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William Hyman: Will Unique Device Identifiers Live Up to the Hype?

  • by AAMI
  • Posted on April 25, 2018November 2, 2018
  • Medical Device Industry

The ongoing roll out of unique device identifiers (UDIs) promises several expected benefits derived from medical devices possessing UDI codes. The Food and Drug Administration (FDA) recently published Medical Device Safety Action Plan that describes […]

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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: 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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William Hyman: Bills in Congress Address Medical Device Safety

  • by AAMI
  • Posted on September 21, 2017
  • Medical Device Industry

In April, Rep. Brian Fitzpatrick (R-PA) introduced HR 2163, the Medical Device Guardians Act. This act proposes to add physicians and physician offices to those that must report medical devices misadventures under the FDA’s Medical […]

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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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