Copyright 1998 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.1998American Medical AssociationThis is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
From FEBRUARY 24 through March 15, 1998, a total of 22 respiratory tract cultures from 13 patients at Childrens Hospital Los Angeles (CHLA), California, were culture-positive for Ralstonia pickettii. Because of this unusual cluster of colonization, on March 16 the Los Angeles County Department of Health Services initiated an investigation. This report summarizes the findings of the investigation, which resulted in a recall of sterile sodium chloride solution that was contaminated with R. pickettii.
A case of R. pickettii colonization was defined as isolation of R. pickettii from any clinical site in a CHLA patient during February 1-March 27, 1998 (epidemic period). To determine the background rate, CHLA microbiology records were reviewed, and all cultures positive for R. pickettii from July 1, 1997, through February 1, 1998 (pre-epidemic period), were identified. Colonized patients' medical records, hospital laboratory culture methods, and respiratory therapy procedures were reviewed. Selected opened and unopened vials of solutions used in respiratory therapy were cultured.
R. pickettii was isolated significantly more frequently from respiratory specimens submitted to the microbiology laboratory during the epidemic than during the pre-epidemic period (36 [7.2%] of 498 compared with three [0.1%] of 2200; relative risk=53, 95% confidence interval=16-171). Seventeen patients had isolates meeting the case definition. Colonized patients ranged in age from 4 days to 17 years (median: 2 months), nine (53%) were female, all had been hospitalized in an intensive-care unit, and all had received respiratory therapy.
Of the 17 patients, 16 (94%) were mechanically ventilated, and one had a tracheostomy. The endotracheal suctioning protocol in this hospital included the pre-suctioning instillation of sterile saline. All colonized patients received endotracheal suctioning after instillation of 0.9% sterile sodium chloride solution (Modudose®, manufactured by Kendall Corporation, Mainsfield, Massachusetts*); no infections or deaths were attributed to R. pickettii.
Cultures of pooled unopened 3-mL vials of Modudose®, lot number 718315, by the Los Angeles County Public Health Laboratory and the Food and Drug Administration (FDA) grew R. pickettii. Patient and product R. pickettii isolates had closely related pulsed-field gel electrophoresis patterns. Since March 30, 1998, when the use of this product was discontinued at CHLA, no further R. pickettii colonization has been detected.
Modudose® is a sterile 0.9% sodium chloride solution for use in respiratory therapy distributed by Kendall Corporation; Umeco Corporation, San Juan, Puerto Rico; and Westmed Corporation, Tucson, Arizona. On confirmation of Modudose® contamination with R. pickettii, the manufacturer voluntarily issued a recall that FDA designated as Class I (defined as having a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death). All lots of the following Modudose® labels and product codes were recalled: Kendall product codes 5251 (3 mL) and 5257 (5 mL), Umeco product code PR5251 (3 mL), and Westmed product code 0454 (1.5 mL).
J Labarca, MD, C Peterson, MD, N Bendaqa, L Mascola, MD, Acute Communicable Diseases Control; L Kilman, S Harvey, PhD, Public Health Microbiology Laboratory, Los Angeles County Dept of Health Svcs, Los Angeles; L Ross, MD, M Meylan, MSPH, P Teitelbaum, Childrens Hospital Los Angeles; S Waterman, MD, State Epidemiologist, California Dept of Health Svcs. Office of Regulatory Affairs, Food and Drug Administration. Hospital Infections Program, National Center for Infectious Diseases, CDC.
R. pickettii is a nonfermentative gram-negative bacillus formerly known as Pseudomonas pickettii and Burkholderia pickettii.1 In 1995, a new genus, Ralstonia, was proposed on the basis of phenotypic characterization, cellular lipid and fatty acid analyses, phylogenetic analysis of 16S rDNA nucleotide sequences, and rRNA-DNA hybridization. The type species of the new genus is R. pickettii.
Since 1972, R. pickettii has been detected as a contaminate of several solutions (e.g., saline, deionized water, "sterile" water, and intravenous ranitidine).2-7 These intrinsically contaminated solutions have been associated with outbreaks of respiratory colonization, bloodstream infections, or catheter-related infections.
Modudose® is filter sterilized. Previous laboratory studies have shown that low numbers (1-10 colony-forming units) of R. pickettii inoculated into 0.9% sodium chloride solution can proliferate over a wide range of temperatures (59 F-108 F [15 C-42 C]).8 Although the filter size used to terminally sterilize this product is not known (proprietary information), previous studies have shown that R. pickettii can pass through a 0.2 µ filter.8
Clinicians detecting patients with R. pickettii colonization or infection associated with use of Modudose® are encouraged to report these episodes through local and state health departments to CDC's Hospital Infections Program, National Center for Infectious Diseases (telephone  639-6413; fax  639-6459) and to MedWatch, the FDA Medical Products Reporting Program, telephone (800) 332-1088.
Nosocomial Ralstonia pickettii Colonization Associated With Intrinsically Contaminated Saline Solution—Los Angeles, California, 1998. JAMA. 1998;279(23):1859. doi:10.1001/jama.279.23.1859-JWR0617-2-1