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…
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…
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…
FDA, USDA, CDC say COVID-19 can’t spread via food, packaging
Editor's Note The Food and Drug Administration (FDA), US Department of Agriculture (USDA), and Centers for Disease Control and Prevention (CDC), on February 18, issued a statement saying there is no epidemiological evidence out of more than 100 million cases globally that COVID-19 can be transmitted through food or food…
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…
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…
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…
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…
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…
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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