AAMIBlog

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 with any questions or difficulties as you tried it for the first time? Now think about the last time you […]

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 of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions.” How […]

“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 Journal article about the 31-year-old American is inspiring, though I wish we could accomplish as much here in the United […]

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 opinion, these rules do not (yet) go far enough to assure safe and effective design and implementation of health IT. […]

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 cases, this revised information directly addressed safety issues; the new instructions or warnings were intended to mitigate a known hazard. […]

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 high school junior in Kansas, used a 3D printer to make a prosthetic hand for a 9-year-old family friend who […]

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 on my frustrating and dangerous experiences using durable medical equipment at home, was this: You’re doing great work, but why […]

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 they did? To provide a “brain” allowing a device to distinguish between patients, the manufacturer would provide the medical staff […]

A buzzword in the design industry, UX stands for user experience.  A UX designer applies a user-centered design (UCD) process in the development of a product, helping to ensure that it is user friendly. The elements of UX design include usability, accessibility, human-computer interaction, and interaction design. Traditionally, engineers designed a device or other product […]

In the wake of the deadly crash landing of the Asiana Airlines jet in San Francisco, there have been several reports in the news media examining whether pilots rely too much on technology. It’s a fair question, and the broader issue of potential hidden dangers in technology is worth keeping in mind for healthcare as […]