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”
CDC released its Antibiotic Use in the United States: Progress and Opportunities, 2018 Update, which is an update to CDC’s 2017 antibiotic stewardship report. Improving antibiotic use is important to effectively treat infections, protect patients from harms caused by unnecessary antibiotic use, and combat antibiotic resistance, one of the most urgent threats to the public’s … Continue reading “Antibiotic Use in the United States: Progress and Opportunities, 2018 Update”
Read about important NHSN updates in the June NHSN eNewslettter. Updates include changes to CMS Quality Reporting Programs, updates to the NHSN Operative Procedure Code documents, new educational material for the Antimicrobial Use and Resistance Module, and registration information for the Long-Term Care Facility Component annual training.
Effective January 1, 2020, new antimicrobial stewardship requirements will be applicable to Joint Commission-accredited ambulatory healthcare organizations that routinely prescribe antimicrobial medications. Read The Joint Commission R3 Report 23.
The FDA is directing healthcare providers to conduct donor screening and MDRO testing of donor stool to protect patients from transmission of life-threatening infections from use of fecal microbiota for transplantation (FMT). Read the FDA safety alert.