Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
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The economic and clinical burden of ventilator-associated pneumonia (VAP) is uncontested. In many hospitals, VAP surveillance is conducted to identify outbreaks and to monitor infection rates. Here, we discuss the concept of benchmarking in health care as modeled on industry, and we contribute personal arguments against considering the VAP rate as a potential candidate for benchmarking or for monitoring the quality of patient care. ⋯ In contrast, some risk factors for VAP are modifiable and can be monitored and used as quality indicators. Process-oriented surveillance permits bypass of case-mix and diagnostic constraints. A well-defined interhospital surveillance system is necessary to prove that interventions on procedures do really lead to a reduction of VAP rates.
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Manufacturers wish to communicate the benefits of probiotics in advertising and labeling with lawful and adequately substantiated claims. Regulatory and substantiation requirements differ for products intended to cure, treat, prevent, or mitigate a disease; to reduce a healthy individual's risk of developing a disease; or to affect the structure or function of the body. ⋯ Food manufacturers must design their claims regarding the benefits of probiotics with the regulatory environment in mind and must develop their research plans to provide evidence that satisfies the agencies' substantiation requirements. This article offers an overview of the applicable laws and regulations, what they mandate regarding legitimate claims, and the issues regarding the design of research to substantiate such claims.
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This article discusses options and examples of regulations or "generally recognized as safe" determinations that are related to microorganisms in food. A balanced picture of information about the microorganism and its characteristics is needed to make conclusions about its safety.