. We need to do the studies to show that such bundles and an IV team work in the non-ICU setting."

While use of a checklist is key, "what’s also key, and what’s supposed to happen with a checklist is you’re supposed to have an independent unbiased, free person monitoring the insertion of the catheter," added Dr. Jarvis. "Sometimes that happens and sometimes that doesn’t happen."

"Next is that those data need to be looked at," he said. "It’s a way to monitor compliance with those recommendations, and then it helps if you feed that data back to your clinicians so they can see who are the outliers and who are not, and hopefully those outliers will move back into the pack and be compliant."

"I think it’s an exciting time, certainly within ICUs being very successful in reducing CLA-BSIs, and hopefully now we’ll start pushing those interventions up outside of the ICU," Dr. Jarvis remarked. "There are several hospitals that have reported they’ve gone several years without a CLA-BSI, inside or outside of the ICU. There are several success stories out there and we should be using those as a model."

"What I found most encouraging about CRBSI [reduction initiatives]," concluded Dr. Parks, "is that we will continue to see a drop in that infection rate, which is best for anyone." He noted that 3M will be hosting a Global IV Leadership Summit, May 18-20, which will bring together bedside clinicians, infusion care experts, infection control practioners, and physicians from around the world to focus on CRBSI prevention.

Olmsted described plans for the upcoming APIC Annual Conference: "The theme of this year’s Annual Conference is Translating Science…Sustainable Solutions. As such there are several sessions demonstrating the value of the IP as a member of the patient care team who has subject matter expertise on prevention and control of HAIs. One aspect that IPs can help provide is the translation of scientific evidence from the peer reviewed literature to application for improving safety and quality of care in their affiliates. Moving evidence from ‘benchtop’ to ‘bedside’ is the challenge, but there is increasing need to accelerate this activity as we work towards elimination of HAIs."

Highlighted below are some of the new or updated recommendations from the CDC 2011 Guidelines for the Prevention of Catheter Related Blood Stream Infections, as well as some products that help meet the guidelines.

"Chlorhexidine has been called out as a specific skin antiseptic agent," said Dr. Parks, noting, "What they did was change the concentration a little bit. They used to say, use 2% chlorhexidine. And in a way what’s new is old. They used to say a long time ago to use at least 0.5%, and they’ve gone back to that. So what they’re saying is, you can use a little less chlorhexidine and get a satisfactory clinical result."

PDI’s Chlorascrub

J. Hudson Garrett Jr., PhD, director, clinical affairs, PDI Healthcare Inc., commented on the updated concentration recommendations. "The CDC guidelines published in 2002 recommended a 2% aqueous CHG solution based on the evidence available at the time of publication. Since then, significant clinical research has been performed on skin antiseptics leading to the 2011 CDC guidelines citing a greater than 0.5% CHG in alcohol solution as a Category 1A recommendation for insertion of central venous lines, arterial lines and for dressing changes. This updated recommendation means the user now has more choice in skin antiseptics."

The use of PDI’s 3.15% Chlorhexidine gluconate (CHG)/70% Isopropyl alcohol Chlorascrub solution is compliant with the new guidelines from the CDC. The product portfolio consists of three pre-activated applicators: 1.0 mL Swab, 1.6 mL Swabstick and 5.1 mL Maxi Swabstick. In addition, the Chlorascrub Swabstick and Maxi Swabstick protect the patient with a seven-day antimicrobial persistence on the skin because of the increased concentration of CHG.

CareFusion’s ChloraPrep

ChloraPrep Patient Preoperative Skin Preparation from CareFusion is a rapid-acting, persistent and broad-spectrum topical antiseptic used to decrease bacteria on the skin prior to a range of minor and major medical procedures. The unique 2 percent Chlorhexidine Gluconate (CHG)/70 percent Isopropyl Alcohol (IPA) formulation acts fast on a broad spectrum of bacteria, and keeps fighting bacteria for at least 48 hours. The ChloraPrep applicator minimizes direct hand-to-patient contact, helping reduce the risk of cross-contamination. ChloraPrep remains active in the presence of blood, serum, and other protein-rich biomaterials unlike traditional iodophors, which are neutralized. CHG demonstrates low incidence of irritation.

