The Scope of The Bacterial Infection Problem

Recently, the UCLA Ronald Reagan Medical Center in Los Angeles notified nearly 200 patients who had been in the hospital between October 2014 and January 2015 that the endoscopy procedure they had undergone may have exposed them to a drug-resistant bacterial infection — Carbapenem-resistant Enterobacteriaceae, or CRE, an extremely dangerous “superbug.” CRE kills up to half of those it infects. Seven UCLA patients came down with the nightmare infection and two have died.

On the heels of this revelation, a hospital in Charlotte, North Carolina, announced that it had had five cases of scope-related bacterial infections in recent months, and two people died.

What’s the scope of the problem?

There are many types of endoscopes, flexible lighted tubes threaded through a natural body opening or a small incision, which help examine and treat internal conditions. In a colonoscopy (everyone’s favorite diagnostic procedure), a scope views the inside of the large intestine and rectum. In a bronchoscopy, a scope is used to look in the airways and lungs.

The recent CRE outbreaks are related to a particular type of scope (a duodenoscope) used for a procedure known as ERCP — endoscopic retrograde cholangiopancreatography. In ERCP, the duodenoscope is used to inject a contrast dye into the bile and pancreatic ducts so that X-rays will reveal blockages, tumors, gallstones and other problems. The design of these particular endoscopes make them difficult to sterilize, so one patient’s bacterial infection can get passed on to another.

Sources estimate that more than 500,000 ERCP procedures are performed in the U.S. each year. While the FDA cautions that only a small percentage of these patients are likely to be victims of CRE spread through unclean scopes, the deadly nature of this particular bacteria has many people worried.

FDA Warning

A Safety Communication issued by the FDA on February 19 warns:

[A] recent FDA engineering assessment and a growing body of literature have identified design issues in duodenoscopes that complicate reprocessing of these devices. For example, one step of the manual cleaning instructions in device labeling is to brush the elevator area. However, the moving parts of the elevator mechanism contain microscopic crevices that may not be reached with a brush. Residual body fluids and organic debris may remain in these crevices after cleaning and disinfection. If these fluids contain microbial contamination, subsequent patients may be exposed to serious infections.

From January 2013 through December 2014, the agency received reports of 135 patients in the U.S. who may have been infected by “reprocessed” (or reused) duodenoscopes.

What Can Be Done?

Rep. Ted Lieu of California is asking Congress to investigate the recent CRE deaths and what can be done to protect patients from further outbreaks.

One of the UCLA victims has filed suit against Olympus Corporation, the manufacturer of the endoscope used in his procedure. It alleges defective design. The plaintiff reportedly is also considering suing the medical center for negligence in the methods they used to sterilize the reusable scope.

Doctors caution that duodenoscopes save many more lives than they harm. That being said, they have a duty to warn patients of the potential risks of ERCP endoscopies, the manufacturers have a duty to design the devices in such a fashion that they may be completely and effectively cleaned after use, and hospitals have a duty to adopt stringent reprocessing protocols to prevent the transmission of bacterial infections between patients.