CS Solutions
The triple threat:
Manufactured catheter securement devices protect patient, safeguard healthcare workers, save money

by Susan Cantrell, ELS

The renewed dedication to patient safety has led to examination of how and why procedures and treatments are performed as they are in health care. "Because that’s the way we’ve always done it" is no longer considered a good reason to continue doing things a certain way. Today, evidence must be presented as validation as to why certain actions are performed in a certain way. Show-me-the-science is the current standard of validation, and this evidenced-based medicine is rooted in scientific studies that result in recommendations and guidelines published by leading healthcare organizations.

One aspect of healthcare that is garnering increased attention by regulatory and advisory organizations as a result of this movement for improved patient safety is catheter securement. In their "Guidelines for the Prevention of Intravascular Catheter-Related Infections," the Centers for Disease Control and Prevention (CDC) acknowledged that "Sutureless securement devices can be advantageous over suture in preventing catheter-related BSIs," but nevertheless made "no recommendation . . . for the use of sutureless securement devices," categorizing catheter securement as an "unresolved issue."1

StatLock CVC Plus from Arrow International

In April, the Infusion Nursing Society (INS) released its new Standards of Practice, 2006. INS took a stronger stand on use of catheter securement devices by saying: "Whenever feasible, using a manufactured catheter stabilization device is preferred."2

Traditionally, suture or tape and gauze have been used to secure catheters. The problem is that these methods just don’t work very well (see sidebar on page 72). Catheters naturally are prone to move with the patient. Even tiny movements can lead to dislodgement of the catheter or can cause infiltration. Infiltration occurs when the needle pokes through a blood vessel, leaking fluid into tissue, which can cause no small discomfort for the patient. Dislodgement or infiltration necessitates unscheduled restarts of the catheter line. Every time the patient’s skin is punctured, a new opportunity for infectious organisms to enter the bloodstream is presented, and a sick patient must endure yet more pain. Every time a healthcare worker sutures in a line, they risk being stuck by a contaminated needle.

Some may balk at using manufactured securement devices, because they may appear to cost more than tape and gauze or suture at first glance; however, when lines have to be restarted, the costs in supplies and labor add up quickly. Infection can cause costs to soar. The CDC estimated that "a total of 250,000 cases of BSIs [bloodstream infections]" occur annually, adding that "The cost of CVC [central venous catheter]-associated BSI is substantial, both in terms of morbidity and in terms of financial resources expended. . . . The attributable cost per infection is an estimated $34,508 to $56,000, and the annual cost of caring for patients with CVC-associated BSIs ranges from $296 million to $2.3 billion."1

Upon closer examination, it becomes clear that catheter stabilization devices can help toward reducing financial burden on healthcare facilities as well as human suffering caused by catheter-associated infection. "When you look at the high cost of infection and the relatively low cost of implementing the technology, in almost every case the technology pays for itself," observed Matt Moore, senior marketing manager, Arrow International Inc, Reading, PA. "Studies show these devices are efficacious in reducing risk of infection. Reducing infection even by one case per year can pay for the higher costs of a catheter stabilization device many times over. The CDC puts the cost of one infection at about $35,000. That would buy a lot of StatLocks (Venetec International, San Diego, CA). The price of the device becomes a non-issue, because the price of not using it is greater. A lot of infection costs are not reimbursable. From the total cost standpoint, reducing risk of catheter-related infection ultimately benefits departments and hospital systems."

Moore emphasized that, while catheter securement devices can be cost-effective, Arrow’s "focus is on reducing risk associated with use of central-line products, an umbrella idea under which catheter securement devices fall." With risk reduction as their goal, Arrow has developed a kit that bundles all components needed for catheterization plus a checklist for process control, thus "eliminating inconvenience as an excuse not to follow process." Their higher end kit uses the StatLock catheter securement device; alternatively, they offer kits with suture, stainless-steel staples, or adhesive for catheter stabilization.

Venetec’s StatLock IV Ultra

"Arrow wants to further the idea of ‘first, do no harm,’" Moore said. "Back-to-basics awareness, more attention to process controls, can result in fewer complications. Placing a catheter should improve treatment for the patient. We don’t want to expose the patient to risks we can control. There are some things we can’t control, but infection control risks can be reduced, and that’s what Arrow focuses on as we constantly strive for continuous improvement." Moore pointed out that "StatLock devices reduce risk of infection by eliminating the need to put additional holes in the patient. No sutures present less area for bacteria to hide in at the insertion site." He echoes infections disease expert Dennis G. Maki, MD (see sidebar) in that risk of sharps injury for healthcare workers also is eliminated with StatLock.

