The FDA and Centers for Disease Control and Prevention (CDC) have alerted hospital personnel and practitioners to incidents in which patients developed serious infections after being examined with bronchoscopes that apparently were inadequately reprocessed in an automated endoscope reprocessor (AER).
Investigation of the incidents by the CDC revealed inconsistencies between the reprocessing instructions of the bronchoscope manufacturer and the AER manufacturer and showed that some bronchoscopes were inadequately reprocessed because of the use of inappropriate channel connectors with the AER. The FDA has received reports that some people use AERs for endoscopes that should not be reprocessed in those devices.
For FDA's and CDC's recommendations to prevent transmittal of infections by endoscopes, see "Bronchoscopy-Related Infections and Pseudoinfections—New York, 1996 and 1998"(MMWR Morb Mortal Wkly Rep. 1999;48:557-560) and FDA's safety notifications at http://www.fda.gov/cdrh/safety/endoreprocess.html, or send questions (via e-mail) to phann@cdrh.fda.gov; (via fax) to Ms Zellner at (301) 594-2968; . . . [Full Text of this Article]
