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Human Factors

Daugherty & Liebel: Classifying Medical Device Human Factors Issues for the MAUDE and Recall Databases

  • by AAMI
  • Posted on June 2, 2020
  • Human Factors

Postmarket surveillance plays a vital role in the product life cycle as it serves to monitor the safety and effectiveness of medical devices in use on the market. An important aspect of postmarket surveillance is […]

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William Hyman: Don’t Forget Secondary Human Factors Effects

  • by AAMI
  • Posted on May 7, 2019
  • Human Factors

Human factors generally focuses on the usability of a single medical device, addressing whether or not the device can be expected to be used safely and efficiently by real users in the real environment of […]

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Melissa Kozak: Put Device Users First with Human Factors-Informed Procurement

  • by AAMI
  • Posted on June 19, 2017June 19, 2017
  • Human Factors

Think about the last time you saw a demonstration of a new medical device. Were you guided through all the new and innovative features by an expert who was able to step in and assist […]

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Matthew B. Weinger: Can We Make Patient-Centered Care Really Patient Centered?

  • by AAMI
  • Posted on September 20, 2016
  • Human Factors

If we are to move from our current provider-centered system toward a more patient-centered system of healthcare, we must understand the obstacles. The Institute of Medicine defines patient-centered care as “providing care that is respectful […]

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Suzanne Steidl: Hello Challenge! Meet Solution

  • by AAMI
  • Posted on November 20, 2015November 2, 2018
  • Human Factors

“There’s nothing worse than watching someone you love suffer and not knowing what to do,” said Edith Elliott who, as a middle-school student, cared for her mother who had a brain tumor. A Wall Street […]

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Matthew B. Weinger: The Path Forward for Satisfying User Interfaces in Health IT

  • by AAMI
  • Posted on November 10, 2015December 18, 2015
  • Healthcare IT

New rules, titled 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications were recently provided for public comment. In my […]

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William Hyman: New Warnings and Old Users

  • by AAMI
  • Posted on March 12, 2014November 2, 2018
  • Human Factors

From time to time, I have evaluated situations in which a manufacturer has revised instructions for use and/or on-device warning labels for a product, and thereby provided this new information for new purchasers. In some […]

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Sean Loughlin: The ‘So Cool’ Story of a Teen, a 3D Printer, Medical Technology, and One Happy Boy

  • by AAMI
  • Posted on February 13, 2014February 13, 2014
  • Healthcare IT

Teens can get a bad rap, so it’s heartening to see a story about one 16-year-old whose embrace of medical technology has made a huge difference in the life of one boy. Mason Wilde, a […]

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Suzanne Steidl: Great Work! Now Make It Available to Me, Please

  • by AAMI
  • Posted on January 28, 2014November 2, 2018
  • Healthcare IT

I am a healthcare consumer and caregiver. Last October, I was lucky enough to speak at the AAMI/FDA Healthcare Technology in Nonclinical Settings Summit. My panel focused on instructions for use (IFUs). My message, based […]

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Mohamed Basiony: What If Medical Devices Had Brains?

  • by AAMI
  • Posted on October 17, 2013
  • Healthcare IT

Medical devices are designed to perform a specific function—for example, provide life support, therapy, or diagnostic services. However, these devices do not recognize or know anything about the patient on the receiving end. What if […]

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