GAO issues report on FDA postmarket studies on medical devices
Editor's Note More than half (56%) of 313 medical device postapproval studies ordered by the Food and Drug Administration (FDA) from January 1, 2007, through February 23, 2015, were for cardiovascular devices, and most are making adequate progress, according to a Government Accountability Office (GAO) report. Postapproval studies are ordered…
FDA: Quest Medical recalls certain lots of Myocardial Protection System delivery sets
Editor's Note Quest Medical, Inc (Allen, Texas), on October 28 initiated a nationwide recall of its Myocardial Protection System delivery sets, Models 5001102, 5001102-AS, and 7001102 of specified lots. The sets have shown possible seal failure along the blood source channel of the main pump cassette, resulting in blood loss…
FDA: Downing Labs recalls all sterile products
Editor's Note Downing Labs, LLC (Farmers Branch, Texas) is recalling all lots of compounded and packaged sterile products because of concerns of sterility assurance. The products were distributed between April 20 and September 15, 2015. Posted 10/21/2015] AUDIENCE: Consumer, Pharmacy ISSUE: Downing Labs, LLC is voluntarily recalling all lots…
FDA launches new features for UDI database
Editor's Note The Food and Drug Administration (FDA) in partnership with the National Library of Medicine on October 19 announced the launch of three new features on AccessGUDID, the public portal to data submitted to the FDA’s Global Unique Device Identification Database (GUDID). Two new APIs (application program interface) and…
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.…
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