FDA: Class I recall of BASE10 Genetics RNAstill MTM specimen collection kits
Editor's Note The Food and Drug Administration (FDA) on February 18 identified the recall by BASE10 Genetics of its RNAstill MTM specimen collection kits as Class I, the most serious. The specimen collection kits are intended for collection, transport, inactivation, stabilization, and long-term storage of nasopharyngeal or oropharyngeal swab samples…
FDA: Class I recall of E25Bio COVID-19 Direct Antigen Rapid Tests
Editor's Note The Food and Drug Administration (FDA) on February 18 identified the recall by E25Bio (Cambridge, Massachusetts) of its COVID-19 Direct Antigen Rapid Tests as Class I, the most serious. The tests are being recalled for several reasons, particularly because they were marketed and distributed in the US without…
HHS says more funding is needed to combat COVID-19
Editor's Note According to the February 16 Becker’s Hospital Review, Health and Human Services (HHS) Secretary Xiaver Becerra said the Biden administration is estimating it will need some $30 billion to continue to fight against COVID-19. Another HHS representative told Politico the funding is needed "for additional resources to support…
Effectiveness of reprocessing ureteroscopes, other endoscopic devices
Each year, there are more studies raising concerns about infections associated with endoscopic procedures and the techniques used to clean and sterilize or high-level disinfect (HLD) endoscopic devices. In this article, in partnership with Boston Scientific, epidemiologist Cori L. Ofstead, MSPH, president and CEO of Ofstead & Associates, St Paul,…
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…
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