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Correspondence |

Disposable vs Reusable Bronchoscope Valves FREE TO VIEW

Keith R. Nelson, BS
Author and Funding Information

Affiliations: Pentax Medical Company, Montvale, NJ,  Cleveland Clinic, Cleveland, OH,  Mayo Medical Center, Rochester, MN,  Beth Israel Deaconess Medical Center, Boston, MA,  Wake Forest University Medical Center, Winston Salem, NC,  Medical College of Virginia, Richmond, VA,  Vanderbilt Medical School, Nashville, TN,  Medical University of South Carolina, Charleston, SC

Correspondence to: Keith R. Nelson, BS, Director of Technical Service, Pentax Medical Company, 102 Chestnut Ridge Rd, Montvale, NJ 07645; e-mail: knelson@pentaxmedical.com



Chest. 2006;130(3):931-932. doi:10.1378/chest.130.3.931
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Published online

To the Editor:

Mehta et al should be congratulated for developing a much-needed American College of Chest Physicians/American Association for Bronchology (ACCP/AAB) consensus statement on preventing infections associated with flexible bronchoscopy, which recently appeared in CHEST (September 2005).1 However, at issue are specific ACCP/AAB recommendations to use only bronchoscopes that have “disposable suction valves and biopsy valves” and that “nonimmersible bronchoscopes and those with a reusable valve should be replaced as soon as possible.”1

These well-intentioned recommendations essentially contraindicate the use of many existing scope/valve designs, and end users may feel compelled to discard their current equipment utilizing reusable valves and seek replacement instruments utilizing only disposable valves. Pentax Medical Company believes these specific recommendations are unnecessary, financially imprudent, and without scientific basis or documented evidence.

In compliance with current regulations and guidance for reusable medical devices,23 manufacturers should provide microbiologically validated reprocessing instructions for cleaning and high-level disinfection (or sterilization) of the endoscope and reusable endoscope components (valves). Provided that manufacturer-validated instructions are supported by simulated-use studies and end users strictly adhere to these recommendations, reusable scope components (valves) should be an acceptable alternative to disposable components for semicritical devices, including bronchoscopes.

The reference4 to support the ACCP/AAB recommendation described a 1986 incident identifying one brand/design and involved a questionably inferior valve design unlike the valves of other manufacturers. Many years of experience has demonstrated that reusable valves, if reprocessed in strict accordance with the validated recommendations of the manufacturer, have not been reported to be vectors of infection.

While we recognize the potential for possible contamination of valves, we believe the same potential risks exist whenever any endoscopic instrument and/or scope component is not reprocessed in strict accordance with the validated instructions of the manufacturer. We hope that the ACCP/AAB can reconsider its current position and accept the use of reusable valves reprocessed by validated high-level disinfection or sterilization processes.

Mr. Nelson is the Director of Technical Services for Pentax Medical Company.

The authors have reported to the ACCP that no significant conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.

Mehta, A, Prakash, U (2005) American College of Chest Physicians and American Association for Bronchology consensus statement on prevention of flexible bronchoscopy-associated infection.Chest128,1742-1755. [CrossRef] [PubMed]
 
Association for the Advancement of Medical Instrumentation. Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: a guide for medical device manufacturers. December 23, 2004. Available at: www.aami.org/applications/search/details.cfm?webid=P890_D3703. Accessed February 28, 2006.
 
US Food and Drug Administration. Labeling reusable medical devices for reprocessing in health care facilities: FDA reviewer guidance. Office of Device Evaluation. April 1996. Available at: www.fda.gov/cdrh/ode/198.pdf. Accessed February 28, 2006.
 
Wheeler, PW, Lancaster, D, Kaiser, AB Bronchopulmonary cross-contamination and infection related to mycobacterial contamination of suction valves of bronchoscopes.J Infect Dis19879;159,954-958
 
To the Editor:

We thank Mr. Nelson for his interest in the consensus statement on the prevention of flexible bronchoscopy-associated infections (November 2005).1 We also appreciate Mr. Nelson’s concerns regarding the recommendation to replace flexible bronchoscopes equipped with reusable biopsy valves with flexible bronchoscopes equipped with the disposable valves.

A faulty valve design was deemed responsible for the outbreaks of “true” as well as “pseudo” infections related to flexible bronchoscope in a significant number of patients.23 These events prompted the development of the consensus. We recognize that several flexible bronchoscope manufacturers have introduced a number of flexible bronchoscope models, and that each of these models has suction and biopsy ports capped with valves of different designs. Therefore, it was beyond the scope of the consensus statement to review each of these valve designs and make specific comments. It was the decision of the committee to make the safest recommendation for using disposable valves. We agree with Mr. Nelson that if a manufacturer of the flexible bronchoscope can ensure the proper sterilization of a reusable valve each time, that should be acceptable.

The consensus statement “highly recommends” and does not mandate the practice or set a time limit. We believe that the financial burden of replacing expensive flexible bronchoscopes would strongly encourage strict adherence to the disinfection practices or the use of properly sterilized reusable valves. We once again stress that, due to the lack of adequate scientific evidence, this consensus statement was based on the opinions of experts.

References
Mehta, AC, Prakash, UBS, Garland, R, et al American College of Chest Physicians and American Association for Bronchology Consensus Statement: prevention of flexible bronchoscopy-associated infection.Chest2005;128,1742-1755. [CrossRef] [PubMed]
 
Kirschke, DL, Jones, TF, Craig, AS, et al Outbreak ofPseudomonas aeruginosaandSeratia marcescensassociated with a manufacturing defect in bronchoscope.N Engl J Med2003;348,214-220. [CrossRef] [PubMed]
 
Srinivasan, A, Wolfenden, LL, Song, X, et al An outbreak ofPseudomonas aeruginosainfections associated with flexible bronchoscopes.N Engl J Med2003;348,221-227. [CrossRef] [PubMed]
 

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Tables

References

Mehta, A, Prakash, U (2005) American College of Chest Physicians and American Association for Bronchology consensus statement on prevention of flexible bronchoscopy-associated infection.Chest128,1742-1755. [CrossRef] [PubMed]
 
Association for the Advancement of Medical Instrumentation. Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: a guide for medical device manufacturers. December 23, 2004. Available at: www.aami.org/applications/search/details.cfm?webid=P890_D3703. Accessed February 28, 2006.
 
US Food and Drug Administration. Labeling reusable medical devices for reprocessing in health care facilities: FDA reviewer guidance. Office of Device Evaluation. April 1996. Available at: www.fda.gov/cdrh/ode/198.pdf. Accessed February 28, 2006.
 
Wheeler, PW, Lancaster, D, Kaiser, AB Bronchopulmonary cross-contamination and infection related to mycobacterial contamination of suction valves of bronchoscopes.J Infect Dis19879;159,954-958
 
Mehta, AC, Prakash, UBS, Garland, R, et al American College of Chest Physicians and American Association for Bronchology Consensus Statement: prevention of flexible bronchoscopy-associated infection.Chest2005;128,1742-1755. [CrossRef] [PubMed]
 
Kirschke, DL, Jones, TF, Craig, AS, et al Outbreak ofPseudomonas aeruginosaandSeratia marcescensassociated with a manufacturing defect in bronchoscope.N Engl J Med2003;348,214-220. [CrossRef] [PubMed]
 
Srinivasan, A, Wolfenden, LL, Song, X, et al An outbreak ofPseudomonas aeruginosainfections associated with flexible bronchoscopes.N Engl J Med2003;348,221-227. [CrossRef] [PubMed]
 
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