Tag: FDA

Safe Flight Instrument Corporation creates ventilator splitter

Editor's Note Safe Flight Instrument Corporation (White Plains, New York), a company that develops aircraft safety and performance technology, has developed the Quad/Vent Splitter that allows four patients to use one ventilator simultaneously, the April 13 Aviation International News Online reports. Using 3-D printing, the device has four independent ports…

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By: Judy Mathias
April 14, 2020
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FDA issues COVID-19 update

Editor's Note The Food & Drug Administration (FDA) on April 7 issued an update on actions the agency has taken in its ongoing response to the COVID-19 pandemic. The actions include: a guidance for remote ophthalmic assessment and monitoring devices to facilitate patient care while reducing patient and healthcare provider…

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By: Judy Mathias
April 8, 2020
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HHS: FDA issues emergency authorization of anti-malaria drugs for COVID-19 treatment

Editor's Note The Department of Health and Human Services (HHS) announced on March 29 that the Food & Drug Administration (FDA) had issued an emergency use authorization for hydroxychloroquine and chloroquine in the treatment of COVID-19. The FDA allowed for the drugs to be “donated to the Strategic National Stockpile…

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By: Judy Mathias
March 30, 2020
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FDA acts to increase COVID-19 supplies with instructions for manufacturers importing PPE, devices

Editor's Note The Food & Drug Administration (FDA) on March 24 took action to increase US supplies in response to the COVID-19 pandemic by providing instructions to manufacturers importing personal protective equipment (PPE) and other devices. The instructions to manufacturers clarify the types of PPE and devices they can import…

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By: Judy Mathias
March 26, 2020
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FDA announces actions taken in response to COVID-19 pandemic

Editor's Note: The Food & Drug Administration (FDA) on March 25 announced several actions it has taken in its response to the COVID-19 pandemic. These include: In response to the demand for hand sanitizers and their active ingredient, alcohol, the FDA issued guidance to alcohol manufacturers on how to incorporate…

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By: Judy Mathias
March 26, 2020
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FDA: Safety Alert on transmission risk of SARS-CoV-2 virus in fecal microbiota

Editor's Note The Food & Drug Administration on March 23 issued a Safety Alert to inform healthcare providers and patients of the potential risk of transmission of SARS-CoV-2 virus by the use of fecal microbiota for transplantation (FMT), and that the agency has determined that additional safety protections are needed.…

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By: Judy Mathias
March 24, 2020
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ASCA releases guidance on necessary surgeries for ASCs during COVID-19 pandemic

Editor's Note In consultation with clinical experts and in response to government guidance that hospitals and ambulatory surgery centers (ASCs) postpone elective surgical procedures during the COVID-19 pandemic, the Ambulatory Surgery Center Association (ASCA) released a statement March 18 on how and when facilities should proceed with cases that should…

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By: Judy Mathias
March 18, 2020
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FDA: Class I recall of Alaris Infusion Pump System and Modules

Editor's Note The Food and Drug Administration (FDA) on March 6 identified the recall by Becton Dickinson (BD)/CareFusion 303 of its Alaris System Infusion Pumps and Modules as Class I, the most serious. The recall was initiated because of multiple system errors, software errors, and use-related errors. The errors can…

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By: Judy Mathias
March 9, 2020
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FDA, CDC increase access to respirators during COVID-19 outbreak

Editor's Note The Food & Drug Administration (FDA) on March 2 announced that it had joined with the Centers for Disease Control and Prevention (CDC) to make more respirators, including certain N95s, available to healthcare personnel during the coronavirus (COVID-19) outbreak. Currently, the majority of respirators are used in industrial…

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By: Judy Mathias
March 4, 2020
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FDA: Class I recall of King Systems’ video laryngoscope adapter

Editor's Note The Food & Drug Administration (FDA) on February 27 identified the recall by King Systems of its King Vision Video Laryngoscope Adapter (size ½) as Class I, the most serious. The recall was initiated because all devices from the affected lots show a reversed image on the display,…

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By: Judy Mathias
March 3, 2020
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