Three Companies Ordered to Further Examine Duodenoscopes by FDA
Olympus America, Fujifilm Medical Systems and Pentax’s Hoya unit had to submit postmarket surveillance studies to the FDA detailing how their duodenoscopes are reprocessed in healthcare facilities.
Duodenoscopes have come under scrutiny after being linked to antibiotic-resistant infections in Chicago, Pittsburgh, Seattle and Los Angeles, some of which resulted in death. Earlier this year, the FDA revealed that from January 2013 to December 2014 it received 75 adverse event reports involving about 135 patients suffering from carbapenem-resistant Enterobacteriaceae transmissions linked to the devices.
Contributing to the problem is the devices’ unique design, which includes small working parts and a moveable elevator mechanism with tiny crevices. The elevator is particularly difficult to clean and disinfect properly, the FDA has said.
William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, says the agency is looking into factors that play a role in the transmission of antibiotic-resistant infections associated with duodenoscopes. The studies are intended to provide information about the effectiveness of current reprocessing instructions.
To that end, the FDA has asked the manufacturers to design studies that answer the following:
- Are user materials, such as user manuals, brochures and quick reference guides sufficient to ensure adherence to the manufacturers’ reprocessing instructions?
- What percentage of clinically used duodenoscopes remains contaminated with viable microorganisms after being reprocessed according to the manufacturer’s instructions?
- What factors contribute to microbial contamination and what steps are necessary to adequately decontaminate the device?
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