FDA: All compounded products by US Compounding recalled
Editor's Note All lots of sterile products aseptically compounded and packaged by US Compounding have been recalled because of concern by the Food and Drug Administration over a lack of sterility assurance. The sterile products were distributed nationwide between March 14 and September 9, 2015. Posted 09/24/2015] AUDIENCE: Health…
FDA posts safety alert on reprocessed flexible bronchoscopes
Editor's Note The Food and Drug Administration (FDA) has identified bronchoscopes as a subset of devices that pose a greater likelihood of microbial transmission and represent a high risk of infection if not adequately reprocessed. The FDA is proactively investigating these devices to determine if additional reprocessing steps should be taken.…
CDC, FDA issue health advisory on reprocessing procedures
Editor's Note On September 11, the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) issued a health advisory recommending that healthcare facilities arrange for a professional to assess their reprocessing procedures for maintaining, cleaning, disinfecting, and sterilizing reusable medical devices. The agencies recommend that facilities…
FDA expands alert on drugs stored in BD syringes
Editor's Note The Food and Drug Administration is expanding its alert for compounded or repackaged drugs stored in Becton-Dickinson (BD) syringes to include certain lots of 1 mL, 10 mL, 20 mL, and 30 mL general use syringes and BD oral syringes. The FDA’s original alert included only 3 mL…
Incidence of removal or revision of mesh used to treat SUI
Editor's Note Ten years after undergoing mesh-based procedures for stress urinary incontinence (SUI), 1 of every 30 women may require a second procedure for mesh removal or revision, this study finds. Patients of lower-volume surgeons had a 37% increased risk for complications. The findings support the Food and Drug Administration’s…
FDA: Class I recall of Alaris Syringe Pump by CareFusion
Editor's Note The Food and Drug Administration on August 27 categorized a recall of the Alaris Syringe Pump (model number 8110) by CareFusion as Class I, the most serious. An error in the pump triggers a visual and audible alarm that causes the pump to stop supplying the infusion to…
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…
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