Tag: FDA

FDA issues EUA for monoclonal antibody treatments for COVID-19

Editor's Note The Food & Drug Administration, on February 9, issued an emergency use authorization (EUA) for Eli Lilly’s (Indianapolis, Indiana) combination therapy of two antibodies, bamlanivimab and etesevimab. The authorization is for the two antibodies to be administered together for treatment of mild to moderate COVID-19 in adults and…

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By: Judy Mathias
February 11, 2021
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FDA reduces N95 decontamination cycles from 20 to 4

Editor's Note The Food & Drug Administration (FDA), on January 22, lowered the number of times an N95 mask can be cleaned and reused to 4, down from a previous maximum of 20 reuses, the January 25 Fierce Biotec reports. The FDA reissued emergency use authorizations for 10 N95 decontamination…

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By: Judy Mathias
January 28, 2021
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FDA revises EUAs for N95 decontamination systems

Editor's Note The Food and Drug Administration on January 21 reissued emergency use authorizations (EUAs) for 10 systems used to decontaminate N95 respirators used by healthcare personnel . The 10 systems are: Michigan State University Decontamination System Technical Safety Services VHP Decontamination System Stryker Sustainability Solutions VHP Decontamination System STERIS…

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By: Judy Mathias
January 26, 2021
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Willingness of US adults to get the COVID-19 vaccine

Editor's Note This study led by researchers from the Virginia Commonwealth University, Richmond, finds that COVID-19 vaccine-related messaging should address concerns about the vaccine and its development and reinforce its benefits to increase the willingness of US adults to get the COVID-19 vaccine and to get the vaccine under an…

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By: Judy Mathias
January 20, 2021
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Parsing COVID-19 transmission routes informs levels of protection needed

Information about COVID-19 transmission and treatment has evolved between the time this infectious disease first emerged and now. As evidence-based knowledge grows and protocols change, and as populations are vaccinated to develop herd immunity, there is increasing optimism about the ability to combat the virus. Meanwhile, it is important to…

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By: Judith M. Mathias, MA, RN
January 19, 2021
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Supply chain strategies shift to meet pandemic-induced demands

Resiliency, a term that has cropped up repeatedly during the COVID-19 pandemic, is often considered a key defense against burnout. But it is also important in the context of the healthcare supply chain, says Ed Hisscock, senior vice president of supply chain management at Trinity Health, a 22-state healthcare system…

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By: Elizabeth Wood
January 19, 2021
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Editorial

The rollout of COVID-19 vaccines starting in December 2020 was the one bright spot in an otherwise tragic year with a rapidly rising death toll currently over 385,000. Distribution of the 20 million doses promised by year end was thwarted by problems such as lack of coordination and lack of…

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By: Elizabeth Wood
January 19, 2021
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Expanding reprocessing programs can yield cost savings

The financial impact of COVID-19 on healthcare providers has been considerable. With experts predicting that half of all US hospitals would be operating in the red by the end of 2020, healthcare leaders have had to seek multiple ways to cut costs. The expansion of single-use medical device (SUD) reprocessing…

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By: OR Manager
January 19, 2021
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CDC: Updated interim recommendation for allocation of COVID-19 vaccine

Editor’s Note On December 20, 2020, the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) updated its interim vaccine allocation recommendations. In Phase 1b, COVID-19 vaccine should be offered to persons aged 75 years or more and non-healthcare frontline essential workers. In Phase 1c, the vaccine should be…

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By: Judy Mathias
January 5, 2021
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Pfizer/BioNTech vaccine reaches 141 of 145 first-day locations

Editor's Note The first batch of the Pfizer/BioNTech's newly authorized COVID-19 vaccine for emergency use reached 141 of 145 targeted locations on the first day of its national rollout, a Department of Health and Human Services spokeswoman told Reuters. Four island territories—American Samoa, Guam, North Mariana Islands, and the US…

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By: Judy Mathias
December 15, 2020
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