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

May 9, 2017

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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 ways that the regulation of medical devices could fundamentally change. Three of these are legislative in which a bill is […]

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Samantha Jacques: Clinical Engineering Has Crucial Role in Facilities Projects

April 18, 2017

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For the past few years, AAMI, ACCE, HIMMS, and others have been working to bridge the gap between the clinical or biomedical engineering (or healthcare technology management) department and the information technology (IT) department within a hospital or hospital system. We continue to learn how valuable a relationship is between CE and IT and how […]

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Matt Baretich: Seize the Day with New TJC Requirements

January 23, 2017

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By now, nearly everyone in the HTM community is aware of the substantial and unexpected changes in Joint Commission requirements for on-schedule completion of scheduled maintenance. I won’t go into the details here because recent webinars from AAMI and ECRI Institute, and one forthcoming from ACCE, are spreading the word. The gist is that we […]

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Donald Armstrong: Remember Your Purpose

June 20, 2016

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Earlier this month, I returned home from another fantastic AAMI conference in Tampa, FL.  I was inspired by many new topics and further educated on several of the familiar subjects we cover from year to year. At the same time, there was one topic that seemed to intertwine almost all of the talks and sessions. […]

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Hillary Groff: HTM’s Crucial Role with Incoming Medical Equipment

May 31, 2016

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According to The Joint Commission (TJC) requirements, “The hospital evaluates new types of equipment before initial use to determine whether they should be included in the inventory. Before initial use of medical equipment on the medical equipment inventory, the hospital performs safety, operational, and functional checks. In addition, the hospital maintains a written inventory of […]

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Malcolm Ridgway: It’s Time for HTM to Take Care of Business

March 13, 2015

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About five years ago, it came to the attention of the Centers for Medicare & Medicaid Services (CMS), that The Joint Commission (TJC), which is the largest provider of hospital accreditation surveys dealing with CMS requirements, was not enforcing a longstanding requirement. Specifically, the requirement—found in in the interpretive guidelines of Medicare’s Conditions of Participation—calls […]

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William Hyman: The Promise and Challenge of UDI

June 19, 2014

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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 horizon, starting in September 2014 for Class III devices (and a few others), and extending through 2020. This then is […]

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William Hyman: New Warnings and Old Users

March 12, 2014

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From time to time, I have evaluated situations in which a manufacturer has revised instructions for use and/or on-device warning labels for a product, and thereby provided this new information for new purchasers. In some cases, this revised information directly addressed safety issues; the new instructions or warnings were intended to mitigate a known hazard. […]

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Theodore Cohen: The Importance of Software Security Updates for Medical Devices

January 21, 2014

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With federal rules such as HIPAA governing patient privacy (and imposing fines if they are violated), regular malware occurrences and the constant threat of breaches, the security of IT-based medical devices has become very important. One security measure that is sometimes overlooked is computer system software updates. The primary problem with the routine updating of […]

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Sean Loughlin: Big News for Medical Equipment Maintenance

December 21, 2013

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You may not think “breaking news” on the Friday afternoon before Christmas, but that’s exactly what we faced yesterday thanks to an e-mail. The e-mail came from a federal agency, the Centers for Medicare & Medicaid Services (CMS), and it contained a four-page memo that addressed one of the hottest issues for healthcare technology management […]

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