FDA Cites ‘Complex Design’ of Scope in Safety Advisory


Posted February 23, 2015

The U.S. Food and Drug Administration (FDA) is urging healthcare facilities to be vigilant in cleaning a certain type of endoscope, known as a duodenoscope, that has been linked to the spread of a deadly type of bacteria in facilities nationwide.

The problem, according to an agency safety communication, is that the “complex design” of duodenoscopes makes it very hard to clean. “Some parts of the scope may be extremely difficult to access, and effective cleaning of all areas of the duodenoscope may not be possible,” says the FDA.

In fact, the agency say that it has received 75 reports—involving approximately 135 patients—of CRE bacteria infections linked to reprocessed duodenoscopes between January 2013 and December 2014. “It is possible that not all cases have been reported to the FDA,” the Feb. 19 advisory notes. As part of the safety communication, the FDA is urging all healthcare facilities to report problems with reprocessing the device to the manufacturer and the agency.

Infections have been reported in facilities in Chicago, Pittsburgh, Seattle, and Los Angeles.  “Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it,” the agency says.

The duodenoscopes, which are flexible, lighted tubes that thread through the mouth and throat and into the top of the small intestine, have a hollow channel that allows for the injection of contrast dye or insertion of instruments to obtain tissue samples.  These devices include a movable elevator mechanism. It is this area where residual body fluids and debris—potentially infectious—can remain after cleaning and disinfection.

To help prevent future infections, the FDA is recommending that facilities closely follow manufacturer instructions for cleaning and processing. In addition, reprocessing professionals should clean the elevator mechanism by hand, even when using an automated endoscope reprocessor. Facilities also should develop a comprehensive quality control program that documents equipment tests, processes, and quality monitors used in the reprocessing procedure.

The agency’s warning came one day after the Ronald Reagan Medical Center at the University of California Los Angeles (UCLA) alerted 179 patients that they may have been exposed to CRE.  The facility has notified seven patients that they were infected. The infection was a contributing factor in the deaths of two patients.

In a statement, UCLA said it followed both national guidelines and the sterilization standards offered by Olympus Medical Systems Group, the instrument’s manufacturer. Despite these precautions, a hospital investigation in late January determined that CRE may have been transmitted by two of the seven Olympus scopes used between Oct. 3, 2014 and Jan. 28. These scopes have been taken out of service and returned to the company.

In its safety communication, the FDA strongly suggests that it may be taking additional steps to address the problem, saying it is working with other government agencies, such as the Centers for Disease Control, and device manufacturers on what can be done “to minimize patient exposure.”

AAMI has a number of resources, including standards, dedicated to reprocessing.