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
Sensors by contacting Nellcor’s Technical Services department, telephone
800-635-5267, option 3.
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.
Nosocomial. JAMA. 2004;292(13):1546. doi:10.1001/jama.292.13.1546