Superbug cases spur FDA warning on dirty medical scopes

WASHINGTON -- The Food and Drug Administration warned doctors and hospitals Thursday to use extra caution in disinfecting a hard-to-clean medical scope that has been linked to the spread of powerful "superbugs" in outbreaks across the country.

The agency said that even meticulous cleaning of the duodenoscopes, which are used on about 500,000 patients a year, may not entirely eliminate the risk. And it advised doctors and hospitals that it is studying possible solutions, including new disinfection protocols.

The FDA announcement followed a report from Ronald Reagan UCLA Medical Center that seven patients — including two who died — were infected with the superbug CRE in an outbreak tied to contaminated duodenescopes. The hospital said in a statement that as many as 179 patients who had undergone procedures using the scopes were potentially exposed to the bacteria from January 2013 to January 2014.

The UCLA cases are the latest of several CRE outbreaks nationwide that have been linked to duodenoscopes, which are used to treat gallstones, certain cancers and other disorders in the digestive system. USA TODAY first reported on the outbreaks in an investigation published last month, and other cases have come to light since.

CRE bacteria are formally known as Carbapenem-Resistant Enterobacteriaceae, reflecting their resistance to carbapenem antibiotics — the last line of defense in the medical toolbox. While it is possible that other infections also may be transmitted from contaminated duodenoscopes, CRE cases generate particular concern because of their risks -- fatality rates for patients with CRE infections can run as high as 40%-50%.

"Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it," the FDA said in its advisory. It noted that the agency is working with duodenoscope manufacturers "to identify the causes and risk factors for transmission of infectious agents and develop solutions to minimize patient exposure."

The scopes are used for a procedure called ERCP, or Endoscopic Retrograde Cholangiopancreatography, in which the devices are used with contrast dyes and X-rays to help doctors locate and treat blockages in the bile and pancreatic ducts. The scopes have "elevator" mechanisms at their tip that control tiny tools used to trim tissue or insert stents.

While there are surgical options for much of the work done in ERCP procedures, the duodenoscopes typically are considered the less invasive and less dangerous option.

Colleen Schmitt, a physician and president of the American Society for Gastrointestinal Endoscopy, says that ERCP remains a relatively safe procedure that generally carries lower risks of complications than surgery.

"Some of these patients (needing ERCP) are very sick and to take them into a surgical procedure could be risky," she says, noting that ERCP is "less invasive than surgical options."

Still, she says, more research is needed "so we can be sure we understand the scope of this (infection) problem," as well as the best strategies for minimizing risks to patients. In the meantime, she adds, the society is looking to raise awareness among doctors and hospitals on the need for special attention in cleaning duodenoscopes.

Lawrence Muscarella, a biomedical engineer and independent consultant who advises hospitals on endoscope safety, says more need to be done to advise patients of the risks so they can make informed decisions on their treatment options. He also called for better tracking of infections associated with contaminated duodenoscopes, noting that many outbreaks likely are going unreported.

The FDA says in its advisory that it is aware of 135 patients nationwide who may have contracted bacterial infections from contaminated endoscopes. However, the agency acknowledges that "it is possible that not all cases have been reported."

USA TODAY's investigation identified three CRE outbreaks linked to duodenoscopes -- in Pittsburgh, Chicago and Seattle. Another outbreak subsequently was reported in Philadelphia. In the UCLA case, like the others, fatalities of infected patients couldn't necessarily be linked directly to the CRE, because most of those patients had other conditions that also could have contributed to their deaths.

In the Seattle outbreak, which occurred in 2012 and was particularly large, 32 patients were diagnosed with CRE and seven died within 30 days -- a window health officials used in identifying potentially associated deaths. Another four patients who had the infection died later.