FDA says duodenoscopes failed disinfection test, plans advisory committee hearing

Olympus TJF-Q180V Duodenoscope--Courtesy of Olympus Australia

Following an outbreak of a deadly antibiotic-resistant pathogen in Illinois linked to a type of endoscope known as a duodenoscope, the FDA tested the cleaning protocols of the device's manufacturers. Their disinfection systems failed. That means future patients undergoing duodenoscope procedures are at risk of picking up the deadly CRE bacteria too.

The Illinois outbreak occurred in early 2014, showing the agency's long-standing awareness of the problem. Efforts to tackle the issue, which has left dead patients in its wake, are only now gathering steam. Public awareness of the safety issue posed by contaminated duodenoscopes surged about a year later following another outbreak of CRE at UCLA's Ronald Reagan Medical Center in Los Angeles, which resulted in at least two deaths. But outbreaks of CRE linked to the devices have been documented going back as far as 1987.

Reuters broke news of the failed disinfection tests, citing FDA chief scientist Dr. Stephen Ostroff. The cleaning protocol is difficult to carry out, and insufficient even when it is, Ostroff told Reuters. He will become the FDA's acting commissioner when Margaret Hamburg retires in March.

Under guidance issued in 1996, duodenoscope disinfection is not reviewed. Following the Illinois outbreak, the agency said it would require future premarket submissions to include the test data. The FDA has not pulled any duodenoscopes from the market for fear of creating a shortage.

"The therapeutic benefits of ERCP outweigh the potential low risk of infection. The infectious complication rate for ERCP overall is in total only about 1 percent. That includes all types of bacteria and these CRE cases do not change the overall risk," said the American Gastroenterological Association in a Feb. 20 statement.

The traditional cleaning method involves brushing, rinsing and treating the scope with chemicals. But some hospitals are now using gas sterilization, including Virginia Mason Medical Center in Seattle (another affected hospital), at a cost of about $1 million.

In the FDA's latest move to take on the safety concerns, Ostroff said the FDA plans an advisory committee meeting of external experts to "to put all the available information on the table and have a discussion about it." The date has not been determined.

Olympus, Fujifilm Holdings and Pentax Medical manufacture duodenoscopes.

- read the article in Reuters

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