MRSA: The Private-Sector Response

The market for effective infection-control interventions is growing. Products that merge information technology with biotechnology can improve quality of care, reduce unnecessary suffering, and eliminate waste of resources.

Abstract

With Medicare eliminating payment for the treatment of several preventable hospital errors and infections, the market for effective infection-control interventions is poised to grow quickly. Products that merge information technology with biotechnology can improve quality of care, reduce unnecessary suffering, and eliminate waste of resources.

In the United States, approximately 1 of every 22 hospitalized patients acquires a post -admission infection (Jarvis 2007). Although incidence estimates vary, hospital-acquired infections (HAIs) affect more than 1.7 million people in the United States annually and cause approximately 99,000 deaths (Klevens 2007a). Moreover, the increased incidence of community-acquired methicillin-resistant Staphylococcus aureus (MRSA) in recent years provides a new threat to efforts to prevent the spread of staph infections in hospitals.

The imperative to fight HAIs is not driven by moral urgency alone. These infections result in $4.5 billion in annual excess healthcare costs (Guadagnino 2006), striking the pockets of state agencies, insurance companies and their employer clients, hospitals, and taxpayers alike. In a 2006 report, the Pennsylvania Health Care Cost Containment Council (PHC4) noted that, in Pennsylvania, the average private-sector insurance payment for the treatment of an inpatient who acquires an infection in the hospital was $53,915, compared with an average of $8,311 for an inpatient without an infection (PHC4 2006). The average length of stay for inpatients with HAIs is more than four times that of inpatients without HAIs. Ultimately, the cost is borne by employers and labor unions in the form of higher healthcare premiums and lost productivity.

The burden of this cost will soon change hands, as new legislation will hold hospitals financially accountable for HAIs. The Centers for Medicare and Medicaid Services is redefining the parameters for reimbursement for care associated with HAIs, and effective October 2008, Medicare will no longer pay for the cost of treating preventable infections, errors, and injuries that occur in hospitals (Pear 2007). Presumably, private insurance companies will follow suit. As HAIs take a front seat in news stories and legislative battles, all parties involved in healthcare payment should stay apprised of efforts to minimize the occurrence of these infections.

MRSA bacteria

Many hospitals are looking to the private sector for solutions. Biotech companies are positioned to profit by bringing new products and services to the market. In this article, we examine the spectrum of responses from the private sector, and focus on MRSA-directed diagnostic tests, infection surveillance systems, and companies that seek to enforce standardization of care.

SCREENING FOR MRSA

Rapid detection of infected and colonized patients, along with their subsequent isolation, has the potential to limit the spread of HAIs. Three state legislatures — Pennsylvania, New Jersey, and Illinois —broke new ground in 2007 by passing bills that require hospitals to routinely test high-risk patients for MRSA (Sack 2007). Because patients bringing community-acquired MRSA into hospitals has increasingly become a problem (Klein 2007), some facilities test every patient who is admitted. Such mandates bring a new sense of urgency to the development of HAI screening tools, and companies are responding by bringing faster, cheaper, and more accurate tests to market.

Active surveillance of MRSA most commonly comes in the form of nasal swabs. Culture-based testing has long been the standard, but these tests traditionally take at least 48 hours to produce results — time that is valuable for isolating colonized patients. Molecular diagnostic tests are now emerging as a more specific, sensitive, and expedient alternative. Three such tests on the market are 3M Health Care’s 3M BacLite Rapid MRSA test, BD GeneOhm’s MRSA assay, and Cepheid’s Xpert MRSA test.

Fast culture method

3M Health Care’s MRSA test is available in Europe. It is a culture-based diagnostic test that the company claims to be the most cost-effective of any of the MRSA tests that deliver same-day results. The system uses the ultrasensitive AK Rapid technology1 to detect MRSA and other dangerous infections (Borgert 2007). The BacLite test can confirm a negative result within five hours and a positive result within one day.

Molecular diagnostics

One of the first successful molecular tests on the market, GeneOhm’s MRSA assay can detect nasal colonization of MRSA in just two hours with 96 percent accuracy (Somers 2005). Recognized as a faster, but generally more expensive, alternative to culture-based tests, this assay works in the following manner: A specimen is obtained from a patient’s nose, polymerase chain reaction (PCR) technology is utilized to amplify DNA and detect unique MRSA gene sequences, a bacterial lysis procedure is performed, and real-time PCR is used to determine the presence of MRSA (Borgert 2007). Dedicated software then interprets the data and produces a definite assay result, allowing incoming patients to be identified quickly as MRSA carriers.

