Supply Chain/Technology

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March 2018
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FDA: PharMEDium recalls 55 lots of compounded sterile drugs

Editor's Note The Food and Drug Administration on January 2 announced the recall by PharMEDium Services (Lake Forest, Illinois) of 55 lots (impacting 25,327 units) of compounded sterile drug products because of a lack of sterility assurance. The recalled products were manufactured in PharMEDium’s Memphis location and distributed nationwide to…

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By: Judy Mathias
January 5, 2018
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FDA: AuroMedics recalls Ampicillin and Sulbactam for Injection

Editor's Note The Food and Drug Administration (FDA) on January 4 announced the recall by AuroMedics Pharma LLC (Windsor, New Jersey) of one lot of Ampicillin and Sulbactam for Injection USP 1.5 g in a single-dose vial. The recall was issued because the lot (Lot AFOI 17001-A, Expiry date December…

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By: Judy Mathias
January 4, 2018
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FDA: Class I recall of Agilis Steerable Reprocessed Introducer Sheath

Editor's Note The Food and Drug Administration (FDA) on January 2 classified the recall by Sterilmed (Plymouth, Minnesota) of its Agilis Steerable Reprocessed Introducer Sheath as Class I, the most serious. The sheath's hemostatic valve, which prevents blood from flowing back through the valve, may fail because of an improper…

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By: Judy Mathias
January 3, 2018
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Robotics: Building a winning business case

Robotic-assisted surgery offers many potential advantages, including shorter operative time, less morbidity, and faster patient recovery. But rigorous comparisons with traditional surgical methods and cost-effectiveness analyses are still limited, and the price tag of the robot (in the neighborhood of $1 million) and annual maintenance contract (roughly $150,000) may give…

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By: Susan London
December 14, 2017
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ECRI Institute issues annual technology hazards list

Editor's Note ECRI Institute on December 12 issued its list of Top 10 Health Technology Hazards for 2018. The list, which is available for free (registration required), identifies sources of technology dangers or difficulties and details steps to minimize the occurrence of adverse events. Topping the list is ransomware and…

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By: Judy Mathias
December 12, 2017
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FDA issues guidance on 3D printing of medical devices

Editor's Note Food and Drug Administration (FDA) commissioner Scott Gottlieb, MD, issued a statement December 4 on the FDA’s final guidance on medical device additive manufacturing, also known as 3D printing. The FDA has reviewed more than 100 devices currently on the market that were manufactured on 3D printers, including…

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By: Judy Mathias
December 7, 2017
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FDA: Recall of Pharmacist Choice Alcohol Prep Pads

  Editor's Note The Food and Drug Administration (FDA) on December 5 announced the recall of 3 lots of Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics (Coral Springs, Florida), which were manufactured by Foshan Flying Medical Products Co Ltd, located in China. The alcohol pads were recalled because of…

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By: Judy Mathias
December 6, 2017
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Joint Commission announces new tool to help with accreditation, CMS compliance

Editor's Note The Joint Commission on November 29 announced a new software tool, “Tracers with AMPTM plus CMS,” to help hospitals and critical access hospitals manage their Joint Commission accreditation and Centers for Medicare & Medicaid Services (CMS) compliance efforts. The tool is a web-based platform that stores a hospital’s…

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By: Judy Mathias
November 30, 2017
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November 30 is deadline to avoid EHR payment adjustment

Editor's Note November 30 is the deadline for critical access hospitals that did not achieve meaningful use for the 2016 reporting period to submit hardship forms to avoid a 2018 payment adjustment, the November 27 AHA News Now reports. Inpatient prospective payment system hospitals that did not achieve meaningful use…

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By: Judy Mathias
November 29, 2017
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EHR vendor linked to MU performance of hospitals

Editor's Note A study in the Journal of the American Medical Informatics Association found that some electronic health record (EHR) vendors consistently outperform others, the November 27 Becker’s Hospital Review reports. Epic had the highest performance on five of six meaningful use (MU) stage 2 criteria, including view, download, and…

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By: Judy Mathias
November 29, 2017
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