The Scope That Couldn't Be Cleaned

Between 2013 and 2015, outbreaks of drug-resistant 'superbug' (CRE) infections were traced to duodenoscopes — flexible endoscopes used in bile-duct procedures. The movable 'elevator' mechanism at the scope's tip contains microscopic crevices that can trap tissue and bacteria, and effective cleaning could be impossible even when the manufacturer's reprocessing instructions were followed exactly.

FDA issued a safety communication in 2015 warning that the device design could impede cleaning, ordered postmarket surveillance of all three US duodenoscope makers, and the case reshaped endoscope reprocessing. At one center, up to 179 patients were notified of possible exposure. (FDA Safety Communication, 2015.)

1. A duodenoscope is used, then reprocessed per the manufacturer's cleaning instructions.
2. The elevator channel's crevices retain biological debris that brushing and disinfection cannot fully reach.
3. The scope passes visual and reprocessing checks and returns to service.
4. Resistant organisms carried in the channel transmit to the next patients.
5. The link surfaces only when a cluster of matching resistant infections is investigated.

A landmark outbreak cluster: at one US center, up to 179 patients were notified of possible CRE exposure, 2014–2015; further clusters occurred elsewhere. (FDA / center reporting)

Patient-to-patient transmission of drug-resistant infection; infections and deaths were reported in the clusters. Shown through the scope, the elevator channel, and the reprocessing sink — never the patient.