SILVER SPRING, MD. – A Food and Drug Administration advisory panel unanimously agreed that duodenoscopes that are properly cleaned and disinfected based on current recommendations for reprocessing do not provide “reasonable assurance of safety and effectiveness,” at a meeting on May 15.
The Food and Drug Administration held a meeting of the agency’s gastroenterology and urology devices panel on May 14 and 15, to address recent concerns about duodenoscopes and several outbreaks in US hospitals of serious infections associated with these devices, used to perform endoscopic retrograde cholangiopancreatography (ERCP).
“Although the incidence of infections appears to be very low relative to the 500,000 to 600,000 cases of ERCP performed a year, there certainly have been infections traced to scopes despite apparent compliance with recommended guidelines for cleaning and disinfection,” said one of the panelists, Dr. Kenneth McQuaid, chief of gastroenterology, at the Veterans Affairs Medical Center, San Francisco.
More than two-thirds of the panel said that they should start to be sterilized, while others supported the continued use of high-level disinfection, which they believed worked well, if done properly. Most of the panel called for innovations in the design of duodenoscopes that make them easier to clean. However, none of the 16 panelists said that the risks of the duodenoscopes outweighed their benefits and should not be used. Halting the use of ERCP would be “catastrophic,” Dr McQuaid commented, noting that the infection risk is small and the benefits are “incredibly large.”
Other recommendations included ensuring the competency and proper training of the technicians involved in duodenoscope reprocessing and continuing to include manual cleaning of the devices, a step that was necessary, they said.
The panel did not officially vote on any of the questions.
In February 2015, the FDA issued safety alerts about the association with duodenoscopes and the transmission of multidrug-resistant bacterial infections in patients who had undergone ERCP procedures with duodenoscopes, despite proper cleaning and disinfection of the devices, pointing out to health care professionals that the “complex design” of duodenoscopes “may impede effective reprocessing. Reprocessing is defined by the FDA as “a detailed, multistep process to clean and disinfect or sterilize reusable devices.” In a March 4 update, the agency said that duodenoscope-associated infections had been reported for all three duodenoscope manufacturers in the United States, and on March 26, announced that Olympus had issued new manual reprocessing instructions for its TJF-Q180V duodenoscope, which had been associated with outbreaks, and was being marketed despite not having received clearance by the FDA for marketing (an application for clearance is now under review).
Among the other questions the panel was asked was what information about the risks of infection should be provided to patients before they undergo an ERCP. Dr. Karen Woods, a gastroenterologist at Baylor University, Houston, said that there should be a discussion with patients that there have been infections with highly resistant microorganisms associated with duodenoscopes. They should be informed if infections have occurred at the institution where they will undergo the procedure, and told what is being done about the problem, and this topic should be included in the written informed consent, she added.
From 2010 through 2014, 3,116,900 ERCP procedures were performed in the United States, including 668,800 in 2014, according to the FDA.
Duodenoscope manufacturers were invited to participate in the meeting but did not come, FDA officials said. The panelists had no disclosures related to the content of this meeting.
Any infections possibly related to duodenoscopes should be reported to the manufacturer and the FDA’s MedWatch program at 800-332-1088 or http://www.fda.gov/Safety/MedWatch/HowToReport/ucm2007306.htm.
*CORRECTION 5/17/2015: An earlier version of this story misstated the photo caption information.