8 S U P P L E M E N T T O O U T P A T I E N T S U R G E R Y M A G A Z I N E M A Y 2 0 1 5
other option for treating complicated obstructions in the bile duct that duodeno-
scopes can remove.
Of the estimated 1 million ERCPs that have been performed over the past 2
years, 150 patients have been infected and less than a dozen have died, says
John Allen, MD, MBA, AGAF, president of the AGA and clinical chief of diges-
tive diseases at Yale University in New Haven, Conn.
"Infection risk is quite low," he adds. "It's unbelievably impactful when it
happens, but the risks of perforation and bleeding are much, much higher.
That's something people have to keep in mind."
Don't assume the UCLA outbreak stimulated real action, warns Bret T.
Petersen, MD, a councilor with the ASGE and a professor of medicine at the
Mayo Clinic in Rochester, Minn. He says the Morbidity and Mortality Weekly
Report (MMWR) published in January 2013 about the outbreak outside of
Chicago sparked significant activity at the CDC and the FDA. He also claims the
FDA conferred with the device manufacturers in early 2014, if not earlier, to
address issues surrounding the outbreaks. The CDC has been conducting con-
ference calls and gathering input from multiple nursing, infectious disease and
hospital epidemiology organizations as well as GI specialty groups since
February 2014, immediately after the MMWR report was published, according to
Dr. Petersen.
"Behind-the-scenes efforts have been ongoing that haven't been announced to
the public or media, but it hasn't been a situation of inaction by any of these
experts," he says.
"When people die, you could always argue that the response wasn't quick
enough," says Dr. Allen, who expects the FDA to release updated cleaning rec-
ommendations for all duodenoscopes in the coming months. "I wish we acted
sooner, but realistically people reacted pretty quickly."
Dr. Petersen believes the FDA has been put in a tough spot. "The benefit of
using these scopes on very sick patients far outweighs the risks, so the FDA
realizes it would be inappropriate to pull the instruments from the market," he
