FDA: Class I recall of Medtronic TurboHawk Plus Directional Atherectomy System
Editor's Note The Food and Drug Administration, on March 9, identified the recall by Medtronic of its TurboHawk Plus Directional Aherectomy System as Class I, the most serious. The recall was initiated because of the risk of the guidewire in the catheter moving downward or prolapsing when force is applied…
FDA: B. Braun Medical recalls 0.9% Sodium Chloride for Injection USP 250 ml in Excel
Editor's Note The Food and Drug Administration (FDA) on March 3 posted the recall by B. Braun Medical Inc of its nationwide recall of five lots of 0.9% Sodium Chloride for Injection USP 250 ml in Excel. The recall was initiated because of fluid leakage or low fill volume of…
Study: Spatial and racial disparities in COVID-19 mortality rates
Editor's Note This study from the University of Chicago finds an association between social determinants of health measures and COVID-19 mortality rates that varied across racial and ethnic groups and community types. Among 3,142 counties in the study, 531 were identified as concentrated longitudinal-impact counties. Of these, 347 (11%) had…
ANSI/AAMI publishes long-waited ST91 updates
Editor's Note After 7 years, ANSI/AAMI has updated its standard for cleaning and storing medical devices, such as flexible bronchoscopes and various endoscopes. The updated standard, “ANSI/AAMI ST91:2021, Flexible and semi-rigid endoscope processing in health care facilities,” addresses new technologies and concerns about device cleanliness and patient safety. “ANSI/AAMI ST91:2021…
FDA: Class I recall of Arrow International’s Arrow-Trerotola PTD
Editor's Note The Food and Drug Administration (FDA) on February 23 identified the recall by Arrow International (Reading, Pennsylvania), a subsidiary of Teleflex Inc, of its Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) as Class I, the most serious. The recall was initiated because of the risk of tip damage during use…
FDA: Class I recall of Vyaire Medical’s Bellavista Ventilators
Editor's Note The Food and Drug Administration (FDA) on February 17 identified the recall by Vyaire Medical (Mettawa, Illinois) of its Bellavista 1000 and 1000e Series Ventilators as Class I, the most serious. The recall was initiated because of issues with the software version 6.0.1600.0 or higher, after reports of…
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,…
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