According to the FDA, the endoscopic retrograde cholangiopancreatography (ERCP) procedure using the scope – about which the agency posted an updated alert Feb. 23, 2015 – exposed 179 patients at UCLA to deadly bacteria, with two deaths confirmed and seven other patients infected. In the UCLA case, the scopes were cleaned according to the company’s guidelines, but the process did not kill the aggressive bacteria, according to reports at the time.

And in March, 2016, ECRI conducted a webinar about the issue, which topped its “2016 Top 10 Health Technology Hazards” list at the time. In the three years prior to that report, the group noted that endoscope cleaning practices had killed 21 patients and sickened hundreds at U.S hospitals.

“It came as a surprise to those investigating contamination that (hospital) staffs doing the reprocessing were often following the manufacturers process to the letter,” Chris Lavanchy, engineering director at ECRI and one of the presenters told HCB News at the time.

Since then, the FDA has worked with all three duodenoscope makers selling scopes in the U.S. to improve processing instructions and ensure they are validated properly, according to the agency.

In February, 2018, the agency, along with the CDC and the American Society for Microbiology (ASM) released “voluntary standardized protocols for duodenoscope surveillance sampling and culturing.”

The agency says it expects Olympus, Fujifilm and Pentax to submit plans in late March that will lay out how the study milestones will be met.

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