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FDA Orders Duodenoscope Makers To Conduct Postmarket Surveillance Studies in Healthcare Facilities

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The U.S. Food and Drug Administration (FDA) ordered three Japanese manufacturers of duodenoscopes marketed in the United States to conduct postmarket studies to evaluate how the devices work and to prevent them from transmitting infections.

Duodenoscopes are flexible and lighted tubes used in over 5,000 procedures each year in the country to drain fluids from pancreatic bile ducts blocked by tumors, gallstones, and other medical issues. They are considered key in illness detection and treatment in the least invasive way.

 According to an FDA release, Olympus America, Fujifilm Medical Systems, and Pentax Medical (a division of Hoya Corp) are given 30 days to submit their postmarket surveillance plans to the agency, detailing the quality of cleaning and disinfection of duodenoscopes between patients and how health care personnel understand the rate and threat of contamination via these tools.

Dr. William Maisel, Center for Devices and Radiological Health director for science and chief scientist at the FDA, deems this directive “a significant step” toward combating spread of infections via duodenoscopes.

Manufacturers are now also required by the FDA to study the devices in clinical settings.

The FDA has cited evidence of duodenoscopes contributing to spread of infections, such as antibiotic-resistant ones, among patients. Earlier this year, contaminated duodenoscopes contributed to two deaths and exposed more to a dangerous “superbug” at Ronald Reagan UCLA Medical Center in Los Angeles, California.

Cedars-Sinai Medical Center in LA also documented four patients infected by a superbug after they underwent a duodenoscope procedure. Similar cases have been reported in other hospitals, including those in Illinois and Washington.

While a procedure called reprocessing cleans and disinfects these medical devices, duodenoscopes have a complex design that make it more difficult to remove contaminants compared to other endoscope types.

Reprocessing guidelines from manufacturers are not always being accurately followed because they are labor-intensive and prone to human error, added the FDA.

Representatives from the three manufacturers have spoken about the FDA order. A spokesman from Olympus, the biggest maker of the device, said their company takes the matter “extremely seriously” and that they intend to comply with the order and provide the needed information.

Photo: Yuya Tamai | Flickr

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