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.
APIC 2019 Annual Conference Wednesday, June 12 – 3:00 PM – 5:30 PM Pennsylvania Convention Center, 108B As the amount of legislation and regulation governing the practice of IPC increases, it becomes more important for policymakers to hear from experts to help guide them and provide advice on evidence-based practices that lead to increased patient … Continue reading “Finding Your Voice: Advocating for IPC”
Pharm D Solutions is voluntarily recalling all sterile compounded drug products due to concerns that practices at the pharmacy have the potential to pose a risk of contamination. Read more.
The FDA has authorized marketing of a diagnostic test to detect Zika virus immunoglobulin (IgM) antibodies in human blood. The ZIKV Detect 2.0 IgM Capture ELISA is the first Zika diagnostic test the FDA has allowed to be marketed in the U.S. Previously, tests for detecting Zika virus IgM antibodies had been authorized only for emergency … Continue reading “FDA Authorizes Marketing of Diagnostic Test for Zika Antibodies”
The FDA approved marketing of the Synovasure Lateral Flow Test Kit as an aid for the detection of periprosthetic joint infection in the synovial fluid of patients being evaluated for revision surgery, which is surgery performed to replace or compensate for a failed implant. Read more.
The FDA is alerting hospitals, laboratories, and providers of a Class 1 recall of Beckman Coulter DxH 800, DxH 600 and DxH 900 hematology analyzers. Device users have reported inaccurate blood platelet counts, which could result in misdiagnosis of diseases and conditions such as anemia, infections, blood clotting problems, blood cancers, and immune system disorders. … Continue reading “Beckman Coulter Recalls Hematology Analyzers”