Physicians complete nearly 500,000 bronchoscopies each year in the United States, with the number and complexity of procedures on the rise.1 Bronchoscopy is usually safe;2 however, as with any medical procedure, it carries inherent risks, and a number of things can go wrong.
Whether used for diagnosis (e.g., lung disease, tumor, chronic cough, infection/inflammation) or treatment (remove a foreign body or clear mucus in the airway),3 the bronchoscopy procedure itself exposes patients to infrequent risks ranging from bleeding and tissue injury to collapsed lung.
Nonetheless, physicians should be aware of a more significant danger before initiating bronchoscopy: Reprocessed bronchoscopes, assumed to be sterile, can contaminate patients with hidden pathogens.
A Persistent Problem
In 2015, the U.S. Food and Drug Administration (FDA) included bronchoscopes among a set of devices that pose a greater likelihood of microbial transmission and represent a high risk of infection if not adequately reprocessed. The FDA warned that when flexible bronchoscopes are not meticulously cleaned and disinfected or sterilized to inactivate microorganisms, the devices can remain contaminated, potentially transmitting infection from one patient to the next.4
Some medical device reports investigated by the FDA found persistent contamination remained even after facilities followed manufacturers’ stringent reprocessing instructions.5
Additionally, damaged bronchoscopes present a potential source of infection. For example, among a cluster of 20 patients observed in 2007 at a 1,000-bed teaching hospital in Atlanta, 11 (55 percent) were exposed to a damaged bronchoscope and had a culture positive for Pseudomonas aeruginosa.6 In a separate 2001/2002 study at Johns Hopkins Hospital in Baltimore, the rate of isolation of P. aeruginosa from bronchoalveolar specimens was three times as high as the usual rate. Contamination appeared to be related to a loose biopsy-port cap on bronchoscopes, “which may have sheltered organisms and thus rendered disinfection procedures ineffective.”7
Other research demonstrates that automated bronchoscope disinfecting machines may become heavily contaminated with mycobacteria that resist usual disinfection, and, as a result, can be a source of bronchoscope contamination.8
What’s more, the FDA has noted “an evolution toward more complex, reusable medical device designs that are more difficult to reprocess” than previous designs.9
Single-use bronchoscopes provide a solution to the challenge of keeping devices clean and ready for use. Having a sterile, flexible bronchoscope immediately available in environments such as intensive care units ensures that patients receive the best possible care in the shortest timeframe. Hospitals should consider the benefits of guaranteed availability along with the reassurance that a disposable, single-use bronchoscope carries no risk of contamination.
That’s not to say, though, that single-use scopes may be re-used when treating a single patient. Researchers have shown that pathogenic bacteria consistently withstand standard bedside cleaning, particularly when there’s an extended time period between procedures on a single patient.10 Therefore, the safest course of action is to use an unopened bronchoscope for every procedure, even if just a single patient is being treated.
1. Pneumothorax after transbronchial needle biopsy. Journal of Thoracic Disease. http://jtd.amegroups.com/article/viewFile/3099/3613 Accessed Nov. 29. 2017.
2. National Heart, Lung, and Blood Institute. Bronchoscopy. https://www.nhlbi.nih.gov/health/health-topics/topics/bron Accessed Nov. 29, 2017.
3. Healthline. Why does a doctor order a bronchoscopy? https://www.healthline.com/health/bronchoscopy#uses Accessed Nov. 29, 2017.
4. U.S. Food and Drug Administration. Reprocessed flexible bronchoscopes: FDA safety communication — risk of infection. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm462979.htm Accessed December 19, 2017.
5. Med Device Online. FDA issues recommendations to reduce bronchoscope infection risk. https://www.meddeviceonline.com/doc/fda-issues-recommendations-to-reduce-bronchoscope-infection-risk-0001 Accessed December 19, 2017.
6. Outbreak of Pseudomonas aeruginosa infection associated with contamination of a flexible bronchoscope. Infection Control & Hospital Epidemiology. https://www.cambridge.org/core/journals/infection-control-and-hospital-epidemiology/article/outbreak-of-pseudomonas-aeruginosa-infection-associated-with-contamination-of-a-flexible-bronchoscope/A61B859A2380D7DC139C914362FE6713 Accessed December 21, 2017.
7. An outbreak of Pseudomonas aeruginosa infections associated with flexible bronchoscopes. New England Journal of Medicine. http://www.nejm.org/doi/full/10.1056/NEJMoa021808#t=article Accessed December 21, 2017.
8. Contamination of flexible fiberoptic bronchoscopes with Mycobacterium chelonae linked to an automated bronchoscope disinfection machine. American Review of Respiratory Disease. http://www.atsjournals.org/doi/abs/10.1164/ajrccm/145.4_Pt_1.853?journalCode=arrd Accessed December 21, 2017.
9. U.S. Food and Drug Administration. Reprocessing medical devices in health care settings. https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM253010.pdf Accessed December 19, 2017.
10. Beware the Trojan Horse — a timely reality check about re-using single-use devices. Journal of the Association of Anaesthetists of Great Britain and Ireland. http://onlinelibrary.wiley.com/doi/10.1111/anae.13523/abstract Accessed December 21, 2017.