FDA

Latest Issue of OR Manager
March 2021

FDA: Class I recall of Medtronic's HVAD Pump Implant Kits

Editor's Note The Food and Drug Administration (FDA) on March 1 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) Pump Implant Kits as Class I, the most serious. The kit is part of the HeartWare HVAD System, which is used to help the heart pump blood…

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By: Judy Mathias
March 3, 2021
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FDA issues EUA for J&J’s single-dose COVID-19 vaccine

Editor's Note The Food and Drug Administration (FDA) on February 27 issued an emergency use authorization (EUA) for Johnson & Johnson’s single-dose COVID-19 vaccine, making it the third coronavirus vaccine approved for use in the US. The vaccine can be administered to people ages 18 and older. Vaccinations will begin…

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By: Judy Mathias
March 1, 2021
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Nearly 4M J&J vaccine doses to be delivered next week, if EUA granted

Editor's Note Up to 4 million doses of the Johnson & Johnson (J&J) single-dose COVID-19 vaccine will be delivered to states, community health centers, and pharmacies next week, if the vaccine receives Emergency Use Authorization (EUA) from the Food & Drug Administration (FDA), the February 24 The Hill reports. An…

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By: Judy Mathias
February 25, 2021
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Diligence in implant processing will decrease infection risks

Implants are foreign bodies, and they increase the risk of a surgical site infection. Processing implants requires strict adherence to the required steps because implants have sustained contact with sterile tissue. An implant is defined as a device that is placed into a surgically or naturally formed cavity of the…

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By: Susan Klacik, BS, CRCST, ACE, CIS, FCS
February 17, 2021
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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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