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Approach to Improving Safety
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Human Factors Engineering
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Search results for "Medical Device Design"
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Web Resource > Multi-use Website
Tubing and Luer Misconnections: Preventing Dangerous Medical Errors.
US Food and Drug Administration.
This Web site provides information about tubing misconnections and how to prevent them.
Book/Report
Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment.
Center for Devices and Radiological Health. Bethesda, MD: Food and Drug Administration, US Dept of Health and Human Services; 2006.
This document provides background on hospital bed injuries, identifies potentially dangerous design flaws, and offers assessment tools to reduce entrapment incidents.
Book/Report
Preventable tragedies: superbugs and how ineffective monitoring of medical device safety fails patients.
US Senate Health, Education, Labor, and Pensions Committee. January 13, 2016.
Insufficient sterilization of duodenoscopes and other medical equipment has been linked to health care–associated infection outbreaks. This report summarizes findings from a government investigation into existing methods for monitoring and reporting device problems and provides recommendations for Congress, hospitals, and the Food and Drug Administration to augment identification and prevention of safety issues associated with medical devices.
Web Resource > Multi-use Website
Injection Safety.
World Health Organization.
Poor injection practices contribute to health care–associated infections. This Web site provides resources related to a global campaign to enhance the safe use of injections through training, communication, policy development, and syringe design.
Press Release/Announcement
Design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes may impede effective cleaning.
FDA Safety Communication. Silver Spring, MD: US Food and Drug Administration; February 23, 2015.
Design limitations and production pressure may contribute to insufficient sterilization of complicated medical devices between uses. This announcement raises awareness of risks associated with inadequate cleaning of duodenoscopes that surfaced after a cluster of nosocomial infections at Ronald Reagan UCLA Medical Center.
Legislation/Regulation > Government Resource
Safety considerations to mitigate the risks of misconnections with small-bore connectors intended for enteral applications.
Rockville, MD: Center for Devices and Radiological Health, US Food and Drug Administration; February 11, 2015.
Mistakes due to small-bore Luer connector similarities can contribute to patient harm. This guidance provides ways for manufacturers, policy makers, and product designers to prevent misconnections, including recommendations regarding improvements for labeling, user testing, and risk assessment.
Newspaper/Magazine Article
Multifaceted initiative to reduce "alarm fatigue" on cardiac unit reduces alarms and increases nurse and patient satisfaction.
Agency for Healthcare Research and Quality. Health Care Innovations Exchange. June 18, 2014.
Clinical alarms have been described as a serious patient safety issue. This article relates how one hospital implemented a series of actions reduce nuisance alarms in a cardiac unit and reports a substantial decrease in audible alerts with no subsequent adverse effects. Interventions included expanding limits for triggering heart rate alarms and collaboration between two nurses to design customized alarm parameters for individual patients.
Press Release/Announcement
Safety Investigation of CT Brain Perfusion Scans: Update 11/9/2010.
Rockville, MD: US Food and Drug Administration; November 9, 2010.
This notice analyzes findings from a government initiative on CT scan injuries and provides recommendations to enhance safety and prevent such incidents.
Web Resource > Multi-use Website
Patient Safety.
Ontario Hospital Association.
This Web site supports the purpose and mandate of the Patient Safety Support Service are (1) to raise patient safety awareness among management and front-line staff, (2) to foster development of local expertise in patient safety, (3) to promote effective strategies to enhance patient safety, (4) to provide leadership and resources to hospitals in their efforts to impact system change, and (5) to provide both focused and practical assistance.
Audiovisual
Possible dose-counter errors with the Asmanex Twisthaler.
Food and Drug Administration (FDA) Patient Safety News. Show #61. March 2007.
This video story alerts providers to a possible problem with an asthma inhaler, which could indicate remaining doses incorrectly if the user forcefully twists the cap.
Press Release/Announcement
United States marshals seize defective infusion pumps made by Alaris Products.
Rockville, MD: Center for Devices and Radiological Health, US Food and Drug Administration; August 29, 2006.
This news release announces a seizure of infusion pumps that have a "key bounce" defect that could result in over-infusion of medication.
Press Release/Announcement
Abbott Diabetes Care blood glucose meters.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; October 27, 2005.
This announcement alerts patients and practitioners to a problem with glucose meters made by Abbott Diabetes Care. The meters have a measurement setting that, if inadvertently switched, could cause an inaccurate reading.
