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James Piepenbrink: I’m Not Just a Clinical Engineer; I’ve Been a Patient, Too

November 14, 2016

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For 36 years, I worked at two major teaching hospitals in Boston. I have been on a cancer ward, in an infusion center, inside an MRI and CT scan, in the OR and PACU, the ER, the cardiac ward, the cath lab, and other diagnostic areas—not only as a clinical engineer, but as a patient. […]

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Mark Swanson: Here It Comes! Are You Ready for Updated Standard for Quality Management Systems?

February 19, 2016


For the first time in 13 years, we will have an update to the backbone quality management system (QMS) requirements document for medical device organizations: ANSI/AAMI/ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes, will be released on March 1. The revision contains numerous clarifications and additions to this important standard, […]

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Karen K. Giuliano: Addressing Technology Deficits to Make IV Smart Pumps Safer, Smarter

November 19, 2015


Intravenous (IV) smart infusion pumps, which are designed to deliver prescribed doses of IV solutions and medications, are among the most frequently used technologies in healthcare. An estimated 90% of hospitalized patients receive IV medications via infusion pumps. However, as highlighted in my article in the fall issue of Horizons (available open-access at, even […]

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