CRE Patient Will Sue Endocope Manufacturer

the Renal and Urology News take:

UCLA Medical Center identified two incompletely cleaned endoscopes as the source of carbapenem-resistant enterobacteriaceae (CRE) bacteria that sickened 7 patients and contributed to the death 2. The scope was used in numerous procedures between October and January. UCLA has notified 179 patients that they may have been exposed.  

Now, an 18-year-old patient will sue the endoscope’s manufacturer, Olympus, for providing inadequate instructions for cleaning the medical device, according to news reports. The teen spent 83 days in the hospital, most of the time in the ICU, as a result of CRE infection. CRE is resistant to antibiotics, which makes it especially difficult to treat.

The FDA has issued a safety notification suggesting design issues in duodenoscopes complicate their reuse. Instructions call for brushing the scope’s elevator area, but the moving parts of the elevator contain microscopic crevices that might not be reached, according to the FDA.  Residual body fluids and organic debris may be left behind and, if contaminated with bacteria, could lead to infection of the next patient.

The FDA advises meticulously cleaning the elevator mechanism and the recesses by hand, even when using an automated endoscope reprocessor (AER). Raising and lowering the elevator throughout the cleaning process will help, although it is not entirely failsafe.