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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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William Hyman: Do We Know How to Evaluate and Compare Risks and Benefits?

August 23, 2016

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It is well known that few things in life are risk free and that we therefore take on risk whenever we seek the benefits of healthcare. This leads to the straightforward notion that we should evaluate risks and benefits, and then compare them in order to make a rational decision about undertaking the activity. While […]

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William Hyman: Early (or Late) Warning with Medical Device Problems

January 7, 2016

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Recalls typically are based on a conclusion reached by the manufacturer that there is a problem with a device that can lead to, for a Class I recall, serious adverse health consequences or death. For Class II and III recalls, the risk is proportionally lower. The recognition of a problem often begins with an increase […]

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Stephen Berger: Here’s How Hospitals Can Prepare for Crucial Spectrum Change

October 8, 2015

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The decision this past summer by the Federal Communications Commission (FCC) to allow TV White Space (TVWS) devices to share Channel 37 with Wireless Medical Telemetry Service (WMTS) systems changes the spectrum environment in an important way. Hospitals and other healthcare organizations have a three-to-five-year planning horizon to prepare for this change. While that may […]

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Mary Logan: Risk Management Is Everyone’s Business

October 6, 2015

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Last week, I listened to an impressive lineup of panelists and attendees at the seventh AAMI-FDA Summit, this one tackling the subject of risk management. The inspiration for this update is a recurring theme in the summit that “risk management is everyone’s business.” Starting with the keynote address of Jeff Natterman, the risk manager for […]

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Stephen Berger: Hospitals Must Address Interference Issue Raised by FCC Ruling

August 31, 2015

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On Aug. 6, 2015, the Federal Communications Commission (FCC) approved the use of TV White Space (TVWS) devices in the 600 MHz band. As part of the order, TVWS devices are allowed to share Channel 37 with Wireless Medical Telemetry Service (WMTS) systems that operate there. Hospitals and healthcare organizations that operate WMTS systems on […]

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Mary Logan: Whose World View Do We Use to Define and Manage Risk?

May 27, 2015

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I’m fascinated by the wide variety in how people in healthcare technology define, view, manage, and tolerate risk. I have added to my reading list on this topic a recent article by Malcolm Gladwell on auto recalls, “The Engineer’s Lament.” In our world of healthcare technology, Gladwell’s piece helps all of us, engineer or not, […]

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Tammy M. Pelnik: The Key to Fewer Do-Overs and More Satisfied Customers

May 11, 2015

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On one hand, a quality management system or QMS sounds like a sterile, standards-based construct: a checklist of things that need to be done. Where’s the value added with all of the procedures and paperwork? But the other hand has the true story: a QMS gives enough structure and support to disparate individuals so that, […]

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William Hyman: The Little-Discussed Device Learning Curve

May 4, 2015

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A reasonable expectation in the adoption of new medical technology is that the direct users will require training and experience in achieving a reasonable level of comfort and efficacy. A corollary of this expectation is that during the initial period, there will be at least a greater challenge in using the equipment and a possible […]

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Michael Appel: The Risk of Unknown Risks

March 30, 2015

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AAMI President Mary Logan’s March quarterly update to the AAMI community describes precisely the essence—and challenge—of safety management: Risk, not outcomes, is what determines safety. A shared challenge among medical device companies, as well as other industries whose focus is safety, is that a low tolerance for risk is confounded by the difficulty of identifying […]

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