3M BacLite Rapid MRSA test

Cleared for marketing by the FDA in April 2007, Cepheid’s Xpert MRSA test is another new molecular test making headlines. Designed to run on the company’s GeneXpert System, this test offers results in 72 minutes. Also, it is the first molecular diagnostic MRSA test to receive the Clinical Laboratory Improvement Amendments’ “moderate complexity” categorization. With the receipt of this designation, Xpert MRSA is available for use both within and outside of the traditional laboratory setting, lending greater flexibility to its operation. Cepheid’s test also has been selected for use by 10 Veterans Affairs medical centers, and is under consideration at an additional 37 centers.

In Scotland, a novel MRSA diagnostic technology is being developed by Blaze Venture Technologies in conjunction with the University of Strathclyde in Glasgow. Naturally occurring bacteriophages, or viruses that prey on bacteria, are used as a MRSA detection sensor. Swabs are obtained from patients and placed onto a card coated with light-emitting bacteriophages. The virus rapidly reproduces when MRSA is detected by the machine. Ward nurses are able to directly access the machine — which is similar to an ATM — instead of having to send tests to a laboratory. Another major benefit of the new system is the speed of results: Initial MRSA findings take only 10 minutes (Duffy 2008).

SURVEILLANCE SYSTEMS

A growing number of U.S. hospitals are adopting data-mining technologies to better identify and track HAIs. Cardinal Health’s Med-Mined services offers analytical software to track laboratory and microbiology tests in every part of a hospital, merge the findings with details of how and where a patient is being treated, and alert infection-control professionals to possible problems — all without labor-intensive detective work. This system allows hospitals to stay up to date on infection tracking, instead of using less effective and more time-consuming retrospective analyses of patient charts. It also frees up the time infection-control practitioners spend in collecting and counting data — they can now focus on prevention and intervention.

Benchmarking capabilities allow hospitals to compare infection rates by unit throughout the hospital and with other facilities throughout the country. MedMined’s Nosocomial Infection Marker generates HAI reports, offering consistent measurements over time. In addition, antimicrobial management services help to correct the use of antibiotics. According to MedMined, this feature alone resulted in a 1.3-day reduced length of stay, improved patient outcomes, and reduced costs (Cardinal Health 2008).

The potential cost savings offered by these surveillance systems makes significant business sense. MedMined not only can identify nearly all HAIs, it also can calculate the cost of treating them. At three hospitals in the Evanston Northwestern Healthcare system, in Illinois, six months of surveillance by MedMined detected a 5.8 percent infection rate and $5 million in un-reimbursed costs of treating HAIs. In the next six months, the system helped reduce infections by 223 cases, cutting the infection rate to 5 percent and saving the hospital system $618,000 in avoided expenses — $3 for every $1 spent on infection surveillance (Morrissey 2004).

In the past, only the most technologically savvy hospitals were interested in these advanced data-mining programs; today, they are increasingly mainstream and may become even more so as the legal environment changes. Pennsylvania, for instance, has become the first state to mandate that hospitals have a surveillance system for infection tracking (Martin 2005), which must be in place by the end of 2008. These systems are required to be compatible with the Centers for Disease Control and Prevention’s National Healthcare Safety Network, which collects data to establish national benchmarks and to share information among hospitals on epidemiology and infection patterns. Most systems already meet this standard by integrating CDC definitions into their software.

In addition to MedMined, two other key companies in this market are TheraDoc and Cereplex. TheraDoc’s Infection Control Assistant is used by Johns Hopkins Hospital, in Baltimore, and Rhode Island Hospital, in Providence, and was recently acquired by Thomas Jefferson University Hospital and Allegheny General Hospital, both in Pennsylvania. Cereplex offers two main products: Setnet, which automates surveillance for infection control, and PharmWatch, which offers the ability to manage and optimize antibiotic therapy. These programs aim to enhance infection control and curb antibiotic resistance.

Radio frequency surveillance

Vecna Medical is a company that takes infection control one step further by integrating radio frequency identification (RFID) technology into its surveillance system. According to its Web site, Vecna believes this technology will enable hospitals to trace the spread of pathogens by tracking staff and patient movements through the use of RFID tags, thus averting the spread of infectious outbreaks. By determining the chain of transmission of HAIs, infection-control practitioners can implement changes to prevent further outbreaks (Vecna 2008).

BD GeneOhm’s MRSA assay

Radio frequency (RF) is not a new technology within the health-care industry. For example, Censis Technologies’ Censitrac uses RF in its instrument tracking system. Censitrac has the ability to locate any instrument, container, or piece of equipment by placing a permanent laser marker on each individual item, allowing these items to be traced to their last known location. InnerWireless’s system then provides a wireless distribution that “pumps” RF signals throughout a hospital to enable applications such as asset tracking for drugs, instruments, and even patients. Combining current data-mining surveillance technology with RFID could further advance infection-tracking capabilities by providing better ways to identify the time, source, and location of outbreaks (Vecna 2008).

