Security issues prompt FDA to extend UDI deadlines
Editor's Note Security issues have prompted the Food and Drug Administration to extend the deadline from September 24 to October 24, 2015, for filing required data and labeling information for the Unique Device Identification system (UDI). The extension applies to implantable life-supporting and life-sustaining devices as well as Class III…
Learn from hybrid OR experts at annual conference Town Hall
The interactive hybrid OR exhibit that debuted at the 2014 OR Manager Conference will once again be showcased in 2015. The exhibit, featuring an extensive array of products and equipment representing more than 10 companies, will be on display during the annual OR Manager Conference, October 7-9, at the Gaylord…
High risk devices backed by few studies before and after FDA premarket approval
Editor's Note Many high risk therapeutic devices receive Food and Drug Administration (FDA) premarket approval with few studies to back their safety and efficacy, Yale researchers find. Studies of how the devices perform once on the market also are few. Of 28 high risk devices that received premarket approval between…
FDA: Serious adverse events associated with LVADs
Editor's Note The Food and Drug Administration on August 5 issued a Safety Communication on serious adverse events linked to left ventricular assist devices (LVADs). Two implantable LVADs are approved by the FDA (HeartMate II by Thoratec Corporation and HeartWare HVAD by HeartWare Inc), and serious events have been associated…
FDA releases supplemental measures for duodenoscope reprocessing
Editor's Note The Food and Drug Administration on August 4 released a Safety Communication that contains supplemental measures to enhance duodenoscope reprocessing. The measures emerged from an expert panel meeting earlier this year. In addition to following manufacturer reprocessing instructions, the FDA says facilities can use one or more of…
Study: Cardiac CT angiography damages DNA
Editor's Note Patients exposed to radiation during cardiac computed tomographic angiography had evidence of deoxyribonucleic acid (DNA) damage that was associated with cell death, DNA damage in cells, and activation of genes involved in DNA repair, in this study. Most cells damaged by the CT scan were repaired, but a…
Spine device market to reach $6.4B by 2024
Editor's Note A report by Q2 Metrics predicts the US market for spinal implants will reach $6.4 billion by 2024, up from $5 billion this year. The largest product segments include posterior thoracolumbar pedicle screw fixation and traditional anterior cervical plating. There is also strong momentum in hospital and physician…
Effectiveness of hybrid coronary revascularization vs CABG
Editor's Note The use of hybrid coronary revascularization is safe and effective, with faster recovery and similar outcomes compared to conventional coronary artery bypass grafting, this study finds. The 30-day composite of mortality, myocardial infarction, or stroke was similar for both procedures, as was mortality during a 3-year follow-up period.…
AANA applauds Washington Post article on cell phone use in the OR
Editor's Note In a response to the July 13 Washington Post article questioning whether cell phones belong in the OR, the American Association of Nurse Anesthetists (AANA) applauded the Post for covering the pros and cons of the issue. AANA president, Sharon Pearce, CRNA, MSN, notes that the AANA supports…
Medtronic to buy RF Surgical’s sponge tracking system for $235 M
Editor's Note Medtronic has agreed to buy RF Surgical Systems for $235 million. The technology embeds radio frequency tags in surgical sponges, towels, and other products to help track and prevent them from being retained in the patient after surgical procedures. Medtronic agreed to pay $235 million to buy…
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