FDA extends shelf life for refrigerated Johnson & Johnson vaccine
Editor's Note Based on data submitted by Janssen Biotech Inc., a pharmaceutical company wholly owned by Johnson & Johnson, The Food and Drug Administration (FDA) authorized on March 7 the extension of the shelf life for refrigerated Johnson & Johnson COVID-19 vaccines, the American Hospital Association March 14 reported. The…
APIC outlines actions needed to battle future pandemics while fighting rising HAIs
Editor's Note The Association for Professionals in Infection Control and Epidemiology (APIC) on March 8 announced the publication of a new report outlining actions needed to successfully battle future pandemics while fighting the rise in healthcare-associated infections (HAIs). Some recommendations in the 66-page report, titled “Between a Rock and Hard…
FDA: Fresenius Kabi recalls Sodium Acetate Injection, USP, 400 mEq/100 mL
Editor's Note The Food and Drug Administration on March 7 posted the recall by Fresenius Kabi USA (Lake Zurich, Illinois) of seven lots of its Sodium Acetate Injection, USP, 400 mEq/100 mL The recall was initiated because of the presence of particulate matter found in reserve and/or stability sample vials.…
Conversation-focused training may help HCWs combat vaccine hesitancy
Editor's Note The biggest obstacle to achieving 100% vaccination rate in the US is no longer whether vaccines will be manufactured fast enough, or if there will be enough for the country’s population, Lisa Doggett, senior medical director at HGS AxisPoint Health, told Health Leaders March 8. “Rather, it's concerns…
FDA: Class I recall of Medtronic TurboHawk Plus Directional Atherectomy System
Editor's Note The Food and Drug Administration, on March 9, identified the recall by Medtronic of its TurboHawk Plus Directional Aherectomy System as Class I, the most serious. The recall was initiated because of the risk of the guidewire in the catheter moving downward or prolapsing when force is applied…
FDA: B. Braun Medical recalls 0.9% Sodium Chloride for Injection USP 250 ml in Excel
Editor's Note The Food and Drug Administration (FDA) on March 3 posted the recall by B. Braun Medical Inc of its nationwide recall of five lots of 0.9% Sodium Chloride for Injection USP 250 ml in Excel. The recall was initiated because of fluid leakage or low fill volume of…
Study: Spatial and racial disparities in COVID-19 mortality rates
Editor's Note This study from the University of Chicago finds an association between social determinants of health measures and COVID-19 mortality rates that varied across racial and ethnic groups and community types. Among 3,142 counties in the study, 531 were identified as concentrated longitudinal-impact counties. Of these, 347 (11%) had…
ANSI/AAMI publishes long-waited ST91 updates
Editor's Note After 7 years, ANSI/AAMI has updated its standard for cleaning and storing medical devices, such as flexible bronchoscopes and various endoscopes. The updated standard, “ANSI/AAMI ST91:2021, Flexible and semi-rigid endoscope processing in health care facilities,” addresses new technologies and concerns about device cleanliness and patient safety. “ANSI/AAMI ST91:2021…
FDA: Class I recall of Arrow International’s Arrow-Trerotola PTD
Editor's Note The Food and Drug Administration (FDA) on February 23 identified the recall by Arrow International (Reading, Pennsylvania), a subsidiary of Teleflex Inc, of its Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) as Class I, the most serious. The recall was initiated because of the risk of tip damage during use…
FDA: Class I recall of Vyaire Medical’s Bellavista Ventilators
Editor's Note The Food and Drug Administration (FDA) on February 17 identified the recall by Vyaire Medical (Mettawa, Illinois) of its Bellavista 1000 and 1000e Series Ventilators as Class I, the most serious. The recall was initiated because of issues with the software version 6.0.1600.0 or higher, after reports of…
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