Improving Clinical Alarm Management: Guidance and Strategies.

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 article also discusses how to use the data collected in alarm reports to help determine which alarms should be targeted first for improved management in a pilot environment. Suggestions are provided on how to reduce false and nonactionable alarm signals and how to monitor to ensure no untoward consequences occur from new alarm default settings. The information provided here can be individualized to hospitals and units to enhance alarm management with physiological monitor alarms. It also can be adapted to reduce nonactionable alarm signals occurring from other medical devices.

FDA working to ensure the safety of medical devices used in the pediatric population.

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 studies implemented by CDRH to ensure this safety and effectiveness in devices used in pediatric patients throughout the devices' total product life-cycles. Pediatricians play a major role in keeping medical devices safe for use in children by reporting device problems to FDA.