FDA issues guidance on 3D printing of medical devices
Editor's Note Food and Drug Administration (FDA) commissioner Scott Gottlieb, MD, issued a statement December 4 on the FDA’s final guidance on medical device additive manufacturing, also known as 3D printing. The FDA has reviewed more than 100 devices currently on the market that were manufactured on 3D printers, including…
FDA issues Safety Alert on human albumin 25% solution (AlbuRx 25) by CSL Behring
Editor's Note The Food and Drug Administration (FDA) on December 1 issued a Safety Alert for human albumin 25% solution (AlbuRx 25) by CSL Behring LLC (Kankakee, Illinois). During routine inspection, the company noted the potential for fading print on 50 mL and 100 mL vials, with more effect on…
FDA: Recall of Pharmacist Choice Alcohol Prep Pads
Editor's Note The Food and Drug Administration (FDA) on December 5 announced the recall of 3 lots of Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics (Coral Springs, Florida), which were manufactured by Foshan Flying Medical Products Co Ltd, located in China. The alcohol pads were recalled because of…
FDA approves first implanted lens that can be adjusted after cataract surgery
Editor's Note The Food and Drug Administration (FDA) on November 22 announced the approval of RxSight Inc’s (Pasadena, California) Light Adjustable Lens and Light Delivery Device. This is the first system that allows ophthalmologists to make small adjustments to the implanted lens’ power after cataract surgery to improve visual…
CMS: Two inpatients needed for hospital survey, resurvey
Editor's Note The Centers for Medicare & Medicaid Services (CMS) has issued a new requirement, effective immediately, that a hospital must have at least two active inpatients at the time of survey, or the survey/resurvey will not be allowed to continue, the Joint Commission reported November 15. The new requirement…
FDA: Baxter recalls one lot of injectable amiodarone
Editor's Note The Food and Drug Administration (FDA) on November 15 announced the recall by Baxter International (Deerfield, Illinois) of one lot of Nexterone (amiodarone HCL) 150 mg/100 mL premixed injection because of the presence of particulate matter. The particulate matter was identified as polyethylene, the primary constituent of the…
FDA clears new, faster CBC test
Editor's Note The Food and Drug Administration (FDA) on November 6 cleared a new complete blood cell count (CBC) test that can be run in more healthcare settings and offers faster results for patients and providers. The FDA granted premarket clearance and a Clinical Laboratory Improvement Amendments of 1988 (CLIA)…
FDA: Safety Alert for Cardinal Health’s Infant/Child Reduced Energy Defibrillation Electrodes
Editor's Note The Food and Drug Administration (FDA) on November 6 issued a Safety Alert saying that Physio-Control (Redmond, Washington) launched a voluntary field action for specific lots of Infant/Child Reduced Energy Defibrillation Electrodes manufactured by Cardinal Health (Dublin, Ohio). There is an issue with the artwork on the electrodes…
FDA: Recall of prefilled syringes labeled Midazolam that are actually Ondansetron
Editor's Note The FDA announced on November 3 that Fresenius Kabi USA (Lake Zurick, Illinois) is recalling one lot of Midazolam Injection, USP, 2 mg/2 mL packaged in 2 mL prefilled single-use glass syringes because the packages labeled as Midazolam actually contain syringes that are filled with and labeled as…
FDA: Increased rate of major adverse events with Absorb GT1 Bioresorbable Vascular Scaffold
Editor's Note The Food and Drug Administration (FDA) on October 31 issued a Safety Alert saying that interim study results continue to show an increased rate of major adverse cardiac events and Bioresorbable Vascular Scaffold (BVS) thrombosis in patients receiving the Absorb GT1 BVS by Abbott Vascular (Abbott Park, Illinois),…
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