"Intravascular catheters are indispensable in modern-day medical practice, particularly in intensive care units (ICUs)," notes the Centers for Disease Control and Prevention (CDC).¹ "Although such catheters provide necessary vascular access, their use puts patients at risk for local and systemic infectious complications, including local site infection, CRBSI, septic thrombophlebitis, endocarditis, and other metastatic infections (eg, lung abscess, brain abscess, osteomyelitis, and endophthalmitis)."¹

The likelihood of a patient becoming infected by means of a catheter is low; however, the volume and frequency of catheters used each year is astronomical; so, they are a considerable source of morbidity. It has been estimated that approximately 250,000 cases of central venous catheter (CVC)-associated BSIs occur in hospitals annually, at a cost of $25,000 per episode.² The study concluded: ". . . [T]he cost of CVC-associated BSI is substantial both in terms of morbidity and in terms of financial resources expended."²

Technological advances

Clearly, the area of catheter-related adverse events is an area that can use some help. Industry is stepping up to the plate with safer technology.

Last year, Baxter Healthcare Corporation introduced the first antimicrobial-coated needle-free IV connector, V-Link with VitaShield. Dave Bonderud, president, U.S. region, medication delivery, Baxter International Inc., Round Lake, IL, explained how it works: "V-Link is coated on both inner and outer surfaces with a unique silver technology called VitalShield. The silver antimicrobial agent helps prevent the microbial contamination and growth of these pathogens within the V-Link device at a point of entry to the patient’s bloodstream. It is designed with a novel coating comprised of nanospheres, which control the release of silver into the fluid path over the use of the device. It has been shown to kill at least 99.99% of 6 common pathogens known to cause CRBSIs, including methicillin-resistant Staphylococcus aureus (MRSA). No other technology can claim this."

Baxter HYLENEX IV alternative

Baxter also is testing a product especially for pediatric use. Bonderud explained: "Launched in October, hospitals around the country are now trying an alternative approach to rehydration, facilitated by HYLENEX recombinant, hyaluronidase human injection, to determine if it will improve the treatment experience for infants and young children suffering from mild to moderate dehydration. HYLENEX is an alternative to IV, as it administers fluids subcutaneously, without the need to access a child’s vein. Advances may be needed, as the current approach to treat pediatric dehydration intravenously can take multiple needlesticks. A study at an academic children’s hospital found that nearly half of patients required two or more IV sticks. Contrastingly, a study in the November issue of Pediatrics showed HYLENEX was easy to administer, as 90% of catheters were successfully inserted and secured on the first attempt."

Another cutting-edge product that employs silver is offered by B. Braun Medical Inc., Bethlehem, PA. Cheryl Wozniak, product manager, vascular access, described their device. "B. Braun’s Ultrasite Ag LAD is a cutting-edge product that combines the benefits of needle-free access for reduced needlestick injuries, positive displacement to help minimize catheter occlusions, and impregnated silver that may help reduce bacterial growth."

Wozniak also cited anecdotal evidence of their device’s effectiveness. "After implementing the Ultrasite Needle-Free IV System and safety procedures, the NICU [neonatal ICU] at Adventist Hinsdale Hospital, Hinsdale, IL, reported no central-line infections from January to June 2007. Normally, the hospital would have reported 6 infections, costing $46,000 each to treat. Implementing the Ultrasite Needle-Free IV System saved approximately $300,000 during that 6-month timeframe."³

The BD Q-Syte Luer Access Split-Septum Device helps reduce the risk of CRBSIs

Wozniak further highlighted why advances in devices for infusion are necessary, citing some astounding figures concerning the cost of CRBSI in the ICU. "Approximately 80,000 CRBSIs occur in U.S. intensive-care units each year, adding $296 million to $2.3 billion in excess healthcare costs."

Chris Trauger, product manager, IV catheters, also at B. Braun, talked about Introcan Safety IV Catheter. "Introcan Safety IV Catheter includes passive technology, which is more effective in reducing needlesticks and more acceptable to clinicians than devices that require a healthcare professional to activate them. With B. Braun’s Introcan Safety catheter, all the user has to do is use it. The safety mechanism does not require any extra steps for activation and cannot be bypassed by the user. It also protects anyone else who might come into contact with the product – nurses, employees, hospital staff, and even patients’ family members – from suffering accidental needlesticks."

