What's New

CMS finalizes revised Infection Control and Antibiotic Stewardship CoP

The Centers for Medicare & Medicaid Services (CMS) published the final rule that combines proposed revisions to Medicare hospital and critical access hospital Conditions of Participation (CoPs), the proposed 2018 regulatory burden reduction rule, and revisions to the 2017 Emergency Preparedness final rule. The new rule:
2020 National Patient Safety Goals Now Available

The 2020 National Patient Safety Goals (NPSGs) are now available on The Joint Commission’s website. You can download the entire chapter from the accreditation standards manual or easy-to-read versions.
Innoveix Recalls All Sterile Compounded Drugs

The U.S. FDA announced that Innoveix Pharmaceuticals is voluntarily recalling all sterile compounded drug products due to lack of sterility assurance. The affected products are injectable Human Chorionic Gonadotropin (HCG) and injectable Sermorelin w/GHRP2. Read FDA safety alert.
FDA approves rapid diagnostic test for Ebola

The U.S. FDA approved marketing of the OraQuick Ebola Rapid Antigen diagnostic test for Ebola Virus Disease (EVD). The OraQuick Ebola Test is intended for use in patients suspected of and with symptoms consistent with EVD. It may also be used in recently deceased individuals with epidemiological risk factors suspected to have died from EVD to inform decisions on safe handling of cadavers. This test is not intended for general Ebola infection screening or testing individuals at risk of exposure. Read FDA news release.
Low Rates of Vaccination during Pregnancy Leave Moms and Babies Unprotected

Newborns who get influenza (flu) or whooping cough are at high risk of hospitalization and death. According to a new Vital Signs report released today by the Centers for Disease Control and Prevention (CDC), the majority (65%) of mothers-to-be in the United States have not received recommended flu and whooping cough vaccines.
DHHS supporting new Ebola treatment

The U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) is providing support and expertise to Ridgeback Biotherapeutics to manufacture an investigational treatment for Ebola virus disease. The therapeutic, mAb114, is a single monoclonal antibody that binds to a virus protein, reducing its ability to infect human cells. The product received FDA Breakthrough Therapy Designation, which helps facilitate development, and is currently being offered to Ebola patients in the Democratic Republic of the Congo as part of a clinical trial co-sponsored by the U.S. National Institute of Allergy and Infectious Diseases and the Congo National Biomedical Research Institute and being coordinated by the World Health Organization. Read the HHS news release.
President issues Executive Order on Flu Vaccine

President Trump issued an Executive Order (EO) relating to influenza vaccines. Calling influenza a national security and public health priority, the EO establishes a National Influenza Vaccine Task Force, co-chaired by the Secretaries of Defense and Health and Human Services. It also directs federal agencies to take action to modernize and expand production of influenza vaccination and promote vaccination according to CDC recommendations. Read the Executive Order.
CDC Webinar on Pediatric Influenza -- Free CE Available

With subject matter experts from the American Academy of Pediatrics, the CDC is offering a webinar on 2019-2020 Recommendations for Influenza Prevention and Treatment in Children. The webinar is September 26 at 2-3 pm Eastern time. Free continuing education is available. Register for the webinar.
FDA Warns IST Over Unapproved Use of One Tray®

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 for terminal sterile storage and terminal sterile storage with retained moisture. IST issued a statement on August 22 disputing FDA’s assertions, and claiming that One Tray’s currently marketed indication for use are within the scope of FDA’s original clearance. Read the FDA warning letter and IST’s response statement.
Updated Guidance on Solid Waste Management

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 disease in otherwise healthy humans or animals. Read the updated guidance document.

Show your support for vaccines

As demonstrated by the multiple measles outbreaks around the country, misinformation about vaccines is becoming a major issue. Contact your member of the House of Representatives and tell them to support House Resolution 179.
Protect Healthcare Funding

The federal budget process is in full swing. The President has requested a $12 billion cut to HHS funding and the House of Representatives has requested a small increase. Will you have your voice heard?
Vaccines Work

Contact your state legislators today to encourage them to support pro-vaccine policies and reject proposals that would limit or delay immunizations.
Do you know the flu?

Inform your Members of Congress about the dangers of the flu and the importance of preventing the spread of this deadly virus.