Automatic endoscope reprocessors could fail
Federal health officials are warning hospital risk managers of a potentially dangerous problem in the surgery department — automated endoscope reprocessors (AERs) may fail to clean the scopes properly, leading to deadly infections in patients.
In a special alert directed to risk managers and others within the hospital system, the Centers for Disease Control and Prevention (CDC) in Atlanta and the Food and Drug Administration in Rockville, MD, say they have received reports of infections traced to faulty endoscope reprocessing. "Both agencies are concerned that endoscopes be properly prepared for patient contact," the alert says.
The warning was issued jointly by David Feigal Jr., MD, MPH , director of the Center for Devices and Radiological Health with the FDA, and James Hughes, MD, director of the National Center for Infectious Diseases at the CDC, in a recent publication titled "Bronchoscopy-related infections and pseudoinfections — New York, 1996 and 1998" (MMWR 1999; 48:557-560). In the special alert, the CDC reports apparent patient- to-patient transmission of infections following bronchoscopic procedures and says the bronchoscopes were inadequately reprocessed by AERs.
The investigation of the reported incidents revealed inconsistencies between the reprocessing instructions provided by the manufacturer of the bronchoscope and the manufacturer of the AER. Investigators also say bronchoscopes were reprocessed inadequately when inappropriate channel connectors were used with the AER.
The FDA’s Medical Device Reporting (MDR) program also has revealed that some staff are using AERs to reprocess endoscopes that should not be processed in AERs. "This practice may have resulted in damaged endoscopes and also raises questions about whether such processing results in an endoscope that is properly prepared for patient contact," the alert says.
The CDC and FDA recommend that risk managers ensure all staff who handle soiled endoscopes comply with the endoscope manufacturer’s instructions for cleaning them. "It is imperative that your staff flush all endoscopes immediately following the procedure. In addition, they should meticulously remove any debris or residuals collected in or on the endoscope, perform leak tests, and visually inspect the endoscope to ensure that it is in proper working order in accordance with the endoscope manufacturer’s recommendations," the alert says. "These steps are critical regardless of whether your facility manually reprocesses endoscopes or uses an AER."
The federal officials also recommend incor porating a final drying step in the reprocessing protocol whether you use manual or automated reprocessing. Studies have demonstrated that a final drying step that includes flushing all channels with alcohol followed by purging the channels with air (to remove the alcohol) greatly reduces the possibility of recontamination of the endoscope by waterborne microorganisms, they say.
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Questions regarding the advisory can be e-mailed to [email protected]; faxed to Marian Zellner at (301) 594-2968; or submitted in writing to Zellner at FDA, CDRH, Office of Surveillance and Biometrics at 1350 Piccard Drive, Mail Stop HFZ-510, Rockville, MD 20850. All of FDA’s medical device postmarket safety notifications can be found on the World Wide Web at http://www.fda.gov/cdrh/safety.html.
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