Published online June 1, 2007
PEDIATRICS Vol. 119 No. 6 June 2007, pp. 1061-1068 (doi:10.1542/10.1542/peds.2006-3739)

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ARTICLE

A National Outbreak of Ralstonia mannitolilytica Associated With Use of a Contaminated Oxygen-Delivery Device Among Pediatric Patients

Michael A. Jhung, MD, MPH^a, Rebecca H. Sunenshine, MD^a, Judith Noble-Wang, PhD^a, Susan E. Coffin, MD^b, Keith St John, MS^b, Felicia M. Lewis, MD^c, Bette Jensen, MMSc^a, Alicia Peterson, MPH^a, John LiPuma, MD^d, Matthew J. Arduino, DrPH^a, Galit Holzmann-Pazgal, MD^e, Jane T. Atkins, MD^f and Arjun Srinivasan, MD^a

^a Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia
^b Department of Infectious Diseases, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
^c Acute Communicable Diseases and Emerging Infections, Philadelphia Department of Public Health, Philadelphia, Pennsylvania
^d Department of Pediatrics and Communicable Diseases, University of Michigan Health System, Ann Arbor, Michigan
^e Division of Pediatric Infectious Diseases, St Louis Children's Hospital/Washington University School of Medicine, St Louis, Missouri
^f Methodist Children's Hospital of South Texas, San Antonio, Texas

OBJECTIVES. In August 2005, the Centers for Disease Control and Prevention was notified of a Ralstonia species outbreak among pediatric patients receiving supplemental oxygen therapy with the Vapotherm 2000i (Vapotherm, Inc, Stevensville, MD). The Vapotherm 2000i is a reusable medical device that was used in >900 hospitals in the United States in 2005. Ralstonia are waterborne bacilli that have been implicated in hospital-acquired infections. We initiated an investigation to determine the source of the outbreak and implement infection control and prevention measures.

PATIENTS AND METHODS. We performed a case-control study at 1 hospital and conducted national case findings to obtain clinical and environmental samples for laboratory analysis. Case-patients had health care–acquired Ralstonia colonization or infection. Isolates were compared by using pulsed-field gel electrophoresis. We tested manufacturer-recommended disinfection protocols for the Vapotherm 2000i under simulated-use conditions.

RESULTS. Case-patients at the hospital (n = 5) were more likely to have received Vapotherm therapy than controls. Nationally, Ralstonia mannitolilytica was confirmed in 38 patients (aged 5 days to 7 years); 35 (92%) of the patients were exposed to the Vapotherm 2000i before recovery of the organism. Pulsed-field gel electrophoresis showed related R mannitolilytica strains from isolates sent from 18 hospitals in 12 states. A Vapotherm machine reprocessed with a protocol proposed by the manufacturer grew Ralstonia spp after 7 days of simulated use. In December 2005, Vapotherm recalled the 2000i.

CONCLUSIONS. Our findings suggest intrinsic contamination of Vapotherm devices with Ralstonia spp. New medical devices may provide therapy equivalent to current devices yet pose novel reprocessing challenges.

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Key Words: Ralstonia • oxygen inhalation therapy • infant • equipment contamination • infection control • intrinsic contamination

Abbreviations: FDA—Food and Drug Administration • PMA—premarket approval • CDC—Centers for Disease Control and Prevention • OR—odds ratio • PFGE—pulsed-field gel electrophoresis • ClO₂—chlorine dioxide

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Accepted Feb 12, 2007.

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