HHS to give $66.5 million towards community-based outreach to boost COVID-19 vaccination rates
Editor's Note According to the February 10 Healthcare Purchasing News, the US Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), announced a new American Rescue Plan funding of $66.5 million to help expand outreach efforts to boost COVID-19 vaccine rates. The funding will…
FDA: Class I recall of Empowered Diagnostics COVID-19 tests
Editor's Note The Food and Drug Administration (FDA) on January 28 identified the recall by Empowered Diagnostics (Pompano Beach, Florida) of its CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test as Class I, the most serious. Empowered Diagnostics distributed these tests with labeling indicating they were…
Prevalence, durability of COVID-19 antibodies in unvaccinated
Editor's Note This study led by Marty Makary, MD, MPH, and Dorry Segev, MD, PhD, at Johns Hopkins University School of Medicine, Baltimore, finds natural immunity in unvaccinated healthy US adults up to 20 months after testing positive for COVID-19. Of 1,580 study participants, antibodies were detected in: 99% of…
Medtronic recalls TurboHawk Plus Directional Athrectomy System
Editor's Note On February 7, Medtronic announced that it had issued a voluntary recall of its 6Fr TurboHawk Plus Directional Atherectomy System because of the risk of tip damage caused by guidewire prolapse. To date, there have been no reports of tip damage and no reports of injuries or deaths…
Study: Racial and ethnic disparities in vaccine uptake, hesitancy
Editor's Note This study by researchers at the Massachusetts General Hospital and Harvard Medical School, Boston, finds that racial and ethnic minorities have been more hesitant or unwilling to be vaccinated for COVID-19, compared to Whites. Of study participants in the US (87,388) and UK (1,254,294): Vaccine hesitancy was greater…
FDA: Update on Class I recall of certain Philips Respironics ventilators, repair kits
Editor's Note The Food and Drug Administration (FDA) on January 26 updated the Class I recall of certain Trilogy Evo ventilators and repair kits for Trilogy Evo muffler assembly, which are manufactured by Philips Respironics. According to the update, the FDA has asked the company to have an independent laboratory…
FDA: Class I recall of Medtronic’s HawkOne Directional Atherectomy System
Editor's Note The Food and Drug Administration (FDA) on January 21 identified the recall by Medtronic Inc of its HawkOne Directional Atherectomy System as Class I, the most serious. The recall was initiated because of the risk of the guidewire within the catheter moving down ward or prolapsing when force…
FDA: Class I recall of Getinge Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems
Editor's Note The Food and Drug Administration (FDA) on January 19 identified the recall by Getinge of its Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems as Class I, the most serious. The recall was initiated because of the potential chemical breakdown of Sevoflurane that may result in inhalation…
FDA: Class I recall of Medtronic Synergy Cranial, StealthStation S7 cranial software
Editor's Note The Food and Drug Administration (FDA) on January 6 identified the recall by Medtronic of its Stealth Station System with Synergy Cranial and StealthStation S7 Cranial Software as Class I, the most serious. The System aids in precisely locating anatomical structures in neurosurgical procedures. The recall was initiated…
FDA: Class I recall of Cardiovascular Systems’ WIRION Embolic Protection Device
Editor's Note The Food and Drug Administration (FDA), on January 10, identified the recall of Cardiovascular Systems’ WIRION Embolic Protection Device as Class I, the most serious. The device, which is used to hold or remove debris or blood clots from the lower limbs, was recalled because of complaints of…
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