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 […]
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 […]
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 […]
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 […]
“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 […]
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 […]
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 […]
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 […]
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 […]
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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