Summary

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?

In summary, multiple federal programs and states collect data on HAIs in hospitals, but none of the data sources we identified provide a national estimate of the number of all HAIs in hospitals associated with medical devices. At the federal level, three HHS agencies, AHRQ, CDC, and CMS, specifically collect or have collected HAI-related data in databases maintained by separate programs, such as CDC's National Healthcare Safety Network (NHSN) program and CMS's Medicare Patient Safety Monitoring System (MPSMS). However, limitations in the scope and collection methods for these databases preclude them from developing a national estimate of HAIs in hospitals associated with medical devices. For example, CDC's NHSN data are not drawn from a representative sample of hospitals nationwide. Similarly, the infection rates included in the MPSMS are based on the experiences of a representative sample of Medicare fee-for-service beneficiaries and are not representative of the experiences of other Medicare or non-Medicare patients. Also, because the HAI-related information in two of these federal databases is gleaned from patient discharge and other medical records, the quality of the data is dependent on the accuracy with which the information was documented. Finally, although a Consumers Union summary report indicates that nearly half of the states mandate public reporting of hospital HAI rates, a number of factors limit the generalizability and usefulness of the state-reported rates. Improper patient examination and treatment practices by health care professionals, such as the improper insertion of urinary catheters, are the most significant factor affecting the occurrence of HAIs in hospitals associated with medical devices, according to most medical experts we interviewed. Certain in-hospital sterilization techniques and improper handling of sterilized medical devices were also commonly identified as significant causes of such infections, as was the inherent risk of using medical devices, which can introduce bacteria into the body. Our review of medical literature corroborated many of the risk factors cited by the experts and identified additional factors. For example, patient characteristics such as old age, diabetes, or compromised immune systems were frequently cited in the literature as risk factors. In terms of preventing HAIs, improved hygiene, such as appropriate hand-washing, and the use of barrier precautions, such as caps and gloves, were commonly identified strategies.