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Larry Fennigkoh: It’s Past Time for HTM to Turn Data into Knowledge

August 11, 2017


How do you scientifically determine the effect of something on something else? The answer (in whatever form it may take and regardless of the branch of science from which it originates) may often be answered through use of a well-established statistical technique referred to as regression analysis. It is through the application and appropriate use […]

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

August 8, 2017

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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 fees that are paid by manufacturers, it also addresses a number of other topics, including a favorite of everyone involved […]

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Paul Kelley: Of Crabs, Crawdads, and HTM

August 1, 2017


Have you ever seen a bucket of crabs or crawdads? You can put them all in the bucket and not worry about any escaping because as one tries to crawl up and out of the bucket, the others grab it and pull it back. It’s akin to a mindset of, “If I can’t have it, […]

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

May 9, 2017


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


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


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


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


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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