Trauger cited a 2003 study by Mendelson that showed no accidental needlestick injuries with the use of B. Braun’s Introcan safety catheter. "The researchers compared the study data with a 36-month baseline period, when healthcare workers in these units utilized a non-safety IV catheter, and reported 13 stylet needlestick injuries, an injury rate of 5.08 per 100,000 uses.⁴

Marcia Wise, RN, clinical marketing manager, BD Medical, Sandy, UT, described their needleless device to Healthcare Purchasing News. Their focus is on effective simplicity. "BD Q-Syte Luer Access Split Septum is a device used to provide needleless access to intravascular catheters. Needleless access devices are a necessary component in the infusion therapy administration process; however, they have been shown to be a reservoir for bacterial growth.⁵ Recent literature suggests that more simple designs offer less risk of device colonization. A split-septum needleless access system has 64% to 70% lower CRBSI rates than mechanical valves.^6,7 The BD Q-Syte device’s simple internal design, smooth surface, and clear housing are consistent with attributes recommended by thought leaders in infection prevention."^6,8

3M Tegaderm CHG IV securement dressing

Wise offered anecdotal evidence to the effectiveness of BD’s Q-Syte. The first experience related took place at Jennie Edmundson Hospital in Council Bluffs, IA. "Jennie Edmundson Hospital demonstrated a 60% reduction in CRBSI rates following conversion to the BD Q-Syte device, decreasing their rate from 4.06 per 1,000 catheter-days down to 1.63 per 1,000 catheter-days. No other specific interventions targeting a reduction in CRBSI were introduced following the change to BD Q-Syte Luer Access Split Septum. This facility completed house-wide conversion to the BD Q-Syte device in January 2008. In comparison to the number of CRBSIs that occurred in 2007, there were 15 fewer CRBSIs in 2008 (data through October 2008).^9,10 At a cost of $36,441 per episode, an annual reduction of 15 CRBSIs saved this institution over $546,000."

The second experience took place at Saint Joseph’s Hospital, Atlanta, GA. Wise related: “Saint Joseph’s Hospital demonstrated a 69% reduction in CRBSI rates with use of the BD Q-Syte device. Their CRBSI rate for 2005 was 7.71 per 1,000 central-line days. They were able to reduce their 2006 rate to 2.36 per 1,000 central-line days. The trial of BD Q-Syte split septum in their MSICU [medical-surgical ICU] lasted from October 2005 through March 2006, the results of which determined that they would continue to use the BD Q-Syte device in the MSICU.¹¹ In June 2006, they implemented BD Q-Syte Luer Access Split Septum house-wide."

Of course, we don’t want to forget that preparing the skin for an infusion is a vital first step. Mitch Fuqua, director, marketing and product management, vascular products, infection prevention, CareFusion, Leawood, KS, stressed an important point: "Microorganisms on the patients’ skin are the number one cause of BSIs and surgical-site infections (SSIs).^12,13 CareFusion’s ChloraPrep is a patient preoperative skin preparation product. It contains a combination of 2% chlorhexidine gluconate (CHG) and 70% isopropyl alcohol and helps to improve clinical patient outcomes by reducing the skin-dwelling microorganisms that can cause BSIs and SSIs. The applicator eliminates hand-to-patient contact, helping to prevent cross-contamination. According to the CDC, the transmission of MRSA happens almost exclusively via the hands, especially the hands of healthcare workers."¹⁴ Additionally, the primary ingredient in ChloraPrep, CHG, is highly recommended for cutaneous antisepsis by 18 organizations and initiatives, with 11 organizations, including the CDC, specifically advocating a 2% formulation."

Fuqua continued: "There is a great deal of rather impressive evidence supporting the use of ChloraPrep as a means to reduce infections. Thirty-seven published studies support the use of ChloraPrep for infection prevention." A study by Tepus et al¹⁵ found that use of ChloraPrep significantly decreased contamination rates, resulting in a savings of $875,000 per year. Another study, by Young et al,¹⁶ found that switching to ChloraPrep and using a larger drape decreased the BSI rate from "a baseline of 11.3 per 1,000 CVC-days before the intervention to 3.7 per 1,000 CVC-days after the intervention.

Baxter's V-Link with VitalShield, antimicrobial needle-free IV connector

These results calculated to an annualized savings to the hospital of approximately $350,000."

3M Health Care’s Tegaderm CHG (chlor-hexidine gluconate) IV Securement Dressing is a transparent, antimicrobial dressing used to cover and protect catheter sites and to secure devices to skin. The dressing, which consists of a transparent adhesive dressing and an integrated gel pad containing the highly effective antiseptic agent, CHG, provides continual antimicrobial activity while maintaining complete site visibility.

