Duodenoscope Reprocessing Lapses and a Look-Back Decision

Yes - this is a high-level disinfection failure, and notification is warranted. The threshold is not 'we found infections'; it is 'we cannot demonstrate that high-level disinfection was achieved.' Here three independent indicators show that:

• MEC was not verified for 47 of 180 cycles, so the concentration of peracetic acid is unknown for those cycles.
• Cycle-abort alarms were overridden three times; a scope that did not complete a full cycle was used on a patient.
• Brushes were reused and stored damp, which compromises mechanical removal of biofilm and organic soil from the elevator mechanism - the exact site implicated in duodenoscope-associated transmission.
• Overdue AER maintenance adds a device-reliability question.

Which organisms matter: multidrug-resistant Enterobacterales, especially carbapenemase-producing E. coli and Klebsiella pneumoniae; Pseudomonas aeruginosa; and other resistant gram-negatives. The duodenoscope elevator is notoriously difficult to clean, and the literature on duodenoscope-associated outbreaks is dominated by CRE.

Who to notify: all 61 patients who underwent ERCP during the window, plus any patients whose scopes went through the three overridden cycles even if outside the window. Notify the state or local health department and risk management early - many jurisdictions have specific notification requirements, and health departments can advise on screening strategy. Do not wait for a positive culture to notify.

Immediately (within 24 hours):

1. Remove affected duodenoscopes and the AER from service until requalified. Arrange alternative capacity - borrow scopes, refer procedures, or use a documented culture-and-quarantine process if available.
2. Switch to single-use or disposable elevator components where the platform allows.
3. Switch to single-use channel brushes; discard damp-stored brushes.
4. Re-verify competency for every technician who reprocesses scopes, with direct observation of pre-cleaning at the bedside, manual channel brushing, and AER loading.
5. Reinstate mandatory MEC documentation and a hard stop on alarm overrides - an aborted cycle means the scope is contaminated and must be fully reprocessed from manual cleaning.
6. Complete AER preventive maintenance and verify the peracetic acid delivery and temperature.

Root cause analysis structured around failure modes rather than blame:

• Policy: is there a written rule that aborted cycles cannot be overridden, and does it name who has authority?
• Equipment: is the AER reliable? How often does it alarm, and what did staff do previously?
• Environment: are brushes and supplies stocked so reuse is unnecessary? Is there space for proper drying and vertical storage?
• People: was the technician trained, and does the staffing ratio allow the required reprocessing time at end of day?
• Verification: what monitoring existed that should have caught 47 undocumented cycles sooner? Why did the audit catch it and not routine supervision?

Fix verification first - the failure that let this run for 10 weeks is the missing audit, and it will recur otherwise.

Testing: offer screening to all exposed patients, free of charge, using a rectal swab or stool culture for carbapenem-resistant Enterobacterales, with additional culture for extended-spectrum beta-lactamase producers and P. aeruginosa if the laboratory supports it. Some programs also screen for vancomycin-resistant enterococci. Timing is imperfect - colonization may have cleared by the time of testing - so a negative result does not fully reassure, and patients with interval infections should be evaluated regardless. Do not offer serology; it is not validated for this purpose.

Operational detail:

• Send a letter from the chief medical officer and a plain-language FAQ, with a phone line staffed by clinical personnel, not a general switchboard.
• Notify each patient's primary care provider in writing, with the recommended screening test and an explanation that a positive result means colonization, not necessarily infection.
• Give patients a specific appointment or kit, not an instruction to 'contact your doctor.'
• Track return of results; report aggregate findings to the health department.
• For patients who screen positive: contact precautions on future admissions, flag the record, and explain the implications for future surgery or screening.

Provider and staff communication: brief the endoscopy team and the hospitalist group before letters go out, so they are not blindsided by calls. Prepare a single script. Coordinate all external statements with risk management and public health, and keep a documented log of who was notified, when, and by what method.