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Risk Management

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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William Hyman: Early (or Late) Warning with Medical Device Problems

  • by AAMI
  • Posted on January 7, 2016January 7, 2016
  • Medical Device Industry

Recalls typically are based on a conclusion reached by the manufacturer that there is a problem with a device that can lead to, for a Class I recall, serious adverse health consequences or death. For […]

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Stephen Berger: Here’s How Hospitals Can Prepare for Crucial Spectrum Change

  • by AAMI
  • Posted on October 8, 2015October 8, 2015
  • Healthcare IT

The decision this past summer by the Federal Communications Commission (FCC) to allow TV White Space (TVWS) devices to share Channel 37 with Wireless Medical Telemetry Service (WMTS) systems changes the spectrum environment in an […]

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Mary Logan: Risk Management Is Everyone’s Business

  • by AAMI
  • Posted on October 6, 2015November 2, 2018
  • Risk Management

Last week, I listened to an impressive lineup of panelists and attendees at the seventh AAMI-FDA Summit, this one tackling the subject of risk management. The inspiration for this update is a recurring theme in […]

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Stephen Berger: Hospitals Must Address Interference Issue Raised by FCC Ruling

  • by AAMI
  • Posted on August 31, 2015September 3, 2015
  • Healthcare IT

On Aug. 6, 2015, the Federal Communications Commission (FCC) approved the use of TV White Space (TVWS) devices in the 600 MHz band. As part of the order, TVWS devices are allowed to share Channel […]

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Mary Logan: Whose World View Do We Use to Define and Manage Risk?

  • by AAMI
  • Posted on May 27, 2015November 2, 2018
  • Risk Management

I’m fascinated by the wide variety in how people in healthcare technology define, view, manage, and tolerate risk. I have added to my reading list on this topic a recent article by Malcolm Gladwell on […]

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Tammy M. Pelnik: The Key to Fewer Do-Overs and More Satisfied Customers

  • by AAMI
  • Posted on May 11, 2015
  • Management

On one hand, a quality management system or QMS sounds like a sterile, standards-based construct: a checklist of things that need to be done. Where’s the value added with all of the procedures and paperwork? […]

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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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Michael Appel: The Risk of Unknown Risks

  • by AAMI
  • Posted on March 30, 2015March 30, 2015
  • Medical Device Industry

AAMI President Mary Logan’s March quarterly update to the AAMI community describes precisely the essence—and challenge—of safety management: Risk, not outcomes, is what determines safety. A shared challenge among medical device companies, as well as […]

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