3M testing in healthy volunteers has shown that Tegaderm CHG reduces the amount of skin flora under the dressing and prevents re-growth. 3M in vitro testing shows CHG has broad spectrum activity against, and is a barrier to, a wide variety of gram-positive and gram-negative bacteria and yeast, including the majority of pathogens that are of most concern to epidemiologists and infection-control practitioners.

Since the Tegaderm dressing and its integrated CHG gel pad are transparent; it allows continuous catheter site visualization, letting healthcare professionals detect any signs of inflammation or infection around the intravascular device. The breathable dressing maintains an effective barrier to outside contaminants and absorbs fluids. The integrated design of a dressing and CHG gel pad reduces application steps and minimizes potential for application error.

3M’s DuraPrep is also a patient preoperative skin preparation product in its own applicator. DuraPrep solution has the ability to form a film that will resist removal during blood and saline challenges inherent to many procedures. Other patient prepping products do not provide persistency data in the presence of blood and saline.

Dialysis patients may benefit from a catheter made by AngioDynamics, Queensbury, NY.

B. Braun Introcan  Safety IV Catheter

John Mousaw, vice president, marketing services, said: "The new DuraMax stepped chronic dialysis catheter is made from Durathane for durability against alcohol and common agents used to care for the entry site. It employs Curved Tip Catheter Technology, providing higher blood flow and lower recirculation, even if the catheter comes up against a blood vessel wall. This eliminates side holes common in other catheters, reducing the potential for clots."

Another AngioDynamics device, Benephit, delivers physician-specified agents directly to the kidneys to prevent and treat acute kidney injury. "This therapy is called ‘targeted renal therapy.’ Acute kidney injury can result from common interventional and surgical procedures, and is a greater problem in elderly and diabetic patients. Benephit delivers therapeutic agents directly into both renal arteries through a bifurcated infusion catheter with self-seeking arms that easily cannulate the renal arteries. The Benephit catheter system allows simultaneous interventional coronary, peripheral, endovascular, and surgical procedures as well as post-procedure infusion."

Eileen Lane, director, marketing IV sets and accessories, CareFusion, San Diego, CA, highlighted just how important needle-free devices are. "The CDC has estimated that more than 800,000 needlesticks and other sharps injuries occur each year in the U.S,¹⁷ and safer needle devices have been shown to reduce 61% to 88% of all needlestick injuries.¹⁸ Needle-free really does matter."

"CareFusion’s SmartSite needle-free valve can be activated by a standard male Luer, completely eliminating the need for needles," said Lane. "This reduces accidental needlestick injuries, and potential transmission of bloodborne pathogens, and makes hospitals a safer place for clinicians. The passive design eliminates caps and cannulas, making IV administration simpler and quicker."

MedPro Safety Products’ intravenous Key-Lok needleless IV system

Lane continued: "The reduction of sharps disposal and needlesticks associated with a needle-free system decreases hospital costs, but the CareFusion SmartSite IV sets and accessories may further reduce cost. The capless valve design eliminates the cost associated with caps, cannulas, and other add-on components. This means facilities need to buy and inventory fewer component parts, and that translates into a more efficient system for an organization."

Walter Weller, CEO, MedPro Safety Products Inc., Lexington, KY, also highlighted the cost-saving aspect of needleless systems. "Needlestick injuries are reported in the U.S. every 30 seconds, or between 850,000 and 1 million times a year, with as many as 5 million going unreported. MedPro passive technologies are designed to reduce the risk of sharps injury and the spread of infection and raise the level of safety for healthcare workers. Healthcare costs are reduced whenever a needlestick injury is prevented, eliminating the need to test for or treat accidental exposure to bloodborne diseases. It costs a hospital $3,500 every time a needlestick injury is reported; if a million needlestick injuries are reported a year, the cost for hospitals is $3.5 billion annually."

Weller described one of their products: "The Key-Lok Needleless IV System is a latex-free infusion system that has been developed and is in preparations to be commercialized. It provides secure connection for a needleless medication infusion delivery system and is designed to be cost competitive with needle-based products."

Weller explained further benefits for users. "MedPro’s technology saves hospital workers time and energy because they require no special training on how to use the safety systems; using a fully passive system requires no additional steps. The additional cost of special training is unnecessary for hospitals, saving them money, too."

Previews

CareFusion’s SmartSite device

Technological advances continue. A couple of companies gave us a preview of what to expect in the near future.

