Put in place a comprehensive quality control program for reprocessing duodenoscopes, including “written procedures for monitoring training and adherence to the program, and documentation of equipment tests, processes, and quality monitors used during the reprocessing procedure.”

Follow all maker instructions for inspection, leak testing and maintenance.

Before using, closely inspect and don't use any scopes that show visible damage.

Test for leaks during reprocessing and pull any devices that do from use.

Return duodenoscopes to the the manufacturer at least once a year for servicing.

Make sure all involved are aware of previous FDA safety communications regarding the devices and the “supplemental duodenoscope reprocessing measures that can be implemented to reduce the risk of infection transmission, such as: microbiological culturing, sterilization, use of a liquid chemical sterilant processing system and repeat high-level disinfection.”

In March, the FDA issued warning letters to all three duodenoscope manufacturers after the trio failed to comply with postmarket reprocessing surveillance studies, which were required of scope makers Olympus, Fujifilm and Pentax in 2015, when failures in reprocessing caused bacterial contamination that made some patients sick and led to the death of others.

A spokesman from Olympus stated at the time that the issue was taken "extremely seriously, and we intend to comply and provide the requested information." And a Pentax Medical representative said it "intends to cooperate fully with FDA to meet this request."

The endoscopic retrograde cholangiopancreatography (ERCP) procedure uses the scope – and exposed 179 patients at UCLA to deadly bacteria, with two deaths confirmed and seven other patients infected. In the UCLA case, scope cleaning followed maker guidelines, but the process failed to kill the bacteria, according to reports at the time.

In March, 2016, ECRI held a webinar about the problem. 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.

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