STANDARDIZATION OF CARE

According to Richard P. Shannon, MD, chair of the Department of Medicine at the University of Pennsylvania School of Medicine in Philadelphia, the private sector’s role is secondary in the fight against HAIs. Shannon states that although the private sector offers new technologies to fight HAIs, the root cause of the infection epidemic in hospitals is a highly unreliable and defect-ridden hospital system (Jackson 2007). Inconsistencies lie in surgical protocols, central lines insertions, error reporting, and hand-washing regimens, among many other areas. Standardization of these processes, Shannon emphasizes, is key.

Enforcing the standardization of medical care is not outside the realm of the private sector. Consulting companies are responding to the call for leadership and standardization by taking the emphasis away from technological advancements and placing it on employee involvement and the medical process itself.

Approaches are sometimes modeled after organizations that handle complexity well, such as the Toyota Production System. For example, Virginia Mason Medical Center, in Seattle, utilizes Toyota’s lean production methods, where waste is considered “any activity that does not serve the valid requirements of the customer” (Grunden 2007). By using this methodology, the facility has reported a decrease in ventilator-acquired pneumonia (VAP) cases from 40 in 2000 to 5 in 2006, and a savings of $1.7 million (Bush 2007).

The Institute for Healthcare Improvement (IHI) also emphasized standardization in its 100,000 Lives Campaign, a national effort to reduce preventable deaths in American hospitals, and its subsequent 5 Million Lives Campaign, a voluntary initiative to protect patients from 5 million incidents of medical harm over two years. IHI has recommended intervention bundles, or a collection of processes needed to effectively care for patients undergoing particular treatments with inherent risks. The idea is to bundle several scientifically grounded practices essential to improving clinical outcomes. Implemented together, these interventions result in better outcomes (IHI 2008).

In response to the IHI campaigns, many companies are offering bundled products that correspond to the recommended intervention bundles. The components of Cardinal Health’s Presource custom procedure kits for central line insertions include a medication label sheet, towels, skin markers, and transparent adherent dressings. The packs contain products from the Convertors line insertion draping system, which allows access to a variety of insertion sites through the use of a three-part draping system for full-body coverage. The packs also include Johnson and Johnson’s BIOPATCH antimicrobial dressing with chlorhexidine gluconate, which has been shown to reduce the incidence of catheter-related bloodstream infections (CRBSIs) and local infections (Maki 2000, Crawford 2004).

Other examples of bundled products include Arrow International’s Maximal Barrier Precautions Central Venous Access kit, a system for combating the five sources of CRBSI, and Kimberly-Clark Health Care’s products and services designed to prevent surgical-site infection and VAP (Akridge 2007).

INFECTION-CONTROL PRODUCTS

The demand for other products also is increasing. For example, research and consulting firm Frost & Sullivan reports that the U.S. antimicrobial coatings market earned revenues of $175.4 million in 2005, and is estimated to reach $558.7 million in 2012, driven in part by improvements in wound dressings and catheters (IHS 2006).

Another sector gaining popularity is interactive wound care. These biocompatible products interact with wound tissues, providing higher healing and absorption rates, thus preventing infection. Dressings are composed either entirely of biological material or denatured through cross-linkage with synthetic or other biological polymers.

Some companies are making HAIs a focal point of their business and marketing strategies. The HAI-based product list is long and includes alcoholic hand washes, innovative surgical drapes, and disposable products. Companies are becoming creative, offering washable keyboards and even an electronic nose that can “sniff out” MRSA and other bacteria.2

DISCUSSION

For the past 40 years, MRSA has been a major concern in hospitals and nursing homes, where it strikes those who are most susceptible to infections, including older adults, immunocompromised individuals, and patients with burns and surgical wounds. In the community, MRSA incidence also has increased dramatically (Klevens 2007b). In schools, it spreads rapidly among children, whose immune systems often are immature, and in athletic programs through cuts and skin-to-skin contact. In the workplace, MRSA commonly is spread by use of telephones and computer keyboards, and in bathrooms and fitness facilities (Armour 2007).

The causes of community-acquired and healthcare-associated MRSA are different (Naimi 2003), but the community-acquired MRSA has become the leading source of skin and soft-tissue infections seen in U.S. emergency departments (Moran 2006).

HAIs are a significant public health threat and cost payers and purchasers billions of dollars annually. But, to a large extent, they are preventable. Mandatory reporting of infection rates and Medicare’s policy to stop paying hospitals for preventable costs has energized the battle against HAIs.

As incentives increase, hospitals are more willing to invest in private-sector products and services to control HAIs. Private companies are racing to develop the most innovative diagnostic, surveillance, and standardization systems and products that combine the needs of healthcare with the promises of information technology and biotechnology. These technologies require an up-front investment, but as with many preventive public health interventions, the return on investment may be incalculably great.