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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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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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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: 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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Mike Ahmadi: When It Comes to Cybersecurity, the Regulatory Will Is Weak

August 3, 2017

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I want to tell a story. I grew up in Cleveland Ohio, a city that has always held its place in the top two or three cities that everyone likes to poke fun at for being a place where you do not want to live—or so it was for most of my life. Thankfully, it […]

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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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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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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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William Hyman: What Do FDA Inspections of Hospitals for MDR Compliance Tell Us?

November 16, 2016

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Medical device reporting (MDR) is mandatory for hospitals and others captured under the definition of “device use facilities,” which does not include physician offices. Also subject to mandatory reporting are manufacturers for which this is a well-entrenched activity. The three categories of device-related events that must be reported are deaths, serious injuries, and, for manufacturers, […]

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