Joint Commission, CDC announce new infection prevention guides for outpatient settings
Editor's Note The Joint Commission and Centers for Disease Control & Prevention (CDC) have been collaborating since late 2015 on a 3-year project titled, “Adaptation & Dissemination of Outpatient Infection Prevention (ADOPT).” The goal of the project is to adapt, enhance, and disseminated current CDC guidance on infection prevention and…
FDA Commissioner updates drug shortage efforts in Puerto Rico
Editor's Note Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, on January 4 issued a statement, updating the continued efforts to mitigate the IV saline and amino acids for injection shortages caused by Hurricane Maria. The FDA expects the IV saline shortage to improve in early 2018. Just before…
FDA: PharMEDium recalls 55 lots of compounded sterile drugs
Editor's Note The Food and Drug Administration on January 2 announced the recall by PharMEDium Services (Lake Forest, Illinois) of 55 lots (impacting 25,327 units) of compounded sterile drug products because of a lack of sterility assurance. The recalled products were manufactured in PharMEDium’s Memphis location and distributed nationwide to…
FDA: AuroMedics recalls Ampicillin and Sulbactam for Injection
Editor's Note The Food and Drug Administration (FDA) on January 4 announced the recall by AuroMedics Pharma LLC (Windsor, New Jersey) of one lot of Ampicillin and Sulbactam for Injection USP 1.5 g in a single-dose vial. The recall was issued because the lot (Lot AFOI 17001-A, Expiry date December…
FDA: Class I recall of Agilis Steerable Reprocessed Introducer Sheath
Editor's Note The Food and Drug Administration (FDA) on January 2 classified the recall by Sterilmed (Plymouth, Minnesota) of its Agilis Steerable Reprocessed Introducer Sheath as Class I, the most serious. The sheath's hemostatic valve, which prevents blood from flowing back through the valve, may fail because of an improper…
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…
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