Considering the rapid pace of innovation in the healthcare arena, an ever-increasing number of strategies for detection, prevention and treatment of diseases are expected in the market. However, budgetary constraints always make it more challenging for policy makers to finance technological innovation in healthcare. Identifying the optimal allocation of available resources in order to maximize health gains in the patient population is a continuous challenge to health-care system sustainability. The dilemma of whether to invest in a new technology or expand existing program to a wider target population is universal. In making those judgments, decision makers apply differing criteria and rely on various sources of information. Economic evaluation analysis, together with assessment of clinical effectiveness, supports decision making processes in public domain by providing necessary information concerning the economic aspects of resource absorption by different healthcare technologies.
Healthcare-associated infections (HAIs) are one of the most serious patient safety issues in healthcare today, affecting over 1.4 million people worldwide (Global Patient Safety Challenge, 2005-2006, World Health Organization). Even though the principal risk factors and appropriate prevention methods have been identified in the past decades, HAIs continue to present one of the major public health problems in the world . Sound and abundant evidence demonstrates that HAIs are associated with increases in morbidity and mortality, as well as greater costs of hospitalization and overall medical care [2–9].
In the United States, the incidence of HAIs has been estimated at 2 million cases per annum, causing approximately 90,000 deaths and imposing an annual financial burden of 6.5 billion dollars [1, 10]. In England, it is estimated that about 320,000 patients acquire one or more infections during hospitalization per annum, costing the National Health Service as much as £1 billion a year . In Italy, every year 450,000-700,000 patients acquire infections while in the hospital; in other words, 5 to 8 of 100 hospitalized patients contract a HAI. A few studies have estimated the clinical burden of HAIs, but the evidence regarding the economic impact is currently very limited [7, 12]. It was estimated that the economic burden of these infections is equal to 1.0% of total National Health Service expenditure [5, 7]. Zotti and colleagues prevalence of HAI was 7.84%, with marked differences among the participating hospitals (range: 0-47.8%). The authors concluded that patients with HAI on average experience longer hospital lengths of stay. Nevertheless, no data was provided in support of that conclusion. Another study investigated the longer hospital stay and extra direct costs of all hospital-acquired laboratory confirmed bacteremia in a 2000-bed teaching hospital. The results showed that HAIs prolonged hospital stay by approximately 20 days and increased direct costs by € 16,536 per case .
The highest rate of majority of HAIs occurs in intensive care units (ICUs), and most are associated with the presence of invasive devices such as a central line (CL) or mechanical ventilator . Several million intravascular devices are purchased each year by hospitals and clinics as they are indispensable for administering lifesaving therapies to critically ill patients. However, their use may put patients at risk of local and systematic infectious complications, including both localized site infections and central line-associated bloodstream infections (CLABSI). Nearly 1 of 4 catheterized patients with a central line in place for an average of 8 days is expected to develop catheter colonization, which increases the risk of more serious bacteremia [14, 15]. Rosenthal et al showed that ventilator-associated pneumonia and CLABSI represented more than 70% of all device-associated infections in 55 ICUs in 8 countries (41% and 30%, respectively) .
CLABSI infections not only complicate illness, but can lead to disability and even death. The mortality attributable to CLABSI was estimated to range between 12 to 25% in several studies [17–20]. In addition, there is a considerable amount of evidence demonstrating that CLABSIs are associated with significant increases in the length of hospital stay and medical care costs [2, 8, 16, 21–25]. Numerous strategies have been evaluated to reduce the clinical and economic burden of CLABSI, such as the use of silver or antiseptic impregnated catheters, cutaneous antisepsis and antimicrobial lock solutions . There is growing evidence that implementation of a "bundle" of multiple interventions can markedly reduce rates of CLABSI . These bundles may include both behavioral (e.g., maximal sterile barrier precautions, catheter placement and optimal timing of replacement, surveillance, education, improved hand hygiene [HH] technique and compliance, etc.), and technological (e.g., use of preferred skin antiseptics such as chlorhexidine gluconate, closed infusion containers, catheter dressings, etc.) practices. Catheter audit programs have also been used to review clinical practice associated with the insertion and subsequent care of CLs and their possible relationship to the development of HAI .
The use of innovative, "closed" infusion container has shown to have remarkable impact in reducing the incidence of CLABSI . Closed infusion containers consist of fully collapsible plastic containers that do not require or use any external vent (air filter or needle) to empty the solution, and have injection ports that are self-sealing. Alternatively, the traditional open infusion container consists of rigid (glass, burette) or semi rigid plastic containers that must admit air to empty (air filter or needle) . The risk of contamination and administration-related BSI is increased with open infusion containers that permit air, and potentially microorganisms, to enter. Innovative closed infusion containers have been developed to reduce this risk.
While open infusion containers have been used worldwide for over 75 years, they have been supplanted by closed containers throughout North America and Western Europe. Open containers are still widely used in Latin America, Asia, Eastern Europe, Germany and Italy. Italy is one of the few Western European countries that mainly use open, externally vented glass or semi-rigid infusion containers. At present, there is no empirical evidence available regarding the economic and clinical impact of the introduction of closed infusion containers into clinical practice in Italy.
In order to allow hospital managers to identify the most convenient strategies for reducing the impact of HAIs, it is important to provide reliable data on the costs borne by the hospital for CLABSI and on the cost opportunity to implement an innovative technology aimed at reducing the burden. The present study was designed to meet these two objectives: (1) to measure and evaluate the direct health care costs of CLABSI and (2) to calculate the cost-effectiveness ratio of the closed vs. open infusion container in a hospital setting.