Bonnie Smith, R.N., IV manager, Holmes Regional Medical Center, Melbourne, FL, and President-Elect of the Space Coast chapter of INS, has used StatLock with success at her hospital. "When I first heard about catheter securement devices, I didn’t think it mattered much. We were using a tape chevron with an overlying tape strip. Our IVs weren’t lasting 72 hours. Then, one of our nurses went to an INS conference in Tennessee and heard that, if you use this IV securement device, it would make IVs last. We had been doing studies on reasons for restarts every 3 months for the past 20 years. I knew that only 8% to 15% of our IVs were lasting to the routine site change. We had no faith in StatLock, but we decided to do a study on it and found that, amazingly, 52% of our IVs lasted.3 We couldn’t believe it. We’ve been using StatLock since 2003 and have continued doing studies every 3 months. The rate continues to stay up."

Smith found that using StatLock cuts down on dislodgements, limits mechanical phlebitis, reduces opportunities for needlesticks and infection, and lessens incidence of infiltration. "We’ve had no BSIs from peripheral IV sites," said Smith. "We have an IV team who monitors catheters closely, but when a catheter is secured with tape and gauze or suture, it can move around; then it gets wet and blood comes out; so, chances of BSI occurring increase. Sutures get red and inflamed, presenting another potential exposure to infection. Every time the needle goes in and out of the skin, bacteria travel through the skin with it."

Smith’s IV team inserviced the anesthesia department, explaining the results they’d had with StatLock. "Only one anesthesiologist would use the StatLock at first," said Smith. "His IVs lasted for days; others had to be changed in 1 day, after the patients roused and began to move around. We’d report those results to the anesthesiologists, and eventually they all started using StatLock. It really made a difference."

Merit Medical’s catheter securement device

Despite impressive results using StatLock, those responsible for purchasing weren’t believers immediately, explained Smith. "Our purchasing department wanted us to find a less expensive catheter securement device. The kit with StatLock costs $3. We tried HubGuard3; it’s only $.50, but you have to add the skin prep, which costs $.75 to $1.00. It just didn’t do as well.3 I think it takes purchasing departments time to really believe that the manufactured catheter securement device will make a difference in IV complications and to see the savings that can be realized by using it," Smith told HPN. "This is what I do for a living, and I didn’t believe it myself until we did the studies.3 It was just amazing."

Merit Medical Systems Inc, South Jordan, UT, is another company deeply involved in developing safety products. They introduced their new catheter stabilization device in April of this year. Revolution is so called because the device is revolved to deploy strings (suture material) that secure the catheter in place, and because "it revolutionizes the marketplace," declared Fred Lampropoulos, chairman and CEO. Lampropoulos had an epiphany when he once witnessed a physician suturing in a fixation device, moving him to design a catheter stabilization device that didn’t involve needles. "Safety is of huge interest to Merit. We have many products related to safety, but this is one of the most fascinating products we’ve developed," Lampropoulos told HPN.

The Revolution catheter securement device also reduces incidence of dislodgements and restarts, increases dwell time, allows patients a higher level of comfort, and is cost competitive. "The Revolution involves no extra cost but provides additional value," said Lampropoulos. "Radiologists are fascinated by what Revolution does. Our primary market for the Revolution is interventional radiologists who will use it to secure drainage catheters that can be in place for up to 90 days. The Revolution’s design allows for clear visualization and easy cleaning of the puncture site. The Revolution also could be used to secure feeding tubes, chest drainage tubes, temporary pacing leads (cardiology), and thrombolytic catheters. It also comes with a plastic cap to cover the site so patients can shower without getting it wet." 

Lampropoulos concluded by saying, "At the end of the day, what counts is if the device meets patient needs and is cost-effective." Clearly, manufactured catheter securement devices are a positive development toward patient safety. Coincidentally, it can protect healthcare workers from potentially contaminated needlesticks. A huge bonus is that it can save money. What more could one ask for in a product? HPN

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 Recomm Rep2002;51(RR-10):1-29. http://www.cdc.
gov/ncidod/dhqp/gl_intravascular.html.

2.Infusion Nurses Society. Infusion Nursing Standards of Practice, 2006. Philadelphia, PA: Lippincott Williams & Wilkins; 2006.

3.Smith B. Peripheral intravenous catheter dwell times: a comparison of 3 securement methods for implementation of a 96-hour scheduled change protocol. J Infus Nurs 2006;29:14-17.

 

