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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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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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Purna Prasad: EMR and the Clinical Internet of Things

June 14, 2016

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Think of an electronic medical record (EMR) as a clinical instrument. It is a platform for integrating monitoring, diagnostic, and therapeutic (MDT) data for the patient, the provider, the payer, the researcher, and the regulator. However, an EMR is only as good as the accuracy and precision of the data it contains. The instrumentation infrastructure […]

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Mary Logan: Civility Matters

March 29, 2016

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Civility has been a recurring topic of conversation in our household recently. The discussions are sparked primarily by harsh political rhetoric among grown men who evidently didn’t learn much in kindergarten. It is deeply troubling to see courtesy toward one another and respect for humankind so readily abandoned in favor of violent speech and action […]

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Phil Cogdill: What Do Hiking the Na Pali Coast and Standards Development Have in Common?

March 1, 2016

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While on vacation on the island of Kauai, Hawaii, I decided to hike the Na Pali Coast trail, one of the most stunning, soul-nourishing, and sometimes treacherous coastlines in the world. I completed an eight-mile round-trip hike from Ke’e Beach to Hanakapi`ai Falls, and it was fantastic. The connection I felt to the earth and […]

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Paul Kelley: When Brains Collide

January 8, 2016

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In my job, I have two very different sets of responsibilities, and I’m lucky enough to have these roles coincide with two of my passions. First, I am responsible for my hospital’s biomedical engineering team and, second, I oversee our Green Initiative. My mind works like two brains: One half is devoted to the HTM […]

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Matthew B. Weinger: The Path Forward for Satisfying User Interfaces in Health IT

November 10, 2015

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New rules, titled 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications were recently provided for public comment. In my opinion, these rules do not (yet) go far enough to assure safe and effective design and implementation of health IT. […]

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Ed Burnard: Why Medical Device Standards Matter

October 13, 2015

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Sometimes the dividing line between regulation and flexibility can be unclear. Somewhere in the middle of the life cycle for new innovations, there exists a period of time when innovation slows and a crystallization of consistent customer expectations takes over. In effect, those expectations from the customer provide a de facto standard for that type […]

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Mary Logan: We Need Science, not Scapegoats, in Sterility Assurance Debate

March 24, 2015

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“How clean is clean enough?” has resurfaced as a pressing question in medical device reprocessing because of national media coverage of superbug outbreaks involving contaminated duodenoscopes. While the intense media interest is new, the issue itself is not. Over the past several years, a number of hospitals have had to send sobering letters to patients […]

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Eamonn Hoxey: How Can We Prepare Standards More Effectively?

December 19, 2014

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This year, I have been participating in the revision of three standards of differing size, scope, and extent of use: ISO 9001, the generic standard for quality management systems to which over one million companies worldwide are certified; ISO 13485, the quality management system standard for the medical devices industry for which there are around […]

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