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Medical Devices

William Hyman: FDA Database for Medical Device Recalls Falls Short

  • by AAMI
  • Posted on January 2, 2018January 2, 2018
  • Medical Device Industry

The FDA’s database for medical device recalls has a search function that includes a pull-down menu for the root cause of the recall. These root causes correspond to the single “FDA Determined Cause” on each […]

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William Hyman: Precision Matters in Medical Device Terminology

  • by AAMI
  • Posted on December 20, 2016December 20, 2016
  • Medical Device Industry

I have long been concerned (some might say obsessed) with the distinction between a medical device being “approved” and one being “cleared.” In simple terms, only a Class III device that has successfully traversed the […]

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William Hyman: Do We Know How to Evaluate and Compare Risks and Benefits?

  • by AAMI
  • Posted on August 23, 2016
  • Patient Safety

It is well known that few things in life are risk free and that we therefore take on risk whenever we seek the benefits of healthcare. This leads to the straightforward notion that we should […]

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Phil Cogdill: What Do Hiking the Na Pali Coast and Standards Development Have in Common?

  • by AAMI
  • Posted on March 1, 2016
  • Medical Device Industry

While on vacation on the island of Kauai, Hawaii, I decided to hike the Na Pali Coast trail, one of the most stunning, soul-nourishing, and sometimes treacherous coastlines in the world. I completed an eight-mile […]

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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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William Hyman: The Little-Discussed Device Learning Curve

  • by AAMI
  • Posted on May 4, 2015May 4, 2015
  • Medical Device Industry

A reasonable expectation in the adoption of new medical technology is that the direct users will require training and experience in achieving a reasonable level of comfort and efficacy. A corollary of this expectation is […]

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Larry Fennigkoh: Getting Real with Unmanageable Inventory Requirements

  • by jpassut
  • Posted on January 22, 2015
  • Healthcare Technology Management

Steve Grimes’ recent paper “Two Steps Forward, One Step Back—How the Industry Must Take in Stride New CMS and TJC Requirements” (BI&T, November/December 2014), provides an excellent but still disturbing summary of the July 2014 […]

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