Correspondence

Outbreaks of Infection Associated with Bronchoscopes

N Engl J Med 2003; 348:2039-2040May 15, 2003

Article

To the Editor:

Kirschke et al. and Srinivasan et al. (Jan. 16 issue)1,2 report contamination associated with a defect in bronchoscopes in the United States. A similar event occurred in Lyons, France, during the same period. From March 5, 2001, to October 19, 2001, 117 instances of contamination of bronchoalveolar-lavage specimens with Enterobacteriaceae were identified among 418 patients during three outbreaks of infection.

Only patients examined with two identified bronchoscopes (bronchoscopes A and B in Figure 1Figure 1Bronchoscopic Procedures Performed during Weeks 10 through 23 of an Outbreak in Lyons, France, in 2001, According to the Bronchoscope Used.) were contaminated. During the first outbreak, each pair of microorganisms detected was associated with one of these bronchoscopes (Klebsiella pneumoniae and Proteus vulgaris with bronchoscope A in 63 of 64 cases and Morganella morganii and P. mirabilis with bronchoscope B in 23 of 25 cases). Isolates from contaminated bronchoalveolar-lavage specimens and bronchoscope A had similar patterns on pulsed-field gel electrophoresis. The outbreak stopped after the removal of the two implicated bronchoscopes from use. The source of contamination was a loose cap on the port of the biopsy channel of the bronchoscope.

Our findings underscore the necessity to test bronchoscopic samples regularly, to improve the design of bronchoscopes, and to implement surveillance. These outbreaks highlight the need for international exchanges to improve both the quality of care and patient safety.

Jean-Charles Cetre, M.D.
Helene Salord, D.Pharm.
Hôpital Croix-Rolusse, 69317 Lyons CEDEX 04, France

Philippe Vanhems, M.D., Ph.D.
Hôpital Edouard Herriot, 69437 Lyons CEDEX 03, France

2 References

1. 1

   Kirschke DL, Jones TF, Craig AS, et al. Pseudomonas aeruginosa and Serratia marcescens contamination associated with a manufacturing defect in bronchoscopes. N Engl J Med 2003;348:214-220
   Full Text | Web of Science | Medline

2. 2

   Srinivasan A, Wolfenden LL, Song X, et al. An outbreak of Pseudomonas aeruginosa infections associated with flexible bronchoscopes. N Engl J Med 2003;348:221-227
   Full Text | Web of Science | Medline

Author/Editor Response

Cetre et al. report the third outbreak attributed to loose biopsy ports on bronchoscopes. That these outbreaks occurred in widespread settings over a period of nearly 11 months and potentially affected more than 800 patients underscores the importance of recall procedures for medical devices. In their Perspective in the same issue of the Journal, Feigal et al.1 indicate that all recalls involving “high-risk” problems are monitored by the Food and Drug Administration (FDA). However, they do not indicate whether the FDA considered the defective bronchoscopes to pose a high risk or whether the FDA was monitoring the recall. It seems that a recall of bronchoscopes related to specimen contamination and possible nosocomial infections would be classified as involving a high-risk problem, yet this was a voluntary recall by the manufacturer with no official notice from the FDA. We believe the experience with the bronchoscope recall merits a reexamination of procedures for the recall of medical devices. We encourage the FDA, the medical community, and industry to work together to optimize the management of medical-device recalls.

Arjun Srinivasan, M.D.
Trish M. Perl, M.D.
Johns Hopkins Medical Institutions, Baltimore, MD 21287

William Schaffner, M.D.
Vanderbilt University School of Medicine, Nashville, TN 37232

Timothy F. Jones, M.D.
Tennessee Department of Health, Nashville, TN 37247

1 References

1. 1

   Feigal DW, Gardner SN, McClellan M. Ensuring safe and effective medical devices. N Engl J Med 2003;348:191-192
   Full Text | Web of Science | Medline

Citing Articles (5)

Citing Articles

1. 1

   M. S. Bojer, K. A. Krogfelt, C. Struve. (2011) The newly discovered ClpK protein strongly promotes survival of Klebsiella pneumoniae biofilm subjected to heat shock. Journal of Medical Microbiology 60:10, 1559-1561
   CrossRef

2. 2

   Jesús Molina-Cabrillana, Juan Carlos Rodríguez-Bermejo, Cristóbal del Rosario-Quintana, Margarita Bolaños-Rivero. (2007) Rápida detección de un brote de colonización por Serratia marcescens asociado a broncoscopias. Enfermedades Infecciosas y Microbiología Clínica 25:3, 222-224
   CrossRef

3. 3

   William A. Rutala, David J. Weber. (2007) How to Assess Risk of Disease Transmission to Patients When There Is a Failure to Follow Recommended Disinfection and Sterilization Guidelines • . Infection Control and Hospital Epidemiology 28:2, 146-155
   CrossRef

4. 4

   J.-C. Cêtre, M.-C. Nicolle, H. Salord, M. Pérol, S. Tigaud, G. David, M. Bourjault, P. Vanhems. (2005) Outbreaks of contaminated broncho-alveolar lavage related to intrinsically defective bronchoscopes. Journal of Hospital Infection 61:1, 39-45
   CrossRef

5. 5

   W. A. Rutala, D. J. Weber. (2004) Disinfection and Sterilization in Health Care Facilities: What Clinicians Need to Know. Clinical Infectious Diseases 39:5, 702-709
   CrossRef