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Alan Lipschultz: Are You Ready? Two Big Changes on the Horizon for HTM

August 9, 2017

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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 manufacturers to get hospital-based and non–manufacturer-based service organizations to follow some of the quality systems requirements that manufacturers currently follow. […]

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William Hyman: Can the FDA Solve the Service Manual Problem?

July 6, 2017

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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 there will be a new element of performance, EC.01.01.01, EP 3, which states: “The organization has a library of information […]

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Melissa Kozak: Put Device Users First with Human Factors-Informed Procurement

June 19, 2017

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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 with any questions or difficulties as you tried it for the first time? Now think about the last time you […]

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Emma Fauss: Remote Monitoring Is No Remote Concern for Hospitals

June 5, 2017

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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 to remotely monitor its rural and sub-acute facility patients. Another driver is the desire to remotely monitor patients in higher […]

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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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Robert Sayle: Attention Biomeds! Your IT Colleague Would Like to Chat

April 4, 2017

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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 ideas on what to do, but I don’t totally understand your systems, so I need your input. Let’s take security […]

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Gregory Herr: HTM Must Rethink Its Role to Thrive in Modern Healthcare

March 27, 2017

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As the term “healthcare technology management (HTM)” becomes more prevalent, those of us who work in this field are still challenged with what this name really means. How does one implement the goals of HTM? What are the new opportunities? Embracing HTM as a name should be the first step in a broader goal of […]

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William Hyman: Precision Matters in Medical Device Terminology

December 20, 2016

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I have long been concerned (some might say obsessed) with the distinction between a medical device being “approved” and one being “cleared.” In simple terms, only a Class III device that has successfully traversed the PMA process has been approved. A Class II device that has reached the market via a 510(k) Premarket Notification has […]

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Wil Vargas: Tackling the Tower of Babel with Health Software Defects

October 31, 2016

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A security flaw is identified in another medical device, another set of patient data results is mixed up, configuration information is lost after a software update, another device fails to perform as intended. News stories continue to implicate software in medical device failures as the use of software in healthcare continues to grow. We don’t […]

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Fu, Halamka, Kufahl, and Logan: Hospitals Need Better Cybersecurity, Not More Fear

September 23, 2016

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We’ve seen unprecedented attention to medical-device security after an unorthodox report was recently released by short-selling investment research firm Muddy Waters Capital and MedSec, which alleged security vulnerabilities in St. Jude Medical’s pacemakers. An independent research team subsequently raised doubts about some of the clinical claims made by the report. St. Jude Medical, meanwhile, has […]

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