Medical Device Innovation is Vital to Patient Safety

One out of every 20 hospital patients contracts a hospital-acquired infection (HAI) during their stay, resulting in approximately 2 million infections and 90,000 deaths each year, reports the Centers for Disease Control and Prevention (CDC) — a mortality rate greater than breast cancer and auto accident deaths combined. Adding to the urgency of eradicating HAIs is the widely discussed methicillin-resistant Staphylococcus aureus (MRSA). Known as a “superbug,” MRSA is becoming an increasing concern as outbreaks continue to occur in the community and in hospital settings.

Needless to say, the medical community is battling these fatal infections from every angle. With increased concern from the public and skyrocketing treatment costs, measures have been designed to assist hospitals and medical centers in reducing infection rates. While there is no silver bullet, compound and complementary efforts merged with due diligence can dramatically lower the rates of infections.

While HAIs can come from a variety of sources, including contaminated bed sheets and dirty hands, it is critical to note more than half of HAIs are attributed to medical devices such as central venous catheters (CVCs), bladder catheters, endotracheal tubes, tracheostomy devices, and surgical implants. Oftentimes, the infection-causing bacteria reside on the patient’s skin surrounding device insertion sites. The bacteria attach themselves to the indwelling devices, form antibiotic-resistant biofilms and cause life-threatening infections when they invade the body. Essentially, these devices bypass the body’s natural lines of defenses against pathogens and provide easy routes for infections to grow. Once this occurs, infections can vary from risk level to type based on the host, the medical device and the virulence of the infectious organism.

One of the most commonly inserted medical devices in the U.S. is a CVC, which also causes one of the most serious HAIs, catheter-related bloodstream infections (CRBSIs). According to data from the CDC, approximately 90 percent of all CRBSIs occur with CVCs. These infections can lead to acute respiratory-distress syndrome, kidney failure, shock and other ailments with treatment costs upwards of $30,000 per patient. According to research conducted by John Hopkins Medical Institution, as many as 28,000 patients die each year in the U.S. because of CRBSIs.

Currently, several institutions, governmental agencies, industry and medical societies, and healthcare providers are working to improve medical device technology and reduce HAIs. Most approaches have relied on input and feedback provided by infectious disease and critical care physicians, surgeons who insert devices, infection control practitioners monitoring device-associated infections, and nurses who care for the patients with indwelling devices.

One of the most notable movements toward improving medical device technology with the goal of improving patient care is the Multidisciplinary Alliance Against Device-Related Infections (MADRI), which is comprised of governmental agencies, healthcare providers, medical societies and drug and device manufacturing companies. The eighth annual MADRI conference met in early June to provide education and promote discussion around medical interventions, surgical advances and regulatory perspectives on device-related infections.

However, one of the difficulties for medical professionals is minimizing the infections without having to actually reduce the number of indwelling devices used. With this in mind, medical device companies are looking at new ways to design, manufacture and sterilize devices. Manufacturers have been investigating surface modification technologies, specifically surface coatings that are engineered to release bactericidal agents in a controlled manner.

Due to their high usage rates, CVCs stand on the front lines of combating HAIs. Still considered commodities in many hospitals, the simple, non-coated CVCs have evolved into highly advanced catheters that are impregnated with antibiotics. In that regard, the use of CVCs impregnated with minocycline and rifampin has been demonstrated to greatly reduce the incidence of CRBSIs to nearly zero. These antimicrobial agents help to protect patients from a wide variety of organisms that initially cause the infection. Of course, antimicrobial and antibiotic-coated medical devices should always be used in conjunction with the aforementioned basic infection control practices to achieve the most effective outcome.

While advances have been made, there simply has not been enough research or attention given to medical-device infections. Infection prevention is a responsibility for all healthcare professionals and, with a solid commitment and adherence to infection control best practices and innovations in medical-device technology, hospitals can significantly reduce HAI rates and unnecessary treatment costs. With the heightened attention to HAI rates and patient awareness, now is the time for a renewed focus on medical device innovation that can help save the lives of thousands of people.

Rabih O. Darouiche, MD, is the VA Distinguished Service Professor in the Departments of Medicine (Infectious Disease Section) and Physical Medicine and Rehabilitation, and director of the Center for Prostheses Infection, 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.

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