FDA issues final rule on adverse event reporting for manufacturers
Editor's Note The Food and Drug Administration (FDA) on November 8 published its final rule on the requirements for reporting adverse events by medical device companies, the November 14 Medical Design & Outsourcing reports. The final rule walks back much of the burden for contract manufacturers that was in the…
New RBC treatment may reduce transfusion side effects
Editor's Note Pretreating red blood cells (RBCs) with nitric oxide may reduce the risk of pulmonary hypertension, a dangerous side effect of transfusions, finds this study. The Food and Drug Administration allows transfusion of RBCs that have been stored for 42 days. However, recent studies suggest that transfusion of RBCs…
FDA: Class I recall of HeartWare Ventricular Assist Device Pumps
Editor's Note The Food and Drug Administration on October 24 categorized HeartWare Inc’s recall of its HeartWare Ventricular Assist Device Pumps as Class I, the most serious. The recall is because of a design problem with the driveline connector that connects the pump to the external controller and power source.…
FDA: Class I recall of Willy Rusch Tracheostomy Tube Set
Editor's Note The Food and Drug Administration (FDA) on October 20 categorized the recall by TeleFlex Medical of its Willy Rusch Tracheostomy Tube Set as Class I, the most serious. The recall was issued because of the possibility that the connector may disconnect from the tracheostomy tube during use on…
FDA: Medtronic recalls certain neurovascular products
Editor's Note The Food and Drug Administration (FDA) on October 18 announced the recall by Medtronic of certain lots of its Pipeline embolization device, Alligator retrieval device, and X-Celerator hydrophilic guidewire. The recall also includes the stylet containing UltraFlow flow directed micro catheters and Marathon flow directed micro catheters. The…
FDA: Class I recall of Skintact DF29N Multi-function Defibrillation Electrodes
Editor's Note The Food and Drug Administration (FDA) on October 14 categorized the recall by Leonhard Lang of its Skintact DF29N Multi-function Defibrillation Electrodes as Class I, the most serious. The electrode is being recalled because of a connector compatibility issue with the Welch Allyn automatic external defibrillator (AED), model…
FDA, CDC issue alerts on Stӧckert 3T Heater-Cooler System
Editor's Note The Food and Drug Administration (FDA) on October 13 updated its Safety Alert on the Stӧckert 3T Heater-Cooler System by LivaNova to provide new information from the Centers for Disease Control and Prevention (CDC) about Mycobacterium chimaera infections associated with the use of the system in US patients…
Action steps for safe use of reprocessed single-use medical devices
In the United States and globally, the use of reprocessed medical devices labeled and marketed by their original equipment manufacturers as “for single use only” has become commonplace. Large health systems have saved many millions of dollars annually and diverted many hundreds of tons of medical waste by using reprocessed…
FDA issues Safety Alert for St Jude defibrillators
Editor's Note The Food and Drug Administration on October 11 issued a Safety Alert for implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) by St Jude Medical (Little Canada, Minnesota). In some cases, full battery drainage can occur in a day to a few weeks after the patient…
FDA: Nurse Assist recalls IV Flush Syringes
Editor's Note The Food and Drug Administration (FDA) on October 5 announced the recall by Nurse Assist of its IV Flush Syringes because of a potential link to Burkholderia cepacia bloodstream infections. The syringes are being recalled until a thorough investigation can be completed by the FDA, Centers for Disease…
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