Editor's Note The Food & Drug Administration (FDA) on October 17 announced a public workshop to discuss the newly released draft guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. The need for effective cybersecurity to ensure medical device function and safety has become more important with…

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Editor's Note The Food and Drug Administration (FDA) on October 16 announced that as part of the Administration’s efforts to strengthen cybersecurity in healthcare, the FDA and Department of Homeland Security (DHS) have agreed to greater coordination and cooperation for addressing cybersecurity in medical devices. Under the agreement, DHS will…

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Editor's Note The Food & Drug Administration on September 28 announced the recall by Endo Pharmaceuticals Inc of two lots of Robaxin 750 mg tablets because of incorrect dosing information on the label. Robaxin contains methocarbamol, which is used as a muscle relaxant. Patients who follow the incorrect dosing information…

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Editor's Note The Food & Drug Administration (FDA) on October 1 released a “Playbook,” developed by the Medical Device Cybersecurity Regional Incident Preparedness and Response (MITRE) Corp, to assist hospitals and other healthcare providers respond to cybersecurity incidents involving medical devices, the American Hospital Association reports.  The MITRE Playbook outlines…

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Editor's Note The Food and Drug Administration (FDA) on September 27 announced the recall by Oscor Inc (Palm Harbor, Florida) of its TB-Temporary Bipolar Pacing Leads, with 2 mm unshrouded connectors. The recall was initiated because the connector cap housing may slide and expose the connection wire. This may cause…

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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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