MMWR Update

Syringe, mouthwash recalls after outbreaks

ICPs should heighten suspicion for additional cases

Two recent incidents of infections linked to contaminated medical products may warrant heightened suspicion and prompt reporting by ICPs and other clinicians investigating similar cases, the Centers for Disease Control and Prevention advises.

The CDC recently reported a cluster of Enterobacter cloacae bloodstream infections associated with contaminated prefilled saline syringes. During the period of Nov. 2-5, 1998, 11 children who received outpatient therapy from the hematology/oncology service at a hospital in California developed sepsis. Of those, 10 had E. cloacae-positive blood cultures.

All patients had received intravascular catheter flushes using prefilled saline syringes (CAPS, Braun-McGaw, Detroit), the CDC reports. Culture of an unopened prefilled syringe grew E. cloacae with identical biochemical profiles to that of the patients. On Nov. 9, 1998, the manufacturer initiated a recall of the syringes.

In addition, a cluster of nosocomial Burkholderia cepacia infections and colonizations was recently linked to an intrinsically contaminated mouthwash used at two hospitals in Arizona.

During the period of August 1996-June 1998, 74 patients at two hospitals had cultures positive for B. cepacia. Most isolates were from the respiratory tracts of patients in intensive care units. 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 Aug. 31, 1996-June 12, 1998 (epidemic period). Hospital microbiology records were reviewed to identify all isolates of B. cepacia during the pre-epidemic period (Jan. 1, 1994-Aug. 30, 1996) and epidemic period. 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. 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 (Kenton Alcohol Free Mouthwash and Gargle, product #711-04, manufactured for Kenton Health Care Inc., Phoenix Cosmetics, Holbrook, NY). The active ingredient in the product is cetyl pyridium.

"This product was produced only during 1994-1995 and was distributed throughout the United States," the CDC reports. "The extent of use of this product in ICU patients at other hospitals is unknown."

Cultures of unopened four-ounce 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, 1998, the Kenton company initiated a voluntary recall of the product, the CDC reports.

Clinicians detecting episodes of sepsis or bloodstream infection associated with prefilled saline syringes, or those who detect ventilator-associated pneumonia or respiratory colonization with B. cepacia associated with the use of non-alcohol containing mouthwash, should report the episodes to:

• CDC Hospital Infections Program, National Center for Infectious Diseases. Telephone: (404) 639-6413; fax: (404) 639-6459.

• MedWatch, the Food and Drug Administra tion’s Medical Products Reporting Program. Telephone: (800) 332-1088; fax: (800) 332-0178; address: MedWatch, 5600 Fishers Lane, Rockville MD 20852-9787; World Wide Web: www.fda.gov/medwatch.

References

1. Centers for Disease Control and Prevention. Enterobacter cloacae bloodstream infections associated with contaminated prefilled saline syringes — California, November 1998. MMWR 1998; 47:

2. Centers for Disease Control and Prevention. Nosocomial Burkholderia cepacia infection and colonization associated with intrinsically contaminated mouthwash — Arizona, 1998. MMWR 1998; 47:926-928.