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…
Baxter recalls two lots of 0.9% sodium chloride injection
Editor's Note Baxter International Inc has announced a recall of two lots of 0.9% sodium chloride injection, USP, 50 mL and 100 mL, because of the presence of particulate matter. The lot numbers are P319921 and P327635. The particulate matter was determined to be an insect and was identified as…
FDA: Class I recall of Medtronic’s Covidien Shiley pediatric trach tubes
Editor's Note The Food and Drug Administration on June 15 issued a Class I recall, the most serious, of certain Covidien Shiley neonatal and pediatric tracheostomy tubes by Medtronic. The recalled tubes were formed with a wider-angle bend than standard models. The company has received reports that patients switching tubes…
FDA issues draft guidance on requirements for surgical gowns
Editor's Note The Food and Drug Administration has issued a draft guidance to describe its premarket regulatory requirements and performance testing needed to support liquid barrier claims for gowns used in health care settings. In the past, a number of terms have been used to refer to gowns intended for…
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