Dennis G. Maki, MD, talks about manufactured catheter securement devices

Dennis G. Maki, MD is the Ovid O. Meyer Professor of Medicine; Head, Section of Infectious Diseases; Attending Physician, Center for Trauma and Life Support, University of Wisconsin Medical School, Madison, WI. Maki is respected worldwide for his work in infectious diseases, and he is a world-renowned expert on catheter-related infection. Maki’s affiliations with professional societies include but are not limited to the American Academy of Microbiology (Fellow), the American College of Chest Physicians (Fellow), the Infectious Diseases Society of America (Fellow), the Surgical Infection Society (Fellow); and American College of Physicians (Master). He is a Past-president of the Society for Hospital Epidemiologists of America. Maki has served in various capacities to leading healthcare journals including JAMA, Infection Control and Hospital Epidemiology, Journal of Infectious Diseases, Critical Care Medicine, Morbidity and Mortality Weekly Report, New England Journal of Medicine, Chest, Mayo Clinic Proceedings, Annals of Internal Medicine, and many more. Maki has served as a consultant to the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration. He has been bestowed with over 100 honors and awards during his career. His abstracts and presentations at scientific meetings number approximately 500. HPN asked Maki to comment on the position taken by the CDC, who, in their "Guidelines for the Prevention of Intravascular Catheter-Related Infections" acknowledged that manufactured catheter securement devices can be advantageous but nevertheless did not recommend them, categorizing them as an unresolved issue, as opposed to the Infusion Nurses Society, whose new Standards of Practice, 2006, state preferential use of manufactured catheter securement devices whenever feasible. The CDC and the Secretary of the Department of Health and Human Services are guided by the Healthcare Infection Control Practices Advisory Committee (HICPAC), a federal advisory committee comprised of 14 external experts who advise on infection control and healthcare-associated infections in U.S. facilities. One of the committee’s main functions is to issue recommendations for preventing and controlling healthcare-associated infections. It is Maki’s opinion that "The CDC-HICPAC guidelines are very conservative. I served on the panel for the last HICPAC guideline for prevention of vascular catheter-related bloodstream infection [BSI]. It baffled me, and it’s something I’ve not quite understood, but HICPAC dampened the strength of the final recommendation for securement devices despite the fact that there was then already more published data favoring securement devices than for a lot of other measures that were rated as Category 1A or 1B recommendations. However, I’m optimistic that there’s a good chance of readdressing this on the next go-round." Maki believes the more strongly stated recommendation on securement in the new INS standards, "will have an impact not only on society members" but also will "trickle out to institutions that don’t necessarily have a staff member who is a member of the Society." Catheter securement only recently surfaced as an issue. Maki explained why: "Catheter securement, as an issue that might bear on the risk of catheter-related infection, has been essentially ignored for decades. It has not been appreciated that it may be very important. Securement first became recognized as an issue with the AIDS epidemic. Suddenly, people appropriately became concerned about bloodborne pathogens and sharps injuries, realizing that, when you suture in lines, people will get needlesticks. A securement device can obviate that risk. Secondly, a securement device does exactly what it’s supposed to do: it secures a catheter far better than tape and gauze or suture. Suturing central lines and arterial lines, which is still the standard of care in most hospitals is, in my mind, now archaic and, I think, a bad idea." "I believe that the concept of a nonsutured catheter securement device is an idea whose time has finally come," continued Maki. "It brings three advantages: First, when you suture in a central line or arterial catheter, the suture site invariably festers. You’ve got the suture wound sitting right next to the insertion site, in essence, a source of organisms that can pour into the tract." "Secondly, even though a catheter is sutured in, the catheter jiggles around; suturing doesn’t secure it very well. It does help prevent it from being jerked out inadvertently, but it still jiggles around, and this jiggling creates capillary action. Capillary action occurs when you have two surfaces close together with a fluid film in between. If you put a tracer organism at the insertion site of a percutaneous catheter and jiggle it a little bit, microorganisms travel, almost instantly, all the way down to the end of the catheter by capillary action. Securement greatly reduces pistoning or jiggling, and I think this may be why the trials suggest that nonsutured securement devices reduce the risk of catheter-related BSI. It’s not smoking-gun data, but it’s pretty suggestive to me that they reduce the risk of infection." "The third reason I’m attracted to nonsutured securement devices is they obviate the ever-present risk of accidental sharps injuries from suturing in lines. I’ve been stuck twice while helping a resident suture in a line on a patient who was hepatitis C-positive, and I was lucky I didn’t get hepatitis C. The point is that suturing in lines results in a lot of injuries. In our hospital, we put in perhaps 10,000 central and arterial lines a year, and we probably have 2 or 3 sharps injuries a month from suturing in lines. If you’re suturing in close to 1,000 lines a month, even if 1 in several hundred results in a stick, that’s a lot of sticks. I just came back from Europe, where I was told that 300,000 catheters were used last year in one large teaching hospital in The Netherlands." "So, there are three advantages of catheter securement devices, as I see it," concluded Maki: "(1) you eliminate the festering suture site, which I think poses risks of infection; (2) you secure the line much better because the device prevents pistoning and jiggling, also contributing to reducing the risk of infection; and (3) you eliminate risk of sharps injuries." "Finally, numerous studies have shown very convincingly that, with these securement devices, you lose far fewer lines accidentally or, with peripheral catheters, from infiltration or accidental dislodgement. There’s just no question about it: the data show that not only do you greatly reduce premature loss of catheters but you reduce the need for unanticipated restarts." An important plus, noted Maki, is that "the devices are clearly cost-effective." HPN Maki asked that it be stated that he has no potential conflict of interest with respect to these securement devices: he has never done funded research on these devices himself, he has never served as a compensated consultant to the manufacturer, and he is not on their (or any other company’s) speakers bureau. He was one of a number of invited speakers at a thought-leader’s conference the manufacturer held last spring but did not accept an honorarium.

June
2006