"At least 18 organizations and initiatives, including the U.S. Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) recommend CHG for preoperative patient skin antisepsis. Additionally, 10 organizations specifically advocate the use of a 2 percent CHG formulation, such as ChloraPrep patient preoperative skin prep for skin antisepsis," said Charles Pigneri, director of Global Marketing Infection Prevention-Surgical Products for CareFusion.

3M’s line of Tegaderm brand dressings, including the new 3M Tegaderm CHG Chlorhexidine Gluconate IV Securement Dressing, "support and reinforce some of the guidelines that CDC has come out with," explained Dr. Parks. "One of the things they talk about is covering the IV site with either tape and gauze or a transparent dressing. And any of the Tegaderm products will fulfill that guideline. They are transparent, they do serve as a cover, and they prevent organisms from coming into the skin."

3M Tegaderm CHG Dressings integrate transparency with a CHG gel pad

The transparent Tegaderm dressings also offer the ability to maintain a visual inspection of the catheter insertion site, which is also specifically recommended in the guidelines, he said. "In addition to Tegaderm dressings being able to serve as a cover and also provide visualization, it provides chlorhexidine and we’ve demonstrated experimentally and clinically that it will reduce the number of bacteria on a patient’s skin." While 3M continues to conduct clinical testing to prove the correlation between skin flora reduction and reduction of CRBSI*, "we do know from the data from our own studies that we can successfully reduce the number of bacteria on the patient’s skin as well," related Dr. Parks.

Ease of use is another key benefit offered with the one-step Tegaderm dressings, he added. "What we have found is that if best practices are critical to preventing infections, it has to be practical to use. What we’re finding with both Tegaderm brand dressings and Tegaderm CHG is its ability to be used is very simple, it fits into standard practice, it is very well accepted by the nursing staff who have to take care of these patients on a day-to-day basis, and essentially it’s almost impossible to use incorrectly."

In addition, the Tegaderm brand dressing are designed to allow for touch-free application, he explained. "It allows you to avoid having to touch the site. One of the critical issues is to prevent the flora of a patient’s skin from entering into the catheter site and causing an infection. That’s one of those things that you critically want to try to avoid is transferring those organisms from the clinical care person to the patient."

Ethicon's BIOPATCH

Dr. Jarvis noted that the elevation of the recommendation for the use of a CHG-impregnated sponge disk to a Category IB, was based on "significant evidence including randomized control trials, the top level of evidence that’s required." More than a dozen randomized control trials specifically evaluated Ethicon’s BIOPATCH sponge dressing but two in particular that were published following the SHEA compendium in October 2008, were particularly important, he explained. One was a randomized control trial in Paris, France involving 7 different hospitals. "First of all, the BSI rate to begin with was relatively low at 1.3 per 1,000 catheter days, much less than median rate, yet when they introduced BIOPATCH, it decreased to 0.4 per 1,000 catheter days."

Another study involved high-risk oncology patients. The facility was already using an insertion bundle along with an antiseptic-impregnated catheter, and they asked "if you’re doing all of that, can the addition of BIOPATCH make a difference?" explained Dr. Jarvis. "So they randomized patients and they found a 44% reduction in BSIs for patients receiving BIOPATCH."

One unique feature of the BIOPATCH sponge disk is that it provides 360-degree contact with the skin around catheter, releasing CHG for at least seven days, explained Dr. Jarvis. "The amount of CHG is high enough that the amount being released constantly is at a level needed to kill most common bacteria that cause catheter infections."

Kimberly-Clark full body CVC and PICC drape/pack

Kimberly-Clark Health Care recently introduced a line of Full Body CVC and PICC Drapes and Packs that meet the CDC guidelines. The drapes and packs provide full head-to-toe coverage for line placements in the jugular, subclavian and brachial access. A clear-view film around the fenestration provides room to see/feel the vein for placement. The PICC drapes conveniently allow for dual access for right or left brachial placement. A perforation option is available for both the CVC and PICC line drapes. Control Plus reinforcement absorb excess fluid at the placement site. The drapes are low-linting and abrasion-resistant and meet AAMI Level 4 liquid barrier performance with non-perforated designs.

