The Case of the Dirty Duodenoscope. Unhygienic scopes infected 250 patients, the majority of them in the United States, a new Senate committee report released this week showed. Medical professionals using unsanitary duodenoscopes – a fiberoptic, endoscopic instrument inserted into a patient’s mouth in order to study the initial, duodenum segment of the small intestine – sickened individuals with life-threatening “superbug” infections.
Writes The Science Times on Jan. 14: “A report commissioned by Sen. Patty Murray, a committee’s ranking member of the Senate Commission on Health, Education, Labor, and Pensions, revealed a staggering number of 250 new cases of scope related infections following the group’s yearlong investigation on antibiotic-resistant infection linked to medical devices.”
The study, which examined incidents of illness between 2012 and early 2015, linked patient infections with the specialized medical devices used in their diagnoses. Senator Murray sanctioned the study following a superbug outbreak of antibiotic-resistant infections at the Virginia Mason Medical Center in Seattle. In 2013, close to three dozen patients contracted the infections. Eleven of them died.
In October of last year, the Food and Drug Administration issued a press announcement warning that three major manufacturers of duodenoscopes marketed in the U.S. were “reprocessing” the devices. The FDA ordered the companies to “conduct postmarket surveillance studies” to better understand how well health care personnel are “following instructions to clean and disinfect duodenoscopes between patients and to better understand the rate of contamination of clinically used duodenoscopes.”
Dr. William Maisel, the deputy director for science and the chief scientist at the FDA’s Center for Devices and Radiological Health, said at the time: “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.”
The Senate report revealed however that even those scopes that were cleaned and disinfected according to manufacturers’ guidelines still contained traces of dangerous bacteria. Huntington Memorial Hospital in Pasadena, California, was cited as one of the facilities that failed to clean their scopes, resulting in individuals contracting infections. Fifteen other hospitals in the U.S. were found culpable as well.
“Patients should be able to trust that the devices they need for treatment are safe and effective,” Sen. Murray said.
Adds the HuffPost: “The report recommends a number of legislative and regulatory changes. It urges Congress to require that unique device identifiers be included in insurance claims, electronic health records and device registries. It says the FDA should evaluate whether design modifications are needed and if so, require manufacturers to implement repairs through a phased recall.”
One of the manufacturers of the scopes, Olympus, which has an 85 percent share of the market on the duodenoscope, was accused of knowing back in 2013 that the scopes “could harbor dangerous bacteria, but didn’t warn U.S. hospitals until early 2015.” The company was also cited by the FDA for selling a scope that had not been approved by the FDA.
Olympus spokesman Mark Miller said in response to the recent study, “Although we do not agree with all of the report’s conclusions, we are closely reviewing the recommendations in the report as part of Olympus’ ongoing efforts to increase patient safety associated with use of Olympus duodenoscopes.”
FDA spokeswoman Deborah Kotz spoke of the Senate report, writing, “We appreciate the report from Sen. Murray and will carefully consider its recommendations, many of which FDA is already taking steps to address.”