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Medical Device Industry

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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Steve Yelton: We Need Your Help for a National Science Foundation Grant

  • by AAMI
  • Posted on September 22, 2017September 22, 2017
  • Healthcare Technology Management

A common theme for many years and escalating now is the need for qualified healthcare technology management (HTM) technicians. We have heard you and are working diligently to effectively look “outside the box” to address […]

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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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Robert Sayle: Get Manufacturers on Board with Digital Certificates

  • by AAMI
  • Posted on September 19, 2017
  • Healthcare IT

Hey, biomed! Thanks for waiting for me after the change control board meeting IT just had. I wanted to follow up on our discussion of supplicants for medical device cybersecurity because the best way to […]

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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: 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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Emma Fauss: Remote Monitoring Is No Remote Concern for Hospitals

  • by AAMI
  • Posted on June 5, 2017June 5, 2017
  • Healthcare IT

Remote monitoring and virtual surveillance are quickly becoming a top priority at hospitals across the country. One of the main drivers is the growth of health systems where the main campus is looking for ways […]

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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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