FDA Orders Studies on Contaminated Duodenoscopes

Share this content:
FDA Orders Studies on Contaminated Duodenoscopes
FDA Orders Studies on Contaminated Duodenoscopes

MONDAY, Oct. 5, 2015 (HealthDay News) -- Recent outbreaks of infections linked to duodenoscopes led the U.S. Food and Drug Administration on Monday to order manufacturers to conduct postmarket studies of the devices in health care facilities.

The FDA has been working with the three manufacturers of duodenoscopes to improve the safety of the devices, including reviewing the companies' cleaning instructions, looking at ways to improve the disinfection process, and considering design changes to make the scopes easier to clean. The findings from the postmarket surveillance studies may help identify additional ways to reduce risks associated with the scopes, such as new labeling with different cleaning/sterilization instructions or new regulations to protect patient safety, the FDA said in a news release.

"These studies will provide critical information about the effectiveness of current reprocessing instructions and practices that may provide additional information to inform the FDA's actions to protect the public health and help reduce the risk of infections," William Maisel, M.D., M.P.H., the deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, said in the news release.

The three companies that sell duodenoscopes in the United States -- Olympus America, Fujifilm Medical Systems USA, and Hoya Corp. (Pentax Life Care Division) -- have 30 days to submit postmarket surveillance plans to the FDA, the agency said. The plans must outline how the companies will conduct the studies in order to find out how well health care workers follow instructions to clean and disinfect the scopes between use in different patients, and to learn more about the rate of contamination associated with the devices.

More Information

Share this content:

is free, fast, and customized just for you!

Already a member?

Sign In Now »


Sign up for myCME e-newsletters


Drug Lookup

Browse drugs by: BrandGenericDisease


More in Home

Dermatography Helps Lessen Appearance of Surgical Scars

Dermatography Helps Lessen Appearance of Surgical Scars

Pigments can restore more natural skin appearance that patients are happy with

Drug-Resistant Bacteria Live in America's Water Systems

Drug-Resistant Bacteria Live in America's Water Systems

Bacteria found in plumbing may sicken thousands each year

Deep Brain Stimulation May Improve TBI Symptoms

Deep Brain Stimulation May Improve TBI Symptoms

Deep brain stimulation appears to boost function and quality of life

is free, fast, and customized just for you!

Already a member?

Sign In Now »