FDA sends warning to duodenoscope manufacturers

The manufacturers have not fulfilled requirements to conduct studies assessing the real-world effectiveness of device reprocessing, the FDA said.


The FDA has issued warning letters to all three duodenoscope manufacturers for failing to fulfill requirements to conduct studies assessing the real-world effectiveness of device reprocessing, the agency announced on March 9.

The FDA in 2013 learned about a potential link between duodenoscopes and multidrug-resistant bacteria and later found that infections were occurring despite users' confirmed efforts to follow manufacturer instructions for cleaning, disinfection, and sterilization. In 2015, the agency ordered manufacturers Olympus, Fujifilm, and Pentax to conduct postmarket surveillance studies in order to determine the ability of health care facilities to properly clean and disinfect the devices.

To date, Olympus has not begun to collect data on cultures of reprocessed duodenoscopes that are in clinical use, and Pentax and Fujifilm have not provided sufficient data. Regarding studies of human factors to assess how well hospital staff are following reprocessing instructions, Fujifilm has met requirements whereas Olympus and Pentax have not complied, according to the FDA. The manufacturers are expected to submit plans that outline study milestones by March 24. If they fail to properly respond to the warning letter, the FDA may take additional punitive action.