Antibiotic for Complicated UTIs Receives Approval From FDA Panel

A new antibiotic for complicated urinary tract infection (cUTI) has received approval from the U.S. Food and Drug Administration's (FDA) Antimicrobial Drugs Advisory Committee, according to a news release.

The investigational antibiotic cefiderocol is made by Shionogi & Co. of Japan. The FDA panel recommended — by a vote of 14-2 — approval of the antibiotic for the treatment of cUTI, including pyelonephritis, in patients with limited or no alternative treatment options.

As the release notes, the Advisory Committee provides the FDA with independent advice and recommendations. The FDA is not bound by the committee's guidance but takes its recommendation into consideration when reviewing investigational medicines.

Cefiderocol was designated as a qualified infectious disease product (QIDP) by the FDA. Under this designation, cefiderocol was previously granted "fast-track" status for FDA approval for its potential as a new antibiotic to treat serious or life-threatening conditions and address unmet medical needs.

While the FDA panel provided its recommendation, there were caveats, reports MedPage Today. These included suggestions for the inclusion of a boxed warning discussing potential mortality risk, with mention of a special risk among patients with hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia, and the conducting of additional research and studies.

If cefiderocol receives FDA approval, it will be marketed under the brand name FETROJA.

CDC Shares New Infection Prevention and PPE Research

In conjunction with International Infection Prevention Week, the Centers for Disease Control and Prevention (CDC) has announced the availability of new research into infection prevention and the use of personal protective equipment (PPE).

The research is available as a supplement to the October issue of Clinical Infectious Diseases. Titled "Personal Protective Equipment for Preventing Contact Transmission of Pathogens: Innovations from CDC's Prevention Epicenters Program," it is composed of more than a dozen CDC-funded, in-depth studies on recent PPE work in U.S. healthcare settings. The research, CDC states, provides evidence to improve routine use of PPE and prevent contact transmission of infectious diseases in healthcare settings.

Topics covered in the studies include:

• antibiotic-resistant bacteria in hospitals;

• doffing;

• gown design;

• hand hygiene;

• glove decontamination; and

• biocontainment unit design.

More specifically, the research was supported by the CDC's Prevention Epicenters Program, a 20-year-old research program intended to implement strategies to improve healthcare quality and patient safety.

Infection Prevention Remains National Patient Safety Goal for All Programs

The Joint Commission continues to stress the importance of infection prevention by including it as a 2020 National Patient Safety Goal (NPSG) for all eight of its programs.

The infection prevention NPSG — goal #7 — is described as "Reduce the risk of healthcare-associated infections."

For the hospital and critical access hospital programs, the infection prevention NPSG includes the following standards:

• NPSG.07.01.01: Use the hand cleaning guidelines from the Centers for Disease Control and Prevention or the World Health Organization. Set goals for improving hand cleaning. Use the goals to improve hand cleaning.

• NPSG.07.03.01: Use proven guidelines to prevent infections that are difficult to treat.

• NPSG.07.04.01: Use proven guidelines to prevent infection of the blood from central lines.

• NPSG.07.05.01: Use proven guidelines to prevent infection after surgery.

• NPSG.07.06.01: Use proven guidelines to prevent infections of the urinary tract that are caused by catheters.

For the nursing care center program, the infection prevention NPSG includes the following standards:

• NPSG.07.01.01: Use the hand cleaning guidelines from the Centers for Disease Control and Prevention or the World Health Organization. Set goals for improving hand cleaning. Use the goals to improve hand cleaning.

• NPSG.07.03.01: Use proven guidelines to prevent infections that are difficult to treat.

• NPSG.07.04.01: Use proven guidelines to prevent infection of the blood from central lines.

• NPSG.07.06.01: Use proven guidelines to prevent infections of the urinary tract that are caused by catheters.

For the ambulatory healthcare and office-based surgery programs, the infection prevention NPSG includes the following standards:

• NPSG.07.01.01: Use the hand cleaning guidelines from the Centers for Disease Control and Prevention or the World Health Organization. Set goals for improving hand cleaning. Use the goals to improve hand cleaning.

• NPSG.07.05.01: Use proven guidelines to prevent infection after surgery.

For the behavioral healthcare, home care and laboratory programs, the infection prevention NPSG includes the following standard:

• NPSG.07.01.01: Use the hand cleaning guidelines from the Centers for Disease Control and Prevention or the World Health Organization. Set goals for improving hand cleaning. Use the goals to improve hand cleaning.

The 2020 NPSGs become effective Jan. 1, 2020.

Sterile Processing Errors Earns Spot on ECRI Top Health Technology Hazards List

ECRI Institute has issued its annual list of the top 10 health technology hazards, and sterile processing errors in some ambulatory settings, including medical and dental offices, comes in at #3.

As ECRI notes in a news release, the challenge associated with sterile processing concerns the "failure to consistently and effectively sterilize contaminated items can lead to patient infections."

An executive brief for the "Top 10 Health Technology Hazards for 2020" report elaborates, stating the following: "Insufficient attention to sterilization processes in medical offices, dental offices and some other ambulatory care settings can expose patients to contaminated instruments, implants or other critical items. … failure to consistently and effectively clean and disinfect or sterilize contaminated items before use can expose patients to virulent pathogens. This concern exists in all healthcare settings where patients may come in contact with contaminated items, particularly those intended to enter sterile tissue or the vascular system."

ECRI also highlighted the infection risks associated with the #4 hazard on the list: central venous catheter (CVC) risk in at-home hemodialysis. ECRI notes that the risks associated with CVCs can be particularly dangerous in the home setting because family members may lack the ability to effectively manage such risks. The executive brief states, "CVCs are typically placed through the jugular vein (or other large central vein), providing a pathway directly from the outside of the body to the patient’s heart. As a result, the conse­quences of infection, clotting, disconnection and air embolism can be severe."

The hazards taking the top spots on the 2020 list are surgical stapler misuse (#1) and point-of-care ultrasound (#2).

The 2019 top hazards list included mattresses remaining contaminated after cleaning, retained surgical sponges and recontamination of endoscopes after disinfection.

Study: Serious Side Effects Associated With Antibiotics Before Dental Visits

The results of a national study raise significant red flags concerning antibiotic prescribing practices in the dental setting.

Researchers examined nearly 170,000 dental visits from 2011-2015 that included the prescribing of antibiotics to prevent infections before the visits. When evaluating practices against current American Dental Association (ADA) and American Heart Association (AHA) guidelines, researchers found that antibiotics were prescribed unnecessarily for about 80% of the visits. Of those, nearly 4% were associated with an adverse event within two weeks, including nearly 4,000 allergic reactions, about 1,600 emergency room visits and several Clostridioides difficile (C. diff) infections.

As a press release about the study notes, antibiotics are often prescribed before dental visits to help prevent infections in certain patients, such as those who have undergone joint replacements. However, current ADA and AHA guidelines no longer recommend this use of antibiotics in most cases. 

In the release, Dr. lan Gross, clinical associate professor at the University of Illinois at Chicago College of Pharmacy and a co-author, is quoted as saying, "While antibiotics can be lifesaving, they can cause significant adverse events even after being taken for only a day or two. Also, misuse can lead to antibiotic resistance. Antibiotics should only be prescribed when necessary and people should talk with their dentist or physician to ask if they truly need antibiotics prior to a dental visit."

The study was recently presented at IDWeek 2019, the annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA) and the Pediatric Infectious Diseases Society (PIDS).