Tag: FDA

FDA: Class I recall of Boston Scientific’s VICI, VICI RDS Venous Stent systems

Editor's Note The Food and Drug Administration (FDA), on May 21, identified the recall by Boston Scientific Corporation of its VICI Venous Stent and VICI RDS Venous Stent systems as Class I, the most serious. The recall was initiated because of reports that the stents may migrate or move from…

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By: Judy Mathias
May 25, 2021
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CDC recommends Pfizer COVID-19 vaccine for adolescents

Editor's Note The Centers for Disease Control and Prevention (CDC) is recommending that the Pfizer-BioNTech COVID-19 vaccine be given to everyone 12 years of age and older. Previously, COVID-19 vaccines had been authorized only for those aged 16 and older. Pfizer is the first vaccine manufacturer to gain emergency use…

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By: Judy Mathias
May 24, 2021
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ISMP releases perioperative medication safety tool

Editor's Note The Institute for Safe Medication Practices (ISMP), on May 18, released a new perioperative medication safety self assessment to help hospitals, ASCs, and other surgery settings evaluate their medication practices and identify challenges and opportunities for improvement. The tool also offers providers a way to document compliance with…

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By: Judy Mathias
May 20, 2021
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Study: Postop opioid prescriptions decreasing, but not to recommended levels

Editor's Note Opioids prescribed after outpatient surgery are going down, but still do not meet expert recommendations, a new study from Epic Health Research Network finds. The researchers examined the median number of opioid tablets prescribed after outpatient surgical procedures between January 2017 and December 2020. For four orthopedic procedures,…

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By: Judy Mathias
May 18, 2021
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CDC relaxes mask guidelines for those fully vaccinated against COVID-19

Editor's Note The Centers for Disease Control and Prevention on May 13 announced that fully vaccinated individuals can discard masks and do away with social distancing outdoors and in most indoor settings. The agency still calls for wearing masks in crowded indoor settings, such as buses, planes, hospitals, prisons, and…

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By: Judy Mathias
May 17, 2021
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FDA: BD recalls certain lots of ChloraPrep

Editor's Note The Food & Drug Administration announced on April 20 that Becton, Dickinson and Company (BD) was recalling certain lots of its ChloraPrep Hi-Lite Orange 26 mL Applicator. ChloraPrep is used as an antiseptic to prepare a patient’s skin before surgery. The recall was initiated because the Applicator, which…

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By: Judy Mathias
May 11, 2021
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Hospira recalls one lot each of 0.5% Bupivacaine and 1% Lidocaine because of mislabeling

Editor's Note Hospira Inc, a Pfizer company, announced May 4 that it is recalling lot EG6023 of 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and lot EG8933 of 1% Lidocaine HCL Injection, USP 30 mL because of mislabeling. A portion of each lot was incorrectly labeled as the other product.…

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By: Judy Mathias
May 6, 2021
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FDA: Class I recall of Alaris Infusion Pump Module 8100

Editor's Note The Food and Drug Administration, on April 30, identified the recall of the Alaris Infusion Pump Module 8100 as Class I, the most serious. The Pacific Medical Group (DBA Avante Health Solutions) is recalling the infusion pump because the front bezel components may crack or separate, leading to…

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By: Judy Mathias
May 3, 2021
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CDC: More than 98M Americans fully vaccinated against COVID-19

Editor's Note The Centers for Disease Control and Prevention (CDC), on April 28, reported that more than 98 million people in the US are fully vaccinated against COVID-19, which is 29.5% of the population. The count included two-dose vaccines from Moderna and Pfizer/BioNTech, as well as the Janssen/Johnson & Johnson’s…

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By: Judy Mathias
April 29, 2021
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CDC revises mask guidelines for fully vaccinated people

Editor's Note The Centers for Disease Control and Prevention (CDC), on April 27, announced new interim public health recommendations on activities fully vaccinated people can resume with and without wearing a mask. Among the recommendations: Fully vaccinated people can attend small gatherings outdoors with other vaccinated people or a mix…

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By: Judy Mathias
April 28, 2021
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