Duodenoscope Superbug Cases May Be Due to Human Factors, Panel Says

May 15, 2015

Panelists and stakeholders at an FDA advisory panel meeting on infectious outbreaks linked to improperly cleaned endoscopes struggled to find ways to enhance device safety while staying within the limits of FDA authority.

The Gastroenterology and Urology Devices Panel met Thursday and Friday to discuss possible ways to improve the safety of duodenoscopes, which have been tied to ongoing outbreaks of antibiotic-resistant bacteria. The agency issued final guidance tightening device reprocessing rules in March after at least 135 cases of suspected superbug transmission were reported between January 2013 and the end of last year (IDDM, March 13).

Most of last week’s discussion focused on the need for proper cleaning and sterilization, rather than just disinfecting the devices, to kill bacteria causing the infections. FDA chemist Elaine Mayhall noted that ethylene oxide sterilization, which kills at least 12 types of bacteria, is used on other hospital equipment and has never been associated with a superbug outbreak.

Kenneth McQuaid, with the Veterans Affairs Medical Center in San Francisco, suggested that the FDA conduct a review of hospitals’ duodenoscope cleaning policies and training. Licensing technicians or requiring validation at the end of the cleaning process could help, he said.

While that might help, Benjamin Fisher, director of CDRH’s Division of Reproductive, Gastro-Renal and Urological Devices, pointed out that the FDA has no authority to regulate hospitals and can’t dictate how technicians should be trained to reprocess equipment.

Eight patients became infected and three died at UCLA Ronald Reagan Medical Center in Los Angeles earlier this year. — Elizabeth Orr