FDA safety alert: Heater-cooler devices linked to infections
Editor's Note The Food and Drug Administration on October 15 issued a safety alert that heater-cooler devices have been associated with Nontuberculous Mycobacteria infections, primarily in patients undergoing cardiothoracic surgical procedures. Devices include: oxygenator heat exchangers cardioplegia heat exchangers warming/cooling blankets. Between January 2010 and August 2015, the FDA received…
FDA orders duodenoscope manufacturers to conduct postmarket surveillance studies
Editor's Note The Food and Drug Administration on October 5 ordered three manufacturers of duodenoscopes marketed in the US to study the reprocessing of their devices in the clinical setting where they are used. The three manufacturers—Olympus America, Inc; Fujifilm Medical Systems, USA, Inc; and Hoya Corp (Pentax Life Care…
FDA: Class I recall of PROFEMUR modular neck prostheses
Editor's Note The Food and Drug Administration on October 2 categorized the recall of PROFEMUR Neck Varus/Valgus CoCr 8 degree, Part number PHAC 1254, by MicroPort Orthopedics as Class I, the most serious. The company has received reports of unexpected fractures after surgery related to this modular neck. If the…
FDA: Cranial perforator automatic clutch mechanism may fail to disengage
Editor's Note The Food and Drug Administration (FDA), on September 28, issued a safety alert for cranial perforators with an automatic clutch mechanism. Most cranial perforators are designed to automatically stop drilling after penetrating the skull to prevent the tip from unintentionally drilling into the brain. However this clutch mechanism…
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…
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