FDA approves Olympus duodenoscope modifications

A Senate investigation has found that numerous patients in the United States were needlessly subjected to potentially deadly infections through the use of a device that allows doctors to view the inside of the small intestine – a risk investigators say was largely created by insufficient federal oversight and failures attributed to the device’s manufacturers and medical facilities. The recall will affect about 4,400 scopes at USA healthcare centers and will be carried out by August 2016, the FDA said. Last March, soon after the news of the contaminated scopes broke, FDA officials also faulted the manufacturers’ testing process for recommended cleaning procedures.

Duodenoscopes are used for endoscopic retrograde cholangiopancreatography procedures, in which the tube-like camera instruments are inserted into the throats of patients for a variety of different treatments, such as draining fluids from pancreative and biliary ducts blocked by tumors or gallstones.

“We have made it a top priority to improve the safety of duodenoscopes and help protect patients from bacterial infections associated with these medical devices”.

The FDA today granted 510(k) clearance of design and labeling modifications to the Olympus TJF-Q180V duodenoscope aimed at reducing bacterial infection risks, according to an FDA news release. At the University of California, Los Angeles Health System, duodenoscope-linked infections were connected to the deaths of two people and infections in nine others. Earlier this week, a group of senators pointed fingers at the FDA and Olympus for sweeping problems with the products under the rug, even as superbug outbreaks continued to proliferate. Patty Murray (D-Wash.), who initiated the investigation after dozens of patients were sickened at a Seattle hospital.

Olympus is just one of several duodenoscope manufacturers linked to bacteria transfers.

The FDA said it never recalled the scopes because no other device is available to perform ERCTs. The committee also said Congress should mandate unique medical device identifiers in insurance claims, electronic health records, and device registries, the AP reported.

Another recommendation submitted by the committee called for timely and routine reporting of incidents to be a requirement for hospitals to participate in Medicare.