FDA: Reprocessing changes for certain Karl Storz urological endoscopes
Editor's Note The Food and Drug Administration (FDA) on April 4 issued a letter to healthcare providers and users saying the agency is aware that current reprocessing instructions for certain urological endoscopes manufactured by Karl Storz are inadequate and are being updated by the company. In the letter, the FDA…
FDA: Class I recall of certain Celltrion USA COVID-19 test kits labeled for research use only
Editor's Note The Food and Drug Administration (FDA), on March 23, identified the recall by Celltrion USA of certain point of care DiaTrust COVID-19 Ag Rapid Test kits (labeled for research use only) as Class I, the most serious. The recall was initiated because the kits were distributed to customers…
FDA: Class I recall of Philips Respironics V60, V60 Plus Ventilators
Editor's Note The Food and Drug Administration (FDA) on March 21 identified the recall by Philips Respironics of certain V60 and V60 Plus Ventilators as Class I, the most serious. The recall was initiated because a subset of these devices had parts that were put together using an expired adhesive.…
End of universal contact tracing leading to 870+ healthcare layoffs in New York City
Editor's Note According to a March 4 notice filed by NYC Test & Trace Corps, New York City's (NYC’s) initiative for COVID-19 testing and contact tracing, the city is ending universal contact tracing by the end of April, Becker’s Hospital Review March 10 reported. This means that NYC Health +…
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…
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