CDC: One bivalent COVID-19 booster is sufficient for now
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…
Impact of expectations, prior experiences on adverse effect reports after COVID-19 vaccinations
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…
Endoscope manufacturer Olympus Medical receives third warning from FDA
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…
FDA updates list of COVID-19 device shortages, discontinued devices
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…
FDA: Class I recall of certain Datascope/Getinge IABPs
Editor's Note The Food and Drug Administration (FDA) on March 17 identified the recall by Datascope/Getinge of certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) as Class I, the most serious. The recall was initiated because the coiled cable connecting the display and base on some units may fail,…
Update to Class I recall of GE HealthCare’s Nuclear Medicine 600/800 Series systems
Editor's Note The Food and Drug Administration (FDA) on February 22 updated the Class I recall of GE HealthCare’s Nuclear Medicine 600/800 Series systems. The recall was initiated by GE HealthCare after identifying an issue with two mechanisms that prevent uncontrolled detector movement—a risk that the ball screw, which serves…
FDA: Class I recall of certain Philips Respironics ventilators
Editor's Note The Food and Drug Administration (FDA) on February 16 identified the recall by Philips Respironics of certain reworked Trilogy 100, Trilogy 200, and Garbin Plus ventilators as Class I, the most serious. The recall was initiated because of the potential for silicone foam adhesive failure and residual polyester-based…
FDA: Class I recall of GE HealthCare’s Nuclear Medicine 600/800 Series systems
Editor's Note The Food and Drug Administration (FDA) on February 15 identified the recall by GE HealthCare of its Nuclear Medicine 600/800 Series systems as Class I, the most serious. The recall was initiated because of an issue with two mechanisms that prevent uncontrolled detector movement. If the mechanisms fail,…
FDA: Class I recall of Skippack Medical Lab COVID-19 tests
Editor's Note The Food and Drug Administration (FDA) on February 8 identified the recall by Universal Meditech Inc of its Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) as Class I, the most serious. The recall was initiated because the tests were distributed to US customers without authorization, clearance,…
FDA: Class I recall of Smiths Medical CADD Infusion System Administration Sets, Cassette Reservoirs
Editor's Note The Food and Drug Administration (FDA) on February 2 identified the recall by Smiths Medical of certain CADDTM Infusion System Administration Sets and Cassette Reservoirs as Class I, the most serious. The recall was initiated because of tubing occlusion and false “no disposable attached” alarm issues, which may…
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