Medical Devices Pose Big Infection Threat

Healthcare workers have long been trying to prevent infections related to medical devices, but must try even harder as of Oct. 1, 2008, when regulations from the Centers for Medicare & Medicaid Services (CMS) go into effect. As a result, hospitals will no longer receive higher payments for the additional costs associated with treating patients for certain hospital-acquired infections, including those caused by catheters, etc.

Device infections can be caused by microorganisms that are on medical devices when they penetrate the epidermis or are put inside the body, but they can also enter the body through the associated wound. Unlike the human body, a medical device lacks natural defenses and is therefore a hospitable place for microorganisms to populate.

Central venous catheters (CVCs) are a common source of medical device infection. Catheters are extremely useful but they weaken skin integrity and thus leave the epidermis vulnerable to bacteria and fungus. The bloodstream can also become infected. Nosocomial bloodstream infections can be deadly, cost between $3,700 and $29,000 per case¹ and increase hospital stays by a mean of seven days.¹

Catheter-related infections deserve a lot of attention. Other device-related infections need attention too though, says Rabih Darouiche, MD, director of the Center for Prostheses Infection at the Michael E. Debakey Veterans Affairs Medical Center and the Baylor College of Medicine in Houston, Texas. He is also the founder of the Multidisciplinary Alliance Against Device-Related Infections.

“There has not been much research done in the areas of infections associated with devices other than catheters, such as surgical implants,” Darouiche says. “In contrast, there has been much more research done on infections associated with vascular and urinary catheters.”

Vascular access devices are an inherent part of current healthcare in that they are used to administer antibiotics, fluids, pain medications, blood and blood products, parenteral nutrition, hemodynamic monitoring and blood sampling, according to Deborah Richardson, RN, MS, CNS, author of the Association for Vascular Access article, “Vascular access nursing practice, standards of care, and strategies in the prevention of infection: a primer on central venous catheters.”

“Even though these devices are commonplace in the healthcare environment, they are not without risks,” Richardson writes. “The most common life-threatening complication associated with central venous catheters is infection. Catheter-related bloodstream infection (CRBSI) is caused by colonization of the catheter, or contamination of the catheter hub or infusate, and/or contamination of the catheter from the skin of the patient or healthcare worker.

“The healthcare worker, such as the vascular access nurse, can affect CRBSI rates by implementing and utilizing the most current technologies, maintaining current knowledge related to IV therapy, utilizing, implementing and maintaining aseptic technique, and incorporating the standards, guidelines and preventive strategies associated with vascular access nursing,” she continues.

According to research by Darouiche, more than half of healthcare-acquired infections are attributed to medical devices such as central venous catheters, bladder catheters, endotracheal tubes, tracheostomy devices, and surgical implants.

Prevention Advice

The science behind infections can be complicated, but some of the associated solutions are quite simple. The first step to prevention of device-related infection is to wash hands properly and put on gloves, says Dennis Maki, MD, professor of medicine in the Section of Infectious Diseases at the University of Wisconsin School of Medicine and Public Health in Madison, Wis. Maki is also a hospital epidemiologist at the University of Wisconsin Hospital and Clinics, and an attending physician in the University of Wisconsin Center for Trauma and Life Support.

“The next step is that every effort needs to be made to follow standard infection control practices with insertion of intravascular devices,” Maki says. “That’s basically to comply with evidence-based guidelines. I think that’s extremely important with urinary catheters, but especially intravenous catheters of all types. ...On a daily basis, every day that a patient is seen the question should be asked by their healthcare worker, ‘Do they need that device any longer? Can it be removed today?’” Maki says.

“I’m a critical care physician as well as an infectious disease consultant and when I’m in the ICU (intensive care unit) and I’m taking care of the patients, every day on rounds we ask ourselves, “What devices can we remove?” No device should be left in a minute longer than is necessary,” Maki adds. “It’s a low-tech recommendation but it’s not a trivial one ... People are busy and they just sort of forget (the catheter’s) there and it’s particularly a problem in ICUs.”

The Centers for Disease Control and Prevention (CDC) offers the following (non-comprehensive) tips for prevention of medical device infections.

In general, reusable medical devices or patient-care equipment that enters the vascular system or through which blood flows should be sterile. Sterilization could occur through a physical or chemical procedure. This may include ethylene oxide gas, chemical germicides, dry heat or include moist heat by steam autoclaving.

There are three levels of disinfection: high, intermediate, and low. High-level disinfection kills all organisms (except high levels of bacterial spores), intermediate kills mycobacteria, most viruses and most bacteria and low-level disinfection kills some viruses and some bacteria.

Heat-stable reusable medical devices that enter tissue or the blood stream should be reprocessed with heat-based methods of sterilization such as a steam autoclave.

Reusable devices or equipment (such as endotracheal tubes, anesthesia breathing circuits, and respiratory therapy equipment) that touch mucous membranes should at least receive high-level disinfection between patients.

Manufacturers' instructions for every device should be followed closely.

CMS Impact

Many healthcare workers are concerned about the consequences of the new CMS changes, but many admit that one advantage is that people will pay more attention to device-related infections.

“I don’t think there’s any question they will,” Maki says. “They have already, I think. The beneficial side of the CMS changes and the Joint Commission’s greater focus in this area has been that hospital administrations have become more cognizant of the issue of infection control. Busy hospital administrators realize they should have an infection control program but it’s not considered a revenue-generating program.

