Updated preliminary results from studies to better understand how duodenoscopes are reprocessed in real-world settings continue to show higher than expected contamination rates after reprocessing, the Food and Drug Administration announced today. The agency reminded health care facilities that reprocess duodenoscopes about the importance of strictly adhering to the manufacturer’s reprocessing and maintenance instructions, following best practices and reporting adverse event information to FDA. In 2015, FDA issued safety recommendations to prevent possible microbial infections from reprocessed reusable duodenoscopes – flexible, lighted tubes that are threaded through the mouth into the small intestine to drain fluids from blocked pancreatic and biliary ducts. The agency also ordered Olympus, Fujifilm and Pentax to conduct postmarket surveillance studies to determine whether health care facilities are able to properly clean and disinfect the devices, and has instructed the manufacturers to conduct root cause analyses. Final results from the analyses are expected later this year. In the meantime, the agency is exploring possible additional steps to reduce contamination rates. “I want to emphasize that an individual patient’s risk of acquiring infection from an inadequately reprocessed medical device remains relatively low given the large number of such devices in use,” said Jeff Shuren, M.D., director of the Center for Devices and Radiological Health.

Related News Articles

Headline
The Joint Commission yesterday recommended that health care organizations review cleaning and disinfection instructions for tonometers and other ophthalmology…
Headline
The Food and Drug Administration last week alerted health care providers and patients that batteries in certain Medtronic implantable pacemakers and cardiac…
Headline
The Food and Drug Administration today proposed reclassifying surgical staplers for internal use as moderate-risk rather than low-risk medical devices.
Headline
The Food and Drug Administration today ordered manufacturers to immediately stop selling and distributing surgical mesh products for transvaginal repair of…
Headline
The Food and Drug Administration Friday warned physicians and patients who use medical devices to monitor levels of the blood thinner warfarin that certain…
Headline
The Food and Drug Administration today issued draft guidance describing the premarket studies that manufacturers should conduct for blood glucose monitoring…