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FDA

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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Rob Jensen: Taking a Side in the Debate over Medical Device Service

  • by AAMI
  • Posted on October 10, 2017November 2, 2018
  • Healthcare Technology Management

This year, we’ve seen an even hotter-than-usual debate about the servicing of medical devices and healthcare technology, thanks in part to calls for new standards, a congressional mandate for an FDA report on the subject, […]

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William Hyman: The Missing Link in Device Interoperability

  • by AAMI
  • Posted on October 6, 2017October 9, 2017
  • Healthcare IT

Last month, the FDA issued its guidance document Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices and a commentary by Bakul Patel. The essence of the form of interoperability addressed is the transfer […]

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Alan Lipschultz: Are You Ready? Two Big Changes on the Horizon for HTM

  • by AAMI
  • Posted on August 9, 2017August 9, 2017
  • Healthcare Technology Management

Two standards in development will, if approved, significantly impact the healthcare technology management (HTM) field. If they aren’t already on your organization’s radar, they should be. The first one involves a push by medical device […]

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William Hyman: Reauthorization Bill Calls for FDA Report on Medical Device Service

  • by AAMI
  • Posted on August 8, 2017November 2, 2018
  • Healthcare Technology Management

The FDA Reauthorization Act of 2017 completed its passage through Congress on Aug. 3, and the bill will become law once signed by President Trump. Although a major focus of this legislation is FDA user […]

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Mike Ahmadi: When It Comes to Cybersecurity, the Regulatory Will Is Weak

  • by AAMI
  • Posted on August 3, 2017August 4, 2017
  • Healthcare IT

I want to tell a story. I grew up in Cleveland Ohio, a city that has always held its place in the top two or three cities that everyone likes to poke fun at for […]

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William Hyman: Can the FDA Solve the Service Manual Problem?

  • by AAMI
  • Posted on July 6, 2017July 6, 2017
  • Healthcare Technology Management

The latest addition to the long-running battle over adequate access to service manuals for medical devices is The Joint Commission’s (TJC) announcement, via George Mills, at the recent AAMI Annual Conference that starting in January […]

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Melissa Kozak: Put Device Users First with Human Factors-Informed Procurement

  • by AAMI
  • Posted on June 19, 2017June 19, 2017
  • Human Factors

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 […]

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William Hyman: Today’s Challenge? Keeping Track of Bills about Medical Device Regulation

  • by AAMI
  • Posted on May 9, 2017November 2, 2018
  • Medical Device Industry

The regulation of medical devices by the FDA remains a hot topic for makers of medical devices and HTM professionals, whether they are employed by hospitals, manufacturers, or third-party entities. There are at least seven […]

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Robert Sayle: Attention Biomeds! Your IT Colleague Would Like to Chat

  • by AAMI
  • Posted on April 4, 2017
  • Healthcare IT

Hey, biomed! It’s me, Bob in IT. I’m from the networking team. I know we haven’t spoken much, but I think we should. You see, we’ve got some problems we need to solve. I have […]

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