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Rob Jensen: Taking a Side in the Debate over Medical Device Service

October 10, 2017

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This year, we’ve seen an even hotter-than-usual debate about the servicing of medical devices and healthcare technology, thanks in part to calls for new standards, a congressional mandate for an FDA report on the subject, and renewed interest in making data-based decisions. The discussion can get particularly heated when we talk about third-party service providers […]

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William Hyman: The Missing Link in Device Interoperability

October 6, 2017

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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 of data from one medical device to another or perhaps from one or more medical devices to a separate processing […]

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

September 22, 2017

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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 this challenge. A group of us at AAMI and beyond are working on attaining a National Science Foundation planning grant […]

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William Hyman: Bills in Congress Address Medical Device Safety

September 21, 2017

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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 Device Reporting (MDR) requirements. The legislation excels in brevity and simplicity by amending the term “covered device user facility” in […]

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Robert Sayle: Get Manufacturers on Board with Digital Certificates

September 19, 2017

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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 leverage 802.1X is to use digital certificates. Why would we do this? Because we can prepare your equipment for authentication […]

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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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