Marilyn Neder Flack

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The U.S. Food and Drug Administration (FDA) attempts to identify and understand new risks associated with medical device use; communicate information and recommendations to device users; help manage known risks by providing strategies to facilitate safe use; guide manufacturers to improve design, labeling, and training to address known risks; and guide(More)
Special initiatives exist in FDA's Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research to ensure the safety and effectiveness of medical products used in the vulnerable pediatric population. This article focuses on the special programs, projects, and special(More)
This article focuses on the type of problems that lead to false or nonactionable clinical alarms and the type of data that can help identify which of these alarms are most prevalent in specific units in healthcare facilities. The process of identifying necessary data is first described, as this activity will drive later choices on capturing data. This(More)