FDA warns against drugs in Becton-Dickinson 3 mL and 5 mL syringes
Editor's Note The Food and Drug Administration on August 18 posted a warning to alert health care professionals not to administer compounded or repackaged drugs stored in 3 mL and 5 mL syringes manufactured by Becton-Dickinson unless there is no suitable alternative. Preliminary information indicates that drugs stored in these…
Security issues prompt FDA to extend UDI deadlines
Editor's Note Security issues have prompted the Food and Drug Administration to extend the deadline from September 24 to October 24, 2015, for filing required data and labeling information for the Unique Device Identification system (UDI). The extension applies to implantable life-supporting and life-sustaining devices as well as Class III…
FDA warns three duodenoscope manufacturers about spread of superbugs
Editor's Note The Food and Drug Administration (FDA) sent warning letters August 12 to three manufacturers of duodenoscopes involved in transmitting deadly bacteria earlier this year, the Boston Globe reports. The FDA says the companies (Olympus, Pentax, and Fujifilm) failed to: report problems with the scopes as required by law…
High risk devices backed by few studies before and after FDA premarket approval
Editor's Note Many high risk therapeutic devices receive Food and Drug Administration (FDA) premarket approval with few studies to back their safety and efficacy, Yale researchers find. Studies of how the devices perform once on the market also are few. Of 28 high risk devices that received premarket approval between…
Class I recall of Beacon Tip angiographic catheters by Cook Medical
Editor's Note The Food and Drug Administration on August 7 labeled the recall of Beacon Tip angiographic catheters by Cook Medical as Class I, the most serious. The catheter tip may split or separate from the catheter and enter the patient’s bloodstream. Cook Medical has received 26 reports of the…
FDA labels recall of Medtronic’s heart valve loading system Class I
Editor's Note The Food and Drug Administration on August 5 categorized the recall of 6,912 units of Medtronic Cardiovascular Surgery’s EnVeo R loading system as Class I, the most serious. The loading system is used with the CoreValve Evolut R replacement heart valve. The recall was issued over concerns about…
FDA: Serious adverse events associated with LVADs
Editor's Note The Food and Drug Administration on August 5 issued a Safety Communication on serious adverse events linked to left ventricular assist devices (LVADs). Two implantable LVADs are approved by the FDA (HeartMate II by Thoratec Corporation and HeartWare HVAD by HeartWare Inc), and serious events have been associated…
FDA releases supplemental measures for duodenoscope reprocessing
Editor's Note The Food and Drug Administration on August 4 released a Safety Communication that contains supplemental measures to enhance duodenoscope reprocessing. The measures emerged from an expert panel meeting earlier this year. In addition to following manufacturer reprocessing instructions, the FDA says facilities can use one or more of…
FDA approves nonsurgical balloon device for bariatric patients
Editor's Note The Food and Drug Administration on July 28 approved a new balloon device to treat obesity without the need for a surgical procedure. The ReShape Integrated Dual Balloon System (ReShape Medical Inc, San Clemente, California) is inserted into the stomach endoscopically and then filled with saline. Patients are…
Senate bill would let Medicare patients self-pay for medical devices
Editor's Note Four US Senators (two democrats, two republicans) are sponsoring legislation—The Accelerating Innovation in Medicine (AIM) Act—that would increase Medicare patients’ access to new medical devices. Currently, Medicare patients who are interested in self-paying for a device not covered by Medicare face significant administrative obstacles. Under AIM, once a…
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