Agencies issue voluntary protocols for duodenoscope surveillance sampling, culturing
Editor's Note The Food & Drug Administration, Centers for Disease Control & Prevention (CDC), American Society for Microbiology, along with other experts on February 26 released voluntary standardized protocols for duodenoscope surveillance sampling and culturing, which update a 2015 CDC interim protocol. For facilities that choose to implement duodenoscope surveillance…
FDA: Class I recall of certain Medtronic ICDs, CRT-Ds
Editor's Note The Food & Drug Administration (FDA) on February 27 classified the recall by Medtronic of certain Implantable Cardiovert Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) as Class I, the most serious. The recall was initiated because of a defect in the manufacturing process. The defect causes an…
FDA: Hospira recalls four lots of Labetalol Hydrochloride
Editor's Note The Food and Drug Administration (FDA) on February 23 announced the recall by Hospira Inc (Lake Forest, Illinois) of three lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL vial (NDC 0409-2267-25), and one lot of Labetalol Hydrochloride Injection, USP, Novaplus (NDC 0409-2267-25). The recall was initiated because…
FDA permits marketing of new blood test for concussions
Editor's Note The Food & Drug Administration (FDA) on February 14 authorized marketing of the first blood test to help evaluate concussions in adults and reduce the need for CT scans. The Banyan Brain Trauma Indicator works by measuring levels of proteins (ie, UCH-L1 and GFAP) that are released from…
FDA permits marketing of software to alert providers of potential strokes in patients
Editor's Note The Food & Drug Administration (FDA) on February 13 announced that it is permitting the marketing of clinical decision support software that alerts providers to potential strokes in their patients. The Viz.AI Contact application is designed to analyze computed tomography images of the brain and send a text…
FDA: Class I recall of HeartStart MRx Defibrillator
Editor's Note The Food & Drug Administration (FDA) on February 9 classified the recall by Philips Electronics (Andover, Massachusetts) of its HeartStart MRx Defibrillator as Class I, the most serious. The recall was initiated because of micro cracks in the gas discharge tube that allow internal gasses to escape and…
FDA: New imaging technology promises stable supply of imaging isotope
Editor's Note The Food & Drug Administration (FDA) Commissioner, Scott Gottlieb, MD, on February 8 announced the role the FDA played in the groundbreaking effort to develop a new imaging technology−the RadioGenix System. The technology, which resulted from a collaboration across the federal government and industry, has the potential to…
FDA clears updated design, labeling for Pentax duodenoscope
Editor's Note The Food and Drug Administration (FDA) on February 7 announced that it had cleared the updated design and labeling for Pentax Medical's duodenoscope Model ED-3490TK. Pentax replaced the forceps elevator mechanism, O-ring seal, and distal end cap, and updated the Operation Manual to recommend annual maintenance. The design…
FDA: Class I recall of AirLife Humidification Chamber, Heated Breathing Circuit Kits
Editor's Note The Food and Drug Administration (FDA) on January 31 classified the recall by Vyaire Medical (Mettawa, Illinois) of its AirLife Humidification Chamber and Heated Breathing Circuit Kits as Class I, the most serious. The recall was initiated because of a manufacturing error that may cause parts of the…
FDA: AuroMedics recalls one lot of Levofloxacin
Editor's Note The Food & Drug Administration (FDA) on January 18 announced the recall by AuroMedics (East Windsor, New Jersey) of one lot of Levofloxacin in 5% Dextrose Injection 250 mg/50 mL in a single-use flexible container (NDC 55150-243-46, Lot CLF160003, Expiry date May 2018). The product has been found…
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