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- Medical Device Design
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.
Wiklund M, Dwyer A, Davis E. Boca Raton, FL: CRC Press; 2015. ISBN: 9781498705790.
Applying human factors engineering to examine mistakes associated with medical device use can lead to valuable learning opportunities. This publication discusses equipment use errors and provides information about utilizing root cause analysis (RCA) to identify weaknesses in device design that enable those mistakes. The book includes examples of RCAs to illustrate how the method can uncover flaws that contribute to error in various situations.
Dekker S. New York, NY: CRC Press; 2011. ISBN: 1439852251.
This book explores the complexity of patient safety improvement through the lens of human factors engineering and provides practical avenues for its application.
Information Design for Patient Safety: A Guide to the Graphic Design of Medication Packaging. 2nd edition.
London, England: The Helen Hamlyn Research Centre and the National Patient Safety Agency; 2007.
This illustrated report provides guidelines for the packaging of pharmaceuticals along with an information design checklist for minimizing medication error.
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.
Norman DA. New York, NY: Basic Books; 2002.
Norman, a cognitive psychologist, outlines the elements of effective user-centered design, which include making the inner workings of devices visible, exploiting natural function, controlling relationships, and using constraints successfully. Through both fable and anecdote, Norman illustrates forcing functions and how bad design can exacerbate the consequences of human error. This classic text is a valuable introduction to the role of design in patient safety. [Note: Originally published in 1988 as The Psychology of Everyday Things.]