FDA: Class I recall of LivaNova VNS Therapy SenTiva Generator
Editor's Note The Food & Drug Administration (FDA) on January 2 identified the recall by LivaNova of its VNS Therapy SenTiva Generator System as Class I, the most serious. The recall was initiated because of an unintended reset error that causes the system to stop delivering vagus nerve stimulation therapy…
FDA workshop: Role of AI in radiological imaging
Editor's Note The Food & Drug Administration (FDA) on December 30 announced a public workshop on the “Evolving Role of Artificial Intelligence [AI] in Radiological Imaging, which will take place February 25-26, 2020, at the Natcher Conference Center, National Institutes of Health, Bethesda, Maryland. The workshop will include discussions on…
FDA: Class I recall of Cook Medical’s CrossCath Support Catheters
Editor's Note The Food and Drug Administration (FDA) on December 17 identified the recall by Cook Medical of its CrossCath Support Catheters as Class I, the most serious. The recall was initiated because of a manufacturing error that may cause the radiopaque marker bands on the catheters to dislodge or…
Boston Scientific receives FDA clearance for single-use duodenoscope
Editor's Note Boston Scientific announced December 13 that it had received Food & Drug Administration (FDA) 510(k) clearance for the EXALT Model D Single-Use Duodenoscope for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures. The EXALT Model D, which was granted Breakthrough Device Designation from the FDA, eliminates the need for…
FDA: Medtronic recalls SynchroMed II implantable drug infusion pump
Editor's Note The Food and Drug Administration (FDA) on December 16 announced that Medtronic has recalled its SynchroMed II implantable infusion pump. The pump is being recalled because of the potential presence of foreign particles inside the pump motor assembly that may lead to a pump motor stall. Medtronic has…
FDA: B. Braun recalls blood administration sets
Editor's Note The Food & Drug Administration (FDA) on November 26 announced a voluntary recall by B. Braun Medical (Bethlehem, Pennsylvania) of 22 lots of blood administration sets. The recall was initiated because of the potential for leakage at the joint between the blood filters and tubing. This could force…
FDA approves first system for insertion of ear tubes with local anesthesia
Editor's Note The Food & Drug Administration (FDA) on November 25 approved a new system for the delivery of tympanostomy tubes into the eardrums of young children without using general anesthesia. The Tubes Under Local Anesthesia (Tula) System (Tusker Medical, Menlo Park, California) is the first ear tube delivery system…
FDA updates device failure linked to Getinge’s Maquet/Datascope Intra-aortic Balloon Pumps
Editor's Note The Food and Drug Administration (FDA) on November 19 updated the device failure associated with Getinge’s Maquet/Datascope Intra-aortic Balloon Pumps (IABPs) in a letter to health care providers. Since 2017, the FDA has received more than 75 reports of the IABPs shutting down while running on battery. Five…
FDA clears first duodenoscope with disposable elevator component
Editor's Note The Food & Drug Administration (FDA) on November 15 announced that it had cleared for marketing in the US the first duodenoscope with a sterile, disposable elevator component. The clearance of the Pentax Medical Video ED34-i10T2 duodenoscope represents a major step toward lowering the risk of infection in…
Sterilization trumps high-level disinfection for semicritical items
In the never-ending quest to improve patient care, we are always seeking better ways to process medical devices. Many leading experts now recommend transitioning from high-level disinfection (HLD) to sterilization for semicritical items. Semicritical items are instruments or objects that contact mucous membranes or nonintact skin of a patient, but…
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