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Health-care-associated infections (HAI) in hospitals can be expensive to treat and, according to the Department of Health and Human Services' (HHS) Centers for Disease Control and Prevention (CDC), HAIs are estimated to be one of the top 10 causes of death in the United States. HAIs can be caused by bacteria or viruses, which may be introduced to a patient through the use of a device used to treat them, such as a needle or tube to deliver medicine, fluids, or blood. Common HAIs that are often associated with the use of medical devices are urinary tract infections (UTI), surgical site infections (SSI), pneumonia, and bloodstream infections (BSI). A number of federal agencies within HHS, including CDC and the Agency for Healthcare Research and Quality (AHRQ), currently collect HAI-related data for a variety of purposes. Nearly half of the states also require public reporting of hospital HAI rates, according to a summary report of these state laws. The Food and Drug Administration Amendments Act of 2007 requires us to conduct work on HAIs in hospitals associated with medical devices. The act defines these infections as those that are acquired while an individual is a patient at a hospital and were neither present nor incubating prior to the patient's receiving services in the hospital. Specifically, the act requires us to report on the number of HAIs in hospitals attributable to new and reused medical devices and on the causes of such infections. As agreed with the committees of jurisdiction, in this report we examine two questions: (1) What is known from available federal and state data about the number of HAIs in hospitals associated with the use of medical devices? (2) What factors affect the occurrence of HAIs in hospitals associated with the use of medical devices?

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