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Notice to Readers: Nosocomial Burkholderia cepacia Infections Associated with Exposure to Sublingual Probes --- Texas, 2004

On August 27, this notice was posted as an MMWR Dispatch on the MMWR website (http://www.cdc.gov/mmwr).

Burkholderia cepacia (formerly known as Pseudomonas cepacia, a gram-negative rod [GNR]) is attributed to nosocomial infections among intensive care unit patients and associated with use of contaminated equipment and solutions (1--4). In August 2004, the Texas Department of Health received reports of positive cultures for B. cepacia from respiratory samples of 13 intensive care unit patients receiving mechanical ventilation at a hospital in Texas during April--August 2004. None of the patients had cystic fibrosis, a condition commonly associated with B. cepacia. Initial investigation by the hospital's infection-control team revealed that nearly all of the patients had been exposed to a sublingual probe indicated for use for monitoring tissue carbon dioxide levels. The probe, an SLS-1 Sublingual Sensor, is part of the Nellcor® CapnoProbe™ Sublingual System (model N-80 monitor), an FDA-regulated medical device (Nellcor, Pleasanton, California). Each probe is packaged in a metal canister filled with a buffered saline solution and sealed in a foil envelope labeled as nonsterile. Each disposable sensor is used only once.

Cultures of the buffered saline solution from at least two lots of unopened probes yielded B. cepacia and other GNRs. B. cepacia isolates from some patients and unopened sensor canisters were indistinguishable by pulsed field gel electrophoresis analysis at the Texas Department of Health laboratory. Investigations into other reports of B. cepacia and other GNRs that might be associated with use of the probes is ongoing at hospitals in Texas and California. The manufacturer has issued a voluntary recall of all SLS-1 Sublingual Sensors.

Clinicians should be aware that patients exposed to these probes might have been exposed to various GNRs, including B. cepacia. Recovery of B. cepacia or GNRs that might be related to use of a sublingual carbon dioxide sensor should be reported to state health departments and CDC's Division of Healthcare Quality and Promotion, telephone 800-893-0485. Health-care facilities are encouraged to report through the voluntary MedWatch reporting program any events not reported under the mandatory process. Additional information is available at http://www.fda.gov/cdrh/mdr/index.html or telephone 800-FDA-1088. Users of this probe should return existing inventory of unused SLS-1 Sublingual Senors by contacting Nellcor's Technical Services department, telephone 800-635-5267, option 3.

Reported by: P Metcalf, K Newman, JD Siegel, MD, Children's Medical Center, Dallas; N Pascoe, Texas Dept of Health. D Terashita, MD, L Mascola, MD, Los Angeles County Dept of Health Svcs, California. A Srinivasan, MD, M Arduino, PhD, Div of Healthcare Quality Promotion, National Center for Infectious Diseases; R Taylor, PhD, EIS Officer, CDC.

References

  1. CDC. Manufacturer's recall of nasal spray contaminated with Burkholderia cepacia complex. MMWR 2004;53:246.
  2. Nasser RM, Rahi AC, Haddad MF, Daoud Z, Irani-Hakime N, Almawi WY. Outbreak of Burkholderia cepacia bacteremia traced to contaminated hospital water used for dilution of an alcohol skin antiseptic. Infect Control Hosp Epidemiol 2004;25:189--91.
  3. Shehabi AA, Abu-Al-Soud WA, Mahafzah A, et al. Investigation of Burkholderia cepacia nosocomial outbreak with high fatality in patients suffering from diseases other than cystic fibrosis. Scand J Infect Dis 2004;36:174--8.
  4. LiPuma JJ. Burkholderia cepacia epidemiology and pathogenesis: implications for infection control. Curr Opin Pulm Med 1998;4:337--41.



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