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UDI

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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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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William Hyman: UDI Database Offers Roller Coaster Experience with Device Descriptions

  • by AAMI
  • Posted on July 9, 2015
  • Healthcare IT

A beta version of the government’s unique device identifier (UDI) database, called AccessGUDID, is available online. After some initial poking around, I have a few observations. A basic search function allows you to search by […]

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William Hyman: Another Visit to the FDA’s Action Plan

  • by AAMI
  • Posted on January 5, 2015January 5, 2015
  • Healthcare Technology Management

In a January 2014 blog post, I reported on a third visit to the FDA’s own scorecard for its 2013 Action Plan. As of Jan. 1, 2015, this page showed a last updated date of […]

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William Hyman: Despite the Hype, UDI Remains a Work in Progress

  • by AAMI
  • Posted on September 16, 2014September 16, 2014
  • Healthcare IT

As I noted in a June blog on unique device identification (UDI), there was a proposal under consideration that would have required electronic health records (EHRs) to have the ability to capture UDIs–at least for […]

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William Hyman: The Promise and Challenge of UDI

  • by AAMI
  • Posted on June 19, 2014November 2, 2018
  • Healthcare Technology Management

The use of unique device identification (UDI) labels for medical devices will soon begin, along with a global UDI database (dubbed GUDID) hosted by the U.S. Food and Drug Administration. Here, “soon” has a multiyear […]

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William Hyman: The FDA’s Self-Imposed Deadlines (Part III)

  • by AAMI
  • Posted on January 6, 2014
  • Healthcare IT

In July 2013 and October 2013, I addressed the U.S. Food and Drug Administration’s progress in completing the various elements of improvements to its postmarket surveillance program. This effort has 14 parts divided among three […]

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William Hyman: The FDA’s Self-Imposed Deadlines (Part II)

  • by AAMI
  • Posted on October 25, 2013
  • Regulations

Back in July, I wrote about the first deadline that the U.S. Food and Drug Administration had set for itself with respect to a series of activities to improve its postmarket surveillance system. Of the […]

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