Early Intervention and Communication Reduces Morbidity from Burkholderia cepacia Contaminated Mouthwash

Abstract

BACKGROUND/OBJECTIVES: Denton Regional Medical Center (DRMC) is a 200 bed acute care hospital. Two Intensive Care Unit (ICU) patients' sputum/lung cultures of Burkholderia cepacia (B.cepacia) prompted an immediate infection control practitioner (ICP) visit to the ICU and collection of various solutions including alcohol-free mouthwash, previously reported as contaminated intrinsically. While generally considered non-pathogenic, B.cepacia can cause bronchitis or pneumonia in immunocompromised patients and was listed as “increasingly a human pathogen” in Emerging Infectious Diseases in 1998. In previous outbreaks of contaminated solutions, 5-245 patients were colonized or infected with B.cepacia. This cluster is unusual in that only 2 cases triggered investigation. B cepacia cultures occur rarely in DRMC; a 20 month-lookback identified only 1 lung-source case 2 months earlier. One additional ICU case occurred after the initial 2 cultures were reported for a total of 4 cases. All other patients in and from the ICU were sputum-culture negative. METHODS: Early investigation identified that alcohol-free mouthwash is considered a “cosmetic” and the only Food and Drug Administration (FDA) requirements are for negative tests for 6 specific microbes and any other microbial growth is limited to <100 colonies per milliliter (ml). RESULTS: Opened and unopened 4 ounce bottles of alcohol-free mouthwash were positive with 100,000 colony counts per ml of B.cepacia. The Health Department, ICP's in the local area and the same health system were all alerted and several hospitals reported seeing recent B.cepacia cases without having identified a source. Denton County Health Department notified local hospitals, the Texas State Health Department and Centers for Disease Control (CDC). The FDA did a national recall. A total of 3,000 DRMC inpatients were presumed exposed and were notified to contact their physicians if ill. Twenty-two follow-up sputum cultures were negative. Nationwide, 116 patients were ultimately reported as culture positive to the CDC; 1 died. CONCLUSIONS: This cluster is unique in early identification of the source and demonstrates the importance of timely and sensitive ICP surveillance, prompt communication with the Health Department and appropriate interventions to prevent or halt major outbreaks of unusual organisms. Recommendation: Mouthwash used in healthcare agencies should be alcohol-based or more rigorous FDA manufacturing standards than “cosmetics” are needed since immunocompromised patients are very high risk for infection and are increasing in numbers. BACKGROUND/OBJECTIVES: Denton Regional Medical Center (DRMC) is a 200 bed acute care hospital. Two Intensive Care Unit (ICU) patients' sputum/lung cultures of Burkholderia cepacia (B.cepacia) prompted an immediate infection control practitioner (ICP) visit to the ICU and collection of various solutions including alcohol-free mouthwash, previously reported as contaminated intrinsically. While generally considered non-pathogenic, B.cepacia can cause bronchitis or pneumonia in immunocompromised patients and was listed as “increasingly a human pathogen” in Emerging Infectious Diseases in 1998. In previous outbreaks of contaminated solutions, 5-245 patients were colonized or infected with B.cepacia. This cluster is unusual in that only 2 cases triggered investigation. B cepacia cultures occur rarely in DRMC; a 20 month-lookback identified only 1 lung-source case 2 months earlier. One additional ICU case occurred after the initial 2 cultures were reported for a total of 4 cases. All other patients in and from the ICU were sputum-culture negative. METHODS: Early investigation identified that alcohol-free mouthwash is considered a “cosmetic” and the only Food and Drug Administration (FDA) requirements are for negative tests for 6 specific microbes and any other microbial growth is limited to <100 colonies per milliliter (ml). RESULTS: Opened and unopened 4 ounce bottles of alcohol-free mouthwash were positive with 100,000 colony counts per ml of B.cepacia. The Health Department, ICP's in the local area and the same health system were all alerted and several hospitals reported seeing recent B.cepacia cases without having identified a source. Denton County Health Department notified local hospitals, the Texas State Health Department and Centers for Disease Control (CDC). The FDA did a national recall. A total of 3,000 DRMC inpatients were presumed exposed and were notified to contact their physicians if ill. Twenty-two follow-up sputum cultures were negative. Nationwide, 116 patients were ultimately reported as culture positive to the CDC; 1 died. CONCLUSIONS: This cluster is unique in early identification of the source and demonstrates the importance of timely and sensitive ICP surveillance, prompt communication with the Health Department and appropriate interventions to prevent or halt major outbreaks of unusual organisms. Recommendation: Mouthwash used in healthcare agencies should be alcohol-based or more rigorous FDA manufacturing standards than “cosmetics” are needed since immunocompromised patients are very high risk for infection and are increasing in numbers.