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From the Centers for Disease Control and Prevention
January 27, 1999

Nosocomial Burkholderia cepacia Infection and Colonization Associated With Intrinsically Contaminated Mouthwash—Arizona, 1998

JAMA. 1999;281(4):318. doi:10.1001/jama.281.4.318-JWR0127-4-1

MMWR. 1998;47:926-928

During August 1996-June 1998, 74 patients at two hospitals in Arizona had cultures positive for Burkholderia cepacia. Most isolates were from the respiratory tracts of patients in intensive-care units (ICUs). Because of the large number of B. cepacia isolates, personnel at both hospitals requested the Arizona Department of Health Services assist in an investigation. This report summarizes the results of the investigation.

A case of infection or colonization was defined as a positive culture for B. cepacia from the respiratory tract of any ICU patient at these hospitals during August 31, 1996-June 12, 1998 (epidemic period). Hospital microbiology records were reviewed to identify all isolates of B. cepacia during the pre-epidemic (January 1, 1994-August 30, 1996) and epidemic periods. Case-patient medical records, respiratory therapy procedures, and ICU nursing procedures were reviewed.

A total of 69 patients had positive cultures and had illness that met the case definition, compared with one ICU patient during the pre-epidemic period. Case-patients ranged in age from 17 to 87 years (median: 73 years), and 36 (52%) were male. Case-patients were admitted to the ICU with various diagnoses. None had medical conditions associated with infection with B. cepacia (e.g., cystic fibrosis or chronic granulomatous disease). Hospital clinicians identified 33 (48%) case-patients as having infections and 36 case-patients as having B. cepacia respiratory tract colonization.

All case-patients had been intubated and mechanically ventilated during their ICU stay. All mechanically ventilated patients had received routine oral care that included swabbing with an alcohol-free mouthwash (Kentron Alcohol Free Mouthwash and Gargle™, product #711-04, manufactured for Kentron Health Care, Inc., Phoenix Cosmetics, Holbrook, New York). The active ingredient in this product is cetyl pyridium chloride; the formulation does not contain alcohol. This product was produced only during 1994-1995 and was distributed throughout the United States. The extent of use of this product in ICU patients at other hospitals is unknown.

Cultures of unopened 4-oz. bottles of the mouthwash grew B. cepacia, Alcaligenes xylosoxidans, and Pseudomonas fluorescens putida group. B. cepacia isolates from case-patients and mouthwash were similar by pulsed-field gel electrophoresis. Other potential reservoirs (e.g., lotion, povidone-iodine solution, water supplies, and a name-brand mouthwash) were culture-negative for B. cepacia.

On June 12, the two hospitals discontinued use of the product, and no further respiratory isolates of B. cepacia have occurred in their ICU patients. On June 16, the Kentron company initiated a voluntary recall of this product.

Reported by:

L Matrician, G Ange, S Burns, L Fanning; C Kioski, G Cage, G Harter, D Reese, D McFall, K Komatsu, R Englund, State Epidemiologist, Arizona Dept of Health Svcs. Investigation Br, Phoenix Resident Post, Food and Drug Administration. Hospital Infections Program, National Center for Infectious Diseases; and an EIS Officer, CDC.

CDC Editorial Note:

B. cepacia (formerly Pseudomonas cepacia) is a motile aerobic gram-negative bacillus commonly found in liquid reservoirs and moist environments. B. cepacia is a well-known nosocomial pathogen that is intrinsically resistant to aminoglycosides and first- and second-generation cephalosporins; it is responsible for 0.6% of all ventilator-associated pneumonias (1; CDC, unpublished data, 1994). Numerous outbreaks of B. cepacia infection have been reported among cystic fibrosis patients.1-3 In December 1995, a similar outbreak involving B. cepacia in respiratory cultures from patients without cystic fibrosis was traced to intrinsically contaminated alcohol-free mouthwash prepared by a different manufacturer.4 An investigation by the Food and Drug Administration (FDA) suggested an association with the deionization procedure of the water used to prepare the product (R. Johnson, FDA, personal communication, 1998).

Potential pathogens may be present in low numbers in many nonsterile products used in hospitals. Mechanically ventilated patients are vulnerable to pathogens in their mouths and upper airways because of their inability to maintain the mucociliary and cough mechanisms that normally protect the lower respiratory tract.5 These outbreaks of B. cepacia related to mouthwash highlight the increased risk for respiratory colonization and infection among patients on ventilators. Hospital surveillance and investigation of unusual clusters are crucial to promptly identifying unexpected sources of these pathogens and protecting patients at risk.

Clinicians who detect ventilator-associated pneumonia or respiratory colonization with B. cepacia associated with the use of nonalcohol containing mouthwash are encouraged to report such episodes through local and state health departments to CDC's Hospital Infections Program, National Center for Infectious Diseases, telephone (404) 639-6413; fax (404) 639-6459; and to MEDWATCH, the FDA Medical Products Reporting Program, telephone (800) 332-1088.

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