FDA orders duodenoscope makers to conduct studies on use

Last Updated: 2015-10-05

By Reuters Staff

(Reuters) - The U.S. Food and Drug Administration has ordered three Japanese manufacturers of duodenoscopes to conduct postmarket surveillance studies to better understand how the devices are reprocessed in real-world settings.

Olympus Corp, Fujifilm Holdings Corp and Pentax Medical, a unit of Hoya Corp, have been asked to submit postmarket surveillance plans within 30 days, the FDA said on Monday.(http://1.usa.gov/1LdYQcG)

"This is a significant step in the effort to combat infections spread through duodenoscopes. The FDA has undertaken an in-depth investigation into the factors that may play a role in infection transmission associated with duodenoscopes, and is now requiring manufacturers to study the devices in the clinical setting where they are being used," Dr. William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, said in an FDA 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," he added.

Duodenoscopes are used in endoscopic retrograde cholangiopancreatography (ERCP) procedures, often to drain fluids from blocked pancreatic and biliary ducts.

The FDA has evidence that duodenoscopes have contributed to the transmission of infections, including antibiotic resistant infections, to patients.

In August, the FDA asked health care facilities using duodenoscopes and other reusable medical devices to meticulously follow the manufacturers' cleaning instructions to avoid the spread of multidrug-resistant infections.

However, the complex design of the devices makes it difficult to remove contaminants compared to other types of endoscopes, the FDA said. And their analysis to date also indicates that manufacturer's reprocessing instructions are not always being followed correctly, as these instructions are labor intensive and prone to human error.