Cook Medical recently expanded its line of Spectrum antibiotic-impregnated central venous catheters. Cook Spectrum catheters work synergistically to provide broad spectrum protection against gram positive and gram negative organisms in both short- and long-term use. Research has demonstrated that use of Cook Spectrum catheters does not promote the growth of antibiotic-resistant strains of bacteria in patients receiving Spectrum catheters, according to Sirota.

Cook Medical’s Spectrum

"Numerous peer-reviewed articles, including a landmark study published in the New England Journal of Medicine, confirm that Cook Medical’s Spectrum minocycline/rifampin catheters, paired with maximal sterile barrier process controls, are more effective than process alone in their ability to help prevent CRBSIs," said Sirota. "The CDC, APIC , SHEA and AHRQ recommend minocycline/rifampin impregnated technology to help with the prevention of CRBSIs."

"Healthcare societies/agencies, such as the CDC, AVA, APIC, INS, the Joint Commission, etc. put forth evidence-based guidelines for healthcare professionals about central line catheter placement procedures, maximal sterile barrier precautions and the use of antimicrobial catheters to prevent catheter-related infection (CRBSI), Sirota continued. "These guidelines vary somewhat; the most progressive stance is from the CDC with a 1A recommendation for the use of antimicrobial catheters in adults if the facility’s catheter-related infection rate is not decreasing after successful implementation of a comprehensive strategy to reduce CRBSIs."

To compliment the Cook Spectrum Turbo-Ject, Cook Medical recently introduced a Bedside Maximal Sterile Barrier Process Tray, which contains all of the components needed to streamline placement of PICCs bedside or in the interventional radiology lab. The tray provides the components for maximal sterile barrier precautions, a significant part of patient safety and infection control, while emphasizing the necessity for process plus Spectrum technology, noted Sirota.

"The 2011 Infusion Nursing Standards of Practice defines a split septum device as a simple needleless connector with a pre-pierced septum that can be of blunt cannula or luer-lock design," said Warye, BD. "What makes the BD Q-Syte device a true split septum is the simple fluid path with no internal mechanism. BD Q-Syte eliminates the complexities of mechanical valves, and with them, the places that may harbor bacteria."

BD Q-Syte

BD’s Q-Syte Luer Access Split Septum design features a smooth surface. "The CDC cites inadequate cleaning of the device surface due to physical characteristics of the plastic housing diaphragm interface as a potential explanation of the increased CRBSI risk with some mechanical valves," said Warye. "The smooth, one-piece surface of the BD Q-Syte device is easily cleaned and does not have any gaps or ridges."

BD Q-Syte also has a clear housing, which allows complete visualization of the entire fluid path, Warye noted. "The CDC identifies an opaque housing as a potential problem in that it obscures visualization of the fluid path during use. According the INS Standards of Practice, ‘If there is blood or debris within the needleless connector,’ the connector should be changed. ‘Needleless connectors with a clear housing provide an unobstructed, transparent view of the complete device...’"

BD Q-Syte also has a unique concave surface designed to make alignment with the mating luer easy for the clinician, and reduce the risk of contamination during attachment.

Warye cited a study by Jarvis that found that a split septum design eliminates the complexities of mechanical valves, and with them, the places that may harbor bacteria. "A split-septum design does not contain any internal mechanisms or ‘moving parts, which introduce irregularities in the fluid flow and may promote areas of stagnation and create potential reservoirs for microbial growth.’"

A study by Rupp and Salgado found that when compared with mechanical valves, split-septum devices have 64%–70% lower CRBSI rates.

BD offers a CRBSI Reduction Guarantee with its Q-Syte. "BD will guarantee a 33% reduction in CRBSI rates by switching to BD Q-Syte," said Warye. "If you do not achieve the 33% reduction in BSI rates, you will be rebated the price difference compared to your previous device. If you achieve a 33% BSI reduction your cost savings will be far greater than the rebate."

*3M™ Tegaderm™ CHG Dressings have not been studied in a randomized clinical study as to their effectiveness in reducing CRBSIs.

References:

1. www.cdc.gov/WinnableBattles

2. www.cdc.gov/hicpac/pdf/guidelines/bsi-guidelines-2011.pdf

3. http://clabsi.apic.org//AM/Template.cfm?Section=Home