Bonderud described a new release on the horizon from Baxter. "Starting this year, the SIGMA Spectrum large-volume infusion pump, one of the latest generation smart pumps, will be exclusively distributed by Baxter Healthcare Corporation. Weighing only approximately 2.5 pounds, and measuring one-tenth the size of many other large-volume pumps, it features smart-pump technology intended to help reduce medication errors through the use of drug libraries that eliminate the need for clinicians to manually enter commonly used drugs. It also is compatible with Baxter’s standard IV administration sets."

AngioDynamics also expects to launch new products in the near future, according to Mousaw. "AngioDynamics’ Smart Port CT Mini and Low Profile Ports are scheduled to launch next year. The mini port is ideal for chest or peripheral placement, while the low-profile model’s larger septum diameter offers a greater target area. Tangential outlet and clear-flow technology set up efficient flushing action to hyper-cleanse the entire chamber, resist sludge build-up, and reduce occlusions and infections."

References:

1. O’Grady NP, Alexander M, Dellinger EP, Gerberding, JL, Heard SO, Maki DG, et al. Guidelines for the prevention of intravascular catheter-related infections. MMWR 2002;51 (RR10):1-26.www.cdc.gov/mmwr/preview/mmwr html/rr5110a1.htm

2. Kluger DM, Maki DG. The relative risk of intravascular device related bloodstream infections in adults [Abstract]. In: Abstracts of the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy. San Francisco, CA: American Society for Microbiology, 1999:514.

3. Cantrell S. Striving for excellence: infection-prevention success stories. Healthcare Purchasing News 2008;32:24-29. www.hpnonline.com/inside/2008-02/0802-IC-prevention.html.

4. Mendelson MH, Loin-Chen BY, Finkelstein-Blond LE, Kogan G, Hollinger I. Study of Introcan Safety IV Catheter (IVC) (B.Braun Medical Inc.) for the prevention of percutaneous injuries (PIs) in healthcare workers (HCWs). Abstract presented at The Society for Healthcare Epidemiology of America. 2003, Arlington, VA.

 5. Karchmer TB, Wood C, Ohl CA, et al. Contamination of mechanical valve needleless devices may contribute to catheter-related bloodstream infections. Annual Meeting of the Society for Healthcare Epidemiology of America; 2006. Presentation number: 221; Poster number 47.

6. Rupp ME, Sholtz LA, Jourdan DR, Marion ND, Tyner LK, Fey PD, et al. Outbreak of bloodstream infection temporally associated with the use of an intravascular needleless valve. Clin Infect Dis 2007;44:1408-1414.

7. Salgado CD, Chinnes L, Paczesny TH, Cantey JR. Increased rate of catheter-related bloodstream infection associated with use of a needleless mechanical valve device at a long-term acute care hospital. Infect Control Hosp Epidemiol. 2007;28:684-688.

8. Jarvis, WR. Preventing central venous catheter (CVC)-associated bloodstream infections in 2005: is zero realistic? Infusion Nursing Society Annual Meeting; 2005.

9. Love KL. Catheter-related bloodstream infection rates decrease to zero in the ICU after implementing a closed Luer access split-septum device. AVA; 2008. Poster.

10. Love KL. Impact of a closed Luer access split-septum device on catheter-related bloodstream infection (CR-BSI) rates in a community hospital adult population. Association for Professionals in Infection Control and Epidemiology; 2009. Poster.

11. Kirley D, Swan J, Whelan L, Hoekstra D. Impact of changing from a Luer access mechanical valve to a Luer access split septum device on the reduction of central line-associated bloodstream infections in a medical surgical intensive care unit. AVA;2008. Poster.

12. Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999;20:250-278.

13. Safdar N, Maki DG. The pathogenesis of catheter-related bloodstream infection with noncuffed short-term central venous catheters. Intensive Care Med 2004;30:62-67.

14. Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the Healthcare Infection Control Practices Advisory Committee. 2007 Guideline for isolation precautions: preventing transmission of infectious agents in healthcare settings. www.cdc.gov/ncidod/dhqp/pdf/isolation2007.pdf

15. Tepus D, Fleming E, Cox S, Hazelett S, Kropp D. Effectiveness of ChloraPrep in reduction of blood culture contamination rates in emergency department. J Nurs Care Qual 2008;23:272–276.

16. Young EM, Commiskey ML, Wilson SJ. Translating evidence into practice to prevent central venous catheter associated bloodstream infections: a systems-based intervention. Am J Infect Control 2006;34:503-506.

17. National Institute for Occupational Safety and Health. NIOSH alert: Preventing needlestick injuries in health care settings. NIOSH Publication no. 2000-108. http://www.cdc.gov/niosh/docs/2000-108/