Editor's Note The Food and Drug Administration (FDA) on September 30 posted an announcement by Getinge that it is voluntarily initiating a worldwide recall involving a field correction of some 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp. The recall is because of the potential for interruption…

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Editor's Note The Food and Drug Administration (FDA) has taken steps to ensure that medical device manufacturers do as much as possible to defend against hacking and other threats to their devices, according to a new report from the Department of Health & Human Services Office of Inspector General. The…

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Editor's Note The Food and Drug Administration (FDA) on September 10 posted the announcement by Pharm D Solutions, LLC, (Houston, Texas) that it had voluntarily issued a recall of all sterile compounded drugs because of a potential lack of sterility. The company says concerns about practices at the pharmacy that…

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Editor's Note The Food and Drug Administration (FDA) on August 28 issued a notice proposing not to include three bulk FDA-approved drug substances−bumetanide, nicardipine hydrochloride, and vasopressin−on the list that outsourcing facilities may use in compounding drug products. The FDA is seeking public comment before finalizing their decision. Comments must…

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Editor's Note The Food & Drug Administration (FDA) on August 17 issued a Safety Alert for SynCardia Systems’ (Tucson, Arizona) Temporary Total Artificial Heart Companion 2 Driver System. Final results from a post-approval study indicate higher mortality and stroke rates for patients initially supported with the C2 Driver System compared…

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Editor's Note Nominees for the Best Medical Technology of 2018 were recently chosen by The Galien Foundation, the August 6 Medical Design & Outsourcing reports. Among the 10 most innovative medical devices are: Boston Scientific’s Axios stent and electrocautery enhanced delivery system Boston Scientific’s SpyGlass direct visualization system for cholangiopancreatoscopy…

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Editor's Note The Food & Drug Administration on August 10 identified the recall of Spacelabs Healthcare’s (Snoqualmie, Washington) Arkon Anesthesia Delivery System as Class I, the most serious. The recall was issued because of the system going into a “failed state,” during which the mechanical ventilation function stops working. This…

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Editor's Note The Food and Drug Administration (FDA) on August 3 issued a warning for azithromycin, saying the antibiotic should not be given long-term to prevent an inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. A clinical trial…

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Editor's Note The Food and Drug Administration (FDA) on July 25 issued an update for the Zoll LifeVest 4000 wearable cardioverter defibrillator. The update provides information on efforts by Zoll to remedy the potential hazard of the device failing to deliver a life-saving shock if not replaced soon after displaying…

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Editor's Note The Food and Drug Administration (FDA) on July 19 finalized its guidance for using electronic health record (EHR) data in FDA-regulated clinical studies. The guidance is meant to encourage the use of EHR data in clinical studies and promote greater interoperability between EHR and electronic data capture systems.…

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