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FDA issues safety alert on bronchoscopes

Accreditation Insider, October 27, 2015

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The FDA issued a safety alert in September around infections associated with reprocessed flexible bronchoscopes. Although the level of concern over infection-related illnesses from bronchoscopes is not as high as the level of concerns over inadequately reprocessed endoscopes, the goal of the alert is to encourage healthcare facilities to take preventive action to reduce the risk of infections to the patient.

Between January 2010 and June 2015, 109 medical device reports (MDR) were filed with the FDA regarding infections or device contamination associated with flexible bronchoscopes. It's important to note that in comparison to the number of procedures performed annually—approximately 500,000—this is a relatively low number of reports.

This is an excerpt from an article in the monthly training resource Briefings on The Joint Commission. To read more, click here to log in or subscribe.



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