Technology

Latest Issue of OR Manager
October 2017

New instrument shows promise as low-cost alternative to robot

Researchers at the University of Michigan (U-M), Ann Arbor, have invented a new surgical instrument with the goal of addressing a vast, unmet need in minimally invasive surgery. For less than a thousand dollars, this platform technology—currently being commercialized by the start-up FlexDex Surgical—offers capabilities similar to those of the…

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By: Judith M. Mathias, MA, RN
June 20, 2017
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FDA issues Safety Alert for frameless stereotaxic navigation systems

Editor's Note The Food and Drug Administration (FDA) on June 15 issued a Safety Alert for frameless stereotaxic navigation systems because of navigational accuracy errors during surgical procedures. Some of these errors have led to patient deaths, serious or life-threatening injuries, and inaccurate, aborted, or prolonged surgical procedures. The FDA…

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By: Judy Mathias
June 16, 2017
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Analysts predict 5% growth for GI endoscopy device market

Editor's Note The global market for gastrointestinal (GI) endoscopy devices is expected to see a compound annual growth rate of 5.09% through 2020, the June 13 Becker’s GI & Endoscopy reports. A large, growing patient pool is driving growth, but risks and complications tied to GI endoscopy procedures also will…

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By: Judy Mathias
June 14, 2017
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FDA releases list of reusable devices requiring new validated IFU, validation data

Editor's Note The Food and Drug Administration (FDA) on June 9 released a list of reusable devices that will require new validated instructions for use (IFU) and validation data in premarket notifications regarding cleaning, disinfection, and sterilization. These actions are effective August 8, 2017. The list includes: Bronchoscopes (flexible or…

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By: Judy Mathias
June 12, 2017
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FDA extends UDI compliance dates for Class I, unclassified devices

Editor's Note The Food and Drug Administration (FDA) has notified medical device labelers that the compliance dates for unique device identifier (UDI) requirements for Class I and unclassified medical devices has been extended from September 24, 2018, to September 24, 2020, and for direct mark requirements from September 24, 2020,…

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By: Judy Mathias
June 12, 2017
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ECRI Institute announces release of CrossCHEQ

Editor's Note ECRI Institute on June 6 announced the release of CrossCHEQ, its new service that offers unbiased guidance on equivalent alternatives for medical-surgical supplies and implants. By comparing key performance indicators, buyers can assess opportunities for standardization and better respond when products are out of stock or recalled. The…

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By: Judy Mathias
June 7, 2017
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Study shows positive results for new AAA graft in women

Editor's Note Thirty-day data from the 225-patient LUCY (Evaluation of FemaLes who are Underrepresented Candidates for Abdominal Aortic AneurYsm Repair) Study showed that at least 28% more women became eligible for  minimally invasive endovascular abdominal aortic aneurysm (AAA) repair when using Endologix’s (Irvine, California) Ovation abdominal stent graft system, according…

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By: Judy Mathias
June 5, 2017
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Healthcare IT market projected to grow by 15.9%

Editor's Note Research N Reports predicts the global healthcare information technology (IT) market will grow by 15.9% and reach $280.25 billion by 2021, according to the May 30 Healthcare Informatics. The growth is driven by demand for healthcare IT solutions that help lower costs while meeting regulatory requirements. Other factors…

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By: Judy Mathias
June 1, 2017
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Joint Commission posts addendums for radiation risks of diagnostic imaging

Editor's Note The Joint Commission on May 30 posted addendums to its Sentinel Event Alert, Issue 47: Radiation risks of diagnostic imaging. Risks associated with ionizing radiation in diagnostic imaging included cancer, burns, and other injuries. The addendums update broken links, resources, and references. Sentinel Event Alert, Issue 47: Radiation…

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By: Judy Mathias
May 31, 2017
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ECRI Institute issues free resource on ransomware attacks

Editor's Note The ECRI Institute (Plymouth Meeting, Pennsylvania) on May 25 issued a free public resource to protect hospitals from ransomware attacks. The new guidance, “Ransomware Attacks: How to Protect Your Medical Device Systems,” provides recommendations for adapting general cybersecurity principles to the requirements of medical devices, including a list…

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By: Judy Mathias
May 25, 2017
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