“We who work in infection control know all too well that we save hospitals tons of money,” Maki adds. “We’re a revenue generating program because by preventing infections we save enormous amounts of money that would otherwise be lost. And now the hospital administrators have a direct interest financially because they can still be non-cognizant of the fact that we’re saving them money but they realize that if a patient gets an infection, it’s going to cost them additional money.”

Darouiche agrees that the CMS changes will not be ignored.

“The recently established CMS guidelines will prompt healthcare providers, infection control groups, and hospital administrators to ponder optimal methods for preventing hospital-acquired device-related infections that would be considered preventable but not reimbursable by CMS,” Darouiche says.


Infection control measures are the “mainstay approach” for preventing device-related infection, but adherence to such measures is inconsistent, according to Darouiche.

“That is why infection control measures need to be complemented with truly protective technology,” he adds. “...Although the healthcare industry has paid attention to infections associated with some devices, they have (been) discouraged by the lengthy and expensive process of securing FDA (Food and Drug Administration) approval for anti-infective devices.”

Healthcare workers need to stay up to date regarding technology advances, Maki says. “Technological advances implicitly reduce risk beyond the simple control measures that we try to implement,” he adds. “Technology such as coded catheters, antiseptic dressings, the biopatch, integrated antiseptic dressings, novel technologies for dealing with the risk of introducing organisms at the hubs of connectors, have all been shown to reduce risk. If hospitals want to get their risk to approaching zero level, starting to adopt technologies as an adjunct to control measures would help them get there quickly.”

Helpful technology for the prevention of device-related infection includes use of the BD Nexiva™ Closed IV Catheter System, according to BD Medical representatives. The pre-assembled system creates a closed single lumen fluid path that is designed to minimize blood leakage from the catheter hub. It also decreases the potential for contamination and exposure to blood.

Additionally, the BD Q-Syte™ Luer Access Split Septum needleless access system has 64 percent-70 percent lower CRBSI rates than mechanical valves.2,3 Patients are three times more likely, on average, to develop a CRBSI with the use of mechanical valves versus a split -septum needleless access system.2,3

Technology can also greatly influence catheter-associated urinary tract infections (CAUTIs). The addition of a Foley catheter with drug eluting technology, for instance, can reduce the incidence of CAUTIs, according to James Carper, a Rochester Medical Corporation spokesman.

“The ReleaseNF Anti-Infection Foley catheter from Rochester Medical elutes the non-systemic antimicrobial nitrofurazone and is clinically proven to reduce the incidence of CAUTI even when compared to standard all silicone catheters,” Carper says. “It is also the only Foley catheter with an indication for reducing bacterial CAUTI.”

Ventilator-Associated Pneumonia (VAP)

Most healthcare workers are well acquainted with the high stakes of VAP. Several prevention guidelines exist but are not followed as often as they should, since VAP remains one of the most common nosocomial infections. It increases the average patient’s hospital stay by an average of 4.3 days, costs between $5,800-$20,000 per incidence, and mortality rates range from 20 percent to 70 percent.4

According to CDC authors of the paper “Best-practice protocols: VAP prevention,” VAP patients exhibit at least three out of the five symptoms: fever, leukocytosis, change in sputum (color and/or amount), radiographic evidence of new or progressive infiltrates, and worsening oxygen requirements.

VAP is largely preventable. Researchers from the Institute for Healthcare Improvement (IHI) — a non-profit organization that strives for healthcare improvement throughout the world — VAP prevention components should be bundled. Important tenets include:

Proper angling of bed elevation

Daily sedation vacations and assessment of readiness to extubate

Peptic ulcer disease prophylaxis

Deep venous thrombosis prophylaxis5

There are several precautionary steps that healthcare workers can take to help prevent VAP, says David Park, general manager of North America Medical Devices for Kimberly-Clark Health Care.

“One step that is often overlooked due to the hectic environment of the ICU is the patient’s oral hygiene,” Park says. “One of the key steps to help decrease the microbial load in the oropharyngeal cavity of the patient’s mouth is by providing consistent and comprehensive oral care to ventilated patients. Because ICU nurses are so busy and have limited amounts of time to spend with each patient, it is important to choose an oral care system specifically designed for convenience and ease-of-use by caregivers.”

Park suggests that oral care systems be equipped with all the proper oral hygiene items that are essential to comprehensive oral care protocols.

“Use an oral health assessment form to determine the state of the patient’s oral health and oral care needs on a daily basis,” he says. “This will help identify if the patient has developed any abnormalities or mucositis, an oral tissue inflammation, which can increase the risk of VAP.”

The human body doesn’t always fend off infection, but at least it has a chance. Medical devices, however, have no defense mechanisms and must therefore be kept clean before and while they’re being used. Any nearby entry site must also be properly cared for. This has always been important, but come Oct. 1, the consequences will increase.


1. Institute for Healthcare Improvement: Getting Started Kit: Prevent Central Line Infections, How-to Guide.

2. Salgado CD, et al. Increased rate of catheter-related bloodstream infection associated with use of a needleless mechanical valve device at a long-term acute care hospital. Infection Control and Hospital Epidemiology. 2007;28.

3. Rupp ME, et al. Outbreak of bloodstream infection temporally associated with the use of an intravascular needleless valve. Clinical Infectious Diseases. 2007;44.

4. Evans B. Best-practice protocols: VAP prevention. December 2005, Volume 36.

5. VHA Inc. Web site: