Duodenoscope Culture Positive During an ERCP Cluster
At a 240-bed community hospital, the endoscopy suite performs about 12 ERCPs per week. Over six weeks, four patients who underwent ERCP with the same duodenoscope develop carbapenem-resistant Enterobacteriaceae (CRE) bacteremia; two have positive blood cultures and one has a liver abscess. The scope has a fixed elevator and is reprocessed in an automated endoscope reprocessor using ortho-phthalaldehyde (OPA) with a 12-minute high-level disinfection cycle and a 7-day hang time. Staff report using a reusable 3-mm elevator brush until it frays; the current brush is visibly worn. The scope is stored coiled in a closed cabinet without active drying. The infection preventionist learns that the scope was cultured after the third case; the culture grew CRE from the elevator area, but the result arrived after the scope had been returned to service following a repeat high-level disinfection. The unit has no written policy for duodenoscope surveillance culture or for quarantining a scope with a positive culture. The gastroenterology chief asks whether all exposed patients should be notified and whether the scope can remain in use.
1. The gastroenterology chief asks whether the duodenoscope can remain in use and whether all exposed patients should be notified. What should the infection preventionist and endoscopy manager decide, and in what order should they act?
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Decision: remove the duodenoscope from service immediately and quarantine it. A positive elevator culture after reprocessing is evidence of persistent biofilm or a reprocessing failure; repeating high-level disinfection and returning the scope to service is not acceptable without remediation and verification. Use an alternative scope or refer ERCP patients until the scope is cleared.
Order of action: (1) stop use and label the scope as contaminated; (2) notify infection prevention, risk management, and hospital leadership; (3) retrieve reprocessing and culture records and identify every patient exposed since the last documented negative culture, not only the four confirmed cases; (4) notify the state or local health department and file an FDA MedWatch report as appropriate; (5) begin patient notification with clinician input, because CRE bacteremia after ERCP is a serious exposure and patients need assessment and culture guidance; (6) culture the scope, the automated endoscope reprocessor, water supply, and brushes, and review reprocessing logs.
Do not wait for a repeat culture before notifying patients. The positive elevator culture plus the cluster is enough to act. The scope should be remediated per the manufacturer's instructions, including service if required, and released only after negative cultures and a validated reprocessing process. Document each decision and the rationale.
2. Which reprocessing and storage deviations most likely contributed to the outbreak, and what changes must be in place before ERCP resumes?
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The strongest contributors are the worn reusable elevator brush, the absence of an effective drying step, the 7-day hang time, and the lack of surveillance culture and quarantine. The duodenoscope elevator is a recessed, hinged area that is difficult to clean; a frayed brush cannot reliably remove biofilm, and biofilm protects organisms from OPA. Storing the scope coiled in a closed cabinet without active drying traps residual moisture and promotes microbial growth. A 7-day hang time must be supported by the manufacturer's validated instructions; it should not be assumed.
Before ERCP resumes, require: single-use or properly inspected and sized elevator brushes; documented cleaning verification, including visual inspection of the elevator with magnification and a light; use of the manufacturer's specified HLD contact time and temperature; forced-air drying and vertical storage per instructions for use; a hang-time policy based on the manufacturer's validation; duodenoscope surveillance culture with quarantine until negative; competency validation for all reprocessing staff; and audit of every step. Also review the automated endoscope reprocessor for channel connectivity and detergent concentration. The plan should specify who clears the scope for reuse and how exceptions are handled.
3. What documentation should be assembled for the exposure investigation and regulatory reporting?
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Assemble a line list with patient identifiers, procedure dates, endoscopist, scope serial number, and culture results. Include the scope's reprocessing records for each procedure: manual cleaning steps, brush type and condition, detergent concentration, HLD exposure time and temperature, drying, storage location, and hang time. Include the culture reports and the dates the scope was returned to service. Add staff training and competency records, the manufacturer's instructions for use, the automated endoscope reprocessor maintenance and water-quality records, and the current policies for surveillance culture, quarantine, and patient notification. Document the cluster investigation meetings, decisions, and communications with the health department and FDA. For patient notification, retain copies of letters, call logs, and clinician communications. For regulatory reporting, keep the exposure investigation timeline and corrective action plan. The documentation should show that the facility identified the risk, removed the device, notified patients and authorities, and implemented controls. Avoid altering original records; use addenda if corrections are needed.