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Standards

Paul Kelley: When Brains Collide

  • by AAMI
  • Posted on January 8, 2016January 8, 2016
  • Medical Device Industry

In my job, I have two very different sets of responsibilities, and I’m lucky enough to have these roles coincide with two of my passions. First, I am responsible for my hospital’s biomedical engineering team […]

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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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Ed Burnard: Why Medical Device Standards Matter

  • by AAMI
  • Posted on October 13, 2015
  • Regulations

Sometimes the dividing line between regulation and flexibility can be unclear. Somewhere in the middle of the life cycle for new innovations, there exists a period of time when innovation slows and a crystallization of […]

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Mary Logan: We Need Science, not Scapegoats, in Sterility Assurance Debate

  • by AAMI
  • Posted on March 24, 2015November 2, 2018
  • Medical Device Industry

“How clean is clean enough?” has resurfaced as a pressing question in medical device reprocessing because of national media coverage of superbug outbreaks involving contaminated duodenoscopes. While the intense media interest is new, the issue […]

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Eamonn Hoxey: How Can We Prepare Standards More Effectively?

  • by AAMI
  • Posted on December 19, 2014December 19, 2014
  • Medical Device Industry

This year, I have been participating in the revision of three standards of differing size, scope, and extent of use: ISO 9001, the generic standard for quality management systems to which over one million companies […]

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Lisa Simone and Daniel Rubery: A Tower of Babel with Medical Device Software Failures

  • by AAMI
  • Posted on October 10, 2014October 10, 2014
  • Healthcare IT

Another set of health information is compromised, another medical device unexpectedly reboots, another set of patient data results is mixed up, another device fails to perform as intended. News stories bring us reports of medical […]

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William Hyman: Beep, Beep

  • by AAMI
  • Posted on April 21, 2014November 2, 2018
  • Healthcare IT

There was an interesting thread recently on the listserv for the National Patient Safety Foundation on whether medication barcode readers should beep (or make some other noise) when read. Such systems are typically part of […]

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