The CDC and the Making Dialysis Safer for Patients Coalition are offering a free webinar, “Bloodstream Infections, Wall Boxes, and Lessons Learned” on Tuesday, December 10, at 1-2 pm ET. Continuing Education Units are available. Register for the Webinar.
Hot tub displays at temporary events may pose a risk for Legionnaires’ disease, a type of pneumonia caused by inhaling mist containing Legionella bacteria. The CDC is alerting environmental and public health practitioners about the public health need to maintain, clean and disinfect hot tubs properly to reduce potential exposure to Legionella. Read the CDC health advisory.
The FDA approved Fetroja (cefiderocol), an antibacterial drug for treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI), including kidney infections caused by susceptible Gram-negative microorganisms, who have limited or no alternative treatment options. Read the FDA news release.
The FDA cleared for marketing in the U.S. the first duodenoscope with a sterile, disposable elevator component that will reduce the number of parts that need to be cleaned and disinfected between uses. The Pentax Medical Video ED34-i10T2 model duodenoscope is intended to provide visualization and access to the upper gastrointestinal tract to treat bile … Continue reading “FDA Approves Duodenoscope with Disposable Parts”
The FDA announced revocation of the Emergency Use Authorization for the xMAP MultiFLEX Zika RNA Assay at the request of the manufacturer, Luminex Corporation, following Luminex’s decision to discontinue the product. Read the FDA notice and Luminex request letter.
KRS Global Biotechnology, Inc. is voluntarily recalling all lots of unexpired human and animal drugs intended to be sterile. The products are being recalled due to lack of assurance of sterility. Read FDA Alert for more information and list of recalled products.
The HHS Office of the Assistant Secretary for Preparedness and Response, in cooperation with the CDC, Environmental Protection Agency, and the Departments of Transportation, Labor, and Defense issued updated guidance on managing solid waste contaminated with a Category A infectious substance. A Category A substance is capable of causing permanent disability or life-threatening or fatal … Continue reading “Updated Guidance on Solid Waste Management”
The FDA issued a warning letter to Innovative Sterilizations Technologies, LLC (IST), for marketing the One Tray® Sealed Sterilization Container for different intended uses outside of its original clearance. FDA claims that One Tray was approved to hold reusable medical devices while they are flash sterilized for immediate use, but the product is being marketed … Continue reading “FDA Warns IST Over Unapproved Use of One Tray®”
Darmerica is voluntarily recalling two lots of Quinacrine Dihydrochloride, bulk API powder packaged in Amber HDPE Bottles because testing revealed that due to a labeling error, the contents of these bottles was a different product. The recalled Quinacrine Dihydrochloride was distributed Nationwide to 14 Compounding Pharmacies. Read the FDA safety alert.
The U.S. Food and Drug Administration today approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia. Xenleta received FDA’s Qualified Infectious Disease Product (QIDP) designation. The QIDP designation is given to antibacterial and antifungal drug products intended to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA … Continue reading “FDA approves new antibiotic to treat community-acquired bacterial pneumonia”