Study: Most nurses dissatisfied with EHRs
Editor's Note A study by Adventist University of Health Sciences (Orlando, Florida) found that 92% of nurses were dissatisfied with their electronic health record (EHR) technology. In addition, 85% said the EHRs had flaws, and 84% said EHRs disrupted their productivity and clinical workflow. The researchers also found an increase…
FDA extends UDI compliance date for certain Class II devices
Editor's Note In a September 6 letter to device labelers, the Food and Drug Administration (FDA) said it is extending unique device identifier (UDI) requirements for certain Class II devices from September 24, 2016 to September 24, 2018. The extension applies to repackaged single-use devices and device convenience kits. The…
Study: Physicians spend half their time on EHRs, desk work
Editor's Note In this study, researchers found that physicians spent 49.2% of their time during the day on electronic health records and desk work and 27% of their time with patients. In addition, they spent an extra 1 to 2 hours each night during their personal time on EHRs. While…
FDA classifies recall of Roadrunner UniGlide Hydrophilic Wire Guides as Class I
Editor's Note The Food and Drug Administration (FDA) on September 6 classified the recall of the Roadrunner UniGlide Hydrophilic Wire Guides by Cook Medical (Bloomington, Indiana) as Class I, the most serious. All serial and lot numbers are being recalled, and the product line is being discontinued because of concern…
Preventing a cyber attack takes commitment--and money
Information technology (IT) has been a lifesaver and a timesaver in healthcare, bringing speed and precision to medical-surgical procedures and replacing paperwork with electronic computation, storage, and communication. But there is a dark side. Systems can be sabotaged, files can be opened, and devices used in surgery can fail at…
iPads help calm children before surgery
Editor's Note Children who played games on an Apple iPad before surgery had a reduction in their stress levels equal to the effect of taking a sedative, according to a study presented at the World Congress of Anaesthesiologists in Hong Kong. In addition, parental satisfaction and quality of anesthesia induction…
FDA, device manufacturers make deal on user fees
Editor's Note The Food and Drug Administration and medical device manufacturers have made a deal on user fees companies pay to have the FDA review their products, the August 23 Mass Device reports. The Medical Device User Fee & Modernization Act IV will allow the FDA to collect nearly $1…
Trends in choledocholithiasis management
Editor's Note This study found a marked decline from 1998 to 2013 in surgical (open and laparoscopic) common bile duct exploration (CBDE) for choledocholithiasis (ie, bile duct stones). At the same time, the rate of endoscopic retrograde cholangiopancreatography (ERCP) increased and is becoming the predominant treatment strategy. The percentage of…
FDA expands indication for two transcatheter aortic valves
Editor's Note The Food and Drug Administration (FDA) on August 18 approved an expanded indication for the Sapien XT and Sapien 3 transcatheter heart valves for patients with aortic stenosis. The new indication is for patients who are at intermediate risk for death or complications associated with open-heart surgery. Previously,…
FDA issues draft guidance on when to seek reapproval for medical devices
Editor's Note The Food and Drug Administration (FDA) on August 8 published draft guidance on when medical device manufacturers and software developers must obtain FDA clearance before making changes to existing products, the August 8 Modern Healthcare reports. The draft says if the “overall structure” of a device’s software is…
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