Wisconsin DHS Health Alert #55: National Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa Associated with Artificial Tears

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DHS Health Alert Network

National Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa Associated with Artificial Tears

Bureau of Communicable Diseases

February 10, 2023

Key Points

  • On February 1, 2023, the Centers for Disease Control and Prevention (CDC) issued a Health Advisory about infections with an extensively drug-resistant strain of Verona Integron-mediated Metallo-β-lactamase (VIM) and Guiana-Extended Spectrum-β-Lactamase (GES)-producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) in 12 states.
  • The VIM-GES-CRPA infections are associated with the use of artificial tears, with the majority of patients reporting use of EzriCare Artificial Tears, a preservative-free, over-the-counter product packaged in multidose bottles.
  • Patients and health care providers should immediately discontinue using EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears pending additional guidance from CDC and the Food and Drug Administration (FDA).
  • Wisconsin identified one case of VIM-GES-CRPA dating back to June 2022 in a Michigan resident who received care at a Wisconsin eye clinic.

Background

On February 1, 2023, CDC issued a Health Advisory regarding a national outbreak of extensively drug-resistant Pseudomonas aeruginosa associated with artificial tears. As of January 31, 2023, CDC has identified VIM-GES-CRPA in 55 case-patients in 12 states. Thirty-five patients are linked to four health care facility clusters. The dates of specimen collection ranged from May 2022 to January 2023. Patients have had a variety of symptoms including keratitis, endophthalmitis, respiratory infection, urinary tract infection, and sepsis. Patient outcomes include permanent vision loss resulting from cornea infection, hospitalization, and one death due to systemic infection.

There has been one case of VIM-GES-CRPA in Wisconsin, dating back to a specimen collected in June 2022 from a Michigan resident who received care at a Wisconsin eye clinic.

A review of common exposures indicates that most patients used artificial tears prior to the identification of VIM-GES-CRPA. Patients have reported use of more than 10 brands of artificial tears, with some using multiple brands. The majority of patients who used artificial tears reported using EzriCare Artificial Tears, a preservative-free product dispensed in multidose bottles. CDC laboratory testing has identified the presence of the outbreak strain in opened EzriCare bottles with different lot numbers. The manufacturer has since issued a voluntary nationwide recall of the product. Testing of unopened bottles of EzriCare Artificial Tears is ongoing to evaluate whether contamination may have occurred during manufacturing.


Recommendations for Health Care Providers 

  • Immediately discontinue recommending and prescribing EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears pending additional guidance from CDC and FDA.
  • Advise patients who have used EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears within the last 14 days to monitor for signs and symptoms of infection. Perform culture and antimicrobial susceptibility testing when clinically indicated.
  • Health care providers treating patients for keratitis or endophthalmitis should ask patients if they have used EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears. Perform culture and antimicrobial susceptibility testing to help guide therapy if patients report use of this product.
  • Health care providers treating VIM-GES-CRPA infections should consult with a specialist knowledgeable in the treatment of antibiotic-resistant bacteria to determine the best treatment option.
    • VIM-GES-CRPA isolates associated with this outbreak that underwent susceptibility testing were not susceptible to cefepime, ceftazidime, piperacillin-tazobactam, aztreonam, carbapenems, ceftazidime-avibactam, ceftolozane-tazobactam, fluoroquinolones, polymyxins, amikacin, gentamicin, and tobramycin.
    • A subset of three isolates that underwent antimicrobial susceptibility testing for cefiderocol were susceptible to this agent.
  • Patients who are infected or colonized with VIM-GES-CRPA and are admitted to acute care settings should be placed in isolation on contact precautions. Use enhanced barrier precautions for nursing home residents who are infected or colonized with VIM-GES-CRPA when contact precautions do not otherwise apply.

  • At this time, CDC does not recommend testing patients who have used this product and who are not experiencing any signs or symptoms of infection. There is not a widespread risk of infection in Wisconsin.

Recommendations for Clinical Laboratories 

  • Clinical laboratories that identify Pseudomonas aeruginosa resistant to imipenem or meropenem are encouraged to perform carbapenem resistance mechanism testing, as capable. Isolates should also be submitted to the Wisconsin State Laboratory of Hygiene for mechanism testing, as a statewide reportable condition.
    • Laboratories wishing to apply a more specific definition when identifying isolates that might be related to this cluster for mechanism testing could limit testing to carbapenem-resistant Pseudomonas aeruginosa that are also resistant to cefepime, ceftazidime, and (if tested) ceftazidime-avibactam and ceftolozane-tazobactam.
  • Clinical laboratories that identify any carbapenem-resistant Pseudomonas aeruginosa from an ocular specimen or VIM-CRPA from any specimen source should submit the isolate to the Wisconsin State Laboratory of Hygiene, the Midwest Antimicrobial Resistance Laboratory Network, for further characterization. Please reach out to the Wisconsin Healthcare-Associated Infections (HAI) Prevention Program at DHSWIHAIPreventionProgram@dhs.wisconsin.gov for assistance submitting isolates.

Recommendations for the Public 

  • Immediately discontinue using EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears pending additional guidance from CDC and FDA.
  • Patients who were advised to use EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears by their health care provider should follow up with their provider for an alternative artificial tears product to use.
  • Patients who used EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears within the last 14 days and who have signs or symptoms of an eye infection should seek medical care.
  • Symptoms of eye infection include:
    • Discharge from the eye
    • Eye pain or discomfort
    • Redness of the eye or eyelid
    • Feeling of something in the eye
    • Increased sensitivity to light
    • Blurry vision
  • At this time, CDC does not recommend testing patients who are not experiencing signs or symptoms after using this product.

Resources 


Sincerely,

Ryan Westergaard, MD, PhD, MPH
Chief Medical Officer and State Epidemiologist
Bureau of Communicable Diseases
Division of Public Health
Wisconsin Department of Health Services


Questions regarding this Health Alert may be directed to the Wisconsin HAI Prevention Program by calling 608-267-7711 or via email to DHSWIHAIPreventionProgram@dhs.wisconsin.gov.