Editor's Note The Food and Drug Administration (FDA) on January 15 classified the recall of Brainlab’s Cranial Image-Guided Surgery (IGS) System as Class I, the most serious. The system is being recalled because of potential inaccuracies in the display by the navigation system compared to the patient’s anatomy. This could…

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Editor's Note The Food and Drug Administration (FDA) on January 4 issued a draft guidance: “Unique Device Identification [UDI]: Convenience Kits—Draft Guidance for Industry and Food and Drug Administration Staff.” The document outlines the FDA’s interpretation that the term “convenience kit,” as defined by 21 CFR 801.3, applies solely to…

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Editor's Note The ECRI Institute on January 4 released its annual Top 10 list of important technology related issues that hospital and health system leaders need to pay close attention to this year. The list includes: Medical device cybersecurity (eg, hacking into pacemakers) Miniature leadless pacemakers Changing landscape of robotic…

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Editor's Note Annual spending on a group of new drug and device therapies may exceed $80 billion if they all make it to market, according to a new report by ECRI Institute. ECRI Institute analyzed the costs of 47 of 700 healthcare interventions with the potential for high impact that…

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Editor's Note The Food and Drug Administration on November 13 identified the recall of Hamilton G5 Ventilators V2.00 and V2.31 as Class I, the most serious. The ventilator may stop working, without sounding an alarm, when the oxygen enrichment key is pressed to attach the mask to the patient. If…

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Editor's Note In patients requiring long coronary stents, the use of intravascular ultrasound (IVUS)-guided vs angiography-guided drug-eluting stent implantation resulted in a significantly lower rate (2.9% absolute reduction, 48% relative reduction) of major adverse cardiac events at 1 year, finds this study. These differences were mainly driven by the reduction…

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Editor's Note Inadequate cleaning of flexible endoscopes is first on the ECRI Institute’s annual Top 10 Health Technology Hazards list for 2016. Failure to effectively monitor postoperative patients for opioid-induced respiratory depression is third, and insufficient training of clinicians on OR technologies is fifth. ECRI Institute releases the Top 10…

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Editor's Note A coalition of 111 medical societies on November 4 sent letters asking Senate and House leaders to take legislative action to pause Stage 3 of the electronic health records meaningful use program and revise Stage 2 so that it enables provider success, HealthData Management reports. Stage 3 requirements…

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Editor's Note A Nielsen survey of 5,000 healthcare recipients found that 15% (aged 18 to 65) communicate with providers through e-mails, 21% schedule appointments online, and 9% get text reminders, the Washington Post reports. Among those who do not communicate electronically, 36% were interested in online appointment scheduling, and 34%…

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OR Manager, Inc, and ECRI Institute have joined in a collaboration to bring OR Manager readers quarterly supplements on topics such as medical technology management and procurement, risk management, and patient safety. ECRI Institute is an independent nonprofit that researches the best approaches to improving patient care. Three-dimensional (3-D) printers…

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