Editor's Note Estimates from the Centers for Disease Control and Prevention find the emerging COVID-19 Omicron subvariant XBB.1.16, dubbed Arcturus, is responsible for more than 14% of COVID-19 cases in the US over the past 2 weeks, up from nearly 7% in the prior 2 weeks, according to the May…

Read More

Editor's Note In response to questions, on April 21, the Food and Drug Administration (FDA) provided an update to its Safety Communication that enables the use of existing inventory of the O&M Halyard FLUIDSHIELD Surgical N95 Respirator Masks, Orange (Regular), Level 3, (Model 46727). The FDA recommends that, if necessary,…

Read More

Editor's Note The Food and Drug Administration (FDA), on April 19, identified the recall by Fresenius Kabi USA of its Ivenix Infusion System as Class I, the most serious. The recall was initiated because of a leak in the system that allows fluid to enter the administration set loading area…

Read More

Editor's Note The Food and Drug Administration (FDA), on April 13, updated prescribing information for all opioid pain medications, including requiring all packaging to have updated labeling and safety information. This includes stating that: for both immediate-release (IR) and extended release/long acting (ER/LA) opioid pain medications, the risk of overdose…

Read More

Editor's Note The Food and Drug Administration (FDA), on April 6, identified the recall by Abbott of its FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems as Class I, the most serious. The recall was initiated because the systems’ reader devices, which use rechargeable…

Read More

Editor's Note The Food and Drug Administration, on April 7, identified the recall by Philips Respironics of certain reworked DreamStation continuous positive airway pressure (CPAP) and bileveled positive airway pressure (BiPAP) machines as Class I, the most serious. These machines also were recalled in June 2021. The recall was initiated…

Read More

Editor's Note The Centers for Disease Control and Prevention (CDC), on March 29, updated its COVID-19 vaccination guidelines to say that one dose of the bivalent booster is all that is recommended at this time, even for those who were last vaccinated more than 6 months ago. The CDC notes…

Read More

Editor's Note This German study finds that expectations and prior experiences were associated with increased adverse effect reports in individuals receiving their second COVID-19 vaccinations. Researchers collected data from 1,678 individuals receiving Pfizer BioNTech and Moderna mRNA vaccines. Severe adverse effect reports were higher in those: expecting a lower benefit…

Read More

Editor's Note The FDA on March 15 issued its third warning letter to endoscope manufacturer Olympus Medical, following a manufacturing site inspection and 160 complaints of device failure, as reported by Beckers. The warning letter comes after a Tokyo, Japan facility inspection, where the Single-Use Distal Covers for Duodenoscopes and…

Read More

Editor's Note The Food and Drug Administration (FDA) on March 16 updated its list of COVID-19 medical device shortages to reflect changes in estimated shortage durations during the public health emergency. These include: Radiological devices General plastic surgery devices Cardiac diagnostic and monitoring products General ICU/hospital products Specimen